Efficacy and safety of pioglitazone in type 2 diabetes mellitus: a postmarketing observational study

to assess the effectiveness and safety profile of pioglitazone in Indonesian type 2 diabetic patients.

type 2 diabetic patients, naive or under oral antidiabetics, with uncontrolled fasting (FBG) or postprandial blood glucose (PPBG) were enrolled from September 2009 to December 2010 from 23 cities in Indonesia. Pioglitazone (Actos®) 15 mg or 30 mg daily was prescribed by the physician and performed observation for 12 weeks. Body weight (BW), body mass index (BMI), FBG and PPBG were measured every 4 weeks and serum transaminase (SGPT) was measured at the beginning and at the end of the study. Changes from baseline to each visit were analyzed using Wilcoxon-test.

190 patients (92 male and 98 female) aged 56.3 (28-80) years were included. Mean FBG decreased from 191.8 mg/dL at baseline to 155.9; 141.0; and 127.3 mg/dL, at week 4, 8, and 12, respectively (p<0.001). Mean PPBG decreased from 267.3 mg/dL at baseline to 209.7; 188.2; and 174.9 at week 4, 8, and 12, respectively (p<0.001). BW slightly increased from 67.3 (range: 40-98) kg at baseline to 67.7 (42.0-98.5) and 67.8 (43.0-99.0) kg at weeks 8 and 12, respectively (p<0.001) and BMI increased from 25.6 (16.2-38.6) kg/m2 at baseline to 25.7 (17.0-36.3) and 25.7 (17.4-36.6) kg/m2 at weeks 8 and 12, respectively (p<0.001). SGPT values were not significantly changed (35.6U/L at baseline and 35.5U/L at week 12, p=0.93).

Pioglitazone is effective in controlling blood glucose, without harmful effect on the liver. However, there was a slight but statistically significant increase in body weight, that mandates the precaution when using this drug in patients with heart failure or other conditions with water retention.