| Title: |
Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial |
| Authors: |
Schlaich, Markus; Bellet, Marc; Weber, Michael, A; Danaietash, Parisa; Bakris, George; Flack, John; Dreier, Roland; Sassi-Sayadi, Mouna; Haskell, Lloyd; Narkiewicz, Krzysztof; Wang, Ji-Guang; Reid, Christopher; Katz, Ivor; Ajani, Andrew; Biswas, Sinjini; Esler, Murray; Elder, Grahame; Roger, Simon; Colquhoun, David; Mooney, John; de Backer, Tine; Persu, Alexandre; Chaumont, Martin; Krzesinski, Jean-Marie; Vanabsche, Thomas; Girard, Ginette; Pliamm, Lew; Schiffrin, Ernesto; Merali, Fatima; Dresser, George; Vallee, Michel; Jolly, Shivinder; Chow, Stephen; Wang, Jiguang; Mu, Jianjun; Yu, Jing; Yuan, Hong; Feng, Yingqing; Zhang, Xin; Xie, Jianhong; Lin, Ling; Soucek, Miroslav; Widimsky, Jiri; Cifkova, Renata; Vaclavik, Jan; Ullrych, Martin; Lukac, Martin; Rychlik, Ivan; Guldager Lauridsen, Thomas; Kantola, Ilkka; Taurio, Jyrki; Ukkola, Olavi; Ormezzano, Olivier; Gosse, Philippe; Azizi, Michel; Courand, Pierre-Yves; Delsart, Pascal; Tartiere, Jean Michel; Mahfoud, Felix; Schmieder, Roland; Stegbauer, Johannes; Lurz, Philipp; Koziolek, Michael; Ott, Christian; Toursarkissian, Nicole; Tsioufis, Konstantinos; Kyfnidis, Konstantinos; Manolis, Athanasios; Patsilinakos, Sotirios; Zebekakis, Pantelis; Karavidas, Apostolos; Denes, Pall; Bezzegh, Katalin; Zsom, Marianna; Kovacs, Laszlo; Sharabi, Yehonatan; Elias, Mazen; Sukholutsky, Ivetta; Yosefy, Chaim; Kenis, Irina; Atar, Shaul; Volpe, Massimo; Lorenza, Muiesan Maria; Taddei, Stefano; Grassi, Guido; Veglio, Franco; Son, Jung Woo; Kim, Jang-Young; Park, Joong-Il; Lee, Chang Hoon; Lee, Hae-Young; Raugaliene, Rasa; Marcinkeviciene, Jolanta Elena; Kavaliauskiene, Roma; Deinum, Jaap; Kroon, Abraham; van den Born, Bert-Jan; Januszewicz, Andrzej; Tykarski, Andrzej; Walczewska, Jolanta; Gaciong, Zbigniew; Wiecek, Andrzej; Chrostowska, Marzena; Kleinrok, Andrzej; Krekora, Jan; Kania, Grzegorz; Podrazka-Szczepaniak, Anna; Golawski, Cezary; Podziewski, Maciej; Kaczmarek, Barbara; Skoczylas, Grzegorz; Wilkolaski, Andrzej; Wozniak, Iwona; Janik-Palazzolo, Marzena; Rewerska, Barbara; Konradi, Alexandra; Shvarts, Yuriy; Pecherina, Tamara; Nikolaev, Konstantin; Liudmila, Gapon; Orlikova, Olga; Mordovin, Viktor; Petrochenkova, Natalia; Kamalov, Gadel; Kosmacheva, Elena; Tyrenko, Vadim; Gorbunov, Vladimir; Obrezan, Andrey; Supryadkina, Tatiana; Ler, Irina; Kotenko, Oleg; Kuzin, Anatoly; Martinez, Fernando; Redon, Josep; Oliveras, Anna; Beltran Romero, Luis; Shatylo, Valerii; Rudenko, Leonid; Bazylevych, Andriiy; Rudyk, Yurii; Karpenko, Oleksandr; Stanislavchuk, Mykola; Tseluyko, Vira; Kushnir, Mykola; Asanov, Ervin; Sirenko, Yuriy; Yagensky, Andriy; Collier, David; Gupta, Pankaj; Webb, David; Macleod, Mary; Mclay, James; Peace, Aaron; Arora, Samir; Buchanan, Patricia; Harris, Robert; Degarmo, Ronald; Guillen, Mario; Karns, Adam; Neutel, Joel; Paliwal, Yogesh; Pettis, Karlton; Toth, Phillip; Wayne, Jeffrey; Butcher, Bain; Diller, Phillip; Oparil, Suzanne; Calhoun, David; Brautigam, Donald; Goldman, Jesse; Rashidi, Arash; Aslam, Nabeel; Haley, William; Andrawis, Nabil; Lang, Brian; Miller, Randy; Powell, James; Dewhurst, Robert; Pritchard, James; Khanna, Dinesh; Tang, Dennis; Gabra, Nashwa; Park, Jean; Jones, Conigliaro; Scott, Cranford; Luna, Blanca; Mussaji, Murtaza; Bhagwat, Ravi; Bauer, Michael; Mcginty, John; Nambiar, Rajesh; Sangrigoli, Renee; Ross Davis, William; Eaves, William; Mcgrew, Frank; Awad, Ahmed; Bolster, Eric; Scott, David; Kalirao, Paramjit; Dabel, Pascal; Calhoun, Wesley; Gouge, Steven; Warren, Mark; Lawrence, Mary Katherine; Jamal, Aamir; El-Shahawy, Mohamed; Mercado, Carlos; Kumar, Jayant; Velasquez-Mieyer, Pedro; Busch, Robert; Lewis, Todd; Rich, Lisa |
| Contributors: |
The University of Western Australia (UWA); Baker Heart and Diabetes Institute; State University of New York (SUNY Canton); University of Chicago; Biozentrum Basel, Suisse; Université de Bâle = University of Basel = Basel Universität (Unibas); Medical University of Gdańsk; Ruijin Hospital Shanghai, Chine; University of Melbourne; Human Neurotransmitter Laboratory; Monash University Clayton -Baker Heart and Diabetes Institute; Imagerie Ultrasonore; Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS); Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon); Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS) |
| Source: |
ISSN: 0140-6736. |
| Publisher Information: |
CCSD; Elsevier |
| Publication Year: |
2022 |
| Collection: |
Université Jean Monnet – Saint-Etienne: HAL |
| Subject Terms: |
[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system; [INFO.INFO-IM]Computer Science [cs]/Medical Imaging; [PHYS.MECA.BIOM]Physics [physics]/Mechanics [physics]/Biomechanics [physics.med-ph] |
| Description: |
Auteurs : the PRECISION investigators ; International audience ; Background Resistant hypertension is associated with increased cardiovascular risk. The endothelin pathway has been implicated in the pathogenesis of hypertension, but it is currently not targeted therapeutically, thereby leaving this relevant pathophysiological pathway unopposed with currently available drugs. The aim of the study was to assess the blood pressure lowering efficacy of the dual endothelin antagonist aprocitentan in patients with resistant hypertension. Methods PRECISION was a multicentre, blinded, randomised, parallel-group, phase 3 study, which was done in hospitals or research centres in Europe, North America, Asia, and Australia. Patients were eligible for randomisation if their sitting systolic blood pressure was 140 mm Hg or higher despite taking standardised background therapy consisting of three antihypertensive drugs, including a diuretic. The study consisted of three sequential parts: part 1 was the 4-week double-blind, randomised, and placebo-controlled part, in which patients received aprocitentan 12•5 mg, aprocitentan 25 mg, or placebo in a 1:1:1 ratio; part 2 was a 32-week single (patient)-blind part, in which all patients received aprocitentan 25 mg; and part 3 was a 12-week double-blind, randomised, and placebo-controlled withdrawal part, in which patients were re-randomised to aprocitentan 25 mg or placebo in a 1:1 ratio. The primary and key secondary endpoints were changes in unattended office systolic blood pressure from baseline to week 4 and from withdrawal baseline to week 40, respectively. Secondary endpoints included 24-h ambulatory blood pressure changes. The study is registered on ClinicalTrials.gov, NCT03541174. Findings The PRECISION study was done from June 18, 2018, to April 25, 2022. 1965 individuals were screened and 730 were randomly assigned. Of these 730 patients, 704 (96%) completed part 1 of the study; of these, 613 (87%) completed part 2 and, of these, 577 (94%) completed part 3 of the study. The ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1016/S0140-6736(22)02034-7 |
| Availability: |
https://hal.science/hal-03872267; https://hal.science/hal-03872267v1/document; https://hal.science/hal-03872267v1/file/1-s2.0-S0140673622020347-main.pdf; https://doi.org/10.1016/S0140-6736(22)02034-7 |
| Rights: |
https://about.hal.science/hal-authorisation-v1/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.6A56B7 |
| Database: |
BASE |