Efficacy and Safety of Saroglitazar in Patients with Cardiometabolic Diseases: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Abstract

The incidence of cardiometabolic diseases is increasing because of an increase in the standard of living. Currently, clinical treatment strategies for cardiometabolic diseases mainly focus on maintaining glycemic and lipid profiles. The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of saroglitazar in patients with metabolic disease and provide evidence for clinical decision making. We searched electronic databases (PubMed, Cochrane Central Register of Controlled Trials [CENTRAL], and Google Scholar) for randomized controlled trials that examined saroglitazar for the treatment of patients with cardiometabolic disease. A total of seven randomized controlled trials were included for the qualitative and quantitative synthesis. Mean difference (MD) and risk ratio with a 95% confidence interval (CI) were applied for continuous and dichotomous data, respectively. The overall effect of saroglitazar showed significant changes in triglycerides, total cholesterol, low-density lipoprotein, non-high-density lipoprotein, high-density lipoprotein, very low-density lipoprotein, alkaline phosphatase, and gamma-glutamyl transferase levels [MD: - 40.50; 95% CI - 58.09 to - 22.92; p < 0.00001; I2 = 78%], [MD: - 7.49; 95% CI - 11.33 to - 3.65; p = 0.0001; I2 = 41%], [MD: - 3.53; 95% CI - 6.91 to - 0.15; p = 0.04; I2 = 19%], [MD: - 8.08; 95% CI - 15.63 to - 0.54; p = 0.04; I2 = 58%], [MD: 2.04; 95% CI 0.17 to 3.92; p = 0.03; I2 = 69%], [MD: - 6.10; 95% CI - 9.40 to - 2.80; p = 0.0003; I2 = 65%], [MD: - 5.89; 95% CI - 7.50 to - 4.28; p < 0.00001; I2 = 98%], and [MD: - 1.64; 95% CI - 2.83 to - 0.45; p = 0.007; I2 = 95%], respectively. A subgroup analysis showed favorable outcomes with sarogiltazar 4 mg. There was a statistically non-significant reduced risk of adverse event occurrence in the saroglitazar treatment group. Our study results conclude that the overall effect of saroglitazar was beneficial only in terms of lipid profiles and liver function parameters, whereas saroglitazar 4 mg showed a better therapeutic role in maintaining lipid and glycemic parameters in patients with cardiometabolic disease.