TL;DR
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A retrospective study of postmenopausal women found that those starting testosterone had higher rates of cardiovascular events than matched women not receiving it. The researchers and outside expert cautioned that the findings do not prove testosterone caused the difference, and treatment details and longer-term safety remain uncertain.
A retrospective study of postmenopausal women found that those starting testosterone therapy had higher rates of cardiovascular events than similar women not receiving it, according to findings presented at the Menopause Society annual meeting. The researchers stressed that the association does not show the treatment caused the events. The report notes that long-term cardiovascular safety data are lacking.
Researchers Xuezhi (Daniel) Jiang, MD, PhD, of Drexel University College of Medicine and Reading Hospital, and a colleague used the TriNetX electronic health record network to compare women aged 45 and older who began testosterone with women not exposed to the treatment. After propensity score matching, each group included 3,164 women. The analysis excluded people with prior cardiovascular disease and certain other conditions that could complicate interpretation.
Within five years, the composite outcome of newly recorded coronary artery disease, cerebrovascular disease or heart failure occurred in 3.8% of women in the testosterone group and 0.5% of the comparison group. The study reported a hazard ratio of 8.08 (95% confidence interval 4.72-13.83). At 10 years, the reported rates were 5.3% and 0.5%, respectively; in an analysis covering follow-up at any time after treatment began, they were 6.2% and 1%.
The researchers also reported a sensitivity analysis comparing women taking testosterone alongside menopausal hormone therapy with women taking menopausal hormone therapy alone. That analysis found an association with higher cardiovascular risk at each follow-up point; at five years, the reported hazard ratio was 6.73 (95% CI 5.00-9.05). The study’s mean follow-up was 2.6 years, and the authors noted there were few events overall. Because the database lacked treatment details, the analysis could not account for testosterone dose, formulation, route, delivery method or reason for prescribing.
Why Heart-Safety Evidence Matters
The findings may matter to patients and clinicians weighing testosterone for menopausal concerns because they point to a possible cardiovascular safety issue that warrants further study. The observed differences are large, but the study design cannot determine whether testosterone itself explains them. Differences between people prescribed treatment and those who were not—including factors absent from the records—could affect the results.
Jiang told MedPage Today that the findings should prompt investigation, not be treated as proof that appropriately prescribed testosterone causes cardiovascular disease. He also cautioned against applying the results to all menopausal women receiving guideline-concordant, physiologic-dose transdermal testosterone. For patients, the report does not establish an individual level of risk or provide a basis for changing treatment without medical advice.
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Limited Data on Women’s Testosterone Use
There are no FDA-approved testosterone products for women, though some clinicians prescribe low doses of products formulated for men off-label. Evidence on whether testosterone relieves menopausal symptoms is limited; some research suggests a benefit for women with low libido. The supplied report does not describe this study as a trial of testosterone’s effectiveness for symptoms.
Jiang said previous clinical trials were often small or short and were not designed to assess major cardiovascular events. The researchers used a large, multicenter electronic health record database. The report describes an association and says the findings should be hypothesis-generating. It also notes the lack of long-term safety data and calls for prospective validation.
“Our findings suggest that testosterone use is associated with a higher risk of cardiovascular events in postmenopausal women.”
— Xuezhi (Daniel) Jiang, MD, PhD, speaking to MedPage Today
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Treatment Details and Causation Remain Unknown
The study cannot establish whether testosterone caused the higher event rates. A retrospective analysis can be affected by residual confounding—differences between groups that were not measured or fully accounted for—as well as misclassification in health records. TriNetX did not provide the treatment dose, formulation, route, delivery method or indication, limiting conclusions about specific prescribing practices.
The mean follow-up was 2.6 years, and the researchers reported few cardiovascular events overall. The report also presents 10-year and unrestricted follow-up analyses. It is unclear from the report how the association applies to particular products, doses or patient groups. Jiang cautioned against generalizing the results to all women receiving guideline-concordant, physiologic-dose transdermal testosterone.
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Prospective Studies Needed to Test Risk
Jiang said the results should be validated in prospective studies. Future research should also parse individual outcomes, including coronary disease, cerebrovascular events and heart failure.
The report notes that long-term cardiovascular safety data are lacking and calls for prospective validation. The study found an association in an observational analysis, but does not establish that testosterone caused the events recorded in the database.
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Key Questions
Did this study prove testosterone causes heart disease?
No. It was a retrospective observational study, which found an association but cannot establish that testosterone caused the cardiovascular events.
How many women were included?
After matching, the study compared 3,164 women who initiated testosterone with 3,164 women who were not exposed to it.
What cardiovascular outcomes did researchers track?
The primary composite outcome included newly recorded coronary artery disease, cerebrovascular disease and heart failure.
Does the report apply to every form or dose of testosterone?
That is not clear. The database did not include dose, formulation, route or delivery method, and Jiang cautioned against generalizing the findings to all women receiving guideline-concordant, physiologic-dose transdermal testosterone.
What evidence is needed next?
The researchers called for prospective studies to validate the association, with enough follow-up and detail to assess treatment regimens and individual cardiovascular outcomes.
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