Isotretinoin and Risk of Cardiovascular Events in Adults with Acne: A Population-based Retrospective Cohort Study.

Background: Case reports have suggested isotretinoin exposure may be associated with adverse cardiac events. There are limited data where the cardiovascular safety of isotretinoin is systematically evaluated.

Objective: The aim of this study was to determine the strength of association between isotretinoin exposure and adverse cardiovascular events.

Methods: This was a population-based retrospective cohort study within an integrated healthcare delivery system. Adults ≥ 18 years of age with acne between 2009 and 2018 were included. Exposure to isotretinoin was identified using pharmacy records, and propensity score 1:1 matching was performed. The primary outcome was a composite of cardiovascular outcomes, including acute myocardial infarction, heart failure, and all-cause death.

Results: The cohort consisted of 12,140 adults (10.5%) exposed to isotretinoin and 103,126 adults who were never exposed. Mean follow-up was 7.1 ± 2.9 years. After propensity score 1:1 matching, 23,844 patients were included. The rates of the composite cardiovascular outcomes were 0.47 versus 0.48 per 1000 person-years in the isotretinoin and non-exposed groups, respectively. No significant association was observed between isotretinoin treatment and the composite cardiovascular outcomes (adjusted hazard ratio [HR] 0.99, 95% confidence interval [CI] 0.62-1.58), all-cause mortality (adjusted HR 1.10, 95% CI 0.62-1.95), acute myocardial infarction (adjusted HR 1.00, 95% CI 0.33-3.09), congestive heart failure (adjusted HR 0.45, 95% CI 0.14-1.40), or atrial fibrillation (adjusted HR 0.44, 95% CI 0.12-1.65).

Conclusions: Among adult patients with acne, no association was found between exposure to isotretinoin and an increased risk of cardiovascular events. Physicians should not be discouraged from prescribing isotretinoin out of concern for cardiovascular effects.