雷诺拉嗪对台湾稳定型心绞痛患者运动耐量和心绞痛频率的影响:CARISA 随机试验的桥接研究。

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2024-10-05 DOI:10.1016/j.jfma.2024.09.018
Jen-Kuang Lee, I-Chang Hsieh, Po-Hsun Huang, Yen-Wen Wu, Jung-Chung Hsu, Jen-Yuan Kuo, Po-Yuan Chang, Cheng-Hsueh Wu, Juey-Jen Hwang
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引用次数: 0

摘要

背景:雷诺拉嗪对慢性心绞痛的疗效已在美国得到证实和推广。本研究旨在确定在服用常规抗心绞痛药物后仍有持续心绞痛症状的台湾人群中,加用雷诺拉嗪是否也有效:这是一项多中心、随机、平行、双盲对比研究。方法:这是一项多中心随机、平行、双盲比较研究,研究终点是比较添加雷诺拉嗪和安慰剂的患者在第12周时运动跑步机测试(ETT)持续时间与基线相比的变化:46名患者接受了疗效和安全性终点评估。第12周时,治疗组和对照组的ETT持续时间与基线相比的平均变化均有所增加,其平均差异为20.8秒。安全性评估显示,患者可以耐受加用雷诺拉嗪治疗。雷诺拉嗪和安慰剂的AE发生率均为34.8%。尽管统计能力有限,但数据与过去的研究结果相当:结论:附加雷诺拉嗪疗法具有提高慢性心绞痛患者运动能力和耐受性的潜力。
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Ranolazine effects on exercise tolerance and angina frequency in Taiwanese stable angina: A bridging study of the CARISA randomized trial.

Background: The effectiveness of Ranolazine on chronic angina had been proved and launched in the United States. This study aimed to determine whether add-on Ranolazine could also be effective in Taiwanese population with persisting angina symptoms despite taking conventional antianginal agents.

Methods: This is a multi-center, randomized, parallel, double-blind comparative study. The endpoint is to compare the change from the baseline of the exercise treadmill test (ETT) performing duration between add-on ranolazine and placebo at week 12.

Results: 46 patients were evaluable for the efficacy and safety endpoints. The mean change from baseline in ETT duration at week 12 was increased in the treatment and control group, and their mean difference was 20.8 s. All data in the Taiwanese population was like those in the CARISA study (24.0 s). The safety evaluation revealed that patients were tolerable to the add-on ranolazine therapy. The AE incidence for both ranolazine and placebo was 34.8%. The data were comparable to the past studies despite the limited statistical power.

Conclusion: The add-on ranolazine therapy shows the potential to raise the exercise performance and tolerance of patients with chronic angina.

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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
自引率
2.10%
发文量
464
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