Effect of saroglitazar on glycaemic parameters: A systematic review and meta-analysis of randomized controlled trials.

Abstract

Aims: Saroglitazar is a dual peroxisome proliferator-activated receptor (PPAR), predominantly a PPAR-α agonist and a moderate PPAR-γ agonist activity, which has shown positive effects in diabetic dyslipidaemia. However, its potential anti-diabetic effect has not been thoroughly investigated, and the data have been inconsistent. Thus, we conducted a meta-analysis to examine the impact of saroglitazar on glycaemic markers in patients with dyslipidaemia, type 2 diabetes and non-alcoholic fatty liver disease.

Materials and methods: The search strategy was conducted in PubMed, Web of Science, Scopus, ClinicalTrials.gov and Google Scholar databases. Randomized controlled trials reporting changes in glycaemic parameters after saroglitazar therapy were selected. The Cochrane risk-of-bias tool for randomized trials version 2 was used to assess the quality of the included studies. For meta-analysis, a random-effects model and the generic inverse variance method were conducted. Also, the leave-one-out method was applied for the sensitivity analysis.

Results: A total of 10 clinical trials (N = 2077; mean age: 49.7 years; 40% female) were included. Regarding the quality of the included studies, two trials had a low risk of bias, seven trials showed some concerns and one study exhibited a high risk of bias. The meta-analysis of 10 randomized controlled trials showed that saroglitazar significantly reduces fasting glucose (weighted mean difference [WMD]: -12.11 mg/dL, 95% CI: -14.79, -9.43, p < 0.0001, I² = 40%), postprandial glucose (WMD: -16.17 mg/dL, 95% CI: -22.29, -10.04, p < 0.0001, I² = 0%) and HbA1c (WMD: -0.39%, 95% CI: -0.57, -0.22, p < 0.0001, I² = 72%) compared to active control or placebo. However, there was no significant effect on insulin levels (WMD: -1.03 μU/mL, 95% CI: -4.12, 2.06, p = 0.51, I² = 37%), HOMA-IR (WMD: -0.41, 95% CI: -0.86, 0.04, p = 0.07, I² = 41%) and C-peptide (WMD: -0.30 ng/mL, 95% CI: -0.76, 0.15, p = 0.19, I² = 0%) after saroglitazar therapy.

Conclusions: Our results revealed that saroglitazar therapy improves glycaemic parameters through the reduction of fasting glucose, postprandial glucose and HbA1c.