Use of baclofen for the treatment of alcohol use disorders between 2014 and 2021 in France

IntroductionThe use of baclofen for the treatment of alcohol use disorders (AUD) in France has increased significantly between 2007 and 2013, initially through off-label prescription (1,2). In April 2014, temporary authorization for use (TAU) was granted, followed by marketing authorization (MA) in October 2018. It was also reported that high doses of baclofen had the potential for serious adverse effects (3). As a result, the maximum dose was limited to 80 mg/day in July 2017. We aimed to assess the impact of the medical authorization (MA) of baclofen for alcohol use disorder (AUD) on the number of newly treated patients in France between 2014 and 2021, and the impact of dose restrictions on baclofen dosage.MethodsA retrospective cohort study of patients newly treated with baclofen for AUD was conducted using data from the French National Health Data System. Characteristics of patients and treatments were described. Interrupted time-series analyses (ARIMA models) were performed to evaluate the effect of MA and dose limitation on baclofen treatment initiations and daily doses.ResultsBetween 2014 and 2021, 478,109 patients were newly treated with baclofen for AUD. A significant decline of initiations of baclofen was observed between 2014 (N=98,552) and 2015 (N=67,555), and a gradual decrease after 2016 (N=48 471 in 2021). The MA of baclofen for AUD did not have a statistically significant impact on the number of baclofen initiations for AUD. Before dose limitation, respectively 78.0% and 0.8% of daily doses were lower than 80mg and higher than 300mg, against 88.3% and 0.5% after July 2017.ConclusionSince the peak in 2014, baclofen use has been steadily decreasing and MA has not resulted in an increase in baclofen initiations for AUD. The part of patients with a dose greater than 300mg is low and has decreased over the period 2014-2021