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A large retrospective cohort study found higher rates of cardiovascular events among postmenopausal women prescribed testosterone than among matched women not receiving it. The researchers say the findings are hypothesis-generating, not proof of cause, and call for prospective studies to assess long-term safety.
A retrospective study presented at the Menopause Society annual meeting found that postmenopausal women prescribed testosterone had higher observed rates of cardiovascular events than matched women not receiving the therapy. The researchers stressed that the results show an association, not proof that testosterone caused the events, and said further research is needed to assess cardiovascular safety.
Xuezhi (Daniel) Jiang, MD, PhD, of Drexel University College of Medicine and Tower Health’s Reading Hospital in Pennsylvania, and a colleague analyzed records from the TriNetX electronic health record network. The retrospective study included women aged 45 and older who were initiating testosterone therapy and a comparison group not exposed to it. After propensity-score matching, each group had 3,164 women; mean follow-up was 2.6 years.
Over five years, the composite outcome—new coronary artery disease, cerebrovascular disease or heart failure—was recorded in 3.8% of women in the testosterone group and 0.5% of the comparison group. The reported hazard ratio was 8.08 (95% confidence interval 4.72 to 13.83). At 10 years, the respective event rates were 5.3% and 0.5%; in an analysis covering any time after treatment initiation, they were 6.2% and 1%.
A sensitivity analysis also found an association among women receiving testosterone alongside menopausal hormone therapy compared with women receiving menopausal hormone therapy alone. At five years, the reported hazard ratio was 6.73 (95% CI 5.00 to 9.05). The study did not establish whether risk differed by dose, formulation, route or reason for prescribing, because those details were not available in the database.
Why the Heart-Safety Signal Matters
The findings add to uncertainty about the long-term cardiovascular safety of testosterone in women, an area where evidence is limited. The study authors said existing clinical trials have often been small or short and were not designed to measure major cardiovascular events. The observational results cannot resolve whether testosterone itself affects heart risk, but they identify a question that larger, purpose-designed studies could investigate.
For patients, the distinction between a statistical association and a demonstrated treatment effect matters. The study does not show that an individual woman’s cardiovascular event was caused by testosterone, nor does it establish that every dose or formulation carries the same risk. It does suggest that long-term safety should not be assumed from a lack of a signal in selected trial populations. Treatment decisions should be discussed with a qualified clinician, who can consider a patient’s circumstances and the uncertainties in the evidence.
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How Testosterone Is Used in Menopause Care
There are no FDA-approved testosterone products for women, according to the source report, though some clinicians prescribe low doses of formulations made for men off-label. Evidence that testosterone relieves menopausal symptoms is insufficient overall; some research suggests a benefit for women with low sexual desire. The study does not assess whether participants experienced symptom improvement or weigh that against possible harms.
Jiang said the research was undertaken because clinical trials had not provided substantial evidence on major cardiovascular events over the long term. The team used a multicenter health-record database to compare women initiating testosterone with unexposed controls. Researchers excluded people with prior cardiovascular disease and other conditions that could complicate interpretation, then matched the cohorts on measured characteristics. These methods can improve comparability but cannot eliminate differences that were not recorded or measured.
“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
Limits of the Available Evidence
The study’s retrospective design leaves room for residual confounding: factors linked both to treatment and cardiovascular health may not have been captured. The authors also cited possible data misclassification, relatively short mean follow-up and few cardiovascular events overall. The hazard ratios describe relative differences in the study analysis; the observed absolute event rates were much lower than those ratios alone might suggest.
TriNetX did not record testosterone dose, formulation, route of delivery or prescribing indication, so the researchers could not assess how those factors shaped the results. The findings also cannot establish that testosterone caused the higher event rates or be generalized to all menopausal women using guideline-concordant physiologic-dose transdermal testosterone. It remains unclear which cardiovascular outcomes, if any, may be most closely associated with treatment.
Prospective Studies Needed
Jiang said the findings should be validated in prospective studies, which can follow participants using more detailed treatment information and planned cardiovascular assessments. Future research should also examine individual outcomes, such as coronary disease, cerebrovascular disease and heart failure, rather than relying only on the composite measure.
Until further evidence is available, the report supports caution in interpreting the association, not a conclusion that testosterone causes cardiovascular disease. No specific follow-up study, timeline or change to treatment guidance was identified in the source report. The unresolved questions include whether risk varies by dose or delivery method and how any potential cardiovascular effects compare with treatment benefits for particular symptoms.
Key Questions
Did the study prove testosterone causes heart disease?
No. It was a retrospective observational study and found an association between testosterone use and higher observed cardiovascular event rates. Its authors said it cannot establish that treatment caused the events.
What cardiovascular events did researchers count?
The study’s composite outcome included coronary artery disease, cerebrovascular disease and heart failure occurring after testosterone initiation.
How common were events in the five-year analysis?
Events were recorded in 3.8% of the testosterone group and 0.5% of matched women not exposed to testosterone over five years. These are the study’s observed rates, not proof that treatment caused the difference.
Do the findings apply to every testosterone treatment for menopause?
The study could not compare risks by dose, formulation or delivery route because those details were unavailable. Jiang cautioned that the results should not be generalized to all women receiving guideline-concordant physiologic-dose transdermal testosterone.
What research is needed next?
The researchers called for prospective studies to validate the association and examine individual cardiovascular outcomes, with better information about treatment dose and delivery.
Source: rss
