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A retrospective study of postmenopausal women found that testosterone users had higher rates of cardiovascular events than matched women who did not use it. The researchers and an outside expert stressed that the association does not prove testosterone caused the events, and the study lacked information on dose and formulation.
A large retrospective study presented at the Menopause Society annual meeting found that postmenopausal women prescribed testosterone had higher rates of cardiovascular events than matched women who were not exposed to the treatment. The researchers cautioned that the study shows an association, not proof of cause and effect, and that its results cannot establish the long-term heart safety of testosterone therapy.
Researchers analyzed electronic health records for women aged 45 and older who were initiating testosterone therapy, comparing them with women who had not received it. After matching the groups on measured characteristics, each included 3,164 women. The primary outcome was a composite of newly recorded coronary artery disease, cerebrovascular disease or heart failure.
At five years, the study recorded cardiovascular events in 3.8% of testosterone users and 0.5% of the matched comparison group. The reported hazard ratio was 8.08 (95% CI 4.72-13.83). At 10 years, event rates were 5.3% and 0.5%, respectively; in the unrestricted follow-up analysis they were 6.2% and 1%. The authors also reported elevated relative hazards at those follow-up intervals.
The average follow-up was 2.6 years, and the study was retrospective. Researchers excluded women with prior cardiovascular disease and certain other conditions, then used propensity-score matching. A separate sensitivity analysis comparing women using testosterone plus menopausal hormone therapy with women using hormone therapy alone also found a higher cardiovascular risk estimate at five years. The study was presented as a meeting poster, not described in the source report as a randomized trial.
Heart Safety Evidence Remains Limited
The findings add to uncertainty around a treatment used by some clinicians for menopausal symptoms, including low sexual desire. There are no FDA-approved testosterone products for women, according to the report, although some doctors prescribe low doses of products formulated for men off-label. The study does not determine whether testosterone itself caused the observed events, but it highlights why long-term cardiovascular safety is a relevant question for patients and prescribers.
Evidence of benefit is also limited: the source report says research suggests testosterone may help some women with low libido, while evidence that it relieves menopausal symptoms more broadly is insufficient. The observed percentages are outcomes in this particular study population, not estimates of an individual patient’s risk. Treatment decisions require clinical judgment and discussion with a qualified health professional; the results alone do not establish that a particular prescription is unsafe.
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Why Researchers Examined Testosterone Use
Jiang and a colleague used the TriNetX multicenter electronic health record network because earlier clinical trials, according to Jiang, were often small or short and were not designed to measure major cardiovascular events. The study examined outcomes at five and 10 years, as well as over unrestricted follow-up, after treatment initiation.
The database did not record the testosterone dose, formulation, route of administration, delivery method or reason for prescribing. Jiang said the findings should not be generalized to all menopausal women receiving guideline-concordant, physiologic-dose transdermal testosterone. The study therefore raises a safety signal for further investigation but cannot resolve how risk may vary across different patients or treatment regimens.
“Our findings suggest that testosterone use is associated with a higher risk of cardiovascular events in postmenopausal women.”
— Xuezhi (Daniel) Jiang, MD, PhD, of Drexel University College of Medicine and Reading Hospital
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Limits on Interpreting the Risk Estimates
The study cannot establish that testosterone caused cardiovascular events. As a retrospective analysis, it may be affected by residual confounding—differences between groups that were not measured or fully accounted for—and by misclassification in electronic health records. Jiang also cited the relatively short average follow-up and the small number of events overall as limitations.
The database’s lack of details about dose, formulation and route makes it impossible to determine whether the association applies to a particular type of treatment or prescribing approach. The report does not establish which specific cardiovascular outcome drove the composite result, or whether the association would be found in prospective research. The study’s relative hazard estimates should also be read alongside the reported event percentages and the study’s limitations.
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Prospective Studies Needed to Clarify Risk
Jiang said the findings should be validated in prospective studies, which can follow participants according to a planned protocol and collect treatment details not available in the records used here. Future research should also examine coronary disease, cerebrovascular events and heart failure separately, and clarify how results differ by dose and formulation.
Until stronger evidence is available, this study is one observational report rather than a final answer on cardiovascular safety. The source report does not describe a scheduled follow-up study or a change to treatment guidance. Patients considering or using testosterone for menopausal concerns can discuss the potential benefits, uncertainties and individual health factors with a qualified clinician.
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Key Questions
What did the study find?
In a retrospective analysis, 3.8% of testosterone users had a recorded cardiovascular event within five years, compared with 0.5% of matched women who were not exposed. The study reported an association and cannot show that testosterone caused the difference.
Which heart and vascular conditions were counted?
The main outcome combined newly recorded coronary artery disease, cerebrovascular disease and heart failure. The source report does not provide separate event rates for each condition.
Does this prove testosterone causes heart disease?
No. This was a retrospective observational study, which can identify an association but cannot establish cause and effect. The authors said prospective research is needed.
Does the finding apply to every testosterone treatment?
That is unclear. The database did not include the dose, formulation or route of testosterone. Jiang cautioned that the results should not be generalized to all women receiving guideline-concordant physiologic-dose transdermal treatment.
What research is needed next?
Researchers called for prospective studies that collect treatment details and examine individual cardiovascular outcomes, rather than combining them into one measure. The report did not identify a timeline for such research.
Source: rss
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