title: Safety and efficacy of acarbose in the treatment of Type 2 diabetes: data from a 5-year surveillance study.
abstract: This 5-year surveillance study assessed the tolerability and safety of acarbose in patients with diabetes. A total of 2035 patients were enrolled of whom 1954 were classified as having Type 2 diabetes. The study was open with no control group. Physicians had sole control of the acarbose doses prescribed. Fasting blood glucose levels, 2-h postprandial glucose levels, HbA(1) or HbA(1c) and other clinical parameters, such as lipids and liver enzyme levels, were also assessed as measures of efficacy and safety. One-third of the patients received acarbose as monotherapy and two-thirds in combination with other glucose-lowering treatment. The concomitant diseases were also assessed. Doses of acarbose were low in the majority of the patients and well tolerated. The incidence of acarbose-associated side effects was 4.7%. No sustained adverse changes in laboratory measures occurred. Over the 5 years, HbA(1) and glycated haemoglobin (HbA(1c)) decreased by 2.4 and 1.8% points, respectively, and the mean fasting glucose and 2-h postprandial glucose decreased by 2.7 and 3.4 mmol/l. Mean body weight was reduced by 0.9 kg. The results suggest that when used in long-term day-to-day management of diabetes, acarbose is well tolerated and can improve glycaemic control as monotherapy, as well as in combination therapy. In a high-risk patient group acarbose proved to be a safe drug.
authors.affiliation: Medical Department, Bayer Vital GmbH, D-51368 Leverkusen, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Mertes
mesh_terms: D020909:Acarbose / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D019518:Postprandial Period; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D020909:Acarbose; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin; D013453:Sulfonylurea Compounds