Post-marketing surveillance of acarbose treatment in patients with type 2 diabetes in the Philippines.

BACKGROUND: Diabetes is a growing health problem in the Western Pacific Region. Oral treatment with the cc-glucosidase inhibitor acarbose has been proven efficacious in controlled studies in Asian patients with type 2 diabetes. The aim of this Post-Marketing Surveillance study was to assess efficacy, safety and acceptance of acarbose treatment in Philippine patients with type 2 diabetes under day-to-day practice conditions.

METHODS: A total of 780 patients were enrolled by 199 physicians throughout the Philippines into an open, prospective, uncontrolled, non-randomised, multi-centre study. Efficacy parameters were the changes in fasting and postprandial blood glucose values, HbAlc concentrations and body weight from the initial to the last follow-up visit.

RESULTS: Many patients (61 percent) had been previously treated with other anti-diabetic medication and the majority (85.5 percent) received acarbose in combination therapy. More than 40 percent of the study population were obese and many patients already suffered from comorbidities and late diabetes complications. Acarbose treatment reduced mean fasting blood glucose concentrations by 62.1 mg/dL to 123.1 mg/dL and 2h-postprandial values by 82.0 mg/dL to 146.1 mg/dL over a mean observation period of 11.5 weeks. A mean weight loss of 1.7 kg was reported for this period. Mean HbAlc decreased by 0.9 percent to 7.7 percent in the first five weeks of acarbose treatment. In 8 patients 17 acarbose-related adverse events occurred. The attending physicians rated treatment efficacy as 'good' or 'very good' for 87.2 percent, tolerability for 89.2 percent, and treatment acceptance for 89.2 percent of all patients.

CONCLUSIONS: Acarbose proved efficacious, safe and well accepted by type 2 diabetes patients in the Philippines under day-to-day treatment conditions.