Open AccessSafety and tolerability of lumateperone for the treatment of schizophrenia: a pooled analysis of late-phase placebo- and active-controlled clinical trials
Author(s) -
John M. Kane,
Suresh Durgam,
Andrew Satlin,
Kimberly E. Vanover,
Richard Chen,
Robert E. Davis,
Sharon Mates
Publication year - 2021
Publication title -
international clinical psychopharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.559
H-Index - 91
eISSN - 1473-5857
pISSN - 0268-1315
DOI - 10.1097/yic.0000000000000371
Subject(s) - tolerability , placebo , discontinuation , risperidone , adverse effect , medicine , extrapyramidal symptoms , somnolence , randomized controlled trial , population , anesthesia , antipsychotic , schizophrenia (object oriented programming) , psychiatry , alternative medicine , environmental health , pathology
Lumateperone, an antipsychotic that is US Food and Drug Administration-approved for the treatment of schizophrenia, has a novel mechanism of action that may confer beneficial effects with improved tolerability. This pooled analysis of three randomized, double-blind, placebo-controlled trials was conducted to evaluate the safety and tolerability of lumateperone 42 mg. The pooled population comprised 1073 patients with an acute exacerbation of schizophrenia randomized to placebo (n = 412), lumateperone 42 mg (n = 406) or risperidone 4 mg (n = 255). Treatment-emergent adverse events (TEAEs) were predominantly mild and rates of discontinuation due to TEAEs with lumateperone 42 mg (0.5%) were similar to placebo (0.5%) and lower than risperidone (4.7%). The only TEAEs that occurred at a rate of ≥5% and twice placebo for lumateperone were somnolence/sedation and dry mouth. Mean change from baseline in metabolic parameters and prolactin were similar to or reduced in lumateperone 42 mg relative to placebo-treated patients and were smaller than risperidone. Mean change in weight and rates of extrapyramidal symptoms-related TEAEs were similar for lumateperone 42 mg and placebo-treated patients and less than for risperidone-treated patients. This pooled analysis demonstrates the safety and favorable tolerability profile of lumateperone 42 mg.