FDA and EMA facilitate a paradigm shift towards alcohol reduction in severe alcohol use disorder

Kurzzusammenfassung in leicht verständlicher Sprache

Abstinence has been the dominant treatment goal in alcohol use disorders but less than one third of patients attain full abstinence. Requiring abstinence as the only acceptable goal has created a paradox: it deters the very people who most need help from seeking it, because they do not accept abstinence as their only goal. A large number of recent studies shows that reductions in alcohol consumption are feasible and sustainable. The US Food and Drug Agency (FDA) has approved this new treatment goal, which facilitates a major paradigm shift towards a harm reduction approach.

Abstract

Hintergrund und Fragestellung
Abstinence has been the dominant benchmark of success in AUD treatment but less than one third of patients in clinical trials attain full abstinence. Requiring abstinence as the only acceptable goal has created a paradox: it deters the very people who most need help from seeking it, because they do not accept abstinence as their only goal. Against this background, we were interested whether severe AUD patients can follow a treatment goal short of abstinence and whether the effects are sustainable?

Methoden
A narrative review of recent work of the “Alcohol Clinical Trials Initiative (ACTIVE)”, a public-private partnership of academic researchers, the FDA, the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and pharmaceutical companies. It systematically assembled the evidence base linking a validated measure to capture drinking reductions (WHO Risk Drinking Level) to improvements in how patients feel and function. The secondary analyses was independently reanalyzed by the FDA which qualified a reduction of at least two World Health Organization (WHO) RDLs as a primary endpoint for alcohol pharmacotherapy clinical trials. This regulatory milestone aligns with an existing European Medicines Agency (EMA) guideline that already recognizes WHO RDL reductions as an intermediate harm-reduction endpoint.

Ergebnisse
Reductions in WHO RDLs are associated with improvements across a broad range of domains: alcohol biomarkers, quality of life, mental health, alcohol-related consequences, and reduced risk of AUD diagnosis, other substance use disorders, liver disease, cardiovascular disease, and depression and anxiety disorders. The effects could be documented for up to three years.

Diskussion und Schlussfolgerung
A substantial amount of scientific efforts provides evidence that a reduction in alcohol consumption as treatment goal in AUD is possible. Individuals show improvements in many domains of physical and psychological health including quality of life. The FDA decision facilitates a major paradigm shift towards a harm reduction approach.

Interessenskonflikte sowie Erklärung zur Finanzierung
Ich bzw. die Koautorinnen und Koautoren erklären, dass während der letzten 3 Jahre keine wirtschaftlichen Vorteile oder persönlichen Verbindungen bestanden, die die Arbeit zum eingereichten Abstract beeinflusst haben könnten.