International noninterventional study of acarbose treatment in patients with type 2 diabetes mellitus

Aim: To obtain data on efficacy, safety and tolerability of acarbose monotherapy or combination therapy during daily-life treatment. Methods: This prospective, non-controlled, observational study enrolled patients with type 2 diabetes, whose physician decided that acarbose treatment was appropriate, from China, Middle East, Indonesia, Morocco, Pakistan, Philippines, Poland and Taiwan. The observation period included an initial visit and up to three follow-up visits; an extension of 2 years was realized in Pakistan and Poland. Results: Of 14,574 patients enrolled, 14,418 comprised the intent-to-treat population. At the initial visit, 74.1% of patients had been treated with a glucose-lowering agent. Fasting blood glucose was reduced from 175.2 mg/dL at the initial visit to 133.7 mg/dL at the last visit (mean of 11.3 weeks after initial visit; P < 0.0001). Mean 2-h postprandial blood glucose decreased from 244.7 mg/dL to 172.4 mg/dL (P < 0.0001). HbA1c reduced from 8.4% to 7.4% (P < 0.0001). Glycemic efficacy was maintained over the 2-year extension period. There were 432 adverse events in 293 patients (2.03%), mainly gastrointestinal. Physicians assessed efficacy as "very good"/"good" in 85.1% of patients, and were "very satisfied"/"satisfied" with acarbose therapy in 94.3% of cases. Conclusion: Acarbose therapy was efficacious and well tolerated in daily life in patients with type 2 diabetes. (C) 2011 Elsevier Ireland Ltd. All rights reserved.