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首页> 外文期刊>Schizophrenia research and treatment >Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison
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Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison

机译：精神分裂症患者的聚甲硫氧磷（LY2140023一水合物）和阿立哌唑：3期，多中心，双盲比较

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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.govNCT01328093.
机译：我们检验了以下假设：精神分裂症患者长期服用甲磺酸聚甲磺隆显示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，将678名精神分裂症患者随机分配到聚甲磺胺甲磺隆（n = 516）或阿立哌唑（n = 162）。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（AEs）停药，突发性治疗不良事件（TEAEs），锥体束外症状（EPS）和自杀相关的想法和行为。与阿立哌唑组相比，聚甲磺酸蛋氨酸组在第24周（第12次就诊）显示出明显更大的体重减轻（-2.8±±0.4相对于0.4±±0.6; P <0.001）。但是，阿立哌唑的正，负综合症量表（PANSS）总分的变化明显大于甲磺酸聚甲磺胺（-15.58％±1.58对-12.03％±0.99; P = 0.045）。与阿立哌唑相比，聚甲磺酸蛋氨酸的SAE发生率（8.2％对3.1％; P = 0.032）和因AE引起的停药发生率（16.2％对8.7％; P = 0.020）显着更高。在治疗组之间，TEAEs，EPS或自杀意念或行为的发生率没有统计学上的显着差异。总之，与阿立哌唑相比，长期服用甲磺酸葡甲胺治疗可使体重增加明显减少。该试验已在ClinicalTrials.govNCT01328093中注册。

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