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首页> 外文期刊>The American Journal of Cardiology >Variation in Placebo Effect on Health-Related Quality of Life in Heart Failure (from the TOPCAT Trial)
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Variation in Placebo Effect on Health-Related Quality of Life in Heart Failure (from the TOPCAT Trial)

机译：安慰剂对心力衰竭生活健康生活质量的变化（来自Topcat试验）

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Globalization of clinical trials has prompted significant interest in assessing regional variation in patient characteristics and treatment effects. Although the placebo effect overall has been well described, it is not known whether differences in placebo effect exist in countries. The objective of this study was to assess the country-level differences in placebo effect. We undertook an exploratory post-hoc analysis of the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial. The main outcomes were changes in the overall summary score (OSS) and clinical summary score (CSS) of the Kansas City Cardiomyopathy Questionnaire at 4, 12, 24, 36, 48, and 60 months. Of 1,723 subjects who were randomized to the placebo arm, 33.6% were enrolled from United States, 9.3% from Canada, 31.2% from Russia, 4.7% from Brazil, 3.5% from Argentina, and 17.7% from Georgia. Although patients from Georgia had the lowest (p 10 points) in CSS at all time points compared with other countries (p <0.001). Patients enrolled in Georgia had more than 3 times the improvement in OSS compared with patients in United States and Canada. Patients enrolled in Argentina had significantly (p <0.001) higher improvement in OSS and CSS at all time points compared with other countries, except Georgia. Greater than 10 points improvement in OSS was observed in patients from Argentina at all time points, which was more than 2-fold improvement seen in patients from United States and Canada. In conclusion, there were significant variations in longitudinal changes in Kansas City Cardiomyopathy Questionnaire scores in countries in patients receiving placebo. (C) 2019 Elsevier Inc. All rights reserved.
机译：临床试验的全球化促使在评估患者特征和治疗效果的区域变异方面促使有益于。虽然整体的安慰剂效应已经很好地描述，但尚不清楚国家是否存在安慰剂效应的差异。本研究的目的是评估安慰剂效应的国家级差异。我们对醛固酮拮抗剂试验进行了探索性后HOC治疗保存心功能心力衰竭的治疗。主要成果是堪萨斯城心肌病问卷调查问卷的整体摘要得分（OSS）和临床摘要评分（CSS）的变化。 1,723名受访安慰剂ARM的受试者，33.6％从美国注册，从加拿大9.3％，俄罗斯31.2％，巴西4.7％，距阿根廷3.5％，距格鲁吉亚有17.7％。虽然来自格鲁吉亚的患者在与其他国家的所有时间点都有最低（P 10分）的CSS（P <0.001）。与美国和加拿大的患者相比，注册格鲁吉亚的患者患有奥斯的改善3倍以上。与格鲁吉亚相比，纳入阿根廷患者的患者在所有时间点的OSS和CSS的改善程度显着（p <0.001）。在阿根廷患者在所有时间点观察到OSS的大于10分，在美国和加拿大的患者中看到了超过2倍的改善。总之，堪萨斯城心肌病问卷调查问卷在接受安慰剂患者患者中的纵向变化发生显着变化。 （c）2019 Elsevier Inc.保留所有权利。

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