Effect of high-dose baclofen on agitation-related events among patients with unhealthy alcohol use receiving mechanical ventilation

A Phase III French study explored whether high-dose baclofen benefits mechanically ventilated patients who have a history of unhealthy alcohol use. These individuals can be vulnerable to agitation in the intensive care unit (ICU), potentially sabotaging their medical care. To determine the value of baclofen—which may reduce or suppress cravings in patients with alcohol use disorder—researchers assembled a study population of 314 adults matching this patient profile. The primary analysis included 159 patients assigned to baclofen and 155 patients who received placebo. The main endpoint was one or more agitation-related event during the course of treatment, which occurred in 19.7% of patients in the intervention group and 29.7% of the controls. The difference was modest but statistically significant in favor of baclofen, but participants who received the study drug also were more likely to experience delayed awakening. Given the frequency of that adverse event and the totality of the evidence, including secondary outcomes such as 28-day mortality and duration of ICU length of stay, the study authors believe additional research is warranted.