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 enr olled; approximately 95% were classified as having Type 2 diabetes. Th e study was open with no control groups. Physicians had sole control o f the acarbose doses prescribed. Doses of acarbose were generally low, and hence well-tolerated. The incidence of acarbose-associated advers e effects and withdrawals was 7.5 and 2.5%, respectively. No sustained adverse changes in laboratory parameters occurred. Fasting blood gluc ose levels, 1- and 2-h postprandial glucose levels, HbA(1c) or HbA(1), and other clinical parameters, such as blood cell counts and liver en zyme levels were also assessed as measures of efficacy and safety. Ove r the 2 years the mean fasting blood glucose level decreased by 2.39 m mol/l in patients with Type 2 diabetes, while mean 1- and 2-h postpran dial blood glucose levels both decreased by 3.56 mmol/l. HbA(1) and Hb A(1c) decreased by 2.0 and 1.1 percentage points, respectively. These results suggest that when used in long-term day-to-day management of d iabetes, acarbose is well tolerated and can improve glycaemic control. (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.