What are the indications for Saroglitazar (a peroxisome proliferator-activated receptor (PPAR) agonist) in adult patients with type 2 diabetes mellitus (T2DM)?

Indications for Saroglitazar

Saroglitazar is indicated for diabetic dyslipidemia in adults with type 2 diabetes mellitus who have hypertriglyceridemia (triglycerides ≥200 mg/dL) not adequately controlled with statin therapy alone. 1, 2

Primary Indication: Diabetic Dyslipidemia

• Saroglitazar 4 mg once daily is specifically approved for managing diabetic dyslipidemia in patients with type 2 diabetes and elevated triglycerides. 1
• The drug targets patients with triglycerides ≥200 mg/dL who remain inadequately controlled despite ongoing statin therapy. 1, 2
• Saroglitazar demonstrates significant triglyceride reduction of approximately 35-47% from baseline, along with reductions in LDL-C (16.4%), total cholesterol (19%), and non-HDL-C (23.4%). 1, 2

Secondary Glycemic Benefits

• Saroglitazar provides additional glycemic control when added to existing antidiabetic medications, with HbA1c reductions of approximately 0.7-0.9%. 1, 3
• Fasting blood glucose decreases by approximately 21-26 mg/dL, and postprandial glucose by 24-32 mg/dL when added to baseline diabetes therapy. 3
• This dual benefit on lipids and glucose makes saroglitazar particularly useful in patients with both poorly controlled dyslipidemia and suboptimal glycemic control. 1

Emerging Indication: Metabolic-Associated Steatotic Liver Disease (MASLD)

• Saroglitazar shows promise in reducing liver stiffness and transaminase levels in patients with type 2 diabetes and NAFLD/MASLD. 4
• In observational studies, saroglitazar improved liver stiffness measured by FibroScan elastography and reduced serum AST and ALT levels. 4, 3
• However, this indication requires further validation through randomized controlled trials before becoming a formal recommendation. 4

Important Context: Not a Guideline-Recommended Agent

Critical caveat: Saroglitazar is NOT mentioned in major international diabetes guidelines (ADA, ESC, ACP) from 2020-2024. 5

• Current guidelines prioritize SGLT-2 inhibitors and GLP-1 receptor agonists for cardiovascular and renal protection in type 2 diabetes. 5
• Thiazolidinediones (which share the PPARγ mechanism with saroglitazar) are explicitly NOT recommended in heart failure due to fluid retention risk. 5
• Saroglitazar's approval is primarily limited to India, where it fills a niche for diabetic dyslipidemia management. 1

Dosing and Safety Profile

• The standard dose is saroglitazar 4 mg once daily, taken orally. 1, 3
• The medication is generally well-tolerated with no serious adverse events reported in observational studies, including no significant edema, weight gain, or renal/hepatic enzyme alterations. 1, 3
• Saroglitazar can be safely combined with statins and multiple antidiabetic medications. 1, 2

Clinical Decision Algorithm

Use saroglitazar when:

1. Patient has type 2 diabetes with triglycerides ≥200 mg/dL
2. Statin therapy alone has failed to control dyslipidemia
3. Patient is not a candidate for or has failed SGLT-2 inhibitors or GLP-1 agonists (guideline-preferred agents)
4. No history of heart failure (due to PPARγ activity concerns)
5. Access to saroglitazar is available (primarily India)

Avoid saroglitazar when:

• Heart failure is present (use SGLT-2 inhibitors instead per guidelines) 5
• Patient would benefit more from cardiovascular/renal protection (prioritize SGLT-2 inhibitors or GLP-1 agonists) 5
• Patient has established cardiovascular disease requiring evidence-based mortality reduction (use empagliflozin or liraglutide) 5