Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
John Cavenagh, PhD, PA-C
OBJECTIVE: The objective of this selective EBM review is to determine whether or not Rimonabant is a safe and effective treatment for patients with alcohol dependence.
STUDY DESIGN: Systematic review of three English language randomized control trials published in 2005, 2008 and 2010.
DATA SOURCES: Three double-blind, placebo controlled randomized trials comparing Rimonabant or Naltrexone to placebo were found using PubMed, OVID, Medline and Cochrane.
OUTCOMES MEASURED: Outcomes measured include event rate of heavy drinking days using the timeline follow back method, which facilitates self-reporting of drinking habits by utilizing calendars and personal recall. Other outcomes measured include the number of self-reported drinks/day using daily
call ins from study participants and number of days until first alcoholic drink and number of days until first heavy drinking (as measured by timeline follow back method).
RESULTS: In a study by George et.al, there was no significant difference found in the number of alcoholic drinks consumed by non-treatment seeking heavy alcohol drinkers when comparing the Rimonabant and placebo groups during the 14 day study. A study by Soyka et.al. discovered that participants treated with once daily Rimonabant showed a marked, but not statistically significant, reduction in relapse to heavy drinking when compared to placebo after 12 weeks of treatment: 27.7% versus 35.6%, respectfully. Finally, another study included in this review investigated the efficacy of intramuscular naltrexone as a treatment for alcohol dependence by measuring the event rate of heavy drinking days. Results of this study showed that long-acting IM naltrexone resulted in 25% reduction in heavy drinking days among treatment-seeking alcohol dependent patients when compared to placebo. The compiled data also demonstrates that both Rimonabant and Naltrexone are relatively safe to use in adult alcoholics, however patients receiving Rimonabant were more likely to have treatment emergent adverse events such as nausea, insomnia, headache, etc.
CONCLUSIONS: The results of two double-blind placebo controlled randomized control trials showed no statistical treatment effect of Rimonabant versus placebo in reducing the number of drinks per day, number of heavy drinking days, or time to heavy drinking relapse. Both Naltrexone and Rimonabant are considered safe for use in adults, despite a modest amount of mild adverse reactions associated with treatment.
Hughes, Samantha L., "Is Rimonabant a Safe and Effective Treatment for Patients with Alcohol Dependence?" (2013). PCOM Physician Assistant Studies Student Scholarship. 115.