David H Adams, Lu Zhang, Brian A Millen, Bruce J Kinon, Juan-Carlos Gomez
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The pomaglumetad methionil group showed significantly greater weight loss at Week 24 (Visit 12) compared with the aripiprazole group (-2.8 ± 0.4 versus 0.4 ± 0.6; P < 0.001). However, change in Positive and Negative Syndrome Scale (PANSS) total scores for aripiprazole was significantly greater than for pomaglumetad methionil (-15.58 ± 1.58 versus -12.03 ± 0.99; P = 0.045). The incidences of SAEs (8.2% versus 3.1%; P = 0.032) and discontinuation due to AEs (16.2% versus 8.7%; P = 0.020) were significantly higher for pomaglumetad methionil compared with aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with pomaglumetad methionil resulted in significantly less weight gain than aripiprazole. 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引用次数: 54
摘要
我们检验了一种假设,即长期使用pomaglumetad methionil治疗精神分裂症患者的体重增加明显少于阿立哌唑。在这项为期24周的多中心、随机、双盲、3期研究中,678名精神分裂症患者被随机分配到pomaglumetad methionil (n = 516)或阿立哌唑(n = 162)组。还比较了治疗组的疗效和各种安全措施,包括严重不良事件(sae)、因不良事件停药(ae)、治疗后出现的不良事件(teae)、锥体外系症状(EPS)和自杀相关的想法和行为。与阿立哌唑组相比,pomaglumetad methionil组在第24周(第12次访问)的体重减轻明显更大(-2.8±0.4 vs 0.4±0.6;P < 0.001)。然而,阿立哌唑组阳性和阴性综合征量表(PANSS)总分的变化显著大于pomaglumetad methionil组(-15.58±1.58 vs -12.03±0.99;P = 0.045)。急性呼吸道感染的发生率(8.2% vs 3.1%;P = 0.032)和因ae而停药(16.2% vs 8.7%;P = 0.020),与阿立哌唑相比,pomaglumetad methionil显著升高。治疗组之间teae、EPS、自杀意念或行为的发生率无统计学差异。总之,与阿立哌唑相比,长期使用pomaglumetad methionil治疗导致的体重增加明显更少。该试验已在ClinicalTrials.gov注册NCT01328093。
Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison.
We tested the hypothesis that long-term treatment with pomaglumetad methionil would demonstrate significantly less weight gain than aripiprazole in patients with schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 3 study, 678 schizophrenia patients were randomized to either pomaglumetad methionil (n = 516) or aripiprazole (n = 162). Treatment groups were also compared on efficacy and various safety measures, including serious adverse events (SAEs), discontinuation due to adverse events (AEs), treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), and suicide-related thoughts and behaviors. The pomaglumetad methionil group showed significantly greater weight loss at Week 24 (Visit 12) compared with the aripiprazole group (-2.8 ± 0.4 versus 0.4 ± 0.6; P < 0.001). However, change in Positive and Negative Syndrome Scale (PANSS) total scores for aripiprazole was significantly greater than for pomaglumetad methionil (-15.58 ± 1.58 versus -12.03 ± 0.99; P = 0.045). The incidences of SAEs (8.2% versus 3.1%; P = 0.032) and discontinuation due to AEs (16.2% versus 8.7%; P = 0.020) were significantly higher for pomaglumetad methionil compared with aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with pomaglumetad methionil resulted in significantly less weight gain than aripiprazole. This trial is registered with ClinicalTrials.gov NCT01328093.
期刊介绍:
Schizophrenia Research and Treatment is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies related to all aspects of schizophrenia.