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阿朴西坦治疗高血压的疗效与安全性:来自随机对照试验证据的荟萃分析

Efficacy and Safety of Aprocitentan in the Treatment of Hypertension: A Meta-Analysis of Evidence from Randomized Controlled Trials.

作者信息

Zheng Li, Liu Ming, Gu Xiaotong, Zhang Yatong, Wang Yan

机构信息

Department of Pharmacy, China Aerospace Science & Industry Corporation 731 Hospital, 100074 Beijing, China.

Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, 730000 Lanzhou, Gansu, China.

出版信息

Rev Cardiovasc Med. 2025 Jan 20;26(1):25909. doi: 10.31083/RCM25909. eCollection 2025 Jan.

DOI:10.31083/RCM25909
PMID:39867183
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11759960/
Abstract

BACKGROUND

Hypertension is one of the most prevalent disorders encountered in medical practice, yet effective pharmacotherapy options for resistant hypertension are limited. In this meta-analysis, we aimed to evaluate the efficacy and safety of aprocitentan in treating hypertension.

METHODS

We searched PubMed, Embase, ClinicalTrials.gov, and the Cochrane Library databases from inception to June 3, 2024, for randomized controlled trials (RCTs) that compared the efficacy and safety between aprocitentan and placebo in treating hypertension. According to the dosage of aprocitentan, the study was divided into a low-dose group (10-12.5 mg), medium-dose group (25 mg), and high-dose group (50 mg).

RESULTS

This meta-analysis included five RCTs, which incorporated 1224 patients, and displayed that aprocitentan can reduce the mean sitting systolic blood pressure (msSBP) [(low dose subgroup: mean difference (MD): -3.85 mmHg; 95% confidence interval (CI): -7.47 to -0.23; = 0.040; medium dose group: MD: -5.56 mmHg; 95% CI: -10.69 to -0.44; = 0.030)], mean sitting diastolic blood pressure (msDBP) (low dose subgroup: MD: -3.95 mmHg; 95% CI: -4.06 to -3.85; < 0.001; medium dose group: MD: -4.75 mmHg; 95% CI: -5.91 to -3.60; < 0.001), 24-hour ambulatory systolic blood pressure (maSBP) (low dose group: MD: -4.18 mmHg; 95% CI: -4.32 to -4.04; < 0.001; medium dose group: MD: -5.89 mmHg; 95% CI: -6.03 to -5.75; < 0.001), and 24-hour ambulatory diastolic blood pressure (maDBP) (low dose group: MD: -4.33 mmHg; 95% CI: -4.42 to -4.24; < 0.001; medium dose group: MD: -5.82 mmHg; 95% CI: -5.91 to -5.73; < 0.001). In the high-dose group, there was no difference between the aprocitentan and placebo groups in the msSBP (MD: -4.83 mmHg; 95% CI: -11.44 to 1.79; = 0.150). Meanwhile, the safety profile of aprocitentan was good, and no significant differences in the frequency of adverse events (AEs) and serious adverse events (SAEs) were observed compared to the placebo.

CONCLUSIONS

Aprocitentan significantly reduces blood pressure and has a good safety profile. However, it is worth noting that high doses of aprocitentan (50 mg) did not yield better blood pressure-lowering effects.

摘要

背景

高血压是医学实践中最常见的疾病之一,但针对顽固性高血压的有效药物治疗选择有限。在这项荟萃分析中,我们旨在评估阿曲生坦治疗高血压的疗效和安全性。

方法

我们检索了从数据库建立至2024年6月3日的PubMed、Embase、ClinicalTrials.gov和Cochrane图书馆数据库,以查找比较阿曲生坦与安慰剂治疗高血压疗效和安全性的随机对照试验(RCT)。根据阿曲生坦的剂量,将研究分为低剂量组(10 - 12.5毫克)、中剂量组(25毫克)和高剂量组(50毫克)。

结果

这项荟萃分析纳入了5项RCT,共1224例患者,结果显示阿曲生坦可降低平均坐位收缩压(msSBP)[(低剂量亚组:平均差值(MD):-3.85 mmHg;95%置信区间(CI):-7.47至-0.23;P = 0.040;中剂量组:MD:-5.56 mmHg;95% CI:-10.69至-0.44;P = 0.030)]、平均坐位舒张压(msDBP)(低剂量亚组:MD:-3.95 mmHg;95% CI:-4.06至-3.85;P < 0.001;中剂量组:MD:-4.75 mmHg;9% CI:-5.91至-3.60;P < 0.001)、24小时动态收缩压(maSBP)(低剂量组:MD:-4.18 mmHg;95% CI:-4.32至-4.04;P < 0.001;中剂量组:MD:-5.89 mmHg;95% CI:-6.03至-5.75;P < 0.001)和24小时动态舒张压(maDBP)(低剂量组:MD:-4.33 mmHg;95% CI:-4.42至-4.24;P < 0.001;中剂量组:MD:-5.82 mmHg;95% CI:-5.91至-5.73;P < 0.001)。在高剂量组中,阿曲生坦组与安慰剂组在msSBP方面无差异(MD:-4.83 mmHg;95% CI:-11.44至1.79;P = 0.150)。同时,阿曲生坦的安全性良好,与安慰剂相比,不良事件(AE)和严重不良事件(SAE)的发生频率无显著差异。

结论

阿曲生坦可显著降低血压且安全性良好。然而,值得注意的是,高剂量阿曲生坦(50毫克)并未产生更好降血压效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af3a/11759960/7def3b327f8e/2153-8174-26-1-25909-g3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af3a/11759960/56bcb7a0a091/2153-8174-26-1-25909-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af3a/11759960/b07ed0e3cfe9/2153-8174-26-1-25909-g2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af3a/11759960/7def3b327f8e/2153-8174-26-1-25909-g3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af3a/11759960/56bcb7a0a091/2153-8174-26-1-25909-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af3a/11759960/b07ed0e3cfe9/2153-8174-26-1-25909-g2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af3a/11759960/7def3b327f8e/2153-8174-26-1-25909-g3.jpg

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