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

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

PURPOSE: We 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). METHODS: This 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. RESULTS: The 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. CONCLUSION: Although 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 REGISTRATION: Clinicaltrials.gov number: NCT00212017. More... »

PAGES

401-411

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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47 schema:description PURPOSE: We 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). METHODS: This 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. RESULTS: The 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. CONCLUSION: Although 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 REGISTRATION: Clinicaltrials.gov number: NCT00212017.
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