Safety and Efficacy of Maintenance Treatment With Aripiprazole Once-Monthly in Black/African American Adults Diagnosed With Bipolar I Disorder: Post Hoc Analysis of a 52-Week, Open-Label Study.

Objective

This exploratory post hoc analysis examined the safety/efficacy of the aripiprazole once-monthly 400 mg (AOM 400) long-acting injectable (LAI) in Black/African American patients diagnosed with bipolar I disorder (BP-I).

Methods

Data were from a 52-week, open-label trial of AOM 400 maintenance treatment in patients diagnosed with DSM-IV-TR-defined BP-I. Outcomes included treatment-emergent adverse events (TEAEs), clinician-rated extrapyramidal symptoms (EPS), patient stability, Young Mania Rating Scale (YMRS), Montgomery-Asberg Depression Rating Scale (MADRS), and Clinical Global Impression-Bipolar Version-Severity (CGI-BP-S) scores, functioning, and quality of life (QoL). Data analyses comprised descriptive statistics and a mixed model for repeated measures.

Results

Outcomes were analyzed in 464 patients (Black/African American, n=104; White, n=255; Asian, n=94; other racial groups, n=11). No notable increase in TEAEs, serious TEAEs, or TEAEs leading to discontinuation were observed in Black/African American patients vs those in other racial groups. Rates of akathisia, tremor, increased weight, or hypertension were lower/similar in Black/African American patients vs other racial groups; changes in EPS scores were minimal in all groups. At last visit, 90.1% of Black/African American patients were stable, similar to other racial groups. Small changes in YMRS total score occurred in all groups, with MADRS total score and CGI-BP-S scores largely unchanged. Functioning and QoL improved in Black/African American patients, to a similar/greater degree than other racial groups. Limitations include the open-label design, prior aripiprazole stabilization, and sparse metabolic laboratory data, constraining causal inference and metabolic conclusions.

Conclusion

The safety and efficacy of AOM 400 is comparable between Black/African American and non-Black/African American patients with BP-I. The data provide valuable evidence supporting second-generation LAI antipsychotic use in these patients. Trial Registration: ClinicalTrials.gov identifier: NCT01710709.