Pentoxifylline improves nonalcoholic steatohepatitis: A randomized placebo-controlled trial

Zein CO et al. – Although not statistically significant (p=0.17), improvement in fibrosis was observed in a greater proportion (35%) of patients in the pentoxifylline(PTX) group compared to placebo (15%). Adverse effects were similar in both groups. PTX improved histological features of NASH compared to placebo. PTX was well tolerated in patients with NASH.

Methods

• 55 adults with biopsy–confirmed NASH were randomized to receive PTX at a dose of 400mg three times a day (n=26) or placebo (n=29) over 1 year.
• Primary efficacy endpoint was defined as improvement on histological features of NASH through reduction in steatosis, lobular inflammation, and/or hepatocellular ballooning as reflected by a decrease of ≥ 2 points in the NAFLD activity score (NAS).

Results

• After 1 year, intention–to–treat analysis showed a decrease of ≥2 points in the NAS in 38.5% of patients on PTX vs 13.8% of those on placebo (p=0.036).
• Per protocol analysis, a decrease of ≥ 2 points in the NAS from baseline was observed in 50% of the patients on PTX versus 15.4% of those on placebo (p=0.01).
• Mean change in NAS score from baseline was –1.6 in the PTX group, vs –0.1 in the placebo group (p<0.001).
• PTX significantly improved steatosis (mean change in score –0.9 vs –0.04 with placebo, p<0.001) and lobular inflammation (median change –1 vs 0 with placebo, p=0.02).
• No significant effects in hepatocellular ballooning were observed. PTX also improved liver fibrosis (mean change in fibrosis score was –0.2 among those on PTX versus +0.4 among those on placebo, p=0.038).
• Although not statistically significant (p=0.17), improvement in fibrosis was observed in a greater proportion (35%) of patients in the PTX group compared to placebo (15%).
• Adverse effects were similar in both groups.

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