Postmarketing surveillance of acarbose treatment in Taiwanese patients with type 2 diabetes Mellitus

Objective: This postmarketing surveillance (PMS) study was conducted to assess the efficacy, safety and acceptance of acarbose treatment in patients with type 2 diabetes mellitus. Methods: Patients were recruited in this open, prospective, uncontrolled, non-randomised multicentre study by 159 physicians throughout Taiwan, following the guidelines of the Bureau of National. Health Insurance (BNHI) of Taiwan. Primary efficacy parameters were changes in fasting blood glucose, postprandial blood glucose and glycosylated haemoglobin (HbA(1c)) values during treatment with acarbose. Results: The majority of the 1558 enrolled patients received acarbose 50mg three times daily, had previously been treated with a sulphonylurea and/or biguanide, and were observed for a mean period of 13.9 weeks. Most patients (91.8%) received concomitant oral antihyperglycaemic agents. Acarbose reduced fasting blood glucose concentrations by 32.0 mg/dL and 2-hour postprandial blood glucose levels by 52.2 mg/dL. HbA(1c) was reduced by 1.0% from 9.9% to 8.9%, and bodyweight remained stable. The attending physicians assessed that acarbose was associated with 'very good' or 'good' general efficacy in 46.0% of patients,,very good' or 'good' tolerability in 60.6% and 'very good' or 'good' patient acceptance in 63.4%. These ratings were higher for patients receiving acarbose monotherapy compared with those taking other antihyperglycaemic therapies in addition to acarbose. Only 2.0% of all patients experienced drug-related adverse events. Conclusion: Acarbose treatment provides an efficacious, safe and well accepted alternative for metabolic improvement in Taiwanese patients with type 2 diabetes under daily-life treatment conditions.