Observational studyPharmacoepidemiology and drug safety2018
Risk of hospitalisation and death related to baclofen for alcohol use disorders: Comparison with nalmefene, acamprosate, and naltrexone in a cohort study of 165 334 patients between 2009 and 2015 in France.
Observational study in Pharmacoepidemiology and drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Optimal Dose of Baclofen for the Treatment of Alcohol Use Disorder: A Systematic Review and Dose-Response Meta-analysis.CNS drugs · 2025Pooled it
- Use of sensitivity analyses to assess uncontrolled confounding from unmeasured variables in observational, active comparator pharmacoepidemiologic studies: a systematic review.American journal of epidemiology · 2025Pooled it
- Trial
- Impact of regulatory changes on the use of baclofen in alcohol use disorders between 2014 and 2021, using the French National Health Data System.Scientific reports · 2026Article
- Acute Intoxication After Baclofen Administration: A Review of the Literature and Methodological Proposals.Toxics · 2025Review
- Risk of Osteoarthritis and Arthroplasty Between Baclofen and Tizanidine: A Target Trial Emulation Study.Clinical drug investigation · 2025Article
- Neurological adverse events associated with baclofen: a pharmacovigilance study based on FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Treatment of alcohol use disorder in patients with alcohol-associated liver disease: Innovative approaches and a call to action.Addiction science & clinical practice · 2024Review
- Baclofen in the treatment of alcohol use disorder: tailored doses matter.Alcohol and alcoholism (Oxford, Oxfordshire) · 2024Review
- GABACurrent topics in behavioral neurosciences · 2022Article
- Moderate Alcoholic Hepatitis.Clinics in liver disease · 2021Review
- Approaching Alcohol Use Disorder After Liver Transplantation for Acute Alcoholic Hepatitis.Clinics in liver disease · 2021Review
- New-user and prevalent-user designs and the definition of study time origin in pharmacoepidemiology: A review of reporting practices.Pharmacoepidemiology and drug safety · 2021Review
- [Pharmacotherapy of alcohol withdrawal: update and new developments].Der Nervenarzt · 2021Review
- Baclofen therapeutics, toxicity, and withdrawal: A narrative review.SAGE open medicine · 2021Review
- Outpatient management of alcohol-related liver disease.The lancet. Gastroenterology & hepatology · 2020Review
- Risk of hospitalisation and death related to baclofen for alcohol use disorders: Comparison with nalmefene, acamprosate, and naltrexone in a cohort study of 165 334 patients between 2009 and 2015 in France.Pharmacoepidemiology and drug safety · 2018Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeBaclofen is widely used off-label for alcohol use disorders (AUD) in France, despite its uncertain efficacy and safety, particularly at high doses. This study was designed to evaluate the safety of this off-label use compared to the main approved drugs for AUD (acamprosate, naltrexone, nalmefene).
methodsThis cohort study from the French Health Insurance claims database included patients, aged 18 to 70 years, with no serious comorbidity (assessed by the Charlson score) initiating baclofen or approved drugs for AUD between 2009 and 2015. The risk of hospitalisation or death associated with baclofen, at variable doses over time (from low doses <30 mg/day to high doses ≥180 mg/day), compared to approved drugs, was evaluated by a Cox model adjusted to sociodemographic and medical characteristics.
resultsThe cohort included 165 334 patients, 47 614 of whom were exposed to baclofen. Patients exposed to baclofen differed from those treated with approved drugs in terms of sociodemographic and medical characteristics (more females, higher socioeconomic status, fewer hospitalisations for alcohol-related problems), but these differences tended to fade at higher doses of baclofen. Baclofen exposure was significantly associated with hospitalisation (hazard ratio [HR] = 1.13 [95%CI: 1.09-1.17]) and death (HR = 1.31 [95%CI: 1.08-1.60]). The risk increased with dose, reaching 1.46 [1.28-1.65] for hospitalisation and 2.27 [1.27-4.07] for death at high doses. Similar results were in patients with a history of hospitalisation for alcohol-related problems.
conclusionsThis study raises concerns about the safety of baclofen for AUD, particularly at high doses, with higher risks of hospitalisation and mortality than approved drugs.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.