Efficacy and safety of pioglitazone in type 2 diabetes in the Indian patients: Results of an observational study

OBJECTIVE: This study was undertaken to assess the efficacy and safetyof pioglitazone in combination with other oral antidiabetics (OADs) in Indian patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: This was an openlabel, prospective, no-randomized, single-center observational study conducted at a single center in India. A total of 958 adult patients with T2DM on OADs, with uncontrolled fasting (FBG) or postprandial blood glucose (PPG), were enrolled. Pioglitazone (7.5/15/30 mg) was added to existing therapy as a combination treatment with other OAD. Body weight (BW), body mass index (BMI), FBG and postprandial plasma glucose (PPPG) and glycosylated hemoglobin (HbA1c) were measured at the beginning (week 0) and at every follow-up treatment visit, i.e., 6 months (week 24), 1 year (week 48) and 2 years (week 96). Changes from baseline to each visit were analyzed using the Wilcoxon test. All patients also went through a urinalysis at baseline, and after 6 months, 1 year and 2 years of treatment, to assess for any abnormalities in the urine (pH, pus or protein), suggestive of bladder abnormalities. RESULTS: The combined analysis was carried out on 958 completed patients in this study who were treated with pioglitazone 7.5 mg, 15 mg and 30 mg tablet and other OADs. The difference in mean value of FBG showed a highly significant decrease (P < 0.0001) from baseline to end of treatment, i.e., from 167.0, (59.16) 172.6 (58.51) and 171.0 (39.47) to 140.2, (26.46) 143.8 (22.04) and 138.5 (27.82) mg/dL. Similarly, PPG showed a significant (P < 0.0001, 0.002 and 0.008) decrease from baseline to end of the treatment, i.e., from 256.0, (61.79) 222.9 (67.88) and 223.6 (69.11) to 195.9, (46.92) 204.0 (48.03) and 187.6 (53.36) mg/dL, and there was a highly significant (P < 0.0001) decrease in HbA1c levels, i.e., from 8.46, 8.34 and 8.42% to 7.781, 7.78 and 7.73%, respectively. However, gain in mean BW was also observed from baseline to end of the treatment, i.e., from 69.90, (9.44) 68.29 (8.62) and 67.64 (7.75) kg to 71.69, (8.35) 70.08 (7.96) and 69.70 (7.99) kg, respectively, and BMI increased from 26.74 (14.18-53.04) kg/m(2) at baseline to 27.45 (12.87-53.73) kg/m(2) at the end of the treatment, respectively (P < 0.0001). No significant changes were found in urine in patients even after 2 years of treatment with pioglitazone. There was little variation in pH or presence of pus and proteins in the urine, indicating no increased risk of bladder-related abnormalities across all treated age groups even after 2 years of treatment with pioglitazone. CONCLUSION: Pioglitazone in combination with other OADs in Indian patients was an effective treatment protocol in glycemic control, reduction in FBG, PPPG and HbA1c and also helps in controlling weight gain in patients with T2DM. In this patient population, there was no increased risk of bladder-related abnormalities. Pioglitazone was therefore found to be a safe and efficacious addition to treatment in patients with poorly controlled diabetes.