Baclofen fails to reduce alcohol use in VA patients with HCV

SAN DIEGO — Baclofen failed to best placebo in controlling metrics of alcohol use in a cohort of veterans with hepatitis C virus, according to findings presented at Digestive Disease Week 2016.

Peter Hauser, MD, of the VA Long Beach Healthcare System and the University of California, Irvine, said that additional medication options are needed for the treatment of alcohol use disorders. “Particularly, we need ones that are not metabolized in the liver,” he said.

He acknowledged shortcomings of baclofen. “Some studies have shown that baclofen can reduce alcohol use, while others have failed to show that result,” he said.

The current study included 88 patients treated with 10 mg of baclofen three times daily, and 92 patients treated on the same schedule with placebo. The duration was 12 weeks. “This is the first study that looked a really large sample size of hepatitis C infected patients,” Hauser said. The double-blind trial was conducted between 2010 and 2014 at four VA centers.

The primary outcome measure was the percent of days abstinent, according to Hauser. Secondary measures included alcohol craving as measured by the Obsessive Compulsive Drinking Scale.

“Our study was different from many studies in that we didn’t require prior abstinence for entry,” he said. Exclusion criteria included decompensated liver disease. Baseline data showed no differences between the two arms. “Veterans in both groups were drinking moderately to heavily.”

After an initial 4-week wash-in period, 8.9% of the cohort became abstinent between weeks 4 and 12 of the study. Results indicated that 7.6% of 79 patients in the study drug group and 10.1% of 80 patients in the placebo group reached abstinence (P = .568). “Both groups had a significant increase over time in reduction in alcohol use,” Hauser said.

Similarly, for the outcome of ‘no heavy drinking,’ results from 4 to 12 weeks indicated that this increased 20.6% overall, but that there were no differences between the groups. No heavy drinking increased by 25.3% in the baclofen group and 16.3% in the placebo group (P = .152).

Regarding the secondary outcome measures, a similar trend emerged. Alcohol craving as measured by the Obsessive Compulsive Drinking Scale decreased from 20.55 (95% CI, 18.51-22.58) to 8.79 (95% CI, 6.71-10.86) in the baclofen arm and from 19.50 (95% CI, 17.51-21.49) to 9.52 (95% CI, 7.51- 11.54) in the placebo arm.

Other findings indicated that 67 individuals in the baclofen arm and 73 individuals in the placebo arm completed the study.

Hauser noted again that metrics of alcohol use decreased in both groups, but that baclofen showed no effect compared with placebo. “It is possible that higher dose baclofen may prove effective, but at this time, clinicians are encouraged to use other medications to reduce alcohol use in patients with chronic liver disease,” he said.

Reference:

Hauser P, et al. Abstract #654. Presented at: Digestive Disease Week; May 21-24, 2016; San Diego.

Disclosures: Hauser reports no relevant financial disclosures.