Xanomeline and Trospium Chloride for the Treatment of Agitation Associated With Schizophrenia: PANSS-Excited Component Results From 3 Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials.
Paul P Yeung, Alan Breier, Haiyuan Zhu, Inder Kaul, Ronald N Marcus
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引用次数: 0
Abstract
Objective: To further characterize the efficacy of oral xanomeline and trospium chloride in the treatment of agitation associated with schizophrenia.
Methods: Analyses were performed on the change from baseline of the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC; composed of excitement, tension, hostility, uncooperativeness, and poor impulse control items) 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. The 3 trials met the primary endpoint of reduction from baseline to week 5 in PANSS total score. Data were analyzed from individual studies and were also pooled.
Results: The population comprised 640 participants from the pivotal trials which were conducted from September 2018 to December 2022. PANSS-EC scores were significantly reduced with xanomeline/trospium vs placebo at week 5 across all 3 EMERGENT trials. In EMERGENT-1, xanomeline/trospium (n = 83) was statistically significantly superior (Cohen's d =0.62, P = .0002) to placebo (n = 87) in improvement (decrease) of PANSS-EC score at week 5. In EMERGENT-2, xanomeline/trospium (n = 117) was significantly superior (d = 0.43, P = .0026) to placebo (n = 119) at week 5. In EMERGENT-3, xanomeline/ trospium (n = 114) was significantly superior (d = 0.62, P < .0001) to placebo (n = 120) at week 5. Pooled results were consistent with the individual trials.
Conclusion: Xanomeline/trospium showed improvement in agitation as measured by PANSS-EC in participants with acute exacerbations of schizophrenia. Xanomeline/trospium is the first in a new class of treatments for schizophrenia based on muscarinic receptor agonism.
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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