Investigating the stratified efficacy and safety of pharmacological blood pressure-lowering: an overall protocol for individual patient-level data meta-analyses of over 300 000 randomised participants in the new phase of the Blood Pressure Lowering Treatment Trialists' Collaboration (BPLTTC)
Investigating the stratified efficacy and safety of pharmacological blood pressure-lowering: an overall protocol for individual patient-level data meta-analyses of over 300 000 randomised participants in the new phase of the Blood Pressure Lowering Treatment Trialists' Collaboration (BPLTTC)
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DOI：
10.1136/bmjopen-2018-028698
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发表时间：
2019-05-01
期刊：
影响因子：
2.9
通讯作者：
Turnbull, F.
中科院分区：
文献类型：
--
作者：
Rahimi, Kazem;Canoy, Dexter;Turnbull, F.
血压降低治疗试验协作组（BPLTTC）和其他人的先前研究表明，药物血压（BP）降低大大降低了主要心血管事件的风险，包括缺血性心脏病，心力衰竭和中风。在这个新的阶段，目的是进行个体患者水平的数据（IPD）荟萃分析，涉及合格的降压随机对照试验（RCT），以解决与降压治疗的疗效和安全性相关的不确定性。方法和分析RCT调查药理降压的效果，每个试验组至少随访1000患者年，是合格的。我们的系统评价确定了100个潜在合格的试验。我们要求他们的研究者/申办者提供基线、随访和结局数据。截至2018年6月，该合作已从49项试验（n= 315046名参与者）中获得数据，目前正在从4项RCT（n= 34642名参与者）中转移更多数据。此外，数据统一工作已经开始。该协作的科学活动由指导委员会监督，所有协作者都提供投入。伦理和传播BPLTTC的这个新的和扩展的阶段已经获得了伦理批准，这是RCT中最大的去识别IPD合作。它提供了一种有效和道德的方式来重新利用现有数据，以回答与BP治疗相关的临床重要问题以及与IPD荟萃分析相关的方法学问题。直接影响将包括可靠量化治疗修饰因素（如基线BP、年龄和既往疾病）对血管和非血管结局的影响。分析将进一步评估降血压对重要但不太清楚的结局的影响，如新发糖尿病和肾脏疾病。研究结果将代表合作发表在同行评审的医学期刊上。
Introduction Previous research from the Blood Pressure Lowering Treatment Trialists' Collaboration (BPLTTC) and others has shown that pharmacological blood pressure (BP)-lowering substantially reduces the risk of major cardiovascular events, including ischaemic heart disease, heart failure and stroke. In this new phase, the aim is to conduct individual patient-level data (IPD) meta-analyses involving eligible BP-lowering randomised controlled trials (RCTs) to address uncertainties relating to efficacy and safety of BP-lowering treatment.Methods and analysis RCTs investigating the effect of pharmacological BP-lowering, with a minimum of 1000 patient-years of follow-up in each trial arm, are eligible. Our systematic review identified 100 potentially eligible trials. We requested their investigators/sponsors to contribute baseline, follow-up and outcomes data. As of June 2018, the collaboration has obtained data from 49 trials (n=315 046 participants), with additional data currently in the process of being transferred from four RCTs (n=34 642 participants). In addition, data harmonisation has commenced. Scientific activities of the collaboration are overseen by the Steering Committee with input from all collaborators. Detailed protocols for individual meta-analyses will be developed and registered on public platforms.Ethics and dissemination Ethics approval has been obtained for this new and extended phase of the BPLTTC, the largest collaboration of de-identified IPD from RCTs. It offers an efficient and ethical manner of re-purposing existing data to answer clinically important questions relating to BP treatment as well as methodological questions relating to IPD meta-analyses. Among the immediate impacts will include reliable quantification of effects of treatment modifiers, such as baseline BP, age and prior disease, on both vascular and non-vascular outcomes. Analyses will further assess the impact of BP-lowering on important, but less well understood, outcomes, such as new-onset diabetes and renal disease. Findings will be published in peer-reviewed medical journals on behalf of the collaboration.