ABSTRACT
Background: On 18th June 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and a popular anti-diabetic drug used in the treatment of type 2 diabetes mellitus (T2DM), but on 21st August 2013, ban was revoked after stiff opposition from diabetologists and pioglitazone was reintroduced to the market again.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 were 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 Fasting blood sugar (FBS), post prandial blood glucose (PPBS), Glycosylated 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.
ABSTRACT
Background: Metformin has been recommended as pharmacological therapy of first choice in Type 2 diabetes mellitus (T2DM) but there remains a gap in the present literature regarding relative efficacy and choice of metformin as monotherapy in patients who are non-obese when compared to obese. Aim and Objectives: The aim of the study was to evaluate the efficacy of Metformin as monotherapy on glycemic markers in normal weight, over weight, and obese T2DM patients. Materials and Methods: After obtaining permission from institutional ethics committee, 90 treatment naïve patients with T2DM who met inclusion criteria were included in this study. They were categorized into normal weight, over weight, and obese based on BMI. Efficacy was measured by reduction in glycemic parameters at end of weeks 4, 8, 12, and 16 from baseline. Safety was assessed by monitoring adverse events. Data analyzed using analysis of variance, Student t-test for continuous data and Chi-square test for categorical data. Results: There was a significant decrease in glycosylated hemoglobin, fasting blood sugar, and postprandial blood sugar levels from baseline to end of 16 weeks in all three groups (P < 0.001) but the difference was not statistically significant between the three groups (P > 0.05). A significant decrease in body weight was observed in overweight and obese group whereas the reduction (0.3 Kg) is not significant in normal weight group. The treatment was well tolerated in all three groups. Conclusion: Metformin in normal weight group was found to be as efficacious as that of overweight and obese group for treating newly detected T2DM. Furthermore, the weight loss in normal weight group is negligible compared to overweight and obese group patients.