Evaluating the cardiovascular safety of low-dose oral minoxidil in patients with non-scarring alopecia: A retrospective cohort study.

Summary: LDOM is an effective treatment for non-scarring alopecia, including androgenic alopecia. Originally used as an antihypertensive, minoxidil has an FDA boxed warning for cardiovascular adverse events (CVAEs), raising concerns about LDOM’s safety. While reports have linked LDOM to pericardial effusion, large-scale ongoing safety data remains limited. Using the TriNetX US Collaborative Network (68 healthcare organizations), we conducted a retrospective cohort study comparing non-scarring alopecia patients (ICD-10-CM: L64 or L65) treated with LDOM (2.5 mg) to non-scarring alopecia patient controls without LDOM exposure. Cohorts were 1:1 propensity score-matched for baseline demographics. Patients with prior myocardial infarction or heart failure were excluded. 1-year Cox proportional hazards models with 95% confidence intervals (CIs) were used to evaluate the development of pericardial effusion, cardiac tamponade, and angina. Compared to 9,724 matched controls, 9,724 LDOM-treated patients had no significant differences in the risks of pericardial effusion (hazard ratio (HR) [95% CI] = 1.09 [0.53, 2.26]), cardiac tamponade (no events), or angina (HR [95% CI] = 0.86 [0.43, 1.70]) at 1 year. Among LDOM-treated patients vs hair loss controls, there were 15 vs. 14 pericardial effusions, 0 vs. <10 cardiac tamponades, and 15 vs. 18 cases of angina within 1 year. LDOM treatment in non-scarring alopecia was not associated with increased CVAE risk. While future studies are needed to investigate long-term LDOM exposure and other potential CVAEs, our findings provide real-world evidence of LDOM’s safety. Christopher J. Thang², Jasmine Levine¹, David Garate², Katie Roster³, Lillian Mo¹, Nicholas Gulati¹, Jónas Adalsteinsson¹, Benjamin Ungar¹ 1. Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, United States. 2. The University of Texas Medical Branch John Sealy School of Medicine, Galveston, TX, United States. 3. Dermatology, Georgetown University School of Medicine, Washington, DC, United States. Clinical Research: Epidemiology and Observational Research