Efficacy, safety and acceptance of Acarbose treatment under day-to-day clinical practice conditions: Post-Marketing Surveillance in Chinese type 2 diabetic patients / 中华内分泌代谢杂志

ABSTRACT

The aim of this Post-Marketing Surveillance study was to assess efficacy, safety and acceptance of acarbose treatment in Chinese type 2 diabetic patients under day-to-day practice conditions. A total of 2 480 patients were enrolled by 231 physicians throughout China into an open, prospective, uncontrolled, nonrandomised, multi-centre study. Main efficacy parameters were the changes in fasting and postprandial blood glucose concentrations as well as in HbA1c levels after acarbose treatment. The majority of patients had been previously treated with other oral anti-diabetic medication or insulin and received concomitant anti-diabetics during the mean observation period of 13.5 weeks. Most patients started on a daily acarbose dose of 50 mgt. i. d. Acarbose treatment reduced fasting blood glucose concentrations by 56. 1 mg/dl ( 18 mg/dl glucose = 1 mmol/Lglucose) and 2h-postprandial values by 111.3 mg/dl over the studyperiod. HbA1c decreased by 1.9％ and body weight by 0.9 kg. 76 acarbose-related adverse events occurred; two patients experienced serious adverse events.The attending physicians assessed treatment efficacy as "very good" or "good" for 90.1％ of the patients, tolerability for 89.1％ and acarbose acceptance for 87.1％ of the patients. Acarbose is efficacious, safe and well accepted by Chinese type 2 diabetic patients under day-to-day routine conditions, both as anti-diabetic mono therapy and in combination with other anti-diabetic drugs.