Abstinence at 3 months
After 3 months, abstinence was noted in 64% of the study population who received naltrexone, compared to 22% of those who received placebo (P < .001). At 6 months, a higher proportion of patients in the naltrexone group achieved abstinence (22% vs. 8% with placebo; P = .09).
“We still need to look at the longer-term effects of naltrexone,” Dr. Alla said. “Here we gave the drug plus counseling for 3 months only, so despite encouraging findings, we need further studies to understand more.”
The researchers analyzed the predictors of abstinence at 3 months. They found that patients who consumed fewer than 17 drinks per month at baseline were more likely to achieve abstinence (sensitivity, 81%).
“Our study showed that patients who are consuming less alcohol at baseline can quit alcohol if adequately motivated. We need the motivation, as well as the drug,” she said.
Patient counseling was also very important and was provided for the 3 months of the study. “Even in the placebo arm, we had some patients who became abstinent [11/50 patients], but this dropped at 6 months [to 4/50],” Dr. Alla said.
At 12 weeks, 28% in the naltrexone group experienced relapse, vs. 72% in the placebo group (P < .001). Regarding the secondary outcome of craving scores and how they were affected by naltrexone, the mean OCDS-O (obsessive element) scores were 6.63, compared with 9.29 in naltrexone and placebo, respectively (P < .01). The mean OCDS-C (compulsive element) scores were 6.34 and 9.02, respectively (P < .01).
“Most important, was the safety of naltrexone in this study,” she said. There were no significant adverse events in either arm, and only one patient discontinued the drug in the naltrexone arm. Three patients in the naltrexone group who continued alcohol consumption developed jaundice, “so the jaundice can be attributed to continuous alcohol intake and may not be secondary to the naltrexone per se. We concluded that naltrexone is safe in a compensated cirrhotic patient,” Dr. Alla said.
Regarding other adverse events, 13.7% of patients experienced gastritis with naltrexone, vs. 3.7% among patients who received placebo. Nausea was more common in the placebo group, at 11.1% compared with 6.8% among patients who received naltrexone. Vomiting was more common in the naltrexone arm, at 10.3% vs. 7.4% with placebo. None of these differences reached statistical significance.
A longer-term study and comparisons to other drugs would provide valuable insights going forward.
Moderator Aleksander Krag, MD, professor and head of hepatology at the University of Southern Denmark and Odense University Hospital, Denmark, said: “Any intervention that can reduce or stop alcohol use in patients with cirrhosis and more advanced cirrhosis will improve outcome as well as reduce complications and mortality.
“In some cases, alcohol rehabilitation can completely revert the damaged liver. We have lots of data that show that continuous alcohol use at the more advanced stages can be devastating and reduction [in alcohol use] improves outcome. Therefore, any intervention that can help us to achieve this on behalf of all patients is most welcome,” he said.
Naltrexone (ADDTREX) and identical placebos were supplied by Rusan Pharma. Dr. Alla has disclosed no relevant financial relationships. Dr. Krag has served as speaker for Norgine, Siemens, and Nordic Bioscience and has participated in advisory boards for Norgine and Siemens outside the submitted work. He receives royalties from Gyldendal and Echosens.
A version of this article appeared on Medscape.com.