TL;DR
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A large retrospective cohort study found higher rates of cardiovascular events among postmenopausal women who started testosterone than among matched women who did not. The researchers say the association is not proof of causation; limited follow-up, few events and missing treatment details mean the results need confirmation.
A retrospective study of postmenopausal women found that those who started testosterone therapy had more cardiovascular events over follow-up than matched women who did not receive it. The study, presented at the Menopause Society annual meeting, reports an association—not evidence that testosterone caused the events—and the researchers say further studies are needed.
Xuezhi (Daniel) Jiang, MD, PhD, of Drexel University College of Medicine and Tower Health’s Reading Hospital in Pennsylvania, and a colleague used the TriNetX electronic health record network to study women aged 45 and older who were postmenopausal and initiating testosterone. After propensity score matching, the analysis included 3,164 women in each group: one exposed to testosterone and a comparison group not exposed to it. Women with previous cardiovascular disease and some other conditions that could complicate the analysis were excluded.
At five years, the study recorded cardiovascular events in 3.8% of the testosterone group and 0.5% of the comparison group. The composite outcome included coronary artery disease, cerebrovascular disease and heart failure. The researchers reported a hazard ratio of 8.08 (95% confidence interval 4.72–13.83) at five years. At 10 years, event rates were 5.3% versus 0.5%; in an unrestricted follow-up analysis, they were 6.2% versus 1%. These are results from the study population, not estimates that establish an individual patient’s risk.
A sensitivity analysis comparing women taking testosterone alongside menopausal hormone therapy with women taking menopausal hormone therapy alone also found a higher cardiovascular risk in the testosterone group at the measured follow-up points. At five years, the reported hazard ratio was 6.73 (95% CI 5.00–9.05). The cohort’s mean follow-up was 2.6 years, shorter than the study’s five- and 10-year analysis windows, and the researchers said there were few cardiovascular events overall.
Why the Heart-Risk Signal Matters
The findings add to uncertainty about the long-term cardiovascular safety of testosterone prescribed for menopausal symptoms. They matter to patients and clinicians weighing treatment because the study found a difference in observed event rates, while existing evidence has not established that testosterone prevents or causes cardiovascular disease in this setting.
Stephen Burgess, PhD, a biostatistics professor at the University of Cambridge, called the reported difference concerning, while stressing that the study cannot prove treatment caused it. He noted that heart disease is relatively common and said the analysis had accounted for several potential alternative causes. His comments, posted through the Science Media Centre, are an interpretation of the findings, not a separate clinical trial result.
The study should not, on its own, be used to predict a patient’s outcome or settle decisions about treatment. It is an observational analysis, and the treatment details were incomplete. Patients considering or using testosterone can discuss the potential benefits, uncertainties and their individual health history with a qualified clinician rather than changing therapy based solely on this report.
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Evidence and Prescribing Background
There are no FDA-approved testosterone products for women, according to the report. Some clinicians prescribe low doses of formulations made for men off-label. Evidence that testosterone improves menopausal symptoms is limited; some research suggests a benefit for women with low libido. That evidence does not answer whether the therapy is safe over the long term for cardiovascular outcomes.
Jiang said earlier clinical trials were often small or short and generally were not designed to measure major cardiovascular events. The research team therefore turned to a large health-record database to examine outcomes in clinical practice. The new study offers a signal for further investigation, but its retrospective design cannot provide the same control over treatment assignment and measurement as a prospective randomized trial.
The authors cautioned against applying the results to all women receiving guideline-concordant, physiologic-dose transdermal testosterone. The database did not record the dose, formulation, route, delivery method or treatment indication, so the researchers could not determine how those differences might relate to outcomes.
“Our findings suggest that testosterone use is associated with a higher risk of cardiovascular events in postmenopausal women.”
— Xuezhi (Daniel) Jiang, MD, PhD, study author
Limits of the Risk Estimate
The study cannot establish cause and effect. Because treatment was not randomly assigned, differences between women who received testosterone and those who did not may have influenced the results, including factors not captured in the records. The authors also cited possible misclassification and residual confounding.
The reported hazard ratios describe relative differences in the study analysis; they do not mean that every patient’s risk rises by the same amount. The observed event percentages were low in both groups, and there were few events overall. The mean follow-up of 2.6 years also limits how confidently the data can describe longer-term outcomes.
It remains unclear how results vary by dose, formulation, route, reason for treatment or patient characteristics, because TriNetX did not provide those details. The findings also do not determine whether testosterone’s possible benefits for particular symptoms outweigh potential risks for an individual. The study’s results have not, by themselves, established a general safety conclusion for all menopausal women using testosterone.
Prospective Studies Needed
Jiang said the results should be validated in prospective studies, which can collect treatment and health information more consistently and follow patients over time. Future research should also distinguish among individual outcomes—including coronary artery disease, cerebrovascular disease and heart failure—instead of relying only on a combined cardiovascular measure.
Researchers will need to examine treatment dose and delivery method, as well as the reasons patients receive testosterone, to clarify which groups and regimens the findings may apply to. Until stronger evidence is available, the current study is best treated as a reason for further research, not proof of harm from appropriately prescribed therapy. The report does not specify when a follow-up study will be published.
Key Questions
Did the study prove testosterone causes heart disease?
No. It found an association in a retrospective observational study. The authors said the results cannot establish that testosterone caused the cardiovascular events.
What cardiovascular outcomes did researchers count?
The study’s composite outcome included coronary artery disease, cerebrovascular disease and heart failure. Researchers also said future work should examine the individual outcomes separately.
Were all forms and doses of testosterone included?
The database did not specify the dose, formulation, route, delivery method or treatment indication. The authors cautioned that the results should not be generalized to every woman receiving guideline-concordant, physiologic-dose transdermal testosterone.
Is testosterone approved for menopause treatment in women?
The report says there are no FDA-approved testosterone products for women. Some clinicians prescribe low doses of products made for men off-label. The study does not provide a treatment recommendation; patients should discuss their circumstances and options with a clinician.
Source: rss
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