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.

中文翻译：

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lumateperone 治疗精神分裂症的安全性和耐受性：晚期安慰剂和活性对照临床试验的汇总分析。

Lumateperone 是一种经美国食品和药物管理局批准用于治疗精神分裂症的抗精神病药，它具有一种新的作用机制，可以带来有益效果并提高耐受性。这项对三项随机、双盲、安慰剂对照试验的汇总分析旨在评估 lumateperone 42 mg 的安全性和耐受性。汇总人群包括 1073 名精神分裂症急性加重患者，随机分配至安慰剂（n = 412）、lumateperone 42 mg（n = 406）或利培酮 4 mg（n = 255）。治疗中出现的不良事件 (TEAE) 主要是轻微的，由于 42 mg lumateperone 的 TEAE 导致的停药率（0.5%）与安慰剂（0.5%）相似，低于利培酮（4.7%）。仅有的 TEAE 发生率 ≥ 5% 和 lumateperone 安慰剂的两倍是嗜睡/镇静和口干。相对于安慰剂治疗的患者，lumateperone 42 mg 代谢参数和催乳素的平均变化与基线相似或降低，并且小于利培酮。lumateperone 42 mg 和安慰剂治疗患者的体重和锥体外系症状相关 TEAE 发生率的平均变化相似，但低于利培酮治疗患者。该汇总分析证明了 lumateperone 42 mg 的安全性和良好的耐受性。lumateperone 42 mg 和安慰剂治疗患者的体重和锥体外系症状相关 TEAE 发生率的平均变化相似，但低于利培酮治疗患者。该汇总分析证明了 lumateperone 42 mg 的安全性和良好的耐受性。lumateperone 42 mg 和安慰剂治疗患者的体重和锥体外系症状相关 TEAE 发生率的平均变化相似，但低于利培酮治疗患者。该汇总分析证明了 lumateperone 42 mg 的安全性和良好的耐受性。