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)
| Autor: | Rahimi, K, Canoy, D, Nazarzadeh, M, Salimi-Khorshidi, G, Woodward, M, Teo, K, Davis, BR, Chalmers, J, Pepine, CJ, Agodoa, L, Algra, A, Asselbergs, FW, Beckett, N, Berge, E, Black, H, Brouwers, FPJ, Brown, M, Bulpitt, CJ, Byington, B, Cutler, J, Devereaux, RB, Dwyer, D, Fagard, R, Fox, K, Fukui, T, Gupta, AJ, Holman, RR, Imai, Y, Ishii, M, Julius, S, Kanno, Y, Kjeldsen, SE, Kostis, J, Kuramoto, K, Lanke, J, Lewis, E, Lievre, M, Lindholm, LH, Lueders, S, MacMahon, S, Matsuzaki, M, Mehlum, MH, Nissen, S, Ogawa, H, Othisgihara, T, Ohkubo, T, Palmer, C, Patel, A, Pepine, C, Pfeffer, M, Poulter, NR, Rakugi, H, Remuzzi, G, Ruggenenti, P, Saruta, T, Schrader, J, Schrier, R, Sever, P, Sleight, P, Staessen, JA, Suzuki, H, Thijs, L, Ueshima, K, Umemoto, S, Van Gilst, WH, Verdecchia, P, Wachtell, K, Yui, Y, Yusuf, S, Baigent, C, Collins, R, De Zeeuw, D, Neal, B, Perkovic, V, Rahman, M, Remme, WJ, Rodgers, A, Sundstrom, J, Turnbull, F |
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| Přispěvatelé: | Foundation for Circulatory Health, Cardiovascular Centre (CVC), Groningen Kidney Center (GKC), Staessen, Jan |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Epidemiology Disease REGIMENS 030204 cardiovascular system & hematology Research Support Phase (combat) 03 medical and health sciences Medicine General & Internal 0302 clinical medicine General & Internal Medicine Diabetes mellitus Protocol medicine Journal Article Humans 030212 general & internal medicine Intensive care medicine Non-U.S. Gov't Stroke Antihypertensive Agents Randomized Controlled Trials as Topic RISK Protocol (science) Medicine(all) Science & Technology efficacy and safety of bp lowering treatment HYPERTENSION business.industry Research Support Non-U.S. Gov't blood pressure General Medicine medicine.disease PROSPECTIVELY-DESIGNED OVERVIEWS MODEL Treatment Outcome MAJOR CARDIOVASCULAR EVENTS Blood pressure Patient level data meta-analyses Blood pressure lowering business Life Sciences & Biomedicine Blood Pressure Lowering Treatment Trialists’ Collaboration |
| Zdroj: | BMJ Open BMJ Open, 9(5):028698. BMJ PUBLISHING GROUP BMJ Open, 9(5), e028698. BMJ Publishing Group |
| ISSN: | 2044-6055 |
| Popis: | IntroductionPrevious 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 analysisRCTs 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 disseminationEthics 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. |
| Databáze: | OpenAIRE |
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