Post-Marketing Surveillance of Acarbose Treatment in Patients with Type 2 Diabetes Mellitus and Subjects with Impaired Glucose Tolerance in China

Patients and methods: A total of 2550 study participants were enrolled by 133 physicians throughout China. Efficacy parameters were the changes from initial visit to the end of study in glycosylated haemoglobin (HbA_1c), fasting blood glucose (FBG), postprandial BG and bodyweight.

Results: The majority of study participants (74.7%) were newly diagnosed. Most (77.0%) were administered acarbose 50mg three times daily (the recommended standard dose in China) throughout the study and more than half (51.7%) received concomitant antihyperglycaemic treatment. Acarbose treatment reduced HbA_1c by 1.4% to 6.7%, FBG by 38.5 mg/dL to 116.4 mg/dL, 2-hour postprandial BG by 92.2 mg/dL to 149.0 mg/dL and bodyweight by 0.4kg to 67.5kg. Subgroup analyses for type 2 diabetes and IGT populations were also conducted. In diabetic patients, HbA_1c was reduced by 1.4%, FBG by 42.1 mg/dL and 2-hour postprandial BG by 98.9 mg/dL. Marked reductions were also achieved in the IGT population (0.9% for HbA_1c, 11.8 mg/dL for FBG and 42.9 mg/dL for 2-hour postprandial BG) despite lower baseline glucose levels in this group than in patients with type 2 diabetes. Bodyweight slightly increased in the IGT population. Only 12 acarbose-related adverse events, none of which was serious, were reported. The attending physicians assessed treatment efficacy as ‘good’ or ‘very good’ for 92.4%, tolerability as ‘good’ or ‘very good’ for 91.1%, and patient acceptance as ‘good’ or ‘very good’ for 89.8% of all study participants.