Post-marketing surveillance of acarbose treatment in patients with type 2 diabetes mellitus and subjects with impaired glucose tolerance in China.

OBJECTIVE: This open, prospective, non-interventional, non-randomised, multi-centre postmarketing surveillance study was conducted over a mean period of 13.9 weeks to assess the efficacy, safety and acceptance of acarbose in Chinese patients with type 2 diabetes mellitus and subjects with impaired glucose tolerance (IGT) in routine clinical practice. Subjects with IGT were included in analyses because acarbose has been approved for treatment of this condition since 2002. 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 0.4 kg to 67.5 kg. 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.
CONCLUSION: Acarbose was efficacious, safe and well accepted by Chinese patients with type 2 diabetes and subjects with IGT under day-to-day treatment conditions, both as monotherapy and in combination with other antihyperglycaemic medication.