From the Guidelines
Saroglitazar, a peroxisome proliferator-activated receptor gamma (PPAR-γ) agonist, has shown efficacy in improving metabolic parameters, but its efficacy data is not directly available in the provided studies, which primarily focus on pioglitazone, another PPAR-γ agonist. However, based on the available evidence on pioglitazone, it can be inferred that PPAR-γ agonists like saroglitazar may have beneficial effects on metabolic parameters and liver function tests. The studies 1 demonstrate that pioglitazone improves insulin sensitivity, reduces steatosis, necroinflammation, and fibrosis in patients with nonalcoholic steatohepatitis (NASH). Some key points from the studies include:
- Pioglitazone treatment improved insulin sensitivity and aminotransferases, steatosis, inflammation, and ballooning in patients with NASH and prediabetes or type 2 diabetes 1.
- The PIVENS trial showed that pioglitazone 30 mg/day significantly reduced steatosis and lobular inflammation in nondiabetic patients with biopsy-proven NASH, although it did not meet the primary endpoint 1.
- A meta-analysis of four good-quality RCTs, including the PIVENS trial, found that thiazolidinediones (TZDs) like pioglitazone improved necroinflammation, but not fibrosis, in patients with NASH 1. It is essential to note that while saroglitazar's efficacy data is not directly available, its dual PPAR-α/γ agonist mechanism may provide beneficial effects on both lipid and glycemic parameters, making it a potential treatment option for patients with combined dyslipidemia and diabetes. However, the use of PPAR-γ agonists like pioglitazone has been associated with increased body weight and congestive heart failure, highlighting the need for careful consideration of the benefits and risks of these medications in clinical practice 1.
From the Research
Efficacy of Saroglitazar
- Saroglitazar has shown improvement in lipid and glycemic parameters through its PPAR-α and γ agonist actions, respectively 2.
- In real-world clinical studies, Saroglitazar 4 mg once daily has consistently reduced triglyceride levels (
45% to 62%), total cholesterol levels (17% to 26%), non-high-density lipoprotein cholesterol levels (21% to 36%), low-density lipoprotein cholesterol levels (11% to 27%), and glycosylated hemoglobin levels (~0.7% to 1.6%) 2. - A systematic review and meta-analysis of interventional studies found that Saroglitazar 4 mg therapy significantly decreased low-density lipoprotein cholesterol and total cholesterol compared to Saroglitazar 2 mg and control groups 3.
- An observational study in Indian diabetic dyslipidemia patients found that Saroglitazar 4 mg once daily led to significant reductions in triglycerides (35.8%), LDL-C (16.4%), total cholesterol (19%), and non-HDL-C (23.4%) at 3 months follow-up 4.
- A randomized clinical trial found that Saroglitazar 4 mg was noninferior to fenofibrate 160 mg in reducing triglyceride levels in hypertriglyceridemic patients, with a significant reduction in TG levels at week 12 relative to baseline 5.
- A Phase III study found that Saroglitazar 2 mg and 4 mg tablets significantly reduced mean plasma triglyceride levels by -45.5% and -46.7%, respectively, compared to placebo in patients with diabetic dyslipidemia not controlled with atorvastatin 10 mg therapy 6.
Safety Profile of Saroglitazar
- Saroglitazar has been found to be safe and well tolerated in patients, with no significant adverse events reported in several studies 2, 3, 4, 5, 6.
- No serious adverse events, alteration in liver or renal enzymes, edema, or weight gain were reported in an observational study in Indian diabetic dyslipidemia patients 4.
- A randomized clinical trial found that Saroglitazar 4 mg was safe and well tolerated, with no serious adverse events reported and no patient discontinuing the study due to adverse events 5.