Fact checked byHeather Biele

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December 05, 2023
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Acamprosate, oral naltrexone linked to improved outcomes in alcohol use disorder

Fact checked byHeather Biele
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Key takeaways:

  • The numbers needed to treat to prevent return to any drinking were 11 for acamprosate and 18 for oral naltrexone.
  • Oral naltrexone 50 mg/d was associated with lower rates of return to heavy drinking vs. placebo.

Acamprosate and oral naltrexone were associated with significantly improved alcohol consumption outcomes compared with placebo and could be used alongside psychosocial interventions as first-line treatment for alcohol use disorder.

“Unhealthy alcohol use is the third leading preventable cause of death in the United States, accounting for 145,000 deaths annually,” Melissa McPheeters, PhD, MPH, of the RTI International-University of North Carolina at Chapel Hill Evidence-Based Practice Center, and colleagues wrote in JAMA. “Among the 29.5 million people reporting a past-year alcohol use disorder in 2021, an estimated 0.9%, or 265,000 people, received pharmacotherapy for alcohol use disorder.”

According to results, the numbers needed to treat to prevent one person from returning to any drinking were 11for acamprosate and 18 for oral naltrexone 50 mg/day.
Data derived from: McPheeters M, et al. JAMA. 2023;doi:10.1001/jama.2023.19761.

In a systematic review and meta-analysis, researchers evaluated data from 118 clinical trials, which included 20,976 participants, to compare the effectiveness of nine therapies for alcohol use disorder. Studies included evaluation of three FDA-approved (acamprosate, disulfiram and naltrexone) and six off-label (baclofen, gabapentin, varenicline, topiramate, prazosin and ondansetron) medications.

The primary outcome was alcohol consumption defined as any alcohol use, return to heavy drinking and the number of drinks per week. Other outcomes included health-related and adverse events.

“Among the medications with an FDA indication for alcohol use disorder, acamprosate and naltrexone were associated with statistically significant improvement in alcohol consumption outcomes,” researchers wrote.

According to results, the numbers needed to treat to prevent one person from returning to any drinking were 11 (95% CI, 1-32) for acamprosate and 18 (95% CI, 4-32) for oral naltrexone 50 mg/day. There was no significant difference in return to heavy drinking between acamprosate and placebo (RR = 0.99; 95% CI, 0.94-1.05; 41.9%-81.5% vs. 45.8%-82.9%) or between injectable naltrexone and placebo (RR = 1; 95% CI, 0.82-1.21; 59.2%-77.2% vs. 52.7%-84.1%).

However, oral naltrexone 50 mg/day was associated with improvement in return to heavy drinking compared with placebo (RR = 0.81; 95% CI, 0.72-0.9; 14.2%-94.6% vs. 29.7%-93.5%), while injectable naltrexone was associated with fewer drinking days over the 30-day treatment period (weighted mean difference = –4.99 days; 95% CI, –9.49 to –0.49).

Compared with placebo, acamprosate was more commonly linked with gastrointestinal distress, including diarrhea (RR = 1.58; 95% CI, 1.27-1.97), while naltrexone-treated patients had higher rates of nausea (RR = 1.73; 95% CI, 1.51-1.98) and vomiting (RR = 1.53; 95% CI, 1.23-1.91).

“In conjunction with psychosocial interventions, these findings support the use of oral naltrexone, 50 mg/d, and acamprosate as first-line pharmacotherapies for alcohol use disorder,” McPheeters and colleagues concluded.