Reuters Health Information (2010-10-20): Nonalcoholic steatohepatitis improves with pentoxifylline
Drug & Device Development
Nonalcoholic steatohepatitis improves with pentoxifylline
Last Updated: 2010-10-20 16:40:20 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Pentoxifylline can reduce steatosis and inflammation in patients with nonalcoholic steatohepatitis (NASH), according to a small randomized trial presented this week at the American College of Gastroenterology's annual meeting in San Antonio, Texas.
"These are very promising findings," researcher Dr. Claudia Zein of the Cleveland Clinic told Reuters Health via e-mail. "Based on current knowledge and the natural history of NASH, medical therapy for this disease will probably need to be lifelong therapy (in the absence of bariatric surgery in selected cases). For that reason, clinicians would much prefer a safe and cost-effective drug for their patients, such as pentoxifylline. Further studies of this agent in NASH are definitely warranted."
One-third of US adults have non-alcoholic fatty liver disease (NAFLD), according to Dr. Zein, and up to 20% of them may have underlying NASH. Rates could be higher in certain patient groups, such as those with type 2 diabetes or metabolic syndrome, she said.
Pentoxifylline is typically used to treat intermittent claudication. To test its effects in patients with NASH, Dr. Zein and her team enrolled 59 patients with biopsy-confirmed disease and randomly assigned them to receive 400 mg three times a day (n=26) or placebo (n=29) for a year.
Fifty-seven percent of the patients taking pentoxifylline had an improvement of 30% or more in alanine aminotransferase levels, compared to 23.1% of patients on placebo (p=0.02).
The intent-to-treat analysis (which included nine patients who didn't have biopsies at the end of follow-up) found a 2-point or greater reduction in NAFLD activity score from baseline in 38.5% in the treatment group and 13.8% in the control group (p=0.036). In the per-protocol analysis these rates were 50% in the treated patients vs 15.4% in controls.
While the researchers saw significant improvement in steatosis and lobular inflammation in patients given active treatment, there was no difference in hepatocellular ballooning, and both groups had similar rates of adverse effects.
"Pentoxifylline is a promising agent that could be of benefit in patients with NASH," Dr. Zein told Reuters Health. "However, it is important to keep in mind that additional studies are needed in order to confirm these encouraging preliminary findings."