Lumateperone in Pooled Late-Phase Schizophrenia Trials: Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed
نویسندگان
چکیده
Abstract Background Lumateperone is an FDA-approved antipsychotic to treat schizophrenia and depressive episodes associated with bipolar I or II disorder as monotherapy adjunctive therapy lithium valproate. This post hoc analysis investigated the efficacy tolerability of lumateperone in patients via number needed (NNT), harm (NNH), likelihood be helped harmed (LHH). Methods Data were pooled from three late-phase 4–6 week placebo-controlled studies 42 mg/day adults acute exacerbation psychosis (Study 005 [NCT01499563], Study 301 [NCT02282761], 302 [NCT02469155]). NNT NNH calculated vs placebo for several different Positive Negative Syndrome Scale [PANSS] Total score response cutoffs (percent reduction baseline) adverse events (AEs), respectively. Results In two informative (placebo, n=221; lumateperone, n=224), was statistically significant PANSS reductions baseline 4 weeks/endpoint ≥20% (NNT=9, 95% confidence interval [CI] 5–36) ≥30% (NNT=8; 95%CI 5–21). all n=412; n=406), study discontinuations due AEs uncommon (389) not placebo. The only AE <10 somnolence/sedation (NNH=8; 6–12). With treatment, weight gain ≥7% similar (NNH=112) fewer experienced akathisia than LHH ratios >>1 (range 13.6–48.6) except (LHH~1). Conclusion Lumateperone’s benefit-risk profile favorable trials. Funding Intra-Cellular Therapies, Inc.
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ژورنال
عنوان ژورنال: CNS spectrums
سال: 2023
ISSN: ['1092-8529', '2165-6509']
DOI: https://doi.org/10.1017/s1092852923001761