Pentoxifylline improves nonalcoholic steatohepatitis: a randomized placebo-controlled trial

Area of Science:

• Hepatology
• Pharmacology
• Gastroenterology

Background:

• Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with limited treatment options.
• Histological assessment is crucial for diagnosing and staging NASH, guiding therapeutic decisions.

Purpose of the Study:

• To evaluate the efficacy of pentoxifylline (PTX) in improving histological features of biopsy-confirmed NASH.
• To compare PTX versus placebo in reducing steatosis, lobular inflammation, and hepatocellular ballooning.

Main Methods:

• A 1-year randomized controlled trial involving 55 adults with biopsy-confirmed NASH.
• Participants received either PTX (400 mg three times daily) or placebo.
• The primary endpoint was a decrease of ≥ 2 points in the NAFLD activity score (NAS).

Main Results:

• A significant decrease in NAS score was observed in 38.5% of patients on PTX versus 13.8% on placebo (intention-to-treat analysis, P = 0.036).
• PTX significantly improved steatosis and lobular inflammation, with notable improvements in liver fibrosis.
• No significant effects on hepatocellular ballooning were observed; adverse events were similar between groups.

Conclusions:

• Pentoxifylline demonstrated efficacy in improving key histological features of NASH.
• PTX is a well-tolerated therapeutic agent for patients diagnosed with NASH.