Long-term safety and tolerability of aripiprazole once-monthly in maintenance treatment of patients with schizophrenia

Apr 26, 2013International clinical psychopharmacology

Long-term safety and side effects of monthly aripiprazole treatment in people with schizophrenia

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Abstract

Patient enrollment included 633 in phase 1 and 403 in phase 4.

Adverse events occurring in more than 5% of participants included insomnia, headache, anxiety, akathisia, weight increase, injection-site pain, and tremor.
Headache, somnolence, and nausea peaked in onset within 4 weeks of starting treatment.
The incidence of extrapyramidal symptoms remained consistent across all study phases.
No unexpected changes in weight or fasting metabolic parameters were observed during the study.
ARI-OM demonstrated a safety and tolerability profile similar to that of oral aripiprazole for maintaining treatment in schizophrenia.

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The aim of this study was to evaluate the safety and tolerability of aripiprazole once-monthly (ARI-OM) for the maintenance treatment of schizophrenia. This long-term, pivotal study had four phases: oral conversion (phase 1, 4-6 weeks); oral stabilization (phase 2, 4-12 weeks); ARI-OM stabilization with coadministration of oral aripiprazole in the first 2 weeks (phase 3, 12-36 weeks); and a 52-week, randomized [phase 4, ARI-OM vs. placebo (2 : 1)], double-blind, maintenance phase. Safety was assessed across study phases by the time of first onset of adverse events, as were objective measures of extrapyramidal symptoms, fasting metabolic parameters, and body weight. Patient enrollment was phase 1=633; phase 2=710, of whom 210 entered phase 2 directly; phase 3=576; and phase 4=403 (ARI-OM, n=269; placebo, n=134). Adverse events (>5%) in any phase were insomnia, headache, anxiety, akathisia, increase in weight, injection-site pain, and tremor. Headache, somnolence, and nausea had a peak first onset within 4 weeks of treatment initiation. The incidence of extrapyramidal symptoms was similar in all phases. There were no unexpected changes in weight or shifts in fasting metabolic parameters across all study phases. ARI-OM had a safety and tolerability profile comparable with oral aripiprazole in maintenance treatment of schizophrenia.

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Long-term safety and tolerability of aripiprazole once-monthly in maintenance treatment of patients with schizophrenia

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