Postmarketing surveillance study of the efficacy and tolerability of pioglitazone in insulin-resistant patients with type 2 diabetes mellitus in general practice.

OBJECTIVE: To evaluate the efficacy and tolerability of pioglitazone in patients with type 2 diabetes mellitus treated in general practice settings. DESIGN AND
SETTING: This was a postmarketing surveillance study involving 2537 primary-care physicians throughout Germany. PATIENTS AND
INTERVENTIONS: A total of 8760 patients with type 2 diabetes were treated with pioglitazone 15 or 30mg once daily and followed for 16 weeks.
RESULTS: Treatment with pioglitazone 15 or 30mg once daily was associated with a reduction in both fasting plasma glucose (mean 50.1 mg/dL) and glycosylated haemoglobin (HbA(1c)) [mean 1.4%] compared with baseline. The proportion of patients with 'normal' fasting glucose levels (70-110 mg/dL) increased from 2.3% at baseline to 24.2% at the final evaluation. Pioglitazone therapy was associated with a reduction in levels of triglycerides, total cholesterol and low-density lipoprotein (LDL)-cholesterol, and an increase in levels of high-density lipoprotein (HDL)-cholesterol. The proportion of patients at high risk of developing vascular complications decreased progressively during pioglitazone therapy according to a number of parameters.
CONCLUSIONS: Pioglitazone was well tolerated and effective in improving glycaemic control and lipid profiles in patients with type 2 diabetes. Pioglitazone may be effective in reducing the risk of vascular complications of diabetes.