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.
Leslie Citrome, Zhen Zhang, Anne M Hutson Walker et al.
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In 30 seconds
This post hoc analysis of a double-blind, randomized controlled trial evaluated aripiprazole once-monthly 400 mg in patients with bipolar I disorder. At 52 weeks, 73.5% of patients on AOM 400 were free from mood episode recurrence compared to 48.9% on placebo, yielding a number needed to treat (NNT) of 5. The study suggests a favorable benefit-risk profile for AOM 400.
Key findings
- 73.5% of patients on AOM 400 were free from mood episode recurrence at Week 52 compared to 48.9% on placebo.
- The number needed to treat (NNT) for AOM 400 was 5 (95% CI: 3, 8).
- Discontinuation due to treatment-emergent adverse events was lower with AOM 400 (17.4%) than placebo (25.6%).
- The likelihood to be helped or harmed (LHH) was 200 for patients free from recurrence versus discontinuation due to any TEAE.
Why it matters
Understanding the benefit-risk profile of long-term treatments for bipolar I disorder is crucial for clinicians to make informed decisions about patient management and to optimize therapeutic outcomes.