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Randomized Controlled Trial Evidence on Peroxisome Proliferator-Activated Receptor (PPAR) Agonists in Primary Biliary
Marrium Sultan Dar1, Tooba Fatima1, Syeda Dua Azhar1
1Department of Medicine, Jinnah Sindh Medical University, Karachi, Pakistan.
International Journal of Hepatology
|December 11, 2025
Summary
Peroxisome proliferator-activated receptor (PPAR) agonists show significant benefits in lowering alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), total bilirubin (TBil), and triglyceride (Tg) levels in patients with primary biliary cholangitis (PBC). These findings suggest a promising role for PPAR agonists in managing this autoimmune liver disease.
Area of Science:
- Hepatology
- Immunology
- Pharmacology
Background:
- Primary biliary cholangitis (PBC) is a progressive autoimmune liver disease that can lead to cirrhosis and liver failure.
- Ursodeoxycholic acid (UDCA) is the standard first-line treatment, but a significant portion of patients show inadequate response.
- Obeticholic acid (OCA) is a second-line option, but recent safety concerns, especially in patients with cirrhosis, necessitate exploration of alternative therapies.
Purpose of the Study:
- To evaluate the efficacy and safety of peroxisome proliferator-activated receptor (PPAR) agonists as a therapeutic option for primary biliary cholangitis (PBC).
- To assess the impact of PPAR agonists on key biochemical markers of liver injury and disease progression in PBC patients.
Main Methods:
- A systematic review and meta-analysis of randomized controlled trials (RCTs) were conducted, searching major databases up to October 2023.
- Eight RCTs involving 515 patients were included, comparing PPAR agonists with placebo.
- Primary outcome was the change in alkaline phosphatase (ALP) levels; secondary outcomes included changes in GGT, ALT, AST, TBil, triglycerides, and pruritus.
Main Results:
- PPAR agonists significantly reduced ALP levels (SMD = -2.81, p < 0.0001) and GGT levels (SMD = -1.29, p = 0.002) compared to placebo.
- Significant reductions were also observed in total bilirubin (TBil) (SMD = -0.77, p = 0.006) and triglyceride (Tg) levels (SMD = -0.99, p = 0.003).
- No significant differences were found in ALT, AST levels, or pruritus between the PPAR agonist and placebo groups.
Conclusions:
- PPAR agonists demonstrate superior efficacy compared to placebo in improving key biochemical markers in PBC, including ALP, GGT, TBil, and Tg.
- These findings highlight the potential therapeutic benefit of PPAR agonists in managing primary biliary cholangitis and improving liver health.
- Further research may be warranted to explore the long-term safety and efficacy of specific PPAR agonists in diverse PBC patient populations.
