People with coronary heart disease and impaired glucose tolerance are at increased risk of future cardiovascular events, and of developing type 2 diabetes. In 2006, 37.3% of Chinese adults hospitalised for coronary artery disease had impaired glucose regulation, a major risk factor for diabetes.
The ACE trial (Acarbose Cardiovascular Evaluation) is the largest cardiovascular disease prevention outcome trial in people with coronary heart disease and impaired glucose regulation in China. It was designed to determine whether acarbose, an alphaglucosidase inhibitor licensed in many countries for the treatment of impaired glucose tolerance, could reduce the risk of further cardiovascular events and whether the rate of development of diabetes in this high-risk population could be lowered.
Launched in 2009 and completed in April 2017, the ACE trial was a placebo-controlled, cardiovascular outcomes trial involving 6,526 patients with coronary artery disease and impaired glucose regulation from 176 hospitals in the Peoples Republic of China. Participants were randomised to receive acarbose 50mg, or matching placebo, orally three times daily with meals. The primary endpoint was a five-point composite outcome of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalisation for unstable angina or hospitalisation for heart failure in the two groups of patients. The median length of follow-up was five years.
The trial did not demonstrate superiority for the primary endpoint, with no reduction seen with acarbose in the risk of major adverse cardiovascular events. It did, however, show a significant 18% reduction in the incidence of new-onset diabetes with acarbose, compared with placebo, with a number needed to treat of 41 to prevent one case of diabetes.
The study is published today in The Lancet Diabetes and Endocrinology entitled, "Effects of Acarbose on Cardiovascular and Diabetes Outcomes in Patients with Coronary Heart Disease and Impaired Glucose Tolerance: A Randomised Controlled Trial" [doi: 10.1016/S2213-8587(17)30309-1]. A slide deck summarising the presentation can be downloaded here, and a Chinese version here.
Professor Rury Holman of Oxford University, Chair of the study, commented "ACE provides reassurance that acarbose may be used safely to improve blood glucose levels in people with coronary heart disease and impaired glucose regulation with no impact on rates of cardiovascular complications or heart failure". "The reduced incidence of diabetes seen with acarbose in the ACE trial may, however, help reduce cardiovascular risk in the longer term by delaying the onset of diabetes in the high-risk population studied."
ACE was designed, run, and analyzed independently by the University of Oxford Diabetes Trials Unit in collaboration with Professor Changyu Pan (Professor in the Endocrinology Department at the PLA General Hospital in Beijing), and Professor Dayi Hu (Chief of the Intervention Centre at Peking University People's Hospital in Beijing). It was sponsored by the University of Oxford with funding provided by Bayer AG.