The Safety and Efficacy of Quadruple Ultra-Low-Dose Combination (Quadpill) for Hypertension Treatment: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2023-11-01 Epub Date: 2023-10-30 DOI:10.1007/s40261-023-01313-3

Mohamed Abuelazm, Shafaqat Ali, Othman Saleh, Amr Badr, Obieda Altobaishat, Majd M AlBarakat, Aya Aboutaleb, Abdelmonem Siddiq, Basel Abdelazeem

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Abstract

Background and objective: Quadpill, a single pill containing a quadruple combination of quarter doses of four antihypertensive agents, has been investigated for hypertension treatment. This meta-analysis aims to evaluate the safety and efficacy of quadpill for hypertension management.

Methods: We conducted a systematic review and meta-analysis synthesizing randomized controlled trials evaluating quadpill versus monotherapy or placebo in patients with hypertension, which were retrieved by systematically searching PubMed, EMBASE, Web of Science, SCOPUS, and Cochrane through 17 February, 2023. Continuous and dichotomous outcomes were pooled using mean difference (MD) and risk ratio (RR) along with confidence interval (CI), using Revman Version 5.4 software. Our protocol has been published in PROSPERO with ID: CRD42023406527.

Results: Four randomized controlled trials with a total of 779 patients were included in our analysis. Quadpill was effective in controlling systolic blood pressure in the short term [4-6 weeks] (RR: - 13.00 with 95% CI [- 17.22, - 8.78], p = 0.00001) and in the long term [12 weeks] (RR: - 6.18 with 95% CI [- 9.35, - 3.01], p = 0.0001). Quadpill was also effective in controlling automated diastolic blood pressure in the short term [4-6 weeks] (MD: - 8.15 with 95% CI [- 9.42, - 6.89], p = 0.00001) and in the long term [12 weeks] (MD: - 6.35 with 95% CI [- 10.37, - 2.33], p = 0.002). Moreover, patients in the quadpill group significantly achieved target blood pressure <140/90 (RR: 1.77 with 95% CI [1.26, 2.51], p = 0.001) compared with the control group.

Conclusions: The quadruple ultra-low-dose combination of antihypertensive drugs (quadpill) was effective and safe for hypertension treatment. However, further large-scale, multicenter, randomized controlled trials are still warranted before endorsement in clinical practice.

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四倍超低剂量联合用药（Quadpill）治疗高血压的安全性和有效性：随机对照试验的系统评价和荟萃分析。

背景和目的：Quadpill是一种含有四分之一剂量四种降压药的单一药丸，已被研究用于治疗高血压。本荟萃分析旨在评估四元片治疗高血压的安全性和有效性。方法：我们进行了一项系统综述和荟萃分析，综合了随机对照试验，评估了四元药丸与单药治疗或安慰剂治疗高血压患者的疗效，这些试验通过系统搜索PubMed、EMBASE、Web of Science、SCOPUS和Cochrane检索到，截至2023年2月17日。使用Revman 5.4版软件，使用平均差（MD）、风险比（RR）和置信区间（CI）合并连续和二分结果。我们的方案已发表在PROSPERO上，ID:CRD42023406527。结果：我们的分析包括四项随机对照试验，共779名患者。Quadpill在短期[4-6周]（RR:-13.00，95%CI[-17.22，-8.78]，p=0.0001）和长期[12周]（RR：-6.18，95%CI[-9.35，-3.01]，p=0.0001，p=0.0001）和长期[12周]（MD:-6.35，95%CI[-10.37，-2.33]，p=0.002）。此外，四元片组患者显著达到了目标血压。结论：四元片超低剂量联合降压药（四元片）治疗高血压是有效和安全的。然而，在临床实践中批准之前，仍有必要进行进一步的大规模、多中心、随机对照试验。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.