The Precision HYpertenSIon Care (PHYSIC) study: a double-blind, randomized, repeated cross-over study.
The Precision HYpertenSIon Care (PHYSIC) study: a double-blind, randomized, repeated cross-over study.
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DOI：
10.1080/03009734.2018.1498958
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发表时间：
2019-01
影响因子：
3.4
通讯作者：
Östlund O
中科院分区：
文献类型：
--
作者：
Sundström J;Lind L;Nowrouzi S;Lytsy P;Marttala K;Ekman I;Öhagen P;Östlund O
高血压是导致过早死亡的主要风险因素，也是世界各地社会的主要代价。有效的降压药物是可用的，但患者对这些药物的依从性很低，部分原因可能是副作用。为了确定治疗效果中不同患者的差异，需要重复交叉设计，即在每个患者体内重复相同的治疗对比。考虑到目前对精准医学的关注，这样的设计出人意料地很少使用。精密高血压护理(PHYIC)研究旨在调查，鉴于血压的人内差异，对临床上相关的常见降压药类别的血压反应是否存在人与人之间的一致差异。这项研究还将调查药物副作用的人与人之间的差异。在一项双盲、随机、重复的交叉试验中，300名轻度高血压患者将接受四种降压药(坎地沙坦、赖诺普利、氨氯地平和氢氯噻嗪)的单一治疗，每名患者重复两种药物。如果这项研究表明有可能进行精确的高血压治疗，将探索对药物的血压和副作用反应最有希望的预测因素，以及开发生物标记物小组的潜力，以根据预期的血压效应和副作用对降血压药物类别对个别患者的适宜性进行排名，最终目标是最大限度地遵守。这项研究遵循了一项在ClinicalTrials.gov预先注册的方案，识别符为NCT02774460。
High blood pressure is the leading risk factor for premature deaths and a major cost to societies worldwide. Effective blood pressure-lowering drugs are available, but patient adherence to them is low, likely partly due to side effects. To identify patient-specific differences in treatment effects, a repeated cross-over design, where the same treatment contrasts are repeated within each patient, is needed. Such designs have been surprisingly rarely used, given the current focus on precision medicine. The Precision HYpertenSIon Care (PHYSIC) study aims to investigate if there is a consistent between-person variation in blood pressure response to the common blood pressure-lowering drug classes of a clinically relevant magnitude, given the within-person variation in blood pressure. The study will also investigate the between-person variation in side effects of the drugs. In a double-blind, randomized, repeated cross-over trial, 300 patients with mild hypertension will be treated with four blood pressure-lowering drugs (candesartan, lisinopril, amlodipine, and hydrochlorothiazide) in monotherapy, with two of the drugs repeated for each patient. If the study indicates that there is a potential for precision hypertension care, the most promising predictors of blood pressure and side effect response to the drugs will be explored, as will the potential for development of a biomarker panel to rank the suitability of blood pressure-lowering drug classes for individual patients in terms of anticipated blood pressure effects and side effects, with the ultimate goal to maximize adherence. The study follows a protocol pre-registered at ClinicalTrials.gov with the identifier NCT02774460.
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影响因子：
3.7
作者：
Araujo A;Julious S;Senn S
通讯作者：
Senn S
影响因子：
168.9
作者：
Lim, Stephen S.;Vos, Theo;Flaxman, Abraham D.;Danaei, Goodarz;Shibuya, Kenji;Adair-Rohani, Heather;Amann, Markus;Anderson, H. Ross;Andrews, Kathryn G.;Aryee, Martin;Atkinson, Charles;Bacchus, Loraine J.;Bahalim, Adil N.;Balakrishnan, Kalpana;Balmes, John;Barker-Collo, Suzanne;Baxter, Amanda;Bell, Michelle L.;Blore, Jed D.;Blyth, Fiona;Bonner, Carissa;Borges, Guilherme;Bourne, Rupert;Boussinesq, Michel;Brauer, Michael;Brooks, Peter;Bruce, Nigel G.;Brunekreef, Bert;Bryan-Hancock, Claire;Bucello, Chiara;Buchbinder, Rachelle;Bull, Fiona;Burnett, Richard T.;Byers, Tim E.;Calabria, Bianca;Carapetis, Jonathan;Carnahan, Emily;Chafe, Zoe;Charlson, Fiona;Chen, Honglei;Chen, Jian Shen;Cheng, Andrew Tai-Ann;Child, Jennifer Christine;Cohen, Aaron;Colson, K. Ellicott;Cowie, Benjamin C.;Darby, Sarah;Darling, Susan;Davis, Adrian;Degenhardt, Louisa;Dentener, Frank;Des Jarlais, Don C.;Devries, Karen;Dherani, Mukesh;Ding, Eric L.;Dorsey, E. Ray;Driscoll, Tim;Edmond, Karen;Ali, Suad Eltahir;Engell, Rebecca E.;Erwin, Patricia J.;Fahimi, Saman;Falder, Gail;Farzadfar, Farshad;Ferrari, Alize;Finucane, Mariel M.;Flaxman, Seth;Fowkes, Francis Gerry R.;Freedman, Greg;Freeman, Michael K.;Gakidou, Emmanuela;Ghosh, Santu;Giovannucci, Edward;Gmel, Gerhard;Graham, Kathryn;Grainger, Rebecca;Grant, Bridget;Gunnell, David;Gutierrez, Hialy R.;Hall, Wayne;Hoek, Hans W.;Hogan, Anthony;Hosgood, H. Dean, III;Hoy, Damian;Hu, Howard;Hubbell, Bryan J.;Hutchings, Sally J.;Ibeanusi, Sydney E.;Jacklyn, Gemma L.;Jasrasaria, Rashmi;Jonas, Jost B.;Kan, Haidong;Kanis, John A.;Kassebaum, Nicholas;Kawakami, Norito;Khang, Young-Ho;Khatibzadeh, Shahab;Khoo, Jon-Paul;Kok, Cindy;Laden, Francine;Lalloo, Ratilal;Lan, Qing;Lathlean, Tim;Leasher, Janet L.;Leigh, James;Li, Yang;Lin, John Kent;Lipshultz, Steven E.;London, Stephanie;Lozano, Rafael;Lu, Yuan;Mak, Joelle;Malekzadeh, Reza;Mallinger, Leslie;Marcenes, Wagner;March, Lyn;Marks, Robin;Martin, Randall;McGale, Paul;McGrath, John;Mehta, Sumi;Mensah, George A.;Merriman, Tony R.;Micha, Renata;Michaud, Catherine;Mishra, Vinod;Hanafiah, Khayriyyah Mohd;Mokdad, Ali A.;Morawska, Lidia;Mozaffarian, Dariush;Murphy, Tasha;Naghavi, Mohsen;Neal, Bruce;Nelson, Paul K.;Miquel Nolla, Joan;Norman, Rosana;Olives, Casey;Omer, Saad B.;Orchard, Jessica;Osborne, Richard;Ostro, Bart;Page, Andrew;Pandey, Kiran D.;Parry, Charles D. H.;Passmore, Erin;Patra, Jayadeep;Pearce, Neil;Pelizzari, Pamela M.;Petzold, Max;Phillips, Michael R.;Pope, Dan;Pope, C. Arden, III;Powles, John;Rao, Mayuree;Razavi, Homie;Rehfuess, Eva A.;Rehm, Juergen T.;Ritz, Beate;Rivara, Frederick P.;Roberts, Thomas;Robinson, Carolyn;Rodriguez-Portales, Jose A.;Romieu, Isabelle;Room, Robin;Rosenfeld, Lisa C.;Roy, Ananya;Rushton, Lesley;Salomon, Joshua A.;Sampson, Uchechukwu;Sanchez-Riera, Lidia;Sanman, Ella;Sapkota, Amir;Seedat, Soraya;Shi, Peilin;Shield, Kevin;Shivakoti, Rupak;Singh, Gitanjali M.;Sleet, David A.;Smith, Emma;Smith, Kirk R.;Stapelberg, Nicolas J. C.;Steenland, Kyle;Stoeckl, Heidi;Stovner, Lars Jacob;Straif, Kurt;Straney, Lahn;Thurston, George D.;Tran, Jimmy H.;Van Dingenen, Rita;van Donkelaar, Aaron;Veerman, J. Lennert;Vijayakumar, Lakshmi;Weintraub, Robert;Weissman, Myrna M.;White, Richard A.;Whiteford, Harvey;Wiersma, Steven T.;Wilkinson, James D.;Williams, Hywel C.;Williams, Warwick;Wilson, Nicholas;Woolf, Anthony D.;Yip, Paul;Zielinski, Jan M.;Lopez, Alan D.;Murray, Christopher J. L.;Ezzati, Majid
通讯作者：
Ezzati, Majid
影响因子：
3
作者：
Hodgson, TA;Cai, LM
通讯作者：
Cai, LM
影响因子：
7.2
作者：
Bell, Katy J. L.;Hayen, Andrew;Irwig, Les
通讯作者：
Irwig, Les
影响因子：
5.8
作者：
Bates, Douglas;Maechler, Martin;Walker, Steven C.
通讯作者：
Walker, Steven C.