Safety and Effectiveness of Naltrexone in the Management of Alcohol Use Disorder in Patients With Alcohol-associated Cirrhosis: First Clinical Observation From Indian Cohort

Abstract

Background and aims

Naltrexone is a promising drug to treat alcohol use disorder with limited evidence of safety in liver diseases. An observational study was performed to study the safety, effectiveness, and tolerability of Naltrexone in the management of alcohol use disorder in patients with alcohol-associated cirrhosis.

Methods

Naltrexone was started in patients with alcohol-related liver disease for the management of alcohol use disorder in 86 patients who were followed up for 4 weeks. Baseline liver parameters were compared with those at 4 weeks to establish safety of the drug. Effectiveness was determined by observing reduction in AUDIT scores, craving, number and days of drinking. Self-report of side effects was noted.

Results

After 4 weeks of starting Naltrexone there was a decrease in AST-89.86 vs 57.61, ALT-50.19 vs 27.08, SAP-121.81 vs 98.19, GGT-166.93 vs 109 and MELD 16.32 vs 12.13 (none statistically significant). There was a statistically significant reduction in Serum Bilirubin- (4.31 vs 1.98), INR (1.49 vs 1.32), self-reported craving (3.71 Vs 1.97; P = 0.01), AUDIT scores (24.13 Vs 16.91; P <0.01) and number of drinking days in last one month (10.22 Vs 4.19; P = 0.03).

Conclusion

The reduction in all liver parameters and AUDIT scores and craving after treatment with Naltrexone supports its safety and utility in the management of alcohol use disorder in alcohol-related liver cirrhosis.