{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T08:31:20Z","timestamp":1790238680711,"version":"4.1.0"},"reference-count":38,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2018,9,25]],"date-time":"2018-09-25T00:00:00Z","timestamp":1537833600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2018,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Baclofen is widely used off\u2010label 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\u2010label use compared to the main approved drugs for AUD (acamprosate, naltrexone, nalmefene).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This cohort study from the French Health Insurance claims database included patients, aged 18 to 70\u00a0years, 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 &lt;30\u00a0mg\/day to high doses \u2265180\u00a0mg\/day), compared to approved drugs, was evaluated by a Cox model adjusted to sociodemographic and medical characteristics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The cohort included 165\u00a0334 patients, 47\u00a0614 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\u2010related problems), but these differences tended to fade at higher doses of baclofen. Baclofen exposure was significantly associated with hospitalisation (hazard ratio [HR]\u00a0=\u00a01.13 [95%CI: 1.09\u20101.17]) and death (HR\u00a0=\u00a01.31 [95%CI: 1.08\u20101.60]). The risk increased with dose, reaching 1.46 [1.28\u20101.65] for hospitalisation and 2.27 [1.27\u20104.07] for death at high doses. Similar results were in patients with a history of hospitalisation for alcohol\u2010related problems.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study raises concerns about the safety of baclofen for AUD, particularly at high doses, with higher risks of hospitalisation and mortality than approved drugs.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4635","type":"journal-article","created":{"date-parts":[[2018,9,25]],"date-time":"2018-09-25T08:28:41Z","timestamp":1537864121000},"page":"1239-1248","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":56,"title":["Risk of hospitalisation and death related to baclofen for alcohol use disorders: Comparison with nalmefene, acamprosate, and naltrexone in a cohort study of 165\u00a0334 patients between 2009 and 2015 in France"],"prefix":"10.1002","volume":"27","author":[{"given":"Christophe","family":"Chaignot","sequence":"first","affiliation":[{"name":"Cnam (French National Health Insurance)  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmoud","family":"Zureik","sequence":"additional","affiliation":[{"name":"ANSM (French National Agency for Medicines and Health Products Safety)  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gr\u00e9goire","family":"Rey","sequence":"additional","affiliation":[{"name":"Inserm, C\u00e9piDc (Epidemiology Centre on Medical Causes of Death)  Kremlin\u2010Bic\u00eatre France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosemary","family":"Dray\u2010Spira","sequence":"additional","affiliation":[{"name":"ANSM (French National Agency for Medicines and Health Products Safety)  Saint\u2010Denis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jo\u00ebl","family":"Coste","sequence":"additional","affiliation":[{"name":"Cnam (French National Health Insurance)  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8687-9092","authenticated-orcid":false,"given":"Alain","family":"Weill","sequence":"additional","affiliation":[{"name":"Cnam (French National Health Insurance)  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,9,25]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/37.5.504"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/agh130"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61814-5"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1530-0277.2010.01273.x"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/agr017"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/ags028"},{"key":"e_1_2_9_8_1","first-page":"103","article-title":"Suppression of alcohol dependence using baclofen: a 2\u2010year observational study of 100 patients","volume":"3","author":"Beaurepaire R","year":"2012","journal-title":"Front Psych"},{"key":"e_1_2_9_9_1","volume-title":"The End of my Addiction","author":"Ameisen O","year":"2008"},{"key":"e_1_2_9_10_1","volume-title":"Le Dernier Verre","author":"Ameisen O","year":"2008"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2013.09.008"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.2515\/therapie\/2015027"},{"key":"e_1_2_9_13_1","first-page":"1","article-title":"On\u2010the\u2010ground application of the \u2018temporary recommendation for use\u2019 regulatory measure on off\u2010label use of baclofen for alcohol dependence in France: a regional survey of community pharmacies","author":"Auffret M","year":"2017","journal-title":"Fundam Clin Pharmacol"},{"key":"e_1_2_9_14_1","unstructured":"Caisse nationale de l'assurance maladie.Open MEDIC: base compl\u00e8te sur les d\u00e9penses de m\u00e9dicaments interr\u00e9gimes.http:\/\/open\u2010data\u2010assurance\u2010maladie.ameli.fr\/medicaments\/index.php#Open_MEDIC."},{"key":"e_1_2_9_15_1","unstructured":"French National Agency for Medicines and Health Products Safety (ANSM).Recommandation Temporaire d'Utilisation du baclof\u00e8ne dans la prise en charge des patients alcoolo\u2010d\u00e9pendants\u20142014. 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