Safety and Tolerability of Xanomeline and Trospium Chloride in Schizophrenia: Pooled Results From the 5-Week, Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials.
Inder Kaul, Amy Claxton, Sharon Sawchak, Colin Sauder, Stephen K Brannan, Edwin Raj, Shiling Ruan, George Konis, David Brown, Andrew J Cutler, Ronald Marcus
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引用次数: 0
Abstract
Objective: To further characterize the safety and tolerability of oral xanomeline and trospium chloride in the treatment of people with schizophrenia experiencing acute psychosis.
Methods: Pooled analyses were performed on safety data from the 5-week, randomized, double-blind, placebo-controlled, inpatient EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials of xanomeline/ trospium in adults with schizophrenia with a recent worsening of psychosis requiring hospitalization. Adverse events (AEs) including extrapyramidal motor symptoms (EPS), vital signs, and clinical laboratory values were monitored. Additional analyses of AEs were conducted on subgroups based on age (<45 years or ≥45 years), sex, race (Black or White), ethnicity (Hispanic/Latino or not Hispanic/ Latino), country (United States or Ukraine), and baseline body mass index (<30 kg/m2 or ≥30 kg/m2).
Results: The pooled safety population comprised 683 participants from the acute trials. Discontinuation rates were similar between groups (xanomeline/ trospium, 27.6%; placebo, 22.7%). Treatment-emergent AEs were reported by 67.9% (xanomeline/trospium) and 51.3% (placebo) of participants, and 51.8% (xanomeline/trospium) and 29.4% (placebo) experienced AEs deemed related to treatment. The most common AEs with xanomeline/trospium were mild or moderate in intensity, transient, and generally gastrointestinal in nature. Subgroups demonstrated clinically nonsignificant differences in incidences of the most common AEs. Rates of EPS, somnolence, and weight gain were low in both groups.
Conclusions: In pooled analyses, xanomeline/trospium was generally well tolerated in people with schizophrenia. The most common AEs were mild or moderate in intensity, transient, and consistent with the activity of xanomeline and trospium at muscarinic receptors. Rates of EPS, somnolence, and weight gain were low.
期刊介绍：
For over 75 years, The Journal of Clinical Psychiatry has been a leading source of peer-reviewed articles offering the latest information on mental health topics to psychiatrists and other medical professionals.The Journal of Clinical Psychiatry is the leading psychiatric resource for clinical information and covers disorders including depression, bipolar disorder, schizophrenia, anxiety, addiction, posttraumatic stress disorder, and attention-deficit/hyperactivity disorder while exploring the newest advances in diagnosis and treatment.
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