Efficacy and safety of standard dose pioglitazone versus low-dose pioglitazone as an add on treatment in type 2 diabetes mellitus: A randomized controlled trial

Background: On June 18, 2013, India banned pioglitazone, a peroxisome proliferation activator gamma agonist, and a popular anti-diabetic drug used in the treatment of type 2 diabetes mellitus (T2DM), but on August 21, 2013, ban was revoked after stiff opposition from diabetologists and pioglitazone was reintroduced to the market again. Aim and Objective: The aim of this study was to assess the efficacy and safety of low-dose pioglitazone compared to standard dose pioglitazone in adults with T2DM. Materials and Methods: After obtaining permission from the Institutional Ethics Committee, 50 patients with T2DM who were not under adequate glycemic control with metformin and glimepiride combination therapy are included in the study. The patients were randomly assigned (1:1) into pioglitazone 7.5 mg group and 15 mg group as an add on treatment to the existing therapy. Results: All the glycemic parameters such as FBS, post prandial blood glucose (PPBS), and hemoglobin (HbA1c) are significantly reduced in both groups from baseline to the end of 12 weeks. FBS reduced from 183.64 ± 20.9 to 152.08 ± 15.2 in the Pioglitazone 7.5 mg group and from 177.32 ± 16.89 to 145.2 ± 11.6 in the pioglitazone 15 mg group (P < 0.05), PPBS was reduced from 260.2 ± 31.09 to 213.8 ± 29.5 and from 256.24 ± 43.72 to 203.52 ± 27.5 (P < 0.05) in 7.5 mg and 15 mg group, respectively. HbA1c was reduced from 8.969 ± 0.88 to 8.508 ± 0.9 in 7.5 mg group (P < 0.05) and in 15 mg group, it was reduced from 8.796 ± 0.79 to 8.19 ± 0.72 (P < 0.05). In the study, Pioglitazone 7.5 mg efficaciously reduced glycemic parameters similar to pioglitazone 15 mg and there was no statistically significant difference between the groups. Three patients reported with pedal edema as adverse effect in pioglitazone 15 mg therapy, whereas only one in 7.5 mg pioglitazone therapy complained of ankle edema. Conclusion: Low-dose pioglitazone offers an attractive alternative option to standard dose pioglitazone as an add on therapy for T2DM due to its effectiveness in reducing glycemic markers and also fewer side effect profile.