Pomaglumetad Methionil (LY2140023 Monohydrate)和阿立哌唑在精神分裂症患者中的作用:3期、多中心、双盲比较

IF 3.6 Q1 PSYCHIATRY Schizophrenia Research and Treatment Pub Date : 2014-01-01 Epub Date: 2014-03-19 DOI:10.1155/2014/758212
David H Adams, Lu Zhang, Brian A Millen, Bruce J Kinon, Juan-Carlos Gomez
{"title":"Pomaglumetad Methionil (LY2140023 Monohydrate)和阿立哌唑在精神分裂症患者中的作用:3期、多中心、双盲比较","authors":"David H Adams,&nbsp;Lu Zhang,&nbsp;Brian A Millen,&nbsp;Bruce J Kinon,&nbsp;Juan-Carlos Gomez","doi":"10.1155/2014/758212","DOIUrl":null,"url":null,"abstract":"<p><p>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. </p>","PeriodicalId":45388,"journal":{"name":"Schizophrenia Research and Treatment","volume":null,"pages":null},"PeriodicalIF":3.6000,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1155/2014/758212","citationCount":"54","resultStr":"{\"title\":\"Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison.\",\"authors\":\"David H Adams,&nbsp;Lu Zhang,&nbsp;Brian A Millen,&nbsp;Bruce J Kinon,&nbsp;Juan-Carlos Gomez\",\"doi\":\"10.1155/2014/758212\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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. </p>\",\"PeriodicalId\":45388,\"journal\":{\"name\":\"Schizophrenia Research and Treatment\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2014-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1155/2014/758212\",\"citationCount\":\"54\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Schizophrenia Research and Treatment\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1155/2014/758212\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2014/3/19 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"PSYCHIATRY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Schizophrenia Research and Treatment","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1155/2014/758212","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2014/3/19 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PSYCHIATRY","Score":null,"Total":0}
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

摘要图片

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
4.60
自引率
0.00%
发文量
2
审稿时长
14 weeks
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.
期刊最新文献
Adherence to Typical Antipsychotics among Patients with Schizophrenia in Uganda: A Cross-Sectional Study. Investigating Body Mass Index and Body Composition in Patients with Schizophrenia: A Case-Control Study Cigarette Smoking and Schizophrenia: Etiology, Clinical, Pharmacological, and Treatment Implications. Comparison of Efficacy and Safety between Long-Acting Injectable Antipsychotic Monotherapy and Combination of Long-Acting Injectable and Oral Antipsychotics in Patients with Schizophrenia. Homocysteine in Schizophrenia: Independent Pathogenetic Factor with Prooxidant Activity or Integral Marker of Other Biochemical Disturbances?
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1