Nonalcoholic fatty liver or Nonalcoholic Steatohepatitis (NASH) currently affects about 4% of the American population and there is no approved therapy. About 15% of patients with NASH progress to cirrhosis and patients with NASH experience fatty liver disease, insulin resistance, and obesity.
The new study is a multicenter trial involving 247 nondiabetic adults with biopsy-proven NASH. Patients were allocated to the following 3 arms:
- 80 patients to the insulin-sensitizer pioglitazone (Actos) (30 mg once daily)
- 84 patients to vitamin E (800 IU/day)
- 83 patients to placebo
After 96 weeks, patients in the vitamin E therapy arm was associated with a significantly higher rate of improvement in NASH when compared with placebo (43% vs 19%; P = .001; number needed to treat, 4.2).
However, the difference in the rate of NASH improvement with pioglitazone compared with placebo did not reach the prespecified 0.025 level of significance (34% vs. 19%; P = .04; number needed to treat, 6.9). Even though the pioglitazone arm did not reach the statistical endpoint, pioglitazone still improve the histology in half of the NASH patients.
Despite the positive results, the investigator, Dr. Harrison, still emphasized the importance of treating the causes (obesity, prediabetes and frank diabetes).
In addition to prescribing vitamin E 800 IU/day, Dr. Harrison still aims to reduce patient’s weight (ideally 10% reduction) with diet and exercise up front. Only in patients who are not able to lose the weight and with advanced disease will he then consider prescribing pioglitazone.
Published online in the April 28, 2010 issue of N Engl J Med.
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