Safety and Persistence of Nalmefene Treatment for Alcohol Dependence. Results from Two Post-authorisation Safety Studies

Abstract

Aims Two post-authorisation studies assessed the safety and persistence of patients’ use of nalmefene. Methods The START study (EUPAS5678) was a non-interventional, multi-country, prospective, 18-month (8 follow-up visits) cohort study including outpatients initiating nalmefene for the first time. The multi-database retrospective cohort study (MDRC, EUPAS14083) included baseline and follow-up data from German, Swedish and UK healthcare databases. Both studies permitted ‘all comers’ without explicit exclusion criteria; predefined subgroups of interest included the elderly (≥65 years) as well as patients with significant psychiatric and/or somatic comorbidities. Results START study: Overall, the mean duration of nalmefene treatment was 10.3 ± 7.3 months (N = 1348), with 49.0% of patients treated for ≥1 year; frequent reasons for treatment discontinuation were ‘goal reached’ and ‘drug cost’. The most frequently reported adverse drug reactions (ADRs) were nausea (4.7%), dizziness (3.2%) and insomnia (2.0%). ADR rates appeared higher in the elderly subpopulation (18.6% reported ≥1 ADR vs. 12.0% in the total population) but were not higher in the other predefined subgroups. MDRC study: The database follow-up analysis followed 2892 patients over 18 months for whom the duration of nalmefene treatment was between 2 and 3 months and <5% of patients used nalmefene for ≥1 year. Conclusions Despite the inclusion of a wider patient population (e.g. elderly patients and those with relevant co-morbidities), the safety and tolerability profile of nalmefene given in routine practice was consistent with previous clinical studies. The differing rates of persistence beyond 1 year likely reflect the different methodologies and highlight the relevance of psychosocial support at follow-up visits.

A Prospective Precision Medicine Phase 3 Clinical Trial of Low-dose Ondansetron (a 5-ht3 Antagonist) to Treat Heavy and Very Heavy Drinkers With Alcohol Use Disorder

“…We know of no study in the alcohol literature showing an e cacious medicine with an AE pro le similar to placebo. Naltrexone has a Food and Drug Administration black box warning for liver toxicity; post-authorization data for nalmefene has noted rare but serious CNS adverse events 43 non-compliance is reported with acamprosate due to gastrointestinal discomfort (with less than 30% of patients being able to tolerate its long-term administration) 44 , and there are potentially fatal AEs with disul ram if a patient concomitantly consumes alcohol. AD04 is a unique medicine that could gain favor among non-specialist clinical practitioners, especially as both 6-month pill-taking and study compliance exceeded 95% and 70%, respectively, in the present study.…”

Alcoholic Liver Disease in China: A Disease Influenced by Complex Social Factors That Should Not Be Neglected

“…A series of withdrawal symptoms occur when alcohol consumption is terminated or abruptly reduced and can only be alleviated by the repeated use of alcohol or pharmacologically similar substances. 64 Alcohol addiction has become a major risk factor for death and disability, affecting approximately 4% of the global adult population. 27 A WHO survey indicated that 3.8% of the 2 billion people worldwide who consume alcoholic beverages are diagnosed with alcohol addiction.…”