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Evidence that testosterone gel does not increase the risk of cardiovascular disease: A Mendelian randomization study

Xin-Yang He, Zhuo-Nan Jia, Bo-Yu Zhang

    International Journal of Clinical Pharmacology and Therapeutics
    |October 22, 2025
    PubMed

    Insights

    Testosterone therapy, specifically testosterone gel, was investigated for its link to cardiovascular disease. This Mendelian randomization study found no significant causal relationship, suggesting testosterone treatment does not increase heart disease risk.

    Area of Science:

    • Cardiovascular Science
    • Endocrinology
    • Genetics

    Background:

    • The association between testosterone therapy and cardiovascular disease (CVD) is debated.
    • Existing studies show conflicting results, lacking definitive causal evidence.
    • Testosterone treatment is prescribed for various conditions, making its safety profile crucial.

    Purpose of the Study:

    • To investigate the potential causal relationship between testosterone gel use and major cardiovascular diseases.
    • To assess risks for stroke, coronary heart disease, hypertension, and cardiomyopathy.
    • To employ a robust Mendelian randomization (MR) approach for causal inference.

    Main Methods:

    • Utilized large-scale Genome-Wide Association Studies (GWAS) data.
    • Applied a two-sample Mendelian randomization (MR) analysis.
    • Employed inverse variance weighted (IVW) as the primary method, with MR-Egger, weighted median, and weighted mode for sensitivity.

    Main Results:

    • The primary IVW analysis indicated no significant causal effect of testosterone gel use on overall cardiovascular disease risk.
    • Sensitivity analyses, including MR-Egger and weighted median, corroborated the primary findings.
    • No significant evidence of horizontal pleiotropy or heterogeneity was detected, supporting result validity.

    Conclusions:

    • Testosterone gel treatment does not appear to significantly elevate the risk of developing cardiovascular disease.
    • Findings contribute to resolving the debate on testosterone therapy safety concerning heart health.
    • Further research may explore specific cardiovascular outcomes or patient subgroups.
    Abstract

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