Holman RR, et al. - Researchers planned this study to evaluate whether acarbose could reduce the frequency of cardiovascular events in Chinese patients with established coronary heart disease and impaired glucose tolerance and whether the incidence of type 2 diabetes could be reduced. Acarbose did not reduce the risk of major adverse cardiovascular events in Chinese patients with coronary heart disease and impaired glucose tolerance but did reduce the incidence of diabetes.

• With patients recruited from 176 hospital outpatient clinics in China, the Acarbose Cardiovascular Evaluation (ACE) trial was a randomised, double-blind, placebo-controlled, phase 4 trial.
• The researchers randomly assigned (1:1) Chinese patients with coronary heart disease and impaired glucose tolerance, in blocks by site, by a centralized computer system to receive oral acarbose (50 mg three times a day) or matched placebo, which was added to standardized cardiovascular secondary prevention therapy.
• For this investigation, all study staff and patients were masked to treatment group allocation.
• The primary outcome was a 5-point composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospital admission for unstable angina, and hospital admission for heart failure, analyzed in the intention-to-treat population (all participants randomly assigned to treatment who provided written informed consent).
• A 3-point composite outcome (cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), death from any cause, cardiovascular death, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, hospital admission for unstable angina, hospital admission for heart failure, development of diabetes, and development of impaired renal function were the secondary outcomes.
• All patients who received at least one dose of study medication formed the safety population.

• The researchers included 6,522 patients between March 20, 2009, and Oct 23, 2015.
• They randomly assigned them in the intention-to-treat population, 3272 assigned to acarbose and 3,250 to placebo.
• In both groups, patients were followed up for a median of 5·0 years (IQR 3·4-6·0).
• The primary 5-point composite outcome occurred in 470 (14%; 3·33 per 100 person-years) of 3,272 acarbose group participants and in 479 (15%; 3·41 per 100 person-years) of 3250 placebo group participants (hazard ratio 0·98; 95% CI 0·86-1·11, p=0·73).
• They found no significant differences between treatment groups for the secondary 3-point composite outcome, death from any cause, cardiovascular death, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, hospital admission for unstable angina, hospital admission for heart failure, or impaired renal function.
• In the acarbose group (436 [13%] of 3272; 3·17 per 100 person-years), diabetes developed less frequently compared with the placebo group (513 [16%] of 3250; 3·84 per 100 person-years; rate ratio 0·82, 95% CI 0·71-0·94, p=0·005).
• The most common adverse event associated with drug discontinuation or dose changes were gastrointestinal disorders (215 [7%] of 3263 patients in the acarbose group vs 150 [5%] of 3241 in the placebo group [p=0·0007]; safety population).
• Between groups, no difference was observed in the numbers of non-cardiovascular deaths (71 [2%] of 3272 vs 56 [2%] of 3250, p=0·19) and cancer deaths (10 [<1%] of 3272 vs 12 [<1%] of 3250, p=0·08).