Efficacy and safety of acarbose in the treatment of type 2 diabetes: data from a 2-year surveillance study.

This 2-year surveillance study assessed the tolerability and safety of acarbose in patients with diabetes. A total of 2035 patients were enrolled; approximately 95% were classified as having Type 2 diabetes. The study was open with no control groups. Physicians had sole control of the acarbose doses prescribed. Doses of acarbose were generally low, and hence well-tolerated. The incidence of acarbose-associated adverse effects and withdrawals was 7.5 and 2.5%, respectively. No sustained adverse changes in laboratory parameters occurred. Fasting blood glucose levels, 1- and 2-h postprandial glucose levels, HbA1c or HbA1, and other clinical parameters, such as blood cell counts and liver enzyme levels were also assessed as measures of efficacy and safety. Over the 2 years the mean fasting blood glucose level decreased by 2.39 mmol/l in patients with Type 2 diabetes, while mean 1- and 2-h postprandial blood glucose levels both decreased by 3.56 mmol/l. HbA1 and HbA1c decreased by 2.0 and 1.1 percentage points, respectively. These results suggest that when used in long-term day-to-day management of diabetes, acarbose is well tolerated and can improve glycaemic control.