TL;DR
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A large retrospective study reported higher rates of cardiovascular events among postmenopausal women who initiated testosterone than among matched women who did not. The researchers caution that the association does not prove causation, and missing treatment details and the short average follow-up limit what can be concluded.
A retrospective study of postmenopausal women found that those who initiated testosterone therapy had higher rates of cardiovascular events than matched women who did not receive the treatment. The findings, presented by Xuezhi (Daniel) Jiang and a colleague at the Menopause Society’s annual meeting, show an association—not proof that testosterone caused the events—and add to limited evidence about its long-term heart safety in women.
Researchers used the TriNetX electronic health record network to compare women aged 45 and older who started testosterone with women who were not exposed to it. After propensity score matching, each group included 3,164 women. The study excluded people with prior cardiovascular disease and some other conditions that could complicate comparisons. Average follow-up was 2.6 years.
The primary outcome combined new cases of coronary artery disease, cerebrovascular disease and heart failure within five years of treatment initiation. The study reported cardiovascular events in 3.8% of the testosterone group and 0.5% of the comparison group. The five-year hazard ratio was 8.08 (95% confidence interval 4.72–13.83). At 10 years, the reported event rates were 5.3% and 0.5%; in an unrestricted follow-up analysis, they were 6.2% and 1%.
A separate analysis comparing women who received testosterone plus menopausal hormone therapy with women receiving menopausal hormone therapy alone also found an association with higher cardiovascular risk. Jiang identified important limitations: the study was retrospective, there were relatively few events, and the database did not record testosterone dose, formulation, route, delivery method or reason for prescribing. The results do not establish which treatment patterns, if any, account for the difference.
What the Heart-Risk Signal Means
The findings raise a safety question for patients and clinicians weighing testosterone for menopausal concerns, particularly because cardiovascular disease is common and long-term safety evidence for women is limited. But the reported relative hazard should not be read as an individual patient’s likelihood of harm: the study’s observed five-year event rates were 3.8% versus 0.5%, and the observational design cannot determine why they differed.
The study also cannot settle whether testosterone is beneficial enough to justify possible risks. Evidence that it helps with menopausal symptoms is limited, although some research suggests a benefit for women with low libido. Decisions about treatment should be discussed with a clinician, taking account of an individual’s health history and the uncertainties in the evidence. The findings are a reason for further investigation, not a basis for concluding that prescribed testosterone causes heart disease.
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Limited Evidence on Women’s Treatment
There are no FDA-approved testosterone products for women, according to the source report. Some doctors prescribe low doses of products formulated for men off-label. The report says evidence is insufficient to establish whether testosterone eases menopausal symptoms broadly, though some studies suggest it may help women with low libido.
Jiang said many clinical trials have been small or short and were not designed to assess major cardiovascular events. That gap led the researchers to examine a larger health-record database. However, a larger retrospective comparison remains different from a prospective trial: records may omit relevant details, and differences between people prescribed testosterone and those who are not may affect the results.
“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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Key Limits of the Heart Data
The study cannot show that testosterone caused the higher event rates. Because it relied on existing health records, residual confounding and misclassification remain possible even after matching and adjustment. The database also lacked key details about treatment dose and delivery, so researchers could not assess whether risk varied by formulation, route or prescribing reason.
Follow-up averaged 2.6 years, despite analyses reporting outcomes over longer time frames, and the number of cardiovascular events was limited. The source report does not provide enough information to determine whether the association differs for specific cardiovascular outcomes or for particular groups of patients. It also does not establish how the findings apply to appropriately prescribed physiologic-dose transdermal testosterone.
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Prospective Studies Needed
Jiang said the results should be validated in prospective studies, which can track treatment and health outcomes over time with more detailed information. He also said future research should examine individual cardiovascular outcomes rather than relying only on a combined measure.
Until stronger evidence is available, patients and clinicians will need to weigh the limited evidence of benefit against uncertain long-term safety. The study does not provide a new treatment recommendation or establish that every form of testosterone therapy carries the same risk. Further research will be needed to clarify whether the observed association reflects treatment effects, differences between patient groups, or both.
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Key Questions
Did the study prove testosterone causes heart disease?
No. It was a retrospective observational study, which can identify an association but cannot establish that testosterone caused the cardiovascular events.
How many women were included?
After propensity score matching, the study included 3,164 women in each group: one group initiating testosterone and one group not exposed to it.
What cardiovascular events did researchers count?
The primary outcome combined coronary artery disease, cerebrovascular disease and heart failure.
Does the study apply to all testosterone treatments for menopause?
That is unclear. The database did not record dose, formulation, route or delivery, and Jiang cautioned against generalizing the findings to all women receiving appropriately prescribed physiologic-dose transdermal testosterone.
Source: rss
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