Hydralazine Use and Risk of Vasculitis
Year: 2026
Type: article
Study design: Observational Study
Abstract: Importance: Hydralazine is a selectively used cardiovascular medication with case reports and case series demonstrating an association between the use of hydralazine and antineutrophil cytoplasmic antibody-associated vasculitis. Objective: To assess the risk of vasculitis associated with hydralazine use compared with use of an angiotensin-converting enzyme inhibitor (ACE) or angiotensin receptor blocker (ARB). Design, Setting, and Participants: This population-based, retrospective cohort study assessed adults 66 years or older from Ontario, Canada, who were newly prescribed hydralazine from January 1, 2008, to December 31, 2021. Data analysis was performed from May to August 2025. Exposure: Newly dispensed hydralazine in an outpatient setting. Main Outcomes and Measures: The main outcome was a diagnosis of vasculitis using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes. Overlap-weighted Cox proportional hazards regression was used to examine the association between hydralazine use (active comparator: ACE or ARB) with new-onset vasculitis. Results: Of a total of 583 136 eligible adults (mean [SD] age, 73.0 [7.2] years; 51 827 [55.2%] female), 40 748 individuals were dispensed hydralazine and 542 388 an ACE or ARB. Hydralazine use compared with ACE or ARB use was associated with a higher risk of vasculitis during follow-up (hydralazine: 328 events [0.8%]; ACE or ARB: 2712 events [0.5%]; absolute risk difference, 0.3 percentage points; hazard ratio, 1.19; 95% CI, 1.04-1.37). Results were no longer significant when accounting for the competing risk of death. Conclusions and Relevance: In this cohort study of adults who were newly prescribed hydralazine, vasculitis associated with hydralazine was rare, despite multiple reported cases. Use of hydralazine is unlikely to be associated with a clinically meaningful increased risk of vasculitis.
Source: JAMA Network Open
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
Funders: Quandamooka Yoolooburrabee Aboriginal Corporation, National Science Foundation, National Endowment for the Arts, Pfizer, Achievement Rewards for College Scientists Foundation, Deutsches Zentrum für Infektionsforschung, Hospital Research Foundation, Wellcome Trust, Swedish Cancer Foundation, UK Research and Innovation, Bloomberg Philanthropies, King Hussein Cancer Center, Universidade Federal de Viçosa, Chongqing Municipal Health Commission, Bethune Charitable Foundation, Boehringer Ingelheim Japan, California Ocean Protection Council, Fonds der Chemischen Industrie, Leverhulme Trust, European Commission, University of Liverpool, Department of Biotechnology, Ministry of Science and Technology, India, Indian Council of Medical Research, Deutsche Forschungsgemeinschaft, Agence Nationale de la Recherche, Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Fundação de Amparo à Pesquisa do Estado de São Paulo, National Natural Science Foundation of China, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, Government of Jiangsu Province, Ministero della Salute, Generalitat Valenciana, Ministry of Oceans and Fisheries, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Korea Health Industry Development Institute, National Research Foundation of Korea, Narodowe Centrum Nauki, Javna Agencija za Raziskovalno Dejavnost RS, Ministerio de Ciencia e Innovación, Fundação de Amparo à Pesquisa do Estado de Minas Gerais, Universitetet i Bergen, Chinese Academy of Medical Sciences, Natural Science Foundation of Chongqing, Fundação Arthur Bernardes, Natural Science Foundation of Tianjin City, Università di Pisa, Chongqing Municipal Education Commission, Southeast University, Université de Montpellier, Department of Health of Hebei Province, Institut Curie, Junta de Andalucía, Korea Institute of Marine Science and Technology promotion, Ministério do Esporte, China Agricultural Research System, Foundation for Innovative Research Groups of the National Natural Science Foundation of China, Ono Pharmaceutical, Ministry of Science and ICT, South Korea, State Key Laboratory of Pathogen and Biosecurity, National Science and Technology Major Project, PanKind, The Australian Pancreatic Cancer Foundation, VLIRUOS, Flinders Foundation, National Institutes of Health, Centers for Disease Control and Prevention, National Park Service, Natural Resources Conservation Service, Winship Cancer Institute, Bureau of Ocean Energy Management, Museum of Natural Science, Louisiana State University, Natural Sciences and Engineering Research Council of Canada, Australian Research Council, National Health and Medical Research Council, Japan Society for the Promotion of Science, Fundação para a Ciência e a Tecnologia, Korea Environmental Industry and Technology Institute, Agencia Estatal de Investigación, National Key Research and Development Program of China, Shenzhen Key Laboratory Fund, Science and Technology Program of Suzhou, High-level Hospital Construction Project of Guangdong Provincial People's Hospital, National Institute on Aging, National Science Foundation Graduate Research Fellowship Program, Sichuan Medical Association, Research Ireland
OpenAlex ID: W7136713348