Asakura M, et al. – This study was meant to assess the impacts of voglibose on cardiovascular events in survivors of myocardial infarction (MI) and impaired glucose tolerance (IGT). According to findings, IGT was effectively treated by voglibose but it did not offer any added benefits for cardiovascular events in patients with previous MI and IGT. Furthermore, it was observed that voglibose may not be a contributing therapy to the secondary prevention in patients with MI and IGT.

Methods

• Researchers performed this prospective, randomized, open, blinded-endpoint study 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.
• Individual components of the primary endpoint in addition to all-cause mortality and hospitalization due to heart failure were considered as secondary endpoints.

Results

• Findings revealed that 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.
• Researchers found that voglibose improved IGT; however, Kaplan–Meier analysis demonstrated no marked 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.