Journal of affective disorders · 2026
Aripiprazole once-monthly for patients diagnosed with bipolar I disorder: Number needed to treat, number needed to harm, and likelihood to be helped or harmed.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Citrome Leslie, Zhang Zhen, Hutson Walker Anne M, Atkins Norman, Bell Lynum Karimah S
Аннотация
BACKGROUND: This post hoc analysis assessed the benefit-risk profile of aripiprazole once-monthly 400 mg (AOM 400) as a long-term maintenance treatment in patients diagnosed with bipolar I disorder (BP-I), using the evidence-based metrics of number needed to treat (NNT), number needed to harm (NNH), and the likelihood to be helped or harmed (LHH).
METHODS: Data were derived from a double-blind, randomized withdrawal study that evaluated the efficacy and safety/tolerability of AOM 400 versus placebo over 52 weeks (NCT01567527). The main efficacy outcome was the proportion of patients free from recurrence of any mood episode, while the main safety/tolerability outcome was the incidence of patient discontinuation due to treatment-emergent adverse events (TEAEs).
RESULTS: Overall, 73.5% of 132 patients randomized to AOM 400 and 48.9% of 133 patients randomized to placebo were free from recurrence of any mood episode at Week 52 (NNT = 5 [95% CI: 3,8]). NNT (95% CI) values were 5 (4, 9), 4 (3, 7), and-116 (not significant) for patients free from recurrence of a manic mood episode, mixed mood episode, and depressive mood episode, respectively. Discontinuation due to TEAEs was lower with AOM 400 (17.4%) versus placebo (25.6%), resulting in a negative NNH. Using an imputed NNH versus placebo of 1000, LHH was 200 for patients free from recurrence of any mood episode relative to discontinuation due to any TEAE at 52 weeks.
CONCLUSIONS: Data suggest a favorable benefit-risk profile for AOM 400 versus placebo as a long-term maintenance treatment for BP-I.
METHODS: Data were derived from a double-blind, randomized withdrawal study that evaluated the efficacy and safety/tolerability of AOM 400 versus placebo over 52 weeks (NCT01567527). The main efficacy outcome was the proportion of patients free from recurrence of any mood episode, while the main safety/tolerability outcome was the incidence of patient discontinuation due to treatment-emergent adverse events (TEAEs).
RESULTS: Overall, 73.5% of 132 patients randomized to AOM 400 and 48.9% of 133 patients randomized to placebo were free from recurrence of any mood episode at Week 52 (NNT = 5 [95% CI: 3,8]). NNT (95% CI) values were 5 (4, 9), 4 (3, 7), and-116 (not significant) for patients free from recurrence of a manic mood episode, mixed mood episode, and depressive mood episode, respectively. Discontinuation due to TEAEs was lower with AOM 400 (17.4%) versus placebo (25.6%), resulting in a negative NNH. Using an imputed NNH versus placebo of 1000, LHH was 200 for patients free from recurrence of any mood episode relative to discontinuation due to any TEAE at 52 weeks.
CONCLUSIONS: Data suggest a favorable benefit-risk profile for AOM 400 versus placebo as a long-term maintenance treatment for BP-I.