Systematic review and meta-analysis on the adverse events of rimonabant treatment: considerations for its potential use in hepatology.
BACKGROUND
The cannabinoid-1 receptor blockers have been proposed in the management of obesity and obesity-related liver diseases (fatty liver as NAFLD or NASH). Due to increasing number of patients to be potentially treated and the need to assess the advantage of this treatment in terms of risk/benefit, we analyze the side events reported during the treatment with rimonabant by a systematic review and meta-analysis of all randomized controlled studies.


METHODS
All published randomized controlled trials using rimonabant versus placebo in adult subjects were retrieved. Relative risks (RR) with 95% confidence interval for relevant adverse events and number needed to harm was calculated.


RESULTS
Nine trials (n = 9635) were considered. Rimonabant 20 mg was associated with an increased risk of adverse event (RR 1.35; 95%CI 1.17-1.56), increased discontinuation rate (RR 1.79; 95%CI 1.35-2.38), psychiatric (RR 2.35; 95%CI 1.66-3.34), and nervous system adverse events (RR 2.35; 95%CI 1.49-3.70). The number needed to harm for psychiatric adverse events is 30.


CONCLUSIONS
Rimonabant is associated with an increased risk of adverse events. Despite of an increasing interest for its use on fatty liver, the security profile and efficacy it is needs to be carefully assessed before its recommendation. At present the use of rimonabant on fatty liver cannot be recommended.
Chavez-Tapia
Norberto C
NC
Centro Studi Fegato - Liver Research Center, Bldg Q - AREA Science Park-Basovizza Campus, Italy. khavez@gmail.com
Tellez-Avila
Felix I
FI
Bedogni
Giorgio
G
Crocè
Lory S
LS
Masutti
Flora
F
Tiribelli
Claudio
C
D063387:Cannabinoid Receptor Antagonists; D005234:Fatty Liver / Q000188:drug therapy*; D006801:Humans; D001523:Mental Disorders / Q000139:chemically induced; D009422:Nervous System Diseases / Q000139:chemically induced; D010880:Piperidines / Q000009:adverse effects* / Q000627:therapeutic use*; D011720:Pyrazoles / Q000009:adverse effects* / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D000077285:Rimonabant; D016896:Treatment Outcome
D063387:Cannabinoid Receptor Antagonists; D010880:Piperidines; D011720:Pyrazoles; D000077285:Rimonabant