Effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (Bax24): a phase 3, randomised, double-blind, placebo-controlled trial

作者：Michel Azizi, Jenifer Michelle Brown, Jamie P. Dwyer, John M. Flack, Erica S W Jones, Raisa Kurlyandskaya, Hongjian Li, Filip Birve, Aina S. Lihn, Shira Perl, Markus P. SCHLAICH, Hirotaka Shibata, Ji-Guang Wang, Bryan Williams, Cesar Javier Zaidman, Sonia Angelica Sassone, Miguel Cuenca, Diego Arakaki, Mariano I. Chahin, María Andrea Steinacher, FREDY ANTONI FERRE PACORA, Juan Loureyro, Jun Yang, Markus P. SCHLAICH, Tine L.M. De Backer, Hans T Kindt, P. Delmotte, Blagovest Stoimenov, Kiril Dzhomanov, Krassimir Cvetkov, Dimitar Raev, Stefan Naydenov, Shivinder Jolly, John R. Vyselaar, Luis Noronha, Daniel Gaudet, Amritanshu Shekhar Pandey, Jennifer Ringrose, Yves Robitaille, Jiri Vesely, J Krupicka, Ladislav Busak, Jitka Pruchova, Wolfgang Jungmair, Sebastian Cremer, Markus van der Giet, Stephan Henrik Schirmer, Spasija Parizova, Michael Doumas, George S. Stergiou, Konstantinos P Tsioufis, Zoltán Járai, András Vorobcsuk, Tibor Kiss, Gizella Pap, Andras Csaba Nagy, Attila Farkas, Desmond Samuel, Mohd Faiz Faizul Fauzi, Mohamad Muslim Jamian, Louie Tirador, Gabriel Jocson, Marek W. Rajzer, Andrzej Januszewicz, Andrzej Tykarski, Michał Hoffmann, Jan Zbigniew Peruga, Edyta Zbroch, Piotr Sobieraj, Abdulmajid Mukhtar, Talal F. Aljabbary, Lubomir Antalik, Ján Fedačko, Peter Fulop, Lesley Jean Burgess, Gulam Latiff, Julián Segura de la Morena, José Antonio García Donaire, Miguel Camafort Babkowski, Alejandro de la Sierra, Javier Sobrino Martínez, Anna Oliveras Serrano, Fernando Martinez, Manuel Gorostidi Pérez, Francisco Fuentes Jimenez, Chern‐En Chiang, Kang-Ling Wang, Yen-Wen Wu, I-Chang Hsieh, Praew Kotruchin, Yongkasem Vorasettakarnkij, Weranuj Roubsanthisuk, Prin Vathesatogkit, Krit Leemasawat, Hilmi Erdem Sümbül, Özge Turgay Yıldırım, ÇAĞRI YAYLA, Ozkan Gungor, Ismail Doruk Kocyigit, Auditi Naziat, Manish Saxena, Gordon Irvine, Andrew Hill, Amardeep Heer, David Wingfield, Sam Davies, John Jackson, Philip Lewis, David B. Bernard, Minesh Rajpal, Christopher Romero, Kianoosh Kaveh, Mario Guillen, Lorena Lewy-Alterbaum, Vanna Gold, Travis Taylor, Justin Arambasick, John Ducker, Rekha John, Eric Kirk, Manuel Montero, Nauman Shahid, George Thomas, Gary R. Sirken, David Guzman, Hai Nguyen, Dung Pham, Hai Nguyen, Hien Nguyen, Thao Dinh, Yen Nguyen · 发表于：The Lancet · 年份：2026 · DOI：10.1016/s0140-6736(25)02549-8 · 被引用次数：26 · 研究领域：Blood Pressure and Hypertension Studies、Renin-Angiotensin System Studies、Neurological Disorders and Treatments

BACKGROUND: Aldosterone dysregulation is an important contributor in the pathogenesis of hard-to-control hypertension. We aimed to assess the effect of baxdrostat, a selective aldosterone synthase inhibitor, on ambulatory blood pressure in patients with resistant hypertension. METHODS: The Bax24 international, phase 3, randomised, double-blind, placebo-controlled trial recruited adults (aged ≥18 years) with seated systolic blood pressure (SBP) ≥140 mm Hg and <170 mm Hg, despite receiving three or more antihypertensive medications, including a diuretic, from 79 clinical sites (primary, secondary, and tertiary centres, in addition to research centres) in 22 countries. Following a 2-week placebo run-in period, patients with 24 h ambulatory SBP ≥130 mm Hg were randomly assigned (1:1) to receive 2 mg baxdrostat or placebo orally once daily for 12 weeks, in addition to background therapy (stratified by baseline ambulatory SBP <140 mm Hg or ≥140 mm Hg). Investigators, patients, and trial staff were masked to treatment assignment. The primary endpoint was change in 24 h ambulatory SBP from baseline to week 12, assessed by analysis of covariance in patients administered at least one dose of study medication with valid ambulatory SBP measurement at baseline and week 12. Missing or invalid ambulatory SBP measurements were not imputed. The safety analysis included all patients who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT0616840...