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IMAI Takumi
University Hospital / Center for Clinical Research
Associate Professor

Researcher basic information

■ Research Keyword
  • Biostatistics
  • Clinical trials
  • Epidemiology

Research activity information

■ Paper
  • Tatsuya Nagano, Nobuyuki Yamamoto, Sae Shinomiya, Hiroshi Kato, Mariko Okamoto, Daisuke Hazama, Ryosuke Bo, Tomohiko Yamamura, Takumi Imai, Koji Fukuzawa, Takuya Funayama, Koji Kano, Naoko Katsurada
    Springer Science and Business Media LLC, May 2025, Scientific Reports, 15(1) (1)
    [Refereed]
    Scientific journal

  • Shunichi Doi, Atsushi Tanaka, Keisuke Kida, Takumi Imai, Yusuke Ueda, Yukiko Nakano, Yoshihisa Kizaki, Daiju Fukuda, Yuya Matsue, Yoshihiro J. Akashi, Koichi Node
    Elsevier BV, May 2025, Journal of Cardiac Failure
    [Refereed]
    Scientific journal

  • Ichiro Morioka, Yasumasa Kakei, Takumi Imai, Kazumichi Fujioka, Naoto Takahashi, Tetsushi Yoshikawa, Hiroyuki Moriuchi, Yoshinori Ito, Akira Oka
    OBJECTIVE: To evaluate the long-term hearing outcomes of infants with symptomatic congenital cytomegalovirus (CMV) disease who received 16 mg/kg of oral valganciclovir (VGCV) twice daily for six months. STUDY DESIGN: We have currently performed a long-term extension study of an investigator-initiated, single-arm, prospective, multicenter clinical trial, in which 24 infants were treated with VGCV. Hearing outcomes up to three years after treatment initiation were described and the longitudinal changes in the proportion of "Improved hearing" were analyzed using logistic regression. The factors associated with these outcomes were explored. Adverse events that occurred after the completion of the administration period were assessed. RESULTS: At 3 years, among 48 ears from 24 infants, the number of "improved hearing," which was 19 (40.0 %) ears at 6 months, increased to 27 (56.3 %) ears (p = 0.032). When including "maintaining normal hearing" or "maintaining normal hearing or the same degree of hearing impairment", the corresponding numbers were observed in 35 (72.9 %) and 45 (93.7 %) ears at 3 years, which were 25 (52.5 %) and 45 (93.7 %) ears at 6 months, respectively. Infants with milder hearing impairment at baseline showed high likelihood of hearing improvement (p for trend = 0.018 by the regression analysis). No adverse events were observed after completion of the administration period. CONCLUSION: Oral administration of VGCV demonstrated efficacy in improving hearing in infants with symptomatic congenital CMV disease at 3 years of age. These results suggest that the treatment response may be particularly favorable in patients with a lower initial degree of hearing impairment.
    Mar. 2025, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 177, 105778 - 105778, English, International magazine
    [Refereed]
    Scientific journal

  • Yasuo Imanishi, Takumi Imai, Hisako Fujii, Rei Aida, Yuki Nagata, Tetsuo Shoji, Shinichiro Kashiwagi, Tsutomu Takashima, Masanori Emoto
    Abstract Context Aromatase inhibitors (AIs) cause bone loss and increase fracture risk in women with hormone receptor-positive early-stage breast cancer (HR + EBC). Bone antiresorptive agents are recommended for patients at risk of fragility fractures. Eldecalcitol, combined with bisphosphonate, increases bone mineral density (BMD) in primary osteoporosis. Objective To determine the effect of eldecalcitol (0.75 ug/day) add-on therapy to risedronate (17.5 mg/week) on bone quantity and quality in women treated with AI. Design Open-label randomized control trial. Setting Postmenopausal women with HR + EBC (TNM stage 0-3A) treated with risedronate for more than 12 months. Patients Two hundred patients were enrolled; 196 patients were eligible for the full analysis set after excluding those without follow-up BMD data. Participants were advised to take vitamin D and calcium, yet many were vitamin D deficient or insufficient. Intervention Participants were randomly assigned in a 1:1 ratio to receive either eldecalcitol add-on therapy or risedronate monotherapy. Main Outcome Measure The primary outcome was the group difference in the change of lumbar spine (LS)-BMD in 24 months. Secondary outcomes included femoral neck (FN)-BMD, total hip (TH)-BMD, trabecular bone score (TBS), and the incidence of vertebral and nonvertebral fractures. Results The increase at LS-, FN-, and TH-BMD at 24 months was larger in the add-on therapy group than in the monotherapy group, with a group difference (add-on therapy minus monotherapy) estimate of 0.020 g/cm2 [95% confidence interval (CI): 0.010-0.029 g/cm2, P < .001] for LS-BMD. The incidence rate ratio (add-on therapy/monotherapy) for morphometric vertebral fractures was 0.292 (95% CI: 0.080-1.061, P = .061). No group difference was detected in the change in TBS. Conclusion Eldecalcitol add-on therapy increased LS-BMD in osteopenic to osteoporotic postmenopausal women treated with an AI and risedronate.
    The Endocrine Society, Jan. 2025, The Journal of Clinical Endocrinology & Metabolism
    [Refereed]
    Scientific journal

  • Suguru Mitsui, Yugo Tanaka, Megumi Nishikubo, Takefumi Doi, Shinya Tane, Daisuke Hokka, Takumi Imai, Yoshimasa Maniwa
    Abstract Purpose This study evaluated the efficacy of ninjin’yoeito for alleviating postoperative symptoms after lung cancer surgery. Methods Overall, 140 patients who underwent lobectomy were randomized into a conventional treatment group and a ninjin’yoeito group. The primary endpoint was change in the Cancer Fatigue Scale (CFS) score from baseline and the secondary endpoints were the Cancer Dyspnea Scale (CDS) scores, the Kihon Checklist, and respiratory function. Results The mean change in the CFS score 8 weeks postoperatively was − 5.56 in the ninjin’yoeito group and − 5.53 in the conventional treatment group (P = 0.425), but this outcome did not meet the primary endpoint. Changes in the mean CDS scores 8 weeks postoperatively were − 5.60 and − 3.38 in the ninjin’yoeito and conventional groups, respectively, with a difference of − 1.95 (P = 0.049). The changes in the mean vital capacity 8 weeks postoperatively were − 340.5 mL in the ninjin’yoeito group and − 473.5 mL in the conventional treatment group, with a difference of + 135.1 mL (P = 0.041). The ninjin’yoeito group had a significantly lower proportion of patients with malnutrition 16 weeks postoperatively than the conventional treatment group (P = 0.040). Conclusion The results of this study show that ninjin’yoeito is effective for alleviating respiratory symptoms and improving malnutrition after lung cancer surgery.
    Springer Science and Business Media LLC, Dec. 2024, Surgery Today
    [Refereed]
    Scientific journal
    Link to Kobe Univ. Repository (Kernel)

  • Ryu Watanabe, Hisako Fujii, Takumi Imai, Yuki Furusawa, Masao Katsushima, Kazuo Fukumoto, Yutaro Yamada, Kenji Mamoto, Tadashi Okano, Shinsuke Yamada, Motomu Hashimoto
    Background: Janus kinase (JAK) inhibitors have emerged as a new class of disease-modifying anti-rheumatic drugs in the treatment of rheumatoid arthritis (RA). However, herpes zoster is one of the common adverse events of JAK inhibitors, including upadacitinib, which is especially high in Japanese patients with RA compared to those from Western countries. Recombinant zoster vaccine (Shingrix®) is an adjuvanted subunit vaccine containing varicella-zoster virus (VZV) glycoprotein E (gE) that is effective in adults over 50 years of age. Despite this, no studies have examined its immunogenicity in Japanese patients receiving upadacitinib. Therefore, this study aims to examine the effectiveness of the recombinant zoster vaccine in Japanese patients with RA receiving upadacitinib. Methods: This is a single-center, exploratory, interventional, open-label, parallel triple-arm, prospective study. A total of 69 patients (23 in each group) aged 50 years or over and treated with a stable dose of methotrexate (MTX) monotherapy (6–12 mg/week), upadacitinib monotherapy (15 mg/day), or MTX (6–12 mg/week) + upadacitinib 15 mg/day (combination) for at least 1 month prior to study entry will be included. Moreover, all three groups will receive two intramuscular injections of the recombinant zoster vaccine at 8-week intervals. The primary endpoint is the proportion of positive anti-gE antibodies 4 weeks after the second injection. Secondary endpoints include RA disease activity, positive gE-specific CD4+ T-cells, and VZV-specific antibodies at indicated time points. Data on outcome measures will be collected at baseline and at 4, 8, 12, and 20 weeks. Endpoints will be summarized using descriptive statistics from baseline therapy, and results will be compared in an exploratory manner. Discussion: Despite the limited generalizability due to its design as a single-center, single-ethnic study, small sample size, and short observation period, this study provides evidence on the effectiveness and tolerability of recombinant zoster vaccine in Japanese patients with RA receiving upadacitinib.
    MDPI AG, Dec. 2024, Journal of Clinical Medicine, 13(23) (23), 7321 - 7321
    [Refereed]
    Scientific journal

  • Akinari Sawada, Takumi Imai, Yasutaka Ihara, Fumio Tanaka, Yasuhiro Fujiwara
    Lead, Elsevier BV, Dec. 2024, Allergology International
    [Refereed]
    Scientific journal

  • Atsushi Tanaka, Takumi Imai, Keisuke Kida, Yuya Matsue, Koichi Node
    Wiley, Nov. 2024, European Journal of Heart Failure
    [Refereed]
    Scientific journal

  • Akinari Sawada, Yasutaka Ihara, Takumi Imai, Fumio Tanaka, Yasuhiro Fujiwara
    Springer Science and Business Media LLC, Nov. 2024, Scientific Reports, 14(1) (1)
    [Refereed]
    Scientific journal

  • Atsushi Tanaka, Keisuke Kida, Yuya Matsue, Takumi Imai, Satoru Suwa, Isao Taguchi, Itaru Hisauchi, Hiroki Teragawa, Yoshiyuki Yazaki, Masao Moroi, Koichi Ohashi, Daisuke Nagatomo, Toru Kubota, Takeshi Ijichi, Yuji Ikari, Keisuke Yonezu, Naohiko Takahashi, Shigeru Toyoda, Tsutomu Toshida, Hiroshi Suzuki, Tohru Minamino, Kazutaka Nogi, Kazuki Shiina, Yu Horiuchi, Kengo Tanabe, Daisuke Hachinohe, Shunsuke Kiuchi, Kenya Kusunose, Michio Shimabukuro, Koichi Node
    Abstract Background and Aims The efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in Japanese patients. Methods This was an investigator-initiated, multicentre, prospective, randomized, open-label, blinded-endpoint pragmatic trial. After haemodynamic stabilization within 7 days after hospitalization, eligible inpatients were allocated to switch from angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to Sac/Val (Sac/Val group) or to continue angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (control group). The primary efficacy endpoint was the 8-week proportional change in geometric means of NT-proBNP levels. Results A total of 400 patients were equally randomized, and 376 (median age 75 years, 31.9% women, de novo heart failure rate 55.6%, and median left ventricular ejection fraction 37%) were analysed. The per cent changes in NT-proBNP level geometric means at Weeks 4/8 were −35%/−45% (Sac/Val group) and −18%/−32% (control group), and their group ratio (Sac/Val vs. control) was 0.80 (95% confidence interval 0.68–0.94; P = .008) at Week 4 and 0.81 (95% confidence interval 0.68–0.95; P = .012) at Week 8, respectively. In the pre-specified subgroup analyses, the effects of Sac/Val were confined to patients with a left ventricular ejection fraction < 40% and were more evident in those in sinus rhythm and taking mineralocorticoid receptor antagonists. No adverse safety signal was evident. Conclusions In-hospital Sac/Val therapy initiation in addition to contemporary recommended therapy triggered a greater NT-proBNP level reduction in Japanese patients hospitalized for AHF. These findings may expand the evidence on Sac/Val therapy in this clinical situation outside North America. Clinical Trial Registration ClinicalTrial.gov (NCT05164653) and Japan Registry of Clinical Trials (jRCTs021210046).
    Oxford University Press (OUP), Aug. 2024, European Heart Journal
    [Refereed]
    Scientific journal

  • Yasutaka Ihara, Kenji Sawa, Takumi Imai, Tsubasa Bito, Yuki Shimomura, Ryota Kawai, Ayumi Shintani
    IMPORTANCE The association between obesity and response to cancer treatment and survival remains unclear, with conflicting findings from various studies. The optimal choice between conventional chemotherapy and immunotherapy for first-line treatment remains uncertain in patients with obesity who potentially have an inadequate therapeutic response to immunotherapy. OBJECTIVE To investigate whether body mass index (BMI) modifies the association of immunotherapy or conventional therapy with overall survival in patients with advanced non–small cell lung cancer (aNSCLC). DESIGN, SETTING, and PARTICIPANTS A retrospective cohort study, using administrative claims data obtained from advanced treatment centers in Japan, was conducted between December 1, 2015, and January 31, 2023. Participants included individuals aged 18 years or older with aNSCLC who received immunotherapy, using immune checkpoint inhibitor (ICI) treatment or conventional chemotherapy. EXPOSURE Immune checkpoint inhibitor therapy as first-line chemotherapy was compared with conventional chemotherapy, identified through patient medical records. MAIN OUTCOMES AND MEASURES The main outcome was overall survival. Survival analysis covered a 3-year follow-up period after the first-line chemotherapy. RESULTS A total of 31 257 patients with aNSCLC were identified. Of these, 12 816 patients received ICI therapy (mean [SD] age, 70.2 [9.1] years; 10 287 [80.3%] men) and 18 441 patients received conventional chemotherapy (mean [SD] age, 70.2 [8.9] years; 14 139 [76.7%] men). Among patients with BMI less than 28, ICI therapy was associated with a significantly lower hazard of mortality (eg, BMI 24: hazard ratio [HR], 0.81; 95% CI, 0.75-0.87) compared with those who underwent conventional chemotherapy. However, no such association was observed among patients with BMI 28 or greater (eg, BMI 28: HR, 0.90; 95% CI, 0.81-1.00). CONCLUSIONS AND RELEVANCE The findings of this retrospective cohort study suggest that BMI modifies the association of ICI therapy compared with conventional chemotherapy with overall survival in patients with aNSCLC. A lack of association between ICI therapy and improved survival in patients with aNSCLC and overweight or obesity compared with conventional chemotherapy was observed. This suggests that ICI therapy may not be the optimal first-line therapy for patients with overweight or obesity and the use of conventional chemotherapy should also be considered in such patients.
    American Medical Association (AMA), Aug. 2024, JAMA Network Open, 7(8) (8), e2425363 - e2425363
    [Refereed]
    Scientific journal

  • Waki Imoto, Yasutaka Ihara, Takumi Imai, Ryota Kawai, Koichi Yamada, Yukihiro Kaneko, Ayumi Shintani, Hiroshi Kakeya
    Abstract Background Coronavirus disease 2019 (COVID‐19)‐associated pulmonary aspergillosis (CAPA) is one of the noticeable complications of COVID‐19 and its incidence varies widely. In Japan, research on the incidence, risk factors and mortality associated with CAPA is limited. Objectives This study aimed to explore the incidence and potential risk factors for CAPA in patients with severe or critical COVID‐19 and evaluate the relationship between CAPA and mortality of patients with severe or critical COVID‐19. Methods We investigated the incidence of CAPA in patients with severe and critical COVID‐19 using administrative claims data from acute care hospitals in Japan. We employed multivariable regression models to explore potential risk factors for CAPA and their contribution to mortality in patients with severe and critical COVID‐19. Results The incidence of CAPA was 0.4%–2.7% in 33,136 patients with severe to critical COVID‐19. Age, male sex, chronic lung disease, steroids, immunosuppressants, intensive care unit admission, blood transfusion and dialysis were potential risk factors for CAPA in patients with severe to critical COVID‐19. CAPA was an independent factor associated with mortality. Conclusions CAPA is a serious complication in patients with severe and critical COVID‐19 and may increase mortality.
    Wiley, Aug. 2024, Mycoses, 67(8) (8)
    [Refereed]
    Scientific journal

  • Takaaki Yano, Yasutaka Ihara, Hisako Yoshida, Takumi Imai, Ryota Kawai, Ayumi Shintani
    The Japan Society of Coloproctology, Jul. 2024, Journal of the Anus, Rectum and Colon, 8(3) (3), 221 - 227
    [Refereed]
    Scientific journal

  • Waki Imoto, Takumi Imai, Ryota Kawai, Yasutaka Ihara, Yuta Nonomiya, Hiroki Namikawa, Koichi Yamada, Hisako Yoshida, Yukihiro Kaneko, Ayumi Shintani, Hiroshi Kakeya
    BACKGROUND: Human cytomegalovirus (HCMV) infection occurs in immunosuppressed individuals and is known to increase mortality. Patients with coronavirus disease 2019 (COVID-19) are often treated with steroids, require intensive care unit (ICU) treatment, and may therefore be at risk for HCMV infection. However, which factors predispose severely ill patients with COVID-19 to HCMV infection and the prognostic value of such infections remain largely unexplored. This study aimed to examine the incidence and potential risk factors of HCMV infection in patients with severe or critical COVID-19 and evaluate the relationship between HCMV infection and mortality. METHODS AND FINDINGS: We used administrative claims data from advanced treatment hospitals in Japan to identify and analyze patients with severe or critical COVID-19. We explored potential risk factors for HCMV infection using multivariable regression models and their contribution to mortality in patients with COVID-19. Overall, 33,151 patients who progressed to severe or critical COVID-19 illness were identified. The incidence of HCMV infection was 0.3-1.7% depending on the definition of HCMV infection. Steroids, immunosuppressants, ICU admission, and blood transfusion were strongly associated with HCMV infection. Furthermore, HCMV infection was associated with patient mortality independent of the observed risk factors for death. CONCLUSIONS: HCMV infection is a notable complication in patients with severe or critical COVID-19 who are admitted to the ICU or receive steroids, immunosuppressants, and blood transfusion and can significantly increase mortality risk.
    Lead, Jun. 2024, Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, English
    [Refereed]
    Scientific journal

  • Michiko Takahashi, Takumi Imai, Tomoko Yamada, Naokazu Muramae, Kai Yoshimura, Yuji Mitomo, Hironori Bando, Kenji Sugawara, Shun-Ichiro Asahara, Yushi Hirota, Yoshikazu Tamori, Yutaka Takahashi, Wataru Ogawa
    Elsevier BV, Jun. 2024, Clinical Nutrition Open Science, 55, 223 - 233
    [Refereed]
    Scientific journal
    Link to Kobe Univ. Repository (Kernel)

  • Junko Hotta, Yukiko Jogu, Haruka Bamba, Yasuhiro Izumiya, Masaharu Kudo, Takumi Imai, Hitoshi Sakuraba, Takashi Hamazaki, Toshiyuki Seto
    Springer Science and Business Media LLC, May 2024, Cureus
    [Refereed]
    Scientific journal

  • Akinari Sawada, Takumi Imai, Yasutaka Ihara, Fumio Tanaka, Ikuo Hirano, Yasuhiro Fujiwara
    Lead, Elsevier BV, May 2024, Clinical Gastroenterology and Hepatology
    [Refereed]
    Scientific journal

  • Yuichiro Miki, Satoshi Nishi, Tatsuro Tamura, Takumi Imai, Mikio Nambara, Tatsunari Fukuoka, Mami Yoshii, Takahiro Toyokawa, Shigeru Lee, Hisako Fujii, Hisako Yoshida, Mitsuhiko Ikebuchi, Kiyoshi Maeda
    Background Subtotal esophagectomy with lymph node dissection followed by neoadjuvant chemotherapy (NAC) is the standard treatment for stage II–III esophageal cancer. Esophagectomy is still associated with high morbidity rates, and reducing these rates remains challenging. Among several complications, postoperative pneumonia (PP) is sometimes fatal, which has been reportedly caused by sarcopenia. Thus, nutritional support and rehabilitation may be promising for preventing skeletal muscle mass loss and reduce the incidence of PP. Methods This single-center, randomized, open-label, pilot trial will randomize a total of 40 patients with esophageal cancer in a 1:1 ratio either to ISOCAL Clear + rehabilitation arm or only rehabilitation arm. Although all patients will be educated about rehabilitation by a specialized physician and will be asked to undergo the prespecified rehabilitation program, patients treated with ISOCAL Clear + rehabilitation arm will be supplemented by 400 mL of ISOCAL Clear (Nestlé Japan Ltd, Tokyo, Japan) per day during two courses of NAC with docetaxel, cisplatin, and fluorouracil. Body composition will be assessed using Inbody (Inbody Co., Ltd., Tokyo, Japan) just before starting NAC and surgery. The primary endpoint is the change of skeletal muscle index (SMI) during NAC. Secondary endpoints include (i) body weight, total skeletal muscle mass, appendicular skeletal muscle mass, and lean body mass index changes; (ii) the percentage of ISOCAL Clear continuation; (iii) appetite evaluation; (iv) the percentage of targeted calorie achievement; (v) adverse events of NAC; (vi) postoperative complication rates; and (vii) postoperative hospital stay. Discussion This prospective trial assesses the efficacy of nutritional support in addition to rehabilitation during NAC for patients with esophageal cancer. The results will be utilized in assessing whether the effects of nutritional support by ISOCAL Clear are promising or not and in planning future larger clinical trials.
    Public Library of Science (PLoS), Apr. 2024, PLOS ONE, 19(4) (4), e0302003 - e0302003
    [Refereed]
    Scientific journal

  • Waki Imoto, Yasutaka Ihara, Takumi Imai, Mitsuhiro Tamoto, Tatoi Ibuki, Koichi Yamada, Yukihiro Kaneko, Ayumi Shintani, Hiroshi Kakeya
    Elsevier BV, Apr. 2024, Journal of Infection and Chemotherapy
    [Refereed]
    Scientific journal

  • Yasumasa Kakei, Ichiro Morioka, Takumi Imai, Kotaro Itohara, Ikuko Yano, Naoto Takahashi, Tetsushi Yoshikawa, Hiroyuki Moriuchi, Yoshinori Ito, Kazumichi Fujioka, Akira Oka, Aya Okahashi, Nobuhiko Nagano, Midori Hijikata, Kazumasa Fuwa, Ryoji Aoki, Ayako Seimiya, Takayuki Imaizumi, Takuya Akimoto, Koichiro Hara, Daichi Katayama, Shinya Abe, Mariko Ashina, Ruka Nakasone, Yuki Kyouno, Kido Takumi, Satoshi Takenaka, Satsuki Kakiuchi, Yu Kakimoto, Kei Kozawa, Yusuke Funato, Hiroki Miura, Yoshiki Kawamura, Tsutomu Ogata, Yumiko Nakashima, Jun-ichi Kawada, Yuka Torii, Takako Suzuki, Yuto Fukuda, Kazunori Haruta, Makoto Yamaguchi, Teranishi Masaaki
    Elsevier BV, Mar. 2024, Journal of Infection and Chemotherapy
    [Refereed]
    Scientific journal

  • Yasutaka Ihara, Kenji Sawa, Takumi Imai, Yuta Nonomiya, Yuki Shimomura, Asahi Ishihara, Ayumi Shintani
    Pharmaceutical Society of Japan, Feb. 2024, Biological and Pharmaceutical Bulletin, 47(2) (2), 454 - 461
    [Refereed]
    Scientific journal

  • Kenya Kusunose, Takumi Imai, Atsushi Tanaka, Masaru Doi, Yuji Koide, Kazuo Fukumoto, Toshiaki Kadokami, Mitsuru Ohishi, Hiroki Teragawa, Nobuyuki Ohte, Hirotsugu Yamada, Masataka Sata, Koichi Node
    Elsevier BV, Feb. 2024, Journal of Cardiology
    [Refereed]
    Scientific journal

  • Masafumi Kurajoh, Seigo Akari, Takashi Nakamura, Yasutaka Ihara, Takumi Imai, Tomoaki Morioka, Masanori Emoto
    Background: Urate-lowering drugs (ULDs) have been approved for treatment of asymptomatic hyperuricemia and gout in Japan. Although serum urate levels and rates of gout onset are known to have seasonal variations, no survey results regarding the seasonality of ULD prescriptions for asymptomatic hyperuricemia and gout have been reported. Methods: A large-scale database of medical claims in Japan filed between January 2019 and December 2022 was accessed. In addition to total size of the recorded population for each month examined, the numbers of patients every month with newly prescribed ULDs for asymptomatic hyperuricemia and gout were noted, based on the International Classification of Diseases, 10th Revision, codes E79.0 and M10. Results: The results identified 201,008 patients with newly prescribed ULDs (median age 49.0 years, male 95.6%). Of those, 64.0% were prescribed ULDs for asymptomatic hyperuricemia and 36.0% for gout. The proportion of new ULD prescriptions was seasonal, with that significantly (p < 0.001) higher in summer (June–August) [risk ratio (RR) 1.322, 95% CI 1.218 to 1.436] and autumn (September–November) (RR 1.227, 95% CI 1.129–1.335) than in winter (December–February), whereas the proportion in spring (March–May) was not significantly different from winter. There was no significant difference after stratification by drug type (uric acid production inhibitor/uricosuric agent) or size of the medical institution, nor subgrouping by age or sex (p for interaction = 0.739, 0.727, 0.886, and 0.978, respectively). On the other hand, the proportions of new ULD prescriptions for asymptomatic hyperuricemia were significantly lower and for gout significantly higher in spring than winter, while those were similar in summer and autumn for both groups (p for interaction<0.001). Conclusion: The present findings indicate that new prescriptions for ULDs to treat asymptomatic hyperuricemia or gout in Japan show seasonal differences, with higher rates noted in summer and autumn as compared to winter.
    Frontiers Media SA, Jan. 2024, Frontiers in Pharmacology, 15
    [Refereed]
    Scientific journal

  • Yuki Shimomura, Kenji Sawa, Takumi Imai, Yasutaka Ihara, Hisako Yoshida, Ayumi Shintani
    Abstract Alectinib is the first‐line therapy for anaplastic lymphoma kinase‐positive non‐small‐cell lung cancer. Although some guidelines have recommended using other anaplastic lymphoma kinase inhibitors after alectinib failure, evidence for such regimens in patients who fail to respond to alectinib is limited. This study involved using administrative claims data from acute care hospitals in Japan. We extracted the data of 634 patients diagnosed with lung cancer between September 1, 2014, and January 31, 2023, who received alectinib treatment before treatment with another anaplastic lymphoma kinase inhibitor. We assessed distributions of patients according to their treatment sequencing and prognosis among three periods defined based on the initial marketing dates of lorlatinib and brigatinib. The type of anaplastic lymphoma kinase inhibitors after alectinib failure changed over time. In the most recent period, lorlatinib (58%) and brigatinib (40%) became predominant. Two‐year overall survival improved over time (47%–84%), accompanied by an increased 2‐year proportion of patients who continuously used anaplastic lymphoma kinase inhibitors after alectinib failure (13%–44%). The times to treatment discontinuation of the regimen between patients treated with lorlatinib and brigatinib were similar, with a hazard ratio of 1.02 (95% confidence interval, 0.64–1.64) in the period after marketing brigatinib. This study provides insights into the evolving treatment landscape for patients with anaplastic lymphoma kinase‐positive non‐small‐cell lung cancer who experience failed alectinib treatment and highlights the need for further studies and data accumulation to determine the optimal treatment strategy.
    Wiley, Dec. 2023, Cancer Science
    [Refereed]
    Scientific journal

  • Yasutaka Ihara, Kenji Sawa, Takumi Imai, Tetsuya Kimura, Miho Otani, Ryota Kawai, Shingo Takatori, Ayumi Shintani
    Springer Science and Business Media LLC, Nov. 2023, Supportive Care in Cancer, 31(12) (12)
    [Refereed]
    Scientific journal

  • Takenao Koseki, Mayumi Teramachi, Minako Koga, Minoru S. H. Ko, Tomokazu Amano, Hong Yu, Misa Amano, Erica Leyder, Maria Badiola, Priyanka Ray, Jiyoung Kim, Akihiro C. Ko, Achouak Achour, Nan-ping Weng, Takumi Imai, Hisako Yoshida, Satsuki Taniuchi, Ayumi Shintani, Hidetsugu Fujigaki, Masashi Kondo, Yohei Doi
    mRNA vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have played a key role in reducing morbidity and mortality from coronavirus disease 2019 (COVID-19). We conducted a double-blind, placebo-controlled phase I/II trial to evaluate the safety, tolerability, and immunogenicity of EXG-5003, a two-dose, controllable self-replicating RNA vaccine against SARS-CoV-2. EXG-5003 encodes the receptor binding domain (RBD) of SARS-CoV-2 and was administered intradermally without lipid nanoparticles (LNPs). The participants were followed for 12 months. Forty healthy participants were enrolled in Cohort 1 (5 µg per dose, n = 16; placebo, n = 4) and Cohort 2 (25 µg per dose, n = 16; placebo, n = 4). No safety concerns were observed with EXG-5003 administration. SARS-CoV-2 RBD antibody titers and neutralizing antibody titers were not elevated in either cohort. Elicitation of antigen-specific cellular immunity was observed in the EXG-5003 recipients in Cohort 2. At the 12-month follow-up, participants who had received an approved mRNA vaccine (BNT162b2 or mRNA-1273) >1 month after receiving the second dose of EXG-5003 showed higher cellular responses compared with equivalently vaccinated participants in the placebo group. The findings suggest a priming effect of EXG-5003 on the long-term cellular immunity of approved SARS-CoV-2 mRNA vaccines.
    MDPI AG, Nov. 2023, Vaccines, 11(12) (12), 1767 - 1767
    [Refereed]
    Scientific journal

  • Yuichi Saito, Atsushi Tanaka, Takumi Imai, Shin‐Ichiro Miura, Masayoshi Ajioka, Kazuhisa Kodama, Yoshio Kobayashi, Koichi Node
    Wiley, Nov. 2023, Diabetes, Obesity and Metabolism
    [Refereed]
    Scientific journal

  • Yuichi Saito, Atsushi Tanaka, Takumi Imai, Ikuko Nakamura, Junji Kanda, Munehide Matsuhisa, Hiroki Uehara, Kazuomi Kario, Yoshio Kobayashi, Koichi Node
    Springer Science and Business Media LLC, Nov. 2023, Hypertension Research
    [Refereed]
    Scientific journal

  • Takeshi Masuda, Satoru Miura, Yuki Sato, Motoko Tachihara, Akihiro Bessho, Atsushi Nakamura, Taichi Miyawaki, Kohei Yoshimine, Masahide Mori, Hideaki Shiraishi, Kosuke Hamai, Koji Haratani, Sumiko Maeda, Eriko Tabata, Chiyoe Kitagawa, Junko Tanizaki, Takumi Imai, Shohei Nogami, Nobuyuki Yamamoto, Kazuhiko Nakagawa, Noboru Hattori
    Abstract Small amounts of epidermal growth factor receptor (EGFR) T790M mutation (micro-T790M), which is detected using droplet digital PCR (ddPCR) but not conventional PCR, in formalin-fixed and paraffin-embedded (FFPE) samples have been investigated as a predictive factor for the efficacy of EGFR-tyrosine kinase inhibitors (TKIs). However, the predictive value of micro-T790M remains controversial, possibly owing to the failure to examine artificial T790M in FFPE specimens. Therefore, we examined the predictive value of micro-T790M in first-generation (1G), second-generation (2G), and third-generation (3G) EGFR-TKI efficacy using a new method to exclude FFPE-derived artificial mutations in our retrospective cohort. The primary objective was time to treatment failure (TTF) of 1G, 2G, and 3G EGFR-TKIs according to micro-T790M status. In total, 315 patients with EGFR-positive non-small cell lung cancer treated with 1G, 2G, and 3G EGFR-TKIs were included in this study. The proportion of patients positive for micro-T790M in the 1G, 2G, and 3G EGFR-TKI groups was 48.2%, 47.1%, and 47.6%, respectively. In the micro-T790M-positive group, the TTF was significantly longer in the 2G and 3G EGFR-TKI groups than in the 1G TKI group. No differences in the micro-T790M-negative group were observed. Micro-T790M status detected using ddPCR, eliminating false positives, may be a valuable predictor of EGFR-TKI efficacy.
    Springer Science and Business Media LLC, Nov. 2023, Scientific Reports, 13(1) (1)
    [Refereed]
    Scientific journal

  • Kenji Sawa, Yasutaka Ihara, Takumi Imai, Akira Sugimoto, Hiroaki Nagamine, Koichi Ogawa, Kenji Nakahama, Yoshiya Matsumoto, Yoko Tani, Hiroyasu Kaneda, Shigeki Mitsuoka, Tomoya Kawaguchi, Ayumi Shintani
    Elsevier BV, Nov. 2023, Clinical Lung Cancer
    [Refereed]
    Scientific journal

  • Masafumi Kurajoh, Shinya Fukumoto, Seigo Akari, Takayo Murase, Takashi Nakamura, Yasutaka Ihara, Takumi Imai, Yuki Nagata, Tomoaki Morioka, Katsuhito Mori, Yasuo Imanishi, Toshio Watanabe, Masanori Emoto
    Elsevier BV, Oct. 2023, IJC Heart & Vasculature, 48, 101264 - 101264
    [Refereed]
    Scientific journal

  • Yusuke Fujita, Koya Hida, Takashi Sakamoto, Daisuke Nishizaki, Shiro Tanaka, Nobuaki Hoshino, Kae Okoshi, Ryo Matsusue, Takumi Imai, Kazutaka Obama
    BACKGROUND: Due to improved survival rates, colorectal cancer patients may try to return to work. Many countries, however, have limited knowledge of their employment status. OBJECTIVE: To explore the employment status of colorectal cancer patients after surgery in Japan and the risk factors affecting the same. DESIGN: This is a prospective multicenter cohort study that uses self-administered questionnaires. Patients were recruited from June 2019 to August 2020 and were followed up for 12 months after surgery. SETTING: Six community hospitals and one university hospital in Japan. PATIENTS: Patients with clinical stages I–III colorectal cancer, employed at the time of diagnosis. INTERVENTIONS: Patients who received surgical resection from June 2019 to August 2020. MAIN OUTCOME MEASUREMENTS: The time it takes patients to return to work after surgery and the proportion of working patients 12 months after surgery were collected using self-administered questionnaires. RESULTS: A total of 129 patients were included in the analyses. The median time to return to work was 1.1 months, and the proportion of working patients at 12 months after surgery was 79%. Risk factors for delayed return-to-work after surgery were an advanced tumor stage, stoma, severe postoperative complications, shorter years of service at the workplace, and lower willingness to return to work. Risk factors for not working 12 months after surgery were stoma, lower willingness to return to work, non-regular employee status, lower income, national health insurance, and no private medical insurance. LIMITATIONS: This study is limited by its short-term follow-up and small sample size. CONCLUSIONS: This study revealed that Japanese patients with stages I–III colorectal cancer found favorable employment outcomes in the 12 months following surgery. These results may help healthcare providers better understand the employment status of colorectal cancer patients and encourage them to consider returning to work after surgery.
    Ovid Technologies (Wolters Kluwer Health), Sep. 2023, Diseases of the Colon & Rectum
    [Refereed]
    Scientific journal

  • Hirofumi Tomiyama, Takumi Imai, Kazuki Shiina, Yukihito Higashi, Hiroki Nakano, Takamichi Takahashi, Masatsune Fujii, Chisa Matsumoto, Akira Yamashina, Taishiro Chikamori
    BACKGROUND: Although some cardiovascular risk factors (CVRFs) are known to be associated with increased arterial stiffness, increased arterial stiffness does not mediate the cardiovascular risk associated with all CVRFs. Here, based on long-term repeated-measurement data, we examined the association of the lifelong status of each CVRF with the rate of progression of arterial stiffness. METHODS: We utilized the data from annual health checkups with the brachial-ankle pulse wave velocity measurements over a 16-year period in middle-aged Japanese occupational cohort. RESULTS: Totally, 29 090 brachial-ankle pulse wave velocity data were obtained during the follow-up of 3763 subjects ranging in age from around 30 to 70 years. Smoking, heavy alcohol intake, hypertension, diabetes, hypertriglyceridemia, and hyperuricemia were independently associated with the fast progression of arterial stiffness. Also, lower values in nondisease range in blood pressure, glycosylated hemoglobin A1c, triglyceride, and uric acid were independently associated with the slow progression of arterial stiffness. For body mass index and low-density lipoprotein cholesterol, no clear associations with the progression of arterial stiffness were observed. CONCLUSIONS: The present prospective study provided more robust epidemiological evidence for the heterogeneity of the significance of contribution of lifelong status of each CVRF to the slow and fast rate of progression of arterial stiffness. These findings suggest the important need to examine, in further studies, the effects of global early interventions to control the levels of the culprit CVRFs, even from middle age, not only to prevent a fast progression of the arterial stiffness but also to maintain a relatively slow progression of arterial stiffness.
    Lead, Ovid Technologies (Wolters Kluwer Health), Aug. 2023, Hypertension
    [Refereed]
    Scientific journal

  • Atsushi Tanaka, Hirotaka Shibata, Takumi Imai, Hisako Yoshida, Motoaki Miyazono, Naohiko Takahashi, Daiju Fukuda, Yosuke Okada, Hiroki Teragawa, Satoru Suwa, Keisuke Kida, Masao Moroi, Isao Taguchi, Shigeru Toyoda, Michio Shimabukuro, Kengo Tanabe, Kenichi Tanaka, Masaomi Nangaku, Koichi Node
    Abstract Background The overactivation of mineralocorticoid receptor (MR) plays a key pathological role in the progression of cardiovascular and renal diseases by promoting pro-inflammatory and pro-fibrotic signaling. Recently, it has been found that finerenone, a novel nonsteroidal selective MR antagonist, can robustly improve cardiorenal outcomes in patients with type 2 diabetes (T2D) and a wide spectrum of chronic kidney disease (CKD). However, the mechanisms underlying the cardiorenal benefits of finerenone are poorly understood. Further, whether the clinical benefits are mediated by an improvement in vascular stiffness is not confirmed. Therefore, the current study aims to evaluate the effects of finerenone on vascular stiffness as assessed using cardio ankle vascular index (CAVI) and relevant cardiorenal biomarkers in patients with T2D and CKD. Methods The Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in Type 2 Diabetes and Chronic Kidney Disease (FIVE-STAR) is an ongoing, investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized clinical trial in Japan. Its target sample size is 100 subjects. Recruitment will be performed from September 2023 to July 2024. After obtaining informed consent, eligible participants with T2D and CKD (25 mL/min/1.73 m2 ≤ estimated glomerular filtration ratio [eGFR] < 90 mL/min/1.73 m2 and 30 mg/g Cr ≤ urinary albumin-to-creatinine ratio [UACR] < 3500 mg/g Cr) will be equally randomized to receive 24-week treatment with either finerenone (starting dose at 10 mg once daily in participants with a baseline eGFR < 60 mL/min/1.73 m2 or at 20 mg once daily in those with a baseline eGFR ≥ 60 mL/min/1.73 m2) or dose-matched placebo. The primary endpoint is the change from baseline in CAVI at 24 weeks. The secondary endpoints are changes from baseline in UACR at 12 and 24 weeks and relevant serum and urinary biomarkers at 24 weeks. As an exploratory endpoint, proteomic analysis using the Olink® Target 96 panels will be also performed. Discussion FIVE-STAR is the first trial evaluating the therapeutic impact of finerenone on vascular stiffness and relevant cardiorenal biomarkers in patients with T2D and CKD. This study will provide mechanistic insights on the clinical benefits of finerenone based on recent cardiovascular and renal outcome trials. Trial registration Unique Trial Number, NCT05887817 (https://clinicaltrials.gov/ct2/show/NCT05887817) and jRCTs021230011 (https://jrct.niph.go.jp/latest-detail/jRCTs021230011).
    Springer Science and Business Media LLC, Jul. 2023, Cardiovascular Diabetology, 22(1) (1)
    [Refereed]
    Scientific journal

  • Satoshi Nishi, Yuichiro Miki, Takumi Imai, Mikio Nambara, Hironari Miyamoto, Tatsuro Tamura, Mami Yoshii, Takahiro Toyokawa, Hiroaki Tanaka, Shigeru Lee, Kiyoshi Maeda
    Introduction: Sarcopenia is often observed in patients with esophageal cancer (EC). However, the influence of sarcopenia during neoadjuvant chemotherapy (NAC) on complications has not been fully investigated. Thus, we aimed to investigate the best way of evaluating sarcopenia for predicting complications, especially postoperative pneumonia (PP), in patients with EC undergoing NAC and esophagectomy.Methods: We retrospectively reviewed 36 patients. The skeletal muscle mass index (SMI) was evaluated by both BIA and CT. Patients were diagnosed with sarcopenia at pre-NAC and preoperatively. Different criteria were compared in terms of the predictability of PP. Next, we evaluated which factors were related to sarcopenia with best PP predictability. Finally, we investigated perioperative factors that were associated with SMI change during NAC.Results: PP occurred in three patients. Pre-NAC modified European Working Group on Sarcopenia in Older People (EWGSOP) criteria showed the best PP predictability.Low pre-NAC BMI and %VC were significantly associated with sarcopenia by the modified EWGSOP criteria. There was a trend that patients of the SMI non-increased group during NAC were more likely to develop PP.Conclusion: Pre-NAC sarcopenia by modified EWGSOP was a significant predictor of PP after esophagectomy. Appropriate interventions for these patients should be explored to prevent PP.
    S. Karger AG, Jul. 2023, Digestive Surgery
    [Refereed]
    Scientific journal

  • Atsushi Tanaka, Takumi Imai, Shigeru Toyoda, Kazuhiro Sugimoto, Ruka Yoshida, Machi Furuta, Koichi Node
    Abstract Backgrounds/Aim Recent studies have shown that the addition of sodium-glucose co-transporter 2 (SGLT2) inhibitors gradually reduces the estimated fluid volume parameters in a broad range of patient populations, suggesting that this mediates the clinical benefits of SGLT2 inhibitors in preventing heart failure. Here, we sought to examine the long-term (24 months) effect of the SGLT2 inhibitor ipragliflozin on the estimated fluid volume parameters in patients with type 2 diabetes mellitus (T2DM). Methods In this prespecified sub-analysis of the PROTECT (Prevention of Atherosclerosis by SGLT2 Inhibitor: Multicenter, Randomized Controlled Study) trial, which was an investigator-initiated, multicenter, prospective, randomized, open-label, clinical trial primarily designed to evaluate the effect of ipragliflozin treatment administered for 24 months on carotid atherosclerosis in patients with T2DM, we evaluated serial changes in estimated plasma volume (ePV, %) calculated using the Straus formula and estimated extracellular volume (eEV, mL) calculated by the body surface area by 24 months following the initiation of 50-mg ipragliflozin once daily and compared them with those following standard care for T2DM (non-SGLT2 inhibitor use). Results This sub-analysis included 464 patients (ipragliflozin, n = 232; control, n = 232), a full analysis set of the PROTECT trial. In an analysis using mixed-effects models for repeated measures, relative to the control group, ipragliflozin significantly reduced ePV by − 10.29% (95% confidence interval [CI]  − 12.47% to − 8.11%; P < 0.001) at 12 months and − 10.76% (95% CI − 12.86% to − 8.67%; P < 0.001) at 24 months. Additionally, ipragliflozin significantly reduced eEV by − 190.44 mL (95% CI − 249.09 to − 131.79 mL; P < 0.001) at 12 months and − 176.90 mL (95% CI  − 233.36 to − 120.44 mL; P < 0.001) at 24 months. The effects of ipragliflozin on these parameters over 24 months were mostly consistent across various patient clinical characteristics. Conclusions This prespecified sub-analysis from the PROTECT trial demonstrated that ipragliflozin treatment, compared with the standard care for T2DM, reduced two types of estimated fluid volume parameters in patients with T2DM, and the effect was maintained for 24 months. Our findings suggest that SGLT2 inhibitor treatment regulates clinical parameters incorporated into the calculating formulas analyzed and consequently fluid volume status for the long-term, and this may be at least partly associated with clinical benefits from chronic use of SGLT2 inhibitors. Trial registration Japan Registry of Clinical Trials, ID jRCT1071220089
    Springer Science and Business Media LLC, Jul. 2023, Diabetology & Metabolic Syndrome, 15(1) (1)
    [Refereed]
    Scientific journal

  • Shinji Kishimoto, Yukihito Higashi, Takumi Imai, Kazuo Eguchi, Kazuo Fukumoto, Hirofumi Tomiyama, Koji Maemura, Atsushi Tanaka, Koichi Node
    Abstract Background We assessed the impact of 24 months of treatment with ipragliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on endothelial function in patients with type 2 diabetes as a sub-analysis of the PROTECT study. Methods In the PROTECT study, patients were randomized to receive either standard antihyperglycemic treatment (control group, n = 241 ) or add-on ipragliflozin treatment (ipragliflozin group, n = 241) in a 1:1 ratio. Among the 482 patients in the PROTECT study, flow-mediated vasodilation (FMD) was assessed in 32 patients in the control group and 26 patients in the ipragliflozin group before and after 24 months of treatment. Results HbA1c levels significantly decreased after 24 months of treatment compared to the baseline value in the ipragliflozin group, but not in the control group. However, there was no significant difference between the changes in HbA1c levels in the two groups (7.4 ± 0.8% vs. 7.0 ± 0.9% in the ipragliflozin group and 7.4 ± 0.7% vs. 7.3 ± 0.7% in the control group; P = 0.08). There was no significant difference between FMD values at baseline and after 24 months in both groups (5.2 ± 2.6% vs. 5.2 ± 2.6%, P = 0.98 in the ipragliflozin group; 5.4 ± 2.9% vs. 5.0 ± 3.2%, P = 0.34 in the control group). There was no significant difference in the estimated percentage change in FMD between the two groups (P = 0.77). Conclusions Over a 24-month period, the addition of ipragliflozin to standard therapy in patients with type 2 diabetes did not change endothelial function assessed by FMD in the brachial artery. Trial registration Registration Number for Clinical Trial: jRCT1071220089 (https://jrct.niph.go.jp/en-latest-detail/jRCT1071220089).
    Springer Science and Business Media LLC, May 2023, Cardiovascular Diabetology, 22(1) (1)
    [Refereed]
    Scientific journal

  • Sanae Kishimoto, Norio Watanabe, Yosuke Yamamoto, Takumi Imai, Rei Aida, Christopher Germer, Risa Tamagawa-Mineoka, Ryosuke Shimizu, Steven Hickman, Yujiro Nakayama, Takafumi Etoh, Ethan Sahker, Martha B. Carnie, Toshi A. Furukawa
    Importance Quality of life (QOL) of patients with atopic dermatitis (AD) is reported to be the lowest among skin diseases. To our knowledge, mindfulness and self-compassion training has not been evaluated for adults with AD. Objective To evaluate the efficacy of mindfulness and self-compassion training in improving the QOL for adults with AD. Design, Setting, and Participants This randomized clinical trial conducted from March 2019 through October 2022 included adults with AD whose Dermatology Life Quality Index (DLQI) score, a skin disease–specific QOL measure, was greater than 6 (corresponding to moderate or greater impairment). Participants were recruited from multiple outpatient institutes in Japan and through the study’s social media outlets and website. Interventions Participants were randomized 1:1 to receive eight 90-minute weekly group sessions of online mindfulness and self-compassion training or to a waiting list. Both groups were allowed to receive any dermatologic treatment except dupilumab. Main Outcomes and Measures The primary outcome was the change in the DLQI score from baseline to week 13. Secondary outcomes included eczema severity, itch- and scratching-related visual analog scales, self-compassion and all of its subscales, mindfulness, psychological symptoms, and participants’ adherence to dermatologist-advised treatments. Results The study randomized 107 adults to the intervention group (n = 56) or the waiting list (n = 51). The overall participant mean (SD) age was 36.3 (10.5) years, 85 (79.4%) were women, and the mean (SD) AD duration was 26.6 (11.7) years. Among participants from the intervention group, 55 (98.2%) attended 6 or more of the 8 sessions, and 105 of all participants (98.1%) completed the assessment at 13 weeks. The intervention group demonstrated greater improvement in the DLQI score at 13 weeks (between-group difference estimate, −6.34; 95% CI, −8.27 to −4.41; P &amp;lt; .001). The standardized effect size (Cohen d) at 13 weeks was −1.06 (95% CI, −1.39 to −0.74). All secondary outcomes showed greater improvements in the intervention group than in the waiting list group. Conclusions and Relevance In this randomized clinical trial of adults with AD, integrated online mindfulness and self-compassion training in addition to usual care resulted in greater improvement in skin disease–specific QOL and other patient-reported outcomes, including eczema severity. These findings suggest that mindfulness and self-compassion training is an effective treatment option for adults with AD. Trial Registration https://umin.ac.jp/ctr Identifier: UMIN000036277
    American Medical Association (AMA), May 2023, JAMA Dermatology
    [Refereed]
    Scientific journal

  • Nobutaka Hattori, Yoshiko Okada, Yayoi Kawata, Yoshihiko Furusawa, Takumi Imai, Hisako Yoshida, Mihoko Ota, Masaki Arai, Ayumi Shintani, Jovelle Fernandez
    Informa UK Limited, May 2023, Patient Preference and Adherence, Volume 17, 1221 - 1235
    [Refereed]
    Scientific journal

  • Keiichi Matsuzaki, Megumi Kitayama, Keiichi Yamamoto, Rei Aida, Takumi Imai, Mami Ishida, Ritsuko Katafichi, Tetsuya Kawamura, Takashi Yokoo, Ichiei Narita, Yusuke Suzuki
    JMIR Publications Inc., Mar. 2023, JMIR Medical Informatics
    [Refereed]
    Scientific journal

  • Masafumi Kurajoh, Yoshikazu Hiura, Ryutaro Numaguchi, Yasutaka Ihara, Takumi Imai, Tomoaki Morioka, Masanori Emoto, Yukio Nishiguchi
    Uric acid has antioxidant properties. To examine whether a low uric acid level is associated with severe coronavirus disease 2019 (COVID-19) progression via inflammation, alveolar damage, and/or coagulation abnormality, a retrospective observational study of 488 patients with non-severe COVID-19 and serum uric acid level ≤7 mg/dL at admission was conducted. Serum C-reactive protein (CRP), serum Krebs von den Lungen 6 (KL-6), and plasma D-dimer levels were also measured as markers of inflammation, alveolar damage, and coagulation abnormality, respectively. Median values for uric acid, CRP, KL-6, and D-dimer at admission were 4.4 mg/dL, 3.33 mg/dL, 252.0 U/mL, and 0.8 µg/mL, respectively. Among the total cohort, 95 (19.5%) progressed to severe COVID-19 with a median (interquartile range) time of 7 (4–14) days. Multivariable Cox proportional hazards regression analysis showed that low uric acid level was associated with a higher rate of severe COVID-19 progression. However, uric acid level was inversely associated with CRP level, and the association between the level of uric acid and severe COVID-19 progression was significantly different with and without CRP level inclusion. In contrast, no such association was found for KL-6 or D-dimer level. Low uric acid may contribute to severe COVID-19 progression via increased inflammation in subjects without hyperuricemia.
    MDPI AG, Mar. 2023, Biomedicines, 11(3) (3), 854 - 854
    [Refereed]
    Scientific journal

  • Sachie Nakagama, Yu Nakagama, Yuko Komase, Masaharu Kudo, Takumi Imai, Evariste Tshibangu-Kabamba, Yuko Nitahara, Natsuko Kaku, Yasutoshi Kido
    More people with a history of prior infection are receiving SARS-CoV-2 vaccines. Understanding the level of protection granted by ‘hybrid immunity’, the combined response of infection- and vaccine-induced immunity, may impact vaccination strategies through tailored dosing. A total of 36 infected (‘prior infection’) and 33 SARS-CoV-2 ‘naïve’ individuals participated. Participants provided sera six months after completing a round of BNT162b2 vaccination, to be processed for anti-spike antibody measurements and the receptor binding domain-ACE2 binding inhibition assays. The relationships between antibody titer, groups and age were explored. Anti-spike antibody titers at 6 months post-vaccination were significantly higher, reaching 13- to 17-fold, in the ‘prior infection’ group. Semi-log regression models showed that participants with ‘prior infection’ demonstrated higher antibody titer compared with the ‘naïve’ even after adjusting for age. The enhancement in antibody titer attributable to positive infection history increased from 8.9- to 9.4- fold at age 30 to 19- to 32-fold at age 60. Sera from the ‘prior infection’ group showed higher inhibition capacity against all six analyzed strains, including the Omicron variant. Prior COVID-19 led to establishing enhanced humoral immunity at 6 months after vaccination. Antibody fold-difference attributed to positive COVID-19 history increased with age, possibly because older individuals are prone to symptomatic infection accompanied by potentiated immune responses. While still pending any modifications of dosing recommendations (i.e. reduced doses for individuals with prior infection), our observation adds to the series of real-world data demonstrating the enhanced and more durable immune response evoked by booster vaccinations following prior infection.
    Frontiers Media SA, Jan. 2023, Frontiers in Immunology, 14, 1087473 - 1087473, English, International magazine
    [Refereed]
    Scientific journal

  • Tomonori Iyoda, Kanako Shimizu, Masami Kawamura, Jun Shinga, Takashi Watanabe, Koya Fukunaga, Taisei Mushiroda, Hideo Saka, Chiyoe Kitagawa, Shin-ichiro Shimamatsu, Mitsuhiro Takenoyama, Youko Suehiro, Takumi Imai, Ayumi Shintani, Suminobu Ito, Shin-ichiro Fujii
    Abstract NK cells are major effector cells involved in the elimination of early tumors and prevent metastasis. They often have an impaired function in patients with cancer. Preclinical studies have demonstrated NK cell activation as the adjunctive effect of invariant NKT (iNKT) cells. Activation of iNKT cells after administration of the glycolipid ligand α-galactosylceramide, loaded with CD1d-expressing human PBMC-derived APCs (APC/Gal), is an attractive cancer therapy to optimize the use of NK cells. However, the subsets of NK cells that are activated following iNKT cell activation as well as the period of NK cell activation remain unclear. In this study, we report that the granzyme B–expressing NK cell response in postoperative lung cancer patients was enhanced 49 d after administration of APC/Gal in a phase II study. We found maximum IFN-γ production on day 49 in 13 out of 27 APC/Gal-treated patients. On day 49, 14 out of 27 patients (51.9%) had higher IFN-γ production by iNKT cells (&gt;6-fold higher than the baseline level). This increment significantly correlated with granzyme B–expressing NK cells. Although IFN-γ production was lower in patients in the nontreated group, we detected maximum IFN-γ production 12 mo after the resection of lung cancer (9 out of 29 patients [31%]). These findings suggest that elimination of cancer cells leads to increased NK cell function, which can be further enhanced by APC/Gal therapy.
    The American Association of Immunologists, Jan. 2023, ImmunoHorizons, 7(1) (1), 1 - 16
    [Refereed]
    Scientific journal

  • Waki Imoto, Koichi Yamada, Ryota Kawai, Takumi Imai, Kengo Kawamoto, Masato Uji, Hidenori Kanda, Minoru Takada, Yoshiteru Ohno, Hiroshi Ohtani, Manami Kono, Atsuhito Hikiishi, Yosuke Eguchi, Hiroki Namikawa, Tomoya Kawaguchi, Hiroshi Kakeya
    Abstract Long-term sequelae of the coronavirus disease (COVID-19) constitute Long COVID. Although Long COVID has been reported globally, its risk factors and effects on quality of life (QOL) remain unclear. We conducted a cross-sectional study using questionnaires and electronic medical records of COVID-19 patients who were diagnosed or hospitalized at five facilities in Japan. Responses were obtained from 285 out of 1,150 patients. More than half of the participants reported Long COVID symptoms of varying severity 1 year after COVID-19. Common sequelae included fatigue, dyspnea, alopecia, concentration problems, memory problems, sleeplessness, and joint pain, which often significantly reduced their QOL. COVID-19 severity was strongly associated with sputum production, chest pain, dyspnea, sore throat, and diarrhea, but not with fatigue, dysgeusia, anosmia, alopecia, and sleeplessness. Fatigue, dysgeusia, anosmia, alopecia, and sleeplessness affected the QOL among participants with asymptomatic or mild COVID-19 during the acute phase. Moreover, these sequelae persisted for prolonged periods.
    Springer Science and Business Media LLC, Dec. 2022, Scientific Reports, 12(1) (1), 22413 - 22413, English, International magazine
    [Refereed]
    Scientific journal

  • Atsushi Tanaka, Takumi Imai, Michio Shimabukuro, Ikuko Nakamura, Kazuo Matsunaga, Yukio Ozaki, Tohru Minamino, Masataka Sata, Koichi Node
    AIMS/INTRODUCTION: Clinical evidence is lacking about the influence of sodium-glucose cotransporter 2 inhibitors on white blood cell (WBC) counts, a commonly used and widely available marker of inflammation. The aim of the present analysis was to assess the effect of canagliflozin relative to glimepiride on WBC counts. MATERIALS AND METHODS: This was a post-hoc subanalysis of the CANDLE trial (Effects of Canagliflozin in Patients with Type 2 Diabetes and Chronic Heart Failure: A Randomized Trial; UMIN000017669), an investigator-initiated, multicenter, open-label, randomized, controlled trial. A total of 233 patients with type 2 diabetes and concomitant heart failure were randomly assigned to either canagliflozin (n = 113) or glimepiride (n = 120) treatment for 24 weeks. Overall, patient baseline characteristics were as follows: mean ± standard deviation age, 68.6 ± 10.1 years; hemoglobin A1c, 7.0 ± 0.9%; left ventricular ejection fraction, 56.7 ± 14.4%; and median N-terminal pro-brain natriuretic peptide, 252 pg/mL (interquartile range 96-563 pg/mL). The mean baseline WBC counts were 6704 cells/μL (95% confidence interval 6,362-7,047) in the canagliflozin group and 6322 cells/μL (95% confidence interval 5,991-6,654) in the glimepiride group. There were no significant differences between treatment groups in terms of changes in WBC counts from baseline to weeks 4 and 12. In contrast, a group difference (canagliflozin minus glimepiride) from baseline to week 24 was significant (mean difference - 456 cells/μL [95% confidence interval -774 to -139, P = 0.005]). CONCLUSIONS: Our findings suggest that 24 weeks of treatment with canagliflozin, relative to glimepiride, reduced WBC counts in patients with type 2 diabetes and heart failure.
    Wiley, Dec. 2022, Journal of Diabetes Investigation, 13(12) (12), 1990 - 1999, English, Domestic magazine
    [Refereed]
    Scientific journal

  • Kazuki Shiina, Hirofumi Tomiyama, Atsushi Tanaka, Takumi Imai, Itaru Hisauchi, Isao Taguchi, Akira Sezai, Shigeru Toyoda, Kaoru Dohi, Haruo Kamiya, Keisuke Kida, Toshihisa Anzai, Taishiro Chikamori, Koichi Node
    Springer Science and Business Media LLC, Nov. 2022, Hypertension Research, 46(2) (2), 495 - 506
    [Refereed]
    Scientific journal

  • Mitsuru Ichii, Masafumi Kurajoh, Yujiro Okute, Yasutaka Ihara, Takumi Imai, Tomoaki Morioka, Katsuhito Mori, Tetsuo Shoji, Yoshihiro Tsujimoto, Takanobu Ubai, Masanori Emoto
    Coronavirus disease 2019 (COVID-19) vaccination reduces the risk of progression to severe COVID-19 in the general population. To examine that preventive effect in dialysis patients, the association of vaccination status with severe COVID-19 progression was investigated in this retrospective observational study conducted from December 2020 to May 2022 of 100 such patients hospitalized for non-severe COVID-19 at Inoue Hospital (Suita, Japan). Fifty-seven were fully vaccinated, defined as receiving a COVID-19 vaccine second dose at least 14 days prior to the onset of COVID-19, while 43 were not. Among all patients, 13 (13.0%) progressed to severe COVID-19 with a median (interquartile range) time of 6 (2.5–9.5) days, while 87 (87.0%) were discharged after 11 (8–16) days. Kaplan–Meier analysis showed that fully vaccinated patients had a significantly lower rate of progression to severe COVID-19 (p = 0.001, log-rank test). Cox proportional hazard analysis also indicated that full COVID-19 vaccination was significantly associated with reduced instances of progression to severe COVID-19 (hazard ratio 0.104, 95% confidence interval 0.022 to 0.483; p = 0.004) after balancing patient background characteristics using an inverse probability of treatment weight method. These results suggest that full vaccination status contributes to reducing the risk of progression from non-severe to severe COVID-19 in dialysis patients.
    MDPI AG, Oct. 2022, Journal of Clinical Medicine, 11(21) (21), 6348 - 6348
    [Refereed]
    Scientific journal

  • Satoshi Yamaguchi, Michio Shimabukuro, Atsushi Tanaka, Takumi Imai, Shinya Hiramitsu, Naohiko Takahashi, Toshiaki Kadokami, Masayoshi Ajioka, Makoto Suzuki, Koichi Node
    Wiley, Oct. 2022, Diabetes, Obesity and Metabolism
    [Refereed]
    Scientific journal

  • Ryutaro Numaguchi, Masafumi Kurajoh, Yoshikazu Hiura, Takumi Imai, Tomoaki Morioka, Mika Saito, Satoshi Shiraishi, Masanori Emoto, Yukio Nishiguchi
    Wiley, Oct. 2022, Journal of Diabetes Investigation, 13(10) (10), 1779 - 1787
    [Refereed]
    Scientific journal

  • Atsushi Tanaka, Takumi Imai, Michio Shimabukuro, Isao Taguchi, Akira Sezai, Shigeru Toyoda, Hirotaka Watada, Junya Ako, Koichi Node
    Abstract Background Insulin resistance and hyperinsulinemia in patients with type 2 diabetes (T2D) are adversely associated with the development and worsening of heart failure (HF). Herein, we sought to investigate the effect of canagliflozin on insulin concentrations and the associations of changes in insulin concentrations with HF-related clinical parameters in patients with T2D and HF. Methods This was a post-hoc analysis of the investigator-initiated, multicenter, open-label, randomized, controlled CANDLE trial for patients with T2D and chronic HF (UMIN000017669). The endpoints were the effects of 24 weeks of canagliflozin treatment, relative to glimepiride treatment, on insulin concentrations and the relationship between changes in insulin concentrations and clinical parameters of interest, including New York Heart Association (NYHA) classification. The effects of canagliflozin on those parameters were also analyzed by baseline insulin level. Results Among the participants in the CANDLE trial, a total of 129 patients (canagliflozin, n = 64; glimepiride, n = 65) who were non-insulin users with available serum insulin data both at baseline and week 24 were included in this analysis. Overall, the mean age was 69.0 ± 9.4 years; 75% were male; the mean HbA1c was 6.8 ± 0.7%; and the mean left ventricular ejection fraction was 59.0 ± 14.1%, with parameters roughly balanced between treatment groups. Canagliflozin treatment significantly reduced insulin concentrations at week 24 (p < 0.001), and the between-group difference (canagliflozin minus glimepiride) in those changes was − 3.52 mU/L (95% confidence interval, − 4.85 to − 2.19; p < 0.001). Decreases in insulin concentrations, irrespective of baseline insulin level, were significantly associated with improvement in NYHA class in patients treated with canagliflozin. Conclusion Our findings suggest that canagliflozin treatment in patients with T2D and HF ameliorated excess insulin overload, contributing to the improvement of clinical HF status. Trial registration: University Medical Information Network Clinical Trial Registry, number 000017669, Registered on May 25, 2015.
    Springer Science and Business Media LLC, Aug. 2022, Cardiovascular Diabetology, 21(1) (1)
    [Refereed]
    Scientific journal

  • Katsuhiro Ono, Sadahiko Uchimoto, Masamune Miyazaki, Natsuki Honda, Katsuhito Mori, Tomoaki Morioka, Takumi Imai, Tetsuo Shoji, Masanori Emoto
    Complete right bundle branch block (CRBBB) is generally regarded as a clinically insignificant abnormality on an electrocardiogram, although its predictive value for cardiovascular events in type 2 diabetes mellitus (T2DM) is unknown. We examined the association of CRBBB with cardiovascular events during a 6-year follow-up in a single-center cohort study. The Fine–Gray model was used to analyze the independent association between CRBBB and composite cardiovascular events including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure during follow up. We analyzed the data of 370 T2DM patients including 62 patients with pre-existing heart disease. CRBBB was found in 34 patients (9.2%). The composite cardiovascular outcome was recorded in 32 patients. When analyzed with the Fine–Gray model with inverse probability of treatment weighting, CRBBB was significantly associated with a higher risk of the cardiovascular outcome (hazard ratio, 2.55; 95% confidence interval, 1.04 to 6.26; p = 0.041). This association remained significant even after further adjustment for each of the potential confounders. This study suggested that CRBBB was an independent predictor of cardiovascular events in T2DM. Further studies with a larger sample size are warranted.
    MDPI AG, Aug. 2022, Journal of Clinical Medicine, 11(15) (15), 4618 - 4618
    [Refereed]
    Scientific journal

  • Akira Sezai, Atsushi Tanaka, Takumi Imai, Keisuke Kida, Hisakuni Sekino, Toyoaki Murohara, Masataka Sata, Norio Suzuki, Koichi Node
    BACKGROUND: We present results of a 24-week comparative study of the effects of the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin vs. the sulfonylurea glimepiride, by baseline body mass index (BMI), in patients with type 2 diabetes and chronic heart failure. METHODS: We conducted a post hoc analysis of the CANDLE trial. This subanalysis evaluated NT-proBNP, BMI, and other laboratory parameters, according to the subgroups stratified by BMI ≥ 25 kg/m2 vs. BMI < 25 kg/m2. RESULTS: A group ratio of proportional changes in the geometric means of NT-proBNP was 0.99 (p = 0.940) for the subgroup with BMI ≥ 25 kg/m2 and 0.85 (p = 0.075) for the subgroup with BMI < 25 kg/m2, respectively. When baseline BMI was modeled as a continuous variable, results for patients with BMI < 30 kg/m2 showed a slightly smaller increase in NT-proBNP in the canagliflozin group vs. the glimepiride group (p = 0.295); that difference was not seen among patients with BMI ≥30 kg/m2 (p = 0.948). Irrespective of obesity, the canagliflozin group was associated with significant reduction in BMI compared to the glimepiride group. CONCLUSION: There was no significant difference in the effects of canagliflozin, relative to glimepiride, on NT-proBNP concentrations irrespective of baseline obesity. UMIN clinical trial registration number: UMIN000017669.
    Jul. 2022, Biomedicines, 10(7) (7), English, International magazine
    [Refereed]
    Scientific journal

  • Yutaka Murata, Takumi Imai, Chikashi Takeda, Toshiyuki Mizota, Shuji Kawamoto
    Abstract In liver transplantation for end-stage liver failure, monitoring of continuous cardiac output (CCO) is used for circulatory management due to hemodynamic instability. CCO is often measured using the minimally invasive FloTrac/Vigileo system (FVS-CCO), instead of a highly invasive pulmonary artery catheter (PAC-CCO). The FVS has improved accuracy due to an updated cardiac output algorithm, but the effect of this change on the accuracy of FVS-CCO in liver transplantation is unclear. In this study, we assessed agreement between fourth-generation FVS-CCO and PAC-CCO in 20 patients aged ≥ 20 years who underwent scheduled or emergency liver transplantation at Kyoto University Hospital from September 2019 to June 2021. Consent was obtained before surgery and data were recorded throughout the surgical period. Pearson correlation coefficient (r), Bland–Altman and 4-quadrant plot analyses were performed on the extracted data. A total of 1517 PAC-CCO vs. FVS-CCO data pairs were obtained. The mean PAC-CCO was 8.73 L/min and the mean systemic vascular resistance was 617.5 dyne·s·cm-5, r was 0.48, bias was 1.62 L/min, the 95% limits of agreement were − 3.04 to 6.27, and the percentage error was 54.36%. These results show that agreement and trending between fourth-generation FVS-CCO and PAC-CCO are low in adult liver transplant recipients.
    Springer Science and Business Media LLC, Jul. 2022, Scientific Reports, 12(1) (1), 11198 - 11198, English, International magazine
    [Refereed]
    Scientific journal

  • Shinya Fujiki, Atsushi Tanaka, Takumi Imai, Michio Shimabukuro, Hiroki Uehara, Ikuko Nakamura, Kazuo Matsunaga, Makoto Suzuki, Takeshi Kashimura, Tohru Minamino, Takayuki Inomata, Koichi Node
    BACKGROUND: In patients with chronic heart failure (CHF) and type 2 diabetes (T2D), sodium-glucose cotransporter-2 (SGLT2) inhibition improves cardiorenal outcomes, but details of the effects on distinct subsets of body fluid volume remain incomplete. METHODS: This was a post hoc analysis of patients with CHF and T2D in the CANDLE trial (UMIN000017669), an investigator-initiated, multi-center, randomized open-label trial that compared the effect of canagliflozin (100 mg, n = 113) with glimepiride (starting dose: 0.5 mg, n = 120) on changes in N-terminal pro-brain natriuretic peptide. The estimated plasma volume (ePV, calculated with the Straus formula) and estimated extracellular volume (eEV, determined by the body surface area) were compared between treatment groups at weeks 4, 12, and 24. RESULTS: Among 233 patients analyzed, 166 (71.2%) had an ejection fraction (EF) > 50%. Reductions in ePV and eEV were observed only in the canagliflozin group until week 12 (change from baseline at week 12, ePV; - 7.63%; 95% confidence interval [CI], - 10.71 to - 4.55%, p < 0.001, eEV; - 123.15 mL; 95% CI, - 190.38 to - 55.92 mL, p < 0.001). While ePV stopped falling after week 12, eEV continued to fall until week 24 ([change from baseline at week 24] - [change from baseline at week 12], ePV; 1.01%; 95%CI, - 2.30-4.32%, p = 0.549, eEV; - 125.15 mL; 95% CI, - 184.35 to - 65.95 mL, p < 0.001). CONCLUSIONS: Maintenance of a modest reduction in ePV and continuous removal of eEV via chronic SGLT2 inhibition suggests that favorable body fluid regulation contributes to the cardiorenal benefits of SGLT2 inhibitors in patients with CHF, irrespective of EF. TRIAL REGISTRATION: UMIN000017669.
    Springer Science and Business Media LLC, Jun. 2022, Clinical Research in Cardiology, 112(1) (1), 87 - 97, English, International magazine
    [Refereed]
    Scientific journal

  • Atsushi Tanaka, Takumi Imai, Makoto Suzuki, Shinya Hiramitsu, Naohiko Takahashi, Toshiaki Kadokami, Arihiro Kiyosue, Masami Nishino, Yasushi Sakata, Koichi Node
    May 2022, DIABETES OBESITY & METABOLISM, 24(5) (5), 962 - 965, English
    [Refereed]

  • Sumihiro Kawano, Takumi Imai, Taiji Sakamoto
    Mar. 2022, JAPANESE JOURNAL OF OPHTHALMOLOGY, English
    [Refereed]
    Scientific journal

  • Takumi Imai, Takayuki Hosoi, Hiroshi Hagino, Takanori Yamamoto, Tatsuhiko Kuroda, Hiroshi Watanabe, Shiro Tanaka
    Lead, Japan Epidemiological Association, 2022, Journal of Epidemiology
    [Refereed]
    Scientific journal

  • Mitsuhiro Tamoto, Takumi Imai, Rei Aida, Yusuke Harada, Yuki Wakabayashi, Gaku Satone, Shunsuke Ichoda, Takeshi Unoki, Ayumi Shintani
    AIM: Accurately calculating the Sequential Organ Failure Assessment (SOFA) score is essential for medical resource allocation and decision-making. This study surveyed Japanese intensive care units regarding their assessment of the Glasgow Coma Scale (GCS) and PaO2/FIO2 ratio, components of the SOFA score. METHODS: A cross-sectional, web-based survey was conducted among healthcare workers. The survey consisted of questions about the intensive care units where they work and questions for respondents. It was distributed to healthcare workers by e-mail through the Japanese Society of Intensive Care Medicine mailing list and social networking service. RESULTS: Among 414 responses, we obtained 211 valid responses and 175 survey results from unique intensive care units. When assessing GCS in patients under the influence of sedatives, 45.1% (95% confidence interval, 37.6-52.8) of intensive care units assessed GCS assuming that the sedatives had no influence. For the PaO2/FIO2 ratio in the SOFA score, calculation based on the Japanese Intensive Care Patient Database definition document and mechanical ventilator settings were the most common methods in patients with oxygen masks and on extracorporeal membrane oxygenation, respectively. Approximately 60% of respondents indicated that it was difficult to assess GCS assuming that sedatives had no influence. CONCLUSION: In patients under the influence of sedatives, approximately half of the intensive care units assessed assumed GCS. There was variation in the methods used to assess the PaO2/FIO2 ratio. Standardized assessment methods for GCS and the PaO2/FIO2 ratio are needed to obtain valid SOFA score.
    Wiley, Jan. 2022, Acute Medicine & Surgery, 9(1) (1), e785, English, International magazine
    [Refereed]
    Scientific journal

  • Hiroaki Tanaka, Mami Yoshii, Takumi Imai, Tatsuro Tamura, Takahiro Toyokawa, Kazuya Muguruma, Kosei Hirakawa, Masaichi Ohira
    Nov. 2021, MOLECULAR AND CLINICAL ONCOLOGY, 15(5) (5), English
    [Refereed]
    Scientific journal

  • Yuma Yamashita, Hiroshi Kawaguchi, Tsubasa Yano, Norihiro Sakurai, Wataru Shibata, Kazuhiro Oshima, Takumi Imai, Koichi Yamada, Yasutaka Nakamura, Katsuya Nagayama, Hiroshi Kakeya
    Nov. 2021, JOURNAL OF INFECTION AND CHEMOTHERAPY, 27(11) (11), 1614 - 1620, English
    [Refereed]
    Scientific journal

  • Yu Nakagama, Yuko Komase, Katherine Candray, Sachie Nakagama, Fumiaki Sano, Tomoya Tsuchida, Hiroyuki Kunishima, Takumi Imai, Ayumi Shintani, Yuko Nitahara, Natsuko Kaku, Yasutoshi Kido
    Oct. 2021, MICROBIOLOGY SPECTRUM, 9(2) (2), English
    [Refereed]
    Scientific journal

  • Kenya Kusunose, Takumi Imai, Atsushi Tanaka, Kaoru Dohi, Kazuki Shiina, Takahisa Yamada, Keisuke Kida, Kazuo Eguchi, Hiroki Teragawa, Yasuchika Takeishi, Nobuyuki Ohte, Hirotsugu Yamada, Masataka Sata, Koichi Node
    Sep. 2021, CARDIOVASCULAR DIABETOLOGY, 20(1) (1), English
    [Refereed]
    Scientific journal

  • Masahiro Suzuki, Takumi Imai, Aki Sakurai, Satoshi Komoto, Tomihiko Ide, Chang Kweng Lim, Ayumi Shintani, Yohei Doi, Takayuki Murata
    Sep. 2021, JOURNAL OF INFECTION AND CHEMOTHERAPY, 27(9) (9), 1350 - 1356, English
    [Refereed]
    Scientific journal

  • Atsushi Tanaka, Shigeru Toyoda, Takumi Imai, Kazuki Shiina, Hirofumi Tomiyama, Yasushi Matsuzawa, Takahiro Okumura, Yumiko Kanzaki, Katsuya Onishi, Arihiro Kiyosue, Masami Nishino, Yasushi Sakata, Koichi Node
    Sep. 2021, CARDIOVASCULAR DIABETOLOGY, 20(1) (1), English
    [Refereed]
    Scientific journal

  • Tomohiko Urano, Masataka Shiraki, Takumi Imai, Norio Iinuma, Tatsuhiko Kuroda, Shiro Tanaka, Mitsuru Saito
    Aug. 2021, GERIATRICS & GERONTOLOGY INTERNATIONAL, 21(8) (8), 651 - 656, English
    [Refereed]
    Scientific journal

  • Yusuke Kimura, Kojiro Taura, Nguyen Hai Nam, Yusuke Uemoto, Kenji Yoshino, Yoshinobu Ikeno, Yukihiro Okuda, Takahiro Nishio, Gen Yamamoto, Kazutaka Tanabe, Yukinori Koyama, Takayuki Anazawa, Ken Fukumitsu, Takashi Ito, Shintaro Yagi, Naoko Kamo, Satoru Seo, Keiko Iwaisako, Koichiro Hata, Takumi Imai, Shinji Uemoto
    Feb. 2021, LIVER TRANSPLANTATION, 27(3) (3), 403 - 415, English
    [Refereed]
    Scientific journal

  • Takumi Imai, Shiro Tanaka, Koji Kawakami
    Lead, Jan. 2021, STATISTICS IN MEDICINE, 40(2) (2), 226 - 239, English
    [Refereed]
    Scientific journal

  • Jun Ishigooka, Tatsuya Hoshino, Takumi Imai, Hisako Yoshida, Midori Ono, Mihoko Ota, Yoshiya Moriguchi, Keita Fujikawa, Ayumi Shintani, Jovelle L. Fernandez
    2021, NEUROPSYCHIATRIC DISEASE AND TREATMENT, 17, 2915 - 2924, English
    [Refereed]
    Scientific journal

  • Sumihiro Kawano, Takumi Imai, Taiji Sakamoto
    Jan. 2021, BRITISH JOURNAL OF OPHTHALMOLOGY, English
    [Refereed]
    Scientific journal

  • Yohei Doi, Masaya Hibino, Ryota Hase, Michiko Yamamoto, Yu Kasamatsu, Masahiro Hirose, Yoshikazu Mutoh, Yoshito Homma, Masaki Terada, Taku Ogawa, Fumihiro Kashizaki, Toshihiko Yokoyama, Hayato Koba, Hideki Kasahara, Kazuhisa Yokota, Hideaki Kato, Junichi Yoshida, Toshiyuki Kita, Yasuyuki Kato, Tadashi Kamio, Nobuhiro Kodama, Yujiro Uchida, Nobuhiro Ikeda, Masahiro Shinoda, Atsushi Nakagawa, Hiroki Nakatsumi, Tomoya Horiguchi, Mitsunaga Iwata, Akifumi Matsuyama, Sumi Banno, Takenao Koseki, Mayumi Teramachi, Masami Miyata, Shigeru Tajima, Takahiro Maeki, Eri Nakayama, Satoshi Taniguchi, Chang Kweng Lim, Masayuki Saijo, Takumi Imai, Hisako Yoshida, Daijiro Kabata, Ayumi Shintani, Yukio Yuzawa, Masashi Kondo
    Dec. 2020, ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 64(12) (12), English
    [Refereed]
    Scientific journal

  • Masataka Shiraki, Shoji Kashiwabara, Takumi Imai, Shiro Tanaka, Mitsuru Saito
    Nov. 2019, JOURNAL OF BONE AND MINERAL METABOLISM, 37(6) (6), 1067 - 1074, English
    [Refereed]
    Scientific journal

  • Yasuyoshi Ouchi, Jun Sasaki, Hidenori Arai, Koutaro Yokote, Kazumasa Harada, Yasuo Katayama, Takao Urabe, Yasufumi Uchida, Masaru Hayashi, Naoto Yokota, Hirokazu Nishida, Takatoshi Otonari, Tadashi Arai, Ichiro Sakuma, Kazuo Sakabe, Masayasu Yamamoto, Takashi Kobayashi, Shinichi Oikawa, Shizuya Yamashita, Hiromi Rakugi, Takumi Imai, Shiro Tanaka, Yasuo Ohashi, Masanari Kuwabara, Hideki Ito
    Sep. 2019, CIRCULATION, 140(12) (12), 992 - 1003, English
    [Refereed]
    Scientific journal

  • Akira Taguchi, Yukari Uemura, Takumi Imai, Shiro Tanaka, Hiroaki Ohta, Toshitaka Nakamura, Hajime Orimo, Toshitsugu Sugimoto, Satoshi Soen, Masataka Shiraki
    Sep. 2019, JOURNAL OF BONE AND MINERAL METABOLISM, 37(5) (5), 886 - 892, English
    [Refereed]
    Scientific journal

  • Ryusuke Miki, Masato Takeuchi, Takumi Imai, Tomotsugu Seki, Shiro Tanaka, Masaki Nakamura, Koji Kawakami
    Aug. 2019, JOURNAL OF CARDIOLOGY, 74(2) (2), 109 - 115, English
    [Refereed]
    Scientific journal

  • K.K. Nakao, A. Kido, T. Imai, K. Abiko, K. Fujimoto, A. Horie, S. Minamiguchi, S. Tanaka, M. Mandai, K. Togashi
    Elsevier BV, Apr. 2019, Clinical Radiology, 74(4) (4), 326.e1 - 326.e8
    [Refereed]
    Scientific journal

  • Kenji Yoshino, Kojiro Taura, Yukihiro Okuda, Yoshinobu Ikeno, Yusuke Uemoto, Takahiro Nishio, Gen Yamamoto, Kazutaka Tanabe, Yukinori Koyama, Satoru Seo, Toshimi Kaido, Hideaki Okajima, Takumi Imai, Shiro Tanaka, Shinji Uemoto
    Apr. 2019, HEPATOLOGY RESEARCH, 49(4) (4), 394 - 403, English
    [Refereed]
    Scientific journal

  • Takahisa Tsukada, Izumi Sato, Norihiro Matsuoka, Takumi Imai, Yuko Doi, Masaru Arai, Yosuke Fujii, Toshiyuki Matsunaga, Koji Kawakami
    Jul. 2018, JOURNAL OF GERIATRIC PSYCHIATRY AND NEUROLOGY, 31(4) (4), 194 - 202, English
    [Refereed]
    Scientific journal

  • Yuji Kanazawa, Kazuo Funabiki, Akiko Taura, Takumi Imai, Hiroko Torii, Hideaki Ogita, Takayuki Okano, Juichi Ito, Koichi Omori
    2018, ACTA OTO-LARYNGOLOGICA, 138(7) (7), 633 - 638, English
    [Refereed]
    Scientific journal

  • T Imai, S Tanaka, K Kawakami, T Miyazaki, H Hagino, M Shiraki
    We assessed the health state utility value (HSUV) reductions associated with vertebral fractures using data collected in the Japanese Osteoporosis Intervention Trial-03 (JOINT-03). Our analysis revealed that assessment of HSUVs after morphometric vertebral fracture is important to capture the burden of vertebral fractures. INTRODUCTION: Evaluation of the HSUV after fracture is important to calculate the quality-adjusted life years (QALYs) of osteoporosis patients, which is essential information in the context of health economic evaluation. METHODS: JOINT-03 study patients were aged ≥65 years and treated with risedronate and vitamin K2 or risedronate alone. Radiographic information and patient-reported outcomes measured by EQ-5D and a visual analogue scale (VAS) were assessed at registration and followed up after 6, 12, and 24 months. According to differences among the dates of these assessments and the radiographic information, we classified the follow-up HSUVs calculated based on EQ-5D results into before or after fracture categories regardless of clinical symptoms. RESULTS: Among 2922 follow-up HSUVs, 201 HSUVs were categorized as HSUVs that were observed after incident vertebral fractures on X-ray films. The median time from the detection of an incident vertebral fracture until the EQ-5D assessment was 53 days (25th percentile, 0 day; 75th percentile, 357 days). The impact of incident vertebral fractures on HSUVs was quantified as -0.03. Among the five health profile domains on the EQ-5D, an incident vertebral fracture had significant effects on anxiety/depression, self-care, and usual activities. CONCLUSIONS: The results suggest that incident morphometric vertebral fracture was associated with impairment of the HSUV for patients with osteoporosis not only immediately but also several months after the fracture.
    Lead, Jun. 2017, Osteoporosis international, 28(6) (6), 1893 - 1901, English, International magazine
    [Refereed]
    Scientific journal

  • Methodology of Semiparametric Estimation for Data with Missingness
    今井匠
    Lead, 2017, 応用統計学, 46(2) (2)
    [Refereed]

  • Takeshi Kimura, Masato Takeuchi, Takumi Imai, Shiro Tanaka, Koji Kawakami
    BACKGROUND: A high proportion of extremely preterm (EPT) infants are born by cesarean section (CS). However, whether the mode of delivery is related to long-term neurodevelopment in these infants is unclear. OBJECTIVES: This study aimed to determine whether the mode of delivery is associated with mortality and long-term outcomes in EPT infants. METHODS: We analyzed data of the Neonatal Research Network in Japan (NRNJ), a population-based, nationwide registry. Inclusion criteria were neonates who were born between 2003 and 2012 with a gestational age <26 weeks. The primary composite outcome was death before 3 years or neurodevelopmental impairment (NDI) at 3 years. Confounder-adjusted odds ratios (OR) were estimated by logistic generalized linear mixed models, which accounted for clustering within hospitals. RESULTS: 2,138 eligible infants (703 by vaginal delivery [VD] and 1,435 by CS) were identified for primary analysis. The composite outcome of death or NDI was not different between both groups (66.7% by VD and 62.7% by CS, p = 0.075). After multivariate analysis adjusting for confounders, we found that CS did not improve the composite outcome of death or NDI (OR = 0.839, 95% confidence interval = 0.816-1.328, p = 0.742). For secondary outcomes, mortality (OR = 0.824, p = 0.150), NDI (OR = 1.237, p = 0.165), and other neurodevelopmental outcomes were not different between the groups. CONCLUSIONS: Among neonates born at <26 weeks, CS does not improve mortality and neurodevelopmental outcomes at 3 years in the NRNJ cohort. However, because of several potential biases such as high rates of infants lost to follow-up, further evidence may be required.
    2017, Neonatology, 112(3) (3), 258 - 266, English, International magazine
    [Refereed]
    Scientific journal

  • Kazuki Ide, Izumi Sato, Takumi Imai, Philip Hawke, Hiroshi Yamada, Yohei Kawasaki, Naohiko Masaki
    Dec. 2016, BIOLOGICAL & PHARMACEUTICAL BULLETIN, 39(12) (12), 2060 - 2065, English
    [Refereed]
    Scientific journal

  • Takumi Imai, K. -I Izawa
    Jun. 2014, PROGRESS OF THEORETICAL AND EXPERIMENTAL PHYSICS, 2014(6) (6), English
    [Refereed]
    Scientific journal

  • Takumi Imai, K-I Izawa, Yuichiro Nakai
    Oct. 2012, PHYSICS LETTERS B, 717(1-3) (1-3), 257 - 260, English
    [Refereed]
    Scientific journal

■ MISC
  • 多施設共同ランダム化臨床試験における治療効果の施設間差評価⼿法の検討
    今井匠
    Lead, Feb. 2025, ⽇本臨床試験学会第16回学術集会総会予稿集 P-143

  • 新型コロナウイルス感染症に関連する統計知識 ～5～11歳に対するワクチン効果の論文を読み解く～
    今井匠
    Lead, Dec. 2022, up-to-date 子どもの感染症, 10(1) (1), 34 - 37

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Nov. 2021, 薬局, 72(12) (12), 3435 - 3443, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Oct. 2021, 薬局, 72(11) (11), 3284 - 3293, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Sep. 2021, 薬局, 72(10) (10), 3148 - 3154, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Aug. 2021, 薬局, 72(9) (9), 3019 - 3026, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Jul. 2021, 薬局, 72(8) (8), 2888 - 2896, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Jun. 2021, 薬局, 72(7) (7), 2723 - 2731, Japanese

  • 毒舌妻と統計家 臨床試験論文を読んでみる(第6回) 新型コロナウイルス感染症のワクチンができるまで(前編)
    今井 匠, 井出 和希
    Lead, (株)南山堂, May 2021, 薬局, 72(6) (6), 2529 - 2540, Japanese

  • 毒舌妻と統計家 臨床試験論文を読んでみる(第5回) カプランマイヤー曲線と患者の半分が回復するまでの時間
    今井 匠, 井出 和希
    Lead, (株)南山堂, Apr. 2021, 薬局, 72(5) (5), 2352 - 2362, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Mar. 2021, 薬局, 72(3) (3), 503 - 509, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Feb. 2021, 薬局, 72(2) (2), 363 - 370, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Dec. 2020, 薬局, 71(13) (13), 3693 - 3702, Japanese

  • 今井 匠, 井出 和希
    Lead, (株)南山堂, Nov. 2020, 薬局, 71(12) (12), 3507 - 3512, Japanese

  • 骨粗鬆症論文で理解する生物統計学講義
    今井 匠
    (一社)日本骨粗鬆症学会, Sep. 2019, 日本骨粗鬆症学会雑誌, 5(Suppl.1) (Suppl.1), 246 - 246, Japanese

  • 骨粗鬆症論文で理解する生物統計学 代表的な手法とその結果の解釈(第13回) 操作変数(instrumental variable)法を用いた交絡の調整
    上村 夕香理, 田中 司朗, 今井 匠
    (一社)日本骨粗鬆症学会, Feb. 2019, 日本骨粗鬆症学会雑誌, 5(1) (1), 17 - 21, Japanese

  • 臨床研究 骨粗鬆症論文で理解する生物統計学 代表的な手法とその結果の解釈(第12回) 医薬品の費用対効果
    田中 司朗, 清水 さやか, 耒海 美穂, 今井 匠, 上村 夕香理
    (一社)日本骨粗鬆症学会, Nov. 2018, 日本骨粗鬆症学会雑誌, 4(4) (4), 461 - 466, Japanese

  • 臨床研究 骨粗鬆症論文で理解する生物統計学 代表的な手法とその結果の解釈(第11回) Inverse Probability of Treatment Weighted法を用いた交絡の調整
    上村 夕香理, 田中 司朗, 今井 匠
    (一社)日本骨粗鬆症学会, Aug. 2018, 日本骨粗鬆症学会雑誌, 4(3) (3), 281 - 286, Japanese

  • 臨床研究 骨粗鬆症論文で理解する生物統計学 代表的な手法とその結果の解釈(第10回) プロペンシティスコアを用いた交絡の調整
    田中 司朗, 今井 匠, 上村 夕香理
    日本骨粗鬆症学会, May 2018, 日本骨粗鬆症学会雑誌, 4(2) (2), 139 - 143, Japanese

  • 臨床研究 骨粗鬆症論文で理解する生物統計学 代表的な手法とその結果の解釈(第10回) プロペンシティスコアを用いた交絡の調整
    田中 司朗, 今井 匠, 上村 夕香理
    (一社)日本骨粗鬆症学会, May 2018, 日本骨粗鬆症学会雑誌, 4(2) (2), 139 - 143, Japanese

  • 臨床研究 骨粗鬆症論文で理解する生物統計学 代表的な手法とその結果の解釈(第9回) データベース研究と交絡
    田中 司朗, 今井 匠, 上村 夕香理
    (一社)日本骨粗鬆症学会, Feb. 2018, 日本骨粗鬆症学会雑誌, 4(1) (1), 19 - 23, Japanese

  • 臨床研究 骨粗鬆症論文で理解する生物統計学 代表的な手法とその結果の解釈(第8回) 平均因果効果とintention-to-treat解析
    上村 夕香理, 田中 司朗, 今井 匠
    (一社)日本骨粗鬆症学会, Nov. 2017, 日本骨粗鬆症学会雑誌, 3(4) (4), 361 - 365, Japanese

  • 栄養指標と骨粗鬆症患者QOLとの関連性 JOINT-03解析結果より
    萩野 浩, 今井 匠, 田中 司朗, 上西 一弘, 宮崎 輝彦, 折茂 肇, 白木 正孝
    (一社)日本骨粗鬆症学会, Sep. 2017, 日本骨粗鬆症学会雑誌, 3(Suppl.1) (Suppl.1), 190 - 190, Japanese

  • BP製剤使用患者における顎骨壊死の発生率と口腔への効果
    田口 明, 上村 夕香理, 今井 匠, 田中 司朗, 太田 博明, 中村 利孝, 折茂 肇, 白木 正孝
    (一社)日本骨粗鬆症学会, Sep. 2017, 日本骨粗鬆症学会雑誌, 3(Suppl.1) (Suppl.1), 192 - 192, Japanese

  • 臨床研究 骨粗鬆症論文で理解する生物統計学 代表的な手法とその結果の解釈(第7回) 代替エンドポイント
    田中 司朗, 今井 匠, 上村 夕香理
    (一社)日本骨粗鬆症学会, Aug. 2017, 日本骨粗鬆症学会雑誌, 3(3) (3), 267 - 272, Japanese

  • C型慢性肝炎患者に対するPeginterferon afla‐2aまたはPeginterferon afla‐2bとリバビリン併用療法の安全性の検討~肝炎に関する全国規模のデータベースを用いて~
    佐藤泉美, 川崎洋平, 田中佐智子, 今井匠, 宮岡悦良, 新保卓郎, 正木尚彦
    (一社)日本薬剤疫学会, Oct. 2014, 日本薬剤疫学会学術総会抄録集, 20th, 70 - 71, Japanese

■ Affiliated Academic Society
  • 日本臨床試験学会
    Nov. 2024 - Present

  • 日本計量生物学会
    Oct. 2014 - Present

■ Research Themes
  • 多施設共同ランダム化臨床試験における治療効果の施設間差評価手法の開発
    今井匠
    日本学術振興会 科学研究費助成事業 若手研究, Apr. 2022 - Mar. 2024, Principal investigator

  • 関節リウマチ患者のサルコペニア改善と分子標的薬の寛解休薬をめざした運動療法の治療ストラテジー開発
    橋本求
    国立研究開発法人日本医療研究開発機構（AMED） 日本医療研究開発機構研究費 免疫アレルギー疾患実用化研究事業, Apr. 2020 - Mar. 2022

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