title: Safety and drinking outcomes among patients with comorbid alcohol dependence and borderline personality disorder treated with high-dose baclofen: a comparative cohort study.
abstract: In France, the off-label use of high-dose baclofen (HDB) for alcohol dependence is spreading. HDB induces frequent neuropsychiatric adverse events (AEs). Borderline personality disorder (BPD) is a major axis-two psychiatric disorder that exposes to frequent comorbid alcohol dependence and increased risky behaviors. We investigated the drinking and safety outcomes of patients with BPD treated with HDB for comorbid alcohol dependence. In a prospective cohort of 204 patients with alcohol dependence treated by HDB, 23 patients fulfilled the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. criteria for BPD. We paired two control participants without a psychiatric history with each BPD patient according to age and sex. We compared the average lengths of follow-up, average doses of baclofen received, rates of heavy drinking days, rates of serious AEs, and rates of AEs resulting in baclofen withdrawal. Between BPD patients (n=23) and controls (n=46), there were no significant differences in mean age (45.3±11.2 vs. 45.2±11.2 years), sex ratio (43.5% women), mean duration of follow-up (8.0±4.0 vs. 7.7±4.2 months; P=0.77), and average daily dose of baclofen (102.2±42.7 vs. 94.6±9.7 mg/day; P=0.44). However, the mean rate of heavy drinking days (74.3±25.3 vs. 41.7±33.3%; P<10E-4), the rate of serious AEs (65.2 vs. 6.5%; P<10E-4), and the rate of treatment discontinuation after AEs (52.2 vs. 8.6%; P<10E-4) were significantly higher in BPD. The benefit/risk balance of HDB appears to be unfavorable in comorbid BPD patients compared with nonpsychiatric patients.
authors.affiliation: aCAMTEA, Supervised Off-label Prescribing System in Addiction Medicine Departments of bAddiction Medicine cBiostatistics dPharmacovigilance eCSAPA, CHU Lille Departments of fPharmacology, EA 1046 gNeurosciences, LNFP, EA 4559, Univ Lille Nord de France, Lille hDepartment of Adult Psychiatry, CH Douai, Douai, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Rolland
authors.forename: Thomas
authors.initials: T
authors.lastname: Valin
authors.forename: Carole
authors.initials: C
authors.lastname: Langlois
authors.forename: Marine
authors.initials: M
authors.lastname: Auffret
authors.forename: Sophie
authors.initials: S
authors.lastname: Gautier
authors.forename: Sylvie
authors.initials: S
authors.lastname: Deheul
authors.forename: Thierry
authors.initials: T
authors.lastname: Danel
authors.forename: Régis
authors.initials: R
authors.lastname: Bordet
authors.forename: Olivier
authors.initials: O
authors.lastname: Cottencin
mesh_terms: D000328:Adult; D064829:Alcohol Abstinence; D000428:Alcohol Drinking / Q000517:prevention & control*; D000437:Alcoholism / Q000175:diagnosis / Q000453:epidemiology / Q000523:psychology / Q000601:surgery*; D001418:Baclofen / Q000008:administration & dosage* / Q000009:adverse effects; D001883:Borderline Personality Disorder / Q000175:diagnosis / Q000453:epidemiology / Q000523:psychology*; D016022:Case-Control Studies; D015897:Comorbidity; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001418:Baclofen