Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial.
Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial.
复制标题
DOI：
10.1016/j.ahj.2022.09.004
复制
发表时间：
2022-12
影响因子：
4.8
通讯作者：
中科院分区：
文献类型：
--
作者：
超过一半的高血压患者需要多种药物治疗来控制血压。然而，与单药治疗相比，多药治疗可能导致依从性降低和更多的药物不良反应。Quadruple Ultra-low-dose Treatment for Hypertension（QUARTET）USA试验旨在评估超低剂量四联疗法是否能更有效地降低办公室血压，并且副作用更少，与SBP < 180且DBP < 110 mm Hg的初治患者和SBP < 110 mm Hg的单药治疗患者相比，160和DBP < 100 mm Hg。QUARTET USA是一项前瞻性、随机、双盲试验（ClinicalTrials.gov NCT 03640312），在美国一个大城市的联邦合格卫生中心进行。患者被随机分配（1：1）至超低剂量四联联合治疗或标准剂量单药治疗。主要结果是12周时诊室收缩压较基线的平均变化，根据基线值进行校正。次要结果包括血压变化和变异性、药物依从性和健康相关生活质量的测量。安全性结局包括严重不良事件的发生、相关药物不良反应和电解质异常。过程评价旨在了解提供者的实施经验和参与者在副作用、依从性和对临床护理的信任方面的经验。QUARTET USA旨在评估与标准剂量单药治疗相比，一种新的血压控制方法是否能更有效地降低办公室血压，副作用更少。QUARTET USA在联邦合格的医疗保健中心网络内进行，旨在生成关于超低剂量四联疗法在经历高血压负担的不同群体中的安全性和有效性的信息。
Over half of patients with elevated blood pressure require multi-drug treatment to achieve blood pressure control. However, multi-drug treatment may lead to lower adherence and more adverse drug effects compared with monotherapy. The Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET) USA trial was designed to evaluate whether initiating treatment with ultra-low-dose quadruple-combination therapy will lower office blood pressure more effectively, and with fewer side effects, compared with initiating standard dose monotherapy in treatment naive patients with SBP < 180 and DBP < 110 mm Hg and patients on monotherapy with SBP < 160 and DBP < 100 mm Hg. QUARTET USA was a prospective, randomized, double-blind trial (ClinicalTrials.gov NCT03640312) conducted in federally qualified health centers in a large city in the US. Patients were randomly assigned (1:1) to either ultra-low-dose quadruple combination therapy or standard dose monotherapy. The primary outcome was mean change from baseline in office systolic blood pressure at 12-weeks, adjusted for baseline values. Secondary outcomes included measures of blood pressure change and variability, medication adherence, and health related quality of life. Safety outcomes included occurrence of serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. A process evaluation aimed to understand provider experiences of implementation and participant experiences around side effects, adherence, and trust with clinical care. QUARTET USA was designed to evaluate whether a novel approach to blood pressure control would lower office blood pressure more effectively, and with fewer side effects, compared with standard dose monotherapy. QUARTET USA was conducted within a network of federally qualified healthcare centers with the aim of generating information on the safety and efficacy of ultra-low-dose quadruple-combination therapy in diverse groups that experience a high burden of hypertension.
登录
查看更多内容
DOI：
10.1016/s0140-6736(21)01330-1
发表时间：
2021-09-11
期刊：
Lancet (London, England)
影响因子：
--
作者：
NCD Risk Factor Collaboration (NCD-RisC)
通讯作者：
NCD Risk Factor Collaboration (NCD-RisC)
影响因子：
120.7
作者：
Webster, Ruth;Salam, Abdul;Patel, Anushka
通讯作者：
Patel, Anushka
影响因子：
2.7
作者：
Kirkwood, Amy A.;Cox, Trevor;Hackshaw, Allan
通讯作者：
Hackshaw, Allan
影响因子：
24
作者：
Whelton, Paul K.;Carey, Robert M.;Wright, Jackson T., Jr.
通讯作者：
Wright, Jackson T., Jr.
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D