Does Treatment of Impaired Glucose Tolerance Improve Cardiovascular Outcomes in Patients with Previous Myocardial Infarction? View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-08-04

AUTHORS

Masanori Asakura, Jiyoong Kim, Hiroshi Asanuma, Toshimitsu Hamasaki, Kengo Tsukahara, Yorihiko Higashino, Tetsuya Ishikawa, Yasuharu Nakama, Shinji Koba, Yasuyuki Maruyama, Mitsuru Tsujimoto, Hideo Himeno, Takanori Ohkusa, Susumu Fujino, Makoto Shimizu, Tsutomu Endo, Shunichi Yoda, Takahiro Muroya, Toyoaki Murohara, Nobuyuki Ohte, Hiroshi Suzuki, Tohru Kohno, Kazuki Fukui, Takaaki Shiono, Hiroyuki Takase, Hiroyasu Uzui, Yoshiyuki Nagai, Yuji Hashimoto, Shuntaro Ikeda, Sumio Mizuno, Koichi Tamita, Masashi Fujita, Kazuo Satake, Yoshihiko Kinoshita, Tatsuya Nunohiro, Satoru Sakagami, Jitsuo Higaki, Isao Morii, Reimin Sawada, Yoshikazu Hiasa, Tomohiko Shigemasa, Makoto Nakahama, Masataka Sata, Osamu Doi, Tetsuro Ueda, Takahisa Yamada, Takayoshi Yamanouchi, Hajime Yamaguchi, Yukiko Morita, Hideki Hayashi, Masafumi Kitakaze, ABC investigators

ABSTRACT

PurposeWe evaluated the effects of an alpha-glucosidase inhibitor, voglibose, on cardiovascular events in patients with a previous myocardial infarction (MI) and impaired glucose tolerance (IGT).MethodsThis prospective, randomized, open, blinded-endpoint study was conducted in 112 hospitals and clinics in Japan in 3000 subjects with both previous MI and IGT receiving voglibose (0.6 mg/day, n = 424) or no drugs (n = 435) for 2 years. The Data and Safety Monitoring Board (DSMB) recommended discontinuation of the study in June 2012 after an interim analysis when the outcomes of 859 subjects were obtained. The primary endpoint was cardiovascular events including cardiovascular death, nonfatal MI, nonfatal unstable angina, nonfatal stroke, and percutaneous coronary intervention/coronary artery bypass graft. Secondary endpoints included individual components of the primary endpoint in addition to all-cause mortality and hospitalization due to heart failure.ResultsThe age, ratio of males, and HbA1C were 65 vs. 65 years, 86 vs. 87%, and 5.6 vs. 5.5% in the groups with and without voglibose, respectively. Voglibose improved IGT; however, Kaplan–Meier analysis showed no significant between-group difference with respect to cardiovascular events [12.5% with voglibose vs. 10.1% without voglibose for the primary endpoint (95% confidence interval, 0.82–1.86)]; there were no significant differences in secondary endpoints.ConclusionAlthough voglibose effectively treated IGT, no additional benefits for cardiovascular events in patients with previous MI and IGT were observed. Voglibose may not be a contributing therapy to the secondary prevention in patients with MI and IGT.Trial RegistrationClinicaltrials.gov number: NCT00212017 More... »

PAGES

401-411

Journal

TITLE

Cardiovascular Drugs and Therapy

ISSUE

4

VOLUME

31

Author Affiliations

  • Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan
  • Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center Suita, 565-8565, Osaka, Japan
  • Cardiovascular Science and Technology, Kyoto Prefectural University of Medicine, Kyoto, Japan
  • Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan
  • Division of Cardiology, Yokohama City University Medical Center, Kanagawa, Japan
  • Department of Cardiology, Higashi Takarazuka Satoh Hospital, Hyogo, Japan
  • Department of Cardiology, Saitama Prefecture Cardiovascular and Respiratory Center, Saitama, Japan
  • Department of Cardiology, Hiroshima City Hospital, Hiroshima, Japan
  • Division of Cardiology, Department of Medicine, Showa University Hospital, Tokyo, Japan
  • Department of Cardiology, Iwatsuki-minami Hospital, Saitama, Japan
  • Department of Cardiology, Cardiovascular Center, Veritas Hospital, Hyogo, Japan
  • Division of Cardiology, Fujisawa City Hospital, Kanagawa, Japan
  • Department of Cardiology, Hokko Memorial Hospital, Hokkaido, Japan
  • Department of Cardiology, Fukui Prefectural Hospital, Fukui, Japan
  • Department of Cardiology, International Goodwill Hospital, Kanagawa, Japan
  • Department of Cardiology, Saiseikai Yokohama City Southern Hospital, Kanagawa, Japan
  • Division of Cardiology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
  • Department of Cardiology, National Hospital Organization Ureshino Medical Center, Saga, Japan
  • Department of Cardiology, Nagoya University Graduate School of Medicine, Aichi, Japan
  • Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan
  • Division of Cardiology, Showa University Fujigaoka Hospital, Kanagawa, Japan
  • Department of Cardiology, Kasukabe Municipal Hospital, Saitama, Japan
  • Division of Cardiology, Kanagawa Cardiovascular Respiratory Center, Kanagawa, Japan
  • Department of Cardiology, Kitasato University Medical Center, Saitama, Japan
  • Department of Internal Medicine, Enshu Hospital, Shizuoka, Japan
  • Department of Cardiology, Fukui University Hospital, Fukui, Japan
  • Department of Cardiology, Rinku General Medical Center, Osaka, Japan
  • Department of Cardiology, Kameda Medical Center, Chiba, Japan
  • Division of Cardiology, Uwajima City Hospital, Ehime, Japan
  • Department of Cardiology, Fukui Cardiovascular Center, Fukui, Japan
  • Department of Cardiology, Nishinomiya Watanabe Cardiovascular Center, Hyogo, Japan
  • Department of Cardiovascular Division, Kansai Rosai Hospital, Hyogo, Japan
  • Department of Cardiology, Fukui General Clinic, Fukui, Japan
  • Kinoshita Clinic, Hiroshima, Japan
  • Nagasaki Harbor Medical Center City Hospital, Nagasaki, Japan
  • Department of Cardiology, National Hospital Organization Kanazawa Medical Center, Ishikawa, Japan
  • Department of Integrated Medicine and Informatics, Ehime University Graduate School of Medicine, Ehime, Japan
  • Department of Cardiology, Hokusetsu General Hospital, Osaka, Japan
  • Department of Cardiology, Hadano Red Cross Hospital, Kanagawa, Japan
  • Department of Cardiology, Tokushima Red Cross Hospital, Tokushima, Japan
  • Department of Cardiovascular Medicine, International University of Health and Welfare Atami Hospital, Shizuoka, Japan
  • Department of Cardiology, Fukuyama City Hospital, Hiroshima, Japan
  • Department of Cardiovascular Medicine, University of Tokushima, Tokushima, Japan
  • Department of Cardiology, Shizuoka Prefectural General Hospital, Shizuoka, Japan
  • Department of Cardiology, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan
  • Division of Cardiology, Osaka General Medical Center, Osaka, Japan
  • Department of Cardiology, Department of Internal Medicine, Hitachi, Ltd. Hitachinaka General Hospital, Ibaraki, Japan
  • Yamaguchi Clinic, Fukushima, Japan
  • Department of Cardiology, National Hospital Organization Sagamihara Hospital, Kanagawa, Japan
  • Department of Internal Medicine, Hoetsu Hospital, Tokurshima, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s10557-017-6740-3

    DOI

    http://dx.doi.org/10.1007/s10557-017-6740-3

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1090994353

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/28779371


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        "description": "PurposeWe evaluated the effects of an alpha-glucosidase inhibitor, voglibose, on cardiovascular events in patients with a previous myocardial infarction (MI) and impaired glucose tolerance (IGT).MethodsThis prospective, randomized, open, blinded-endpoint study was conducted in 112 hospitals and clinics in Japan in 3000 subjects with both previous MI and IGT receiving voglibose (0.6\u00a0mg/day, n\u00a0=\u00a0424) or no drugs (n\u00a0=\u00a0435) for 2\u00a0years. The Data and Safety Monitoring Board (DSMB) recommended discontinuation of the study in June 2012 after an interim analysis when the outcomes of 859 subjects were obtained. The primary endpoint was cardiovascular events including cardiovascular death, nonfatal MI, nonfatal unstable angina, nonfatal stroke, and percutaneous coronary intervention/coronary artery bypass graft. Secondary endpoints included individual components of the primary endpoint in addition to all-cause mortality and hospitalization due to heart failure.ResultsThe age, ratio of males, and HbA1C were 65 vs. 65\u00a0years, 86 vs. 87%, and 5.6 vs. 5.5% in the groups with and without voglibose, respectively. Voglibose improved IGT; however, Kaplan\u2013Meier analysis showed no significant between-group difference with respect to cardiovascular events [12.5% with voglibose vs. 10.1% without voglibose for the primary endpoint (95% confidence interval, 0.82\u20131.86)]; there were no significant differences in secondary endpoints.ConclusionAlthough voglibose effectively treated IGT, no additional benefits for cardiovascular events in patients with previous MI and IGT were observed. Voglibose may not be a contributing therapy to the secondary prevention in patients with MI and IGT.Trial RegistrationClinicaltrials.gov number: NCT00212017", 
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    26 schema:description PurposeWe evaluated the effects of an alpha-glucosidase inhibitor, voglibose, on cardiovascular events in patients with a previous myocardial infarction (MI) and impaired glucose tolerance (IGT).MethodsThis prospective, randomized, open, blinded-endpoint study was conducted in 112 hospitals and clinics in Japan in 3000 subjects with both previous MI and IGT receiving voglibose (0.6 mg/day, n = 424) or no drugs (n = 435) for 2 years. The Data and Safety Monitoring Board (DSMB) recommended discontinuation of the study in June 2012 after an interim analysis when the outcomes of 859 subjects were obtained. The primary endpoint was cardiovascular events including cardiovascular death, nonfatal MI, nonfatal unstable angina, nonfatal stroke, and percutaneous coronary intervention/coronary artery bypass graft. Secondary endpoints included individual components of the primary endpoint in addition to all-cause mortality and hospitalization due to heart failure.ResultsThe age, ratio of males, and HbA1C were 65 vs. 65 years, 86 vs. 87%, and 5.6 vs. 5.5% in the groups with and without voglibose, respectively. Voglibose improved IGT; however, Kaplan–Meier analysis showed no significant between-group difference with respect to cardiovascular events [12.5% with voglibose vs. 10.1% without voglibose for the primary endpoint (95% confidence interval, 0.82–1.86)]; there were no significant differences in secondary endpoints.ConclusionAlthough voglibose effectively treated IGT, no additional benefits for cardiovascular events in patients with previous MI and IGT were observed. Voglibose may not be a contributing therapy to the secondary prevention in patients with MI and IGT.Trial RegistrationClinicaltrials.gov number: NCT00212017
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