Abstract 16336: Efficacy and Safety of Saroglitazar in the Management of Atherogenic Dyslipidemia: An Updated Meta-Analysis of Randomized Clinical Trials

Background: Saroglitazar is a novel drug used in the treatment of atherogenic dyslipidemia. However, its effect on this condition remains uncertain. Herein, we performed a systematic review and meta-analysis to assess the efficacy and safety of saroglitazar in the management of atherogenic dyslipidemia.

Methods: PubMed, Scopus and Embase were systematically searched for randomized controlled trials (RCTs) comparing saroglitazar 4 mg, saroglitazar 2 mg, and placebo in the treatment of atherogenic dyslipidemia. A random-effects model was used to compute the pooled mean difference (MD) for continuous outcomes, with 95% confidence interval (CI). Heterogeneity was assessed with I ² statistics.

Results: We included 7 RCTs with 1,095 patients, of whom 340 (31.0%) were randomized to saroglitazar 2 mg; 513 (46.8%) to the 4 mg dose; and 242 (22.11%) to placebo. Mean age ranged from 40.2 to 62.6 years, and 436 (39.8%) were women. Saroglitazar 4 mg significantly lowered triglycerides (MD -51.18 mg/dL; 95% CI -66.80 to -35.55 mg/dL; p<0.001; figure 1A) and LDL-cholesterol levels (MD -9.15 mg/dL; 95% CI -10.52 to -7.77 mg/dL; p<0.001; figure 1B) when compared with placebo. Moreover, saroglitazar 4 mg minimally increased HDL-cholesterol (MD 2.73 mg/dL; 95% CI 0.49 to 4.97 mg/dL; p=0.02) in comparison with placebo. There were no significant differences between groups in the alanine aminotransferase levels (MD -26.40 U/L; 95% CI -72.15 to 19.36 U/L; p=0.26). There was a slight increase in body weight in the saroglitazar 4 mg group when compared with placebo (MD 0.90 Kg; 95% CI 0.31 to 1.48 Kg; p=0.003). In the comparison of saroglitazar 4 mg vs. 2 mg, the higher dose significantly outperformed the lower dose with regards to reduction in triglycerides (MD -32.38 mg/dL; 95% CI -53.62 to -11.14 mg/dL; p=0.003).

Conclusion: Our findings suggest that saroglitazar 4 mg is effective for the reduction of triglycerides and LDL-C, with a small increase in body weight relative to placebo.