ObjectiveTo assess the effects of treatment with lurasidone on risk for metabolic syndrome (MetS) in patients with schizophrenia.MethodsRates of metabolic syndrome during treatment with lurasidone (40-160 mg/d) were analyzed using pooled, short-term data from three randomized, double-blind, placebo-controlled studies (vs olanzapine and quetiapine XR); long-term data from two active-comparator-controlled studies (vs risperidone and quetiapine XR); and data from two open-label studies in which patients were switched from olanzapine or risperidone to lurasidone.ResultsMetS was defined based on the National Cholesterol Education Program criteria. In short-term studies, the odds of meeting criteria for MetS at week 6 LOCF (adjusted for baseline metabolic syndrome status) was similar for the lurasidone and placebo groups (OR = 1.18; [95% CI, 0.81-1.71]; P = .39), but the odds (vs placebo) were significantly greater for olanzapine (OR = 2.81; [95% CI, 1.53-5.15]; P < .001) and quetiapine (OR = 3.49; [95% CI, 1.93-6.29]; P < .0001). No dose effect was observed for lurasidone across the dose range of 40-160 mg/d. In long-term studies, the odds of MetS after 12 months of treatment was significantly higher for risperidone compared with lurasidone (OR = 2.12; 95% CI, 1.15-3.90; P = .016) and for quetiapine XR compared with lurasidone (OR = 3.92; 95% CI, 1.15-13.40; P = .029). In open-label extension studies, the rate of MetS decreased in patients switched to lurasidone after 6 weeks of treatment with olanzapine or 12 months of treatment with risperidone.ConclusionIn this analysis of lurasidone clinical trials, the odds of developing metabolic syndrome were minimal during short- and long-term treatment with lurasidone (40-160 mg/d).

中文翻译：

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鲁拉西酮与代谢综合征风险：精神分裂症患者短期和长期临床研究的结果

目的评估卢拉西酮治疗对精神分裂症患者代谢综合征（MetS）风险的影响。方法使用来自三个随机、双盲、安慰剂对照研究（对比奥氮平和喹硫平 XR）；来自两项活性对照研究的长期数据（对比利培酮和喹硫平 XR）；以及来自两项开放标签研究的数据，其中患者从奥氮平或利培酮转换为鲁拉西酮。ResultsMetS 是根据国家胆固醇教育计划标准定义的。在短期研究中，lurasidone 组和安慰剂组在第 6 周 LOCF（根据基线代谢综合征状态调整）达到 MetS 标准的几率相似（OR = 1.18；[95% CI，0.81-1.71]；磷= .39），但奥氮平的优势（与安慰剂相比）显着更高（OR = 2.81；[95% CI，1.53-5.15]；磷< .001) 和喹硫平 (OR = 3.49；[95% CI, 1.93-6.29]；磷< .0001)。lurasidone 在 40-160 mg/d 的剂量范围内未观察到剂量效应。在长期研究中，利培酮治疗 12 个月后发生 MetS 的几率显着高于鲁拉西酮（OR = 2.12；95% CI，1.15-3.90；磷= .016）和喹硫平XR与鲁拉西酮相比（OR = 3.92；95% CI，1.15-13.40；磷= .029)。在开放标签扩展研究中，在奥氮平治疗 6 周或利培酮治疗 12 个月后改用鲁拉西酮的患者的 MetS 发生率下降。结论在对鲁拉西酮临床试验的分析中，在短期内发生代谢综合征的几率很小- 和长期使用鲁拉西酮 (40-160 mg/d) 治疗。