{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T02:35:26Z","timestamp":1793414126096,"version":"4.5.0"},"reference-count":22,"publisher":"American Medical Association (AMA)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,7,1]]},"abstract":"\n Importance<\/jats:title>\n In prior monotherapy studies of patients with hypertension, single subcutaneous doses of zilebesiran, an investigational RNA interference therapeutic, reduced serum angiotensinogen levels and systolic blood pressure (SBP) at 3 and 6 months.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the efficacy and safety of zilebesiran vs placebo when added to a standard antihypertensive medication.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This phase 2, randomized, prospective, double-blinded trial enrolled adults with uncontrolled hypertension from 150 sites across 8 countries between January 2022 and June 2023. The final follow-up date was December 11, 2023, and analyses were conducted on March 1, 2024.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Eligible patients were initially randomized in cohorts to receive open-label run-in treatment for at least 4 weeks with indapamide 2.5 mg, amlodipine 5 mg, or olmesartan 40 mg (4:7:10 randomization), each administered once daily. Within cohorts, adherent patients with 24-hour mean ambulatory SBP of 130 mm\u2009Hg to 160 mm\u2009Hg were subsequently randomized (1:1) to additional blinded treatment to receive single subcutaneous doses of zilebesiran 600 mg or matching placebo.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary end point in each cohort was the difference between zilebesiran and placebo in change from baseline in 24-hour mean ambulatory SBP at 3 months.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 1491 patients entering the run-in phase, 663 (130 receiving indapamide, 240 receiving amlodipine, and 293 receiving olmesartan) were randomized to receive zilebesiran (n = 332) or placebo (n = 331). The least-squares mean difference between zilebesiran and placebo in change from baseline to 3 months in 24-hour mean ambulatory SBP was \u221212.1 mm\u2009Hg (95% CI, \u221216.5 to \u22127.6;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) for indapamide, \u22129.7 mm\u2009Hg (95% CI, \u221212.9 to \u22126.6;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) for amlodipine, and \u22124.5 mm\u2009Hg (95% CI, \u22128.2 to \u22120.8;\n P<\/jats:italic>\n \u2009=\u2009.02) for olmesartan. Across cohorts, more patients who received zilebesiran than placebo experienced hyperkalemia (18 [5.5%] vs 6 [1.8%]), hypotension (14 [4.3%] vs 7 [2.1%]), and acute kidney failure (16 [4.9%] vs 5 [1.5%]) events, but most episodes were mild and resolved without medical intervention.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In patients with uncontrolled hypertension despite treatment with indapamide, amlodipine, or olmesartan, the addition of single-dose zilebesiran resulted in significant SBP reductions compared with placebo at 3 months, with low rates of serious adverse events.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05103332<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2025.6681","type":"journal-article","created":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T11:31:04Z","timestamp":1748431864000},"page":"46","source":"Crossref","is-referenced-by-count":57,"title":["Add-On Treatment With Zilebesiran for Inadequately Controlled Hypertension"],"prefix":"10.1001","volume":"334","author":[{"given":"Akshay S.","family":"Desai","sequence":"first","affiliation":[{"name":"Division of Cardiovascular Medicine, Brigham and Women\u2019s Hospital, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam D.","family":"Karns","sequence":"additional","affiliation":[{"name":"Entertainment Medical Group, Beverly Hills, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jolita","family":"Badariene","sequence":"additional","affiliation":[{"name":"Medical Faculty, Vilnius University, Vilnius, 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