PMID- 36883881
OWN - NLM
STAT- MEDLINE
DCOM- 20230312
LR  - 20230402
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 84
IP  - 2
DP  - 2023 Mar 6
TI  - Lumateperone for the Treatment of Schizophrenia: Number Needed to Treat, Number 
      Needed to Harm, and Likelihood to Be Helped or Harmed.
LID - 22r14631 [pii]
LID - 10.4088/JCP.22r14631 [doi]
AB  - Objective: To describe lumateperone for the treatment of schizophrenia in adults 
      using number needed to treat (NNT), number needed to harm (NNH), and likelihood 
      to be helped or harmed (LHH). Methods: Data were obtained from the 3 phase 2/3 
      lumateperone trials, conducted between 2011 and 2016, in patients with 
      schizophrenia diagnosed using the Diagnostic and Statistical Manual of Mental 
      Disorders, Fourth Edition, Text Revision, or Fifth Edition. Efficacy was assessed 
      using various response criteria; tolerability was principally assessed using 
      rates of adverse events (AEs). Results: Pooled data of the 2 informative studies 
      showed statistically significant estimates of NNT versus placebo for lumateperone 
      42 mg/d for the responder thresholds of >/= 20% and >/= 30% improvement on Positive 
      and Negative Syndrome Scale (PANSS) total scores, with NNT for response versus 
      placebo at 4 weeks and endpoint of 9 (95% confidence interval [CI], 5-36) and 8 
      (95% CI, 5-21), respectively. Pooling all studies, discontinuation because of AEs 
      was uncommon, and the NNH versus placebo was 389 (not statistically significant 
      from placebo [NS]). Rates of individual AEs resulted in NNH versus placebo > 10 
      except for somnolence/sedation (NNH of 8; 95% CI, 6-12). The occurrence of weight 
      gain >/= 7% from baseline yielded a NNH estimate of 122 (NS). Rates of akathisia 
      were lower for patients receiving lumateperone compared with placebo. LHH for 
      response versus somnolence/sedation was ~ 1 for lumateperone (similar to the 
      risperidone active control group); otherwise, lumateperone exhibited LHH ratios 
      that were much greater than 1 for all other AEs and that ranged from 13.6 to 48.6 
      for these other benefit-risk calculations. Conclusions: In 3 phase 2/3 trials, 
      the benefit-risk assessment of lumateperone was favorable as measured by NNT, 
      NNH, and LHH. Trial Registration: ClinicalTrials.gov identifiers: NCT01499563, 
      NCT02282761, NCT02469155.
CI  - (c) Copyright 2023 Physicians Postgraduate Press, Inc.
FAU - Citrome, Leslie
AU  - Citrome L
AD  - New York Medical College, Valhalla, New York.
AD  - Corresponding author: Leslie Citrome, MD, MPH, 11 Medical Park Drive, Ste 102, 
      Pomona, NY 10970 (nntman@gmail.com).
FAU - Durgam, Suresh
AU  - Durgam S
AD  - Intra-Cellular Therapies, Inc., New York, New York.
FAU - Edwards, John B
AU  - Edwards JB
AD  - Intra-Cellular Therapies, Inc., New York, New York.
FAU - Davis, Robert E
AU  - Davis RE
AD  - Intra-Cellular Therapies, Inc., New York, New York.
LA  - eng
SI  - ClinicalTrials.gov/NCT01499563
SI  - ClinicalTrials.gov/NCT02282761
SI  - ClinicalTrials.gov/NCT02469155
SI  - ClinicalTrials.gov/NCT01499563
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230306
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - 70BSQ12069 (lumateperone)
RN  - L6UH7ZF8HC (Risperidone)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Antipsychotic Agents/adverse effects
MH  - Heterocyclic Compounds, 4 or More Rings/therapeutic use
MH  - Risperidone/therapeutic use
MH  - *Schizophrenia/drug therapy/chemically induced
MH  - Sleepiness
EDAT- 2023/03/09 06:00
MHDA- 2023/03/11 06:00
CRDT- 2023/03/08 09:22
PHST- 2023/03/08 09:22 [entrez]
PHST- 2023/03/09 06:00 [pubmed]
PHST- 2023/03/11 06:00 [medline]
AID - 22r14631 [pii]
AID - 10.4088/JCP.22r14631 [doi]
PST - epublish
SO  - J Clin Psychiatry. 2023 Mar 6;84(2):22r14631. doi: 10.4088/JCP.22r14631.