Brexpiprazole (Rexulti) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of agitation associated with dementia due to Alzheimer’s disease. This approval is based on evidence from multiple clinical trials demonstrating its efficacy and safety in this population.
Clinical Evidence:
Several randomized, double-blind, placebo-controlled trials have evaluated brexpiprazole’s effectiveness in managing agitation in Alzheimer’s dementia. In these studies, patients receiving brexpiprazole at doses of 2 mg or 3 mg per day showed statistically significant improvements in agitation symptoms compared to those receiving placebo. The primary measure for these improvements was the change in the Cohen-Mansfield Agitation Inventory (CMAI) total score over a 12-week period. These findings suggest that brexpiprazole can be an effective option for reducing agitation in this patient population.
Safety and Tolerability:
Brexpiprazole was generally well-tolerated in clinical trials. Common side effects included headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances such as somnolence and insomnia. Importantly, the incidence of these adverse events was comparable to that observed in the placebo groups. However, as with other antipsychotic medications, brexpiprazole carries a boxed warning regarding an increased risk of mortality in elderly patients with dementia-related psychosis.
Conclusion:
Brexpiprazole represents a significant advancement in the pharmacological management of agitation associated with Alzheimer’s dementia. Its approval provides clinicians with a new therapeutic option for addressing this challenging symptom, which can significantly impact the quality of life for both patients and caregivers.
