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Randomized Controlled Trial
. 2017 Aug;31(4):401-411.
doi: 10.1007/s10557-017-6740-3.

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

Masanori Asakura  1   2 , Jiyoong Kim  1 , Hiroshi Asanuma  3   4 , Toshimitsu Hamasaki  5   6 , Kengo Tsukahara  7 , Yorihiko Higashino  8 , Tetsuya Ishikawa  9 , Yasuharu Nakama  10 , Shinji Koba  11 , Yasuyuki Maruyama  12 , Mitsuru Tsujimoto  13 , Hideo Himeno  14 , Takanori Ohkusa  15 , Susumu Fujino  16 , Makoto Shimizu  17 , Tsutomu Endo  18 , Shunichi Yoda  19 , Takahiro Muroya  20 , Toyoaki Murohara  21 , Nobuyuki Ohte  22 , Hiroshi Suzuki  23 , Tohru Kohno  24   25 , Kazuki Fukui  26 , Takaaki Shiono  27 , Hiroyuki Takase  28 , Hiroyasu Uzui  29 , Yoshiyuki Nagai  30 , Yuji Hashimoto  31 , Shuntaro Ikeda  32 , Sumio Mizuno  33 , Koichi Tamita  34 , Masashi Fujita  35 , Kazuo Satake  36 , Yoshihiko Kinoshita  37 , Tatsuya Nunohiro  38   39 , Satoru Sakagami  40 , Jitsuo Higaki  41 , Isao Morii  42 , Reimin Sawada  43 , Yoshikazu Hiasa  44 , Tomohiko Shigemasa  45 , Makoto Nakahama  46 , Masataka Sata  47 , Osamu Doi  48 , Tetsuro Ueda  49 , Takahisa Yamada  50 , Takayoshi Yamanouchi  51 , Hajime Yamaguchi  52 , Yukiko Morita  53 , Hideki Hayashi  54 , Masafumi Kitakaze  55   56 ; ABC investigators
Affiliations
Randomized Controlled Trial

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

Masanori Asakura et al. Cardiovasc Drugs Ther. 2017 Aug.

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.

Keywords: Alpha-glucosidase inhibitor; Cardiovascular events; Impaired glucose tolerance; Myocardial infarction.

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