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

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Abstract

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.

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Author information

Authors and Affiliations

  1. Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

    Serena Ghanshani

  2. Division of Cardiology, Department of Cardiology, Kaiser Permanente Los Angeles Medical Center, 1526 North Edgemont Street, 2nd Floor, Los Angeles, CA, 90027, USA

    Cheng Chen & Ming-Sum Lee

  3. Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, USA

    Bryan Lin & Hui Zhou

Authors
  1. Serena Ghanshani
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  2. Cheng Chen
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  3. Bryan Lin
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  4. Hui Zhou
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  5. Ming-Sum Lee
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Corresponding author

Correspondence to Ming-Sum Lee.

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Funding

No funding was received for the conduct of this study or the preparation of this article.

Conflict of interest

Serena Ghanshani, Cheng Chen, Bryan Lin, Hui Zhou, and Ming-Sum Lee have no conflicts of interest that are directly relevant to the contents of this article.

Ethics approval

This study was approved by the KPSC Institutional Review Board.

Consent to participate

Not applicable. A waiver of informed consent was obtained because of the observational nature of the study.

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Not applicable.

Availability of data and materials

The data that support the findings of this study may be made available from Kaiser Permanente Southern California (https://www.kp-scalresearch.org/aboutus/contact-us/). Restrictions apply to the availability of these data.

Code availability

Codes may be made available from Kaiser Permanente Southern California (https://www.kp-scalresearch.org/aboutus/contact-us/).

Author contributions

M-SL and BL had full access to all the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis. M-SL, SG, CC, BL, and HZ were involved in the study concept and design, and critical revision of the manuscript for important intellectual content. M-SL, SG, and BL were responsible for the acquisition of data, and analysis and interpretation of the data. M-SL and BL were involved in statistical analysis. SG and M-SL were responsible for drafting of the manuscript.

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Ghanshani, S., Chen, C., Lin, B. et al. Isotretinoin and Risk of Cardiovascular Events in Adults with Acne: A Population-based Retrospective Cohort Study. Am J Clin Dermatol 22, 267–274 (2021). https://doi.org/10.1007/s40257-020-00568-2

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  • DOI: https://doi.org/10.1007/s40257-020-00568-2

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