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Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men
Open accessAbstract
BACKGROUND: An association between testosterone therapy (TT) and cardiovascular disease has been reported and TT use is increasing rapidly. METHODS: We conducted a cohort study of the risk of acute non-fatal myocardial infarction (MI) following an initial TT prescription (N = 55,593) in a large health-care database. We compared the incidence rate of MI in the 90 days following the initial prescription (post-prescription interval) with the rate in the one year prior to the initial prescription (pre-prescription interval) (post/pre). We also compared post/pre rates in a cohort of men prescribed phosphodiesterase type 5 inhibitors (PDE5I; sildenafil or tadalafil, N = 167,279), and compared TT prescription post/pre rates with the PDE5I post/pre rates, adjusting for potential confounders using doubly robust estimation. RESULTS: In all subjects, the post/pre-prescription rate ratio (RR) for TT prescription was 1.36 (1.03, 1.81). In men aged 65 years and older, the RR was 2.19 (1.27, 3.77) for TT prescription and 1.15 (0.83, 1.59) for PDE5I, and the ratio of the rate ratios (RRR) for TT prescription relative to PDE5I was 1.90 (1.04, 3.49). The RR for TT prescription increased with age from 0.95 (0.54, 1.67) for men under age 55 years to 3.43 (1.54, 7.56) for those aged ≥ 75 years (p trend = 0.03), while no trend was seen for PDE5I (p trend = 0.18). In men under age 65 years, excess risk was confined to those with a prior history of heart disease, with RRs of 2.90 (1.49, 5.62) for TT prescription and 1.40 (0.91, 2.14) for PDE5I, and a RRR of 2.07 (1.05, 4.11). DISCUSSION: In older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.
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“Some epidemiological studies have reported an increase in cardiovascular mortality related to TRT while others have not been able to establish a correlation between the two [19,20].”
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“However, following reports from observational studies describing a link between TT and myocardial infarction risk, the FDA issued a safety communication in 2014, which led to a gradual decline in TT prescriptions [6, 7].”
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“From these data, the authors concluded that the risk of MI after starting TT is substantially increased in younger and older men who have coexisting heart diseases.(40) The drawback of this study was the use of men taking PDE5-I as a supposed benign control group.”
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Yafi, F. A., Haney, N. M., Anaissie, J. E., DeLay, K. J., Trost, L. W., Khera, M., & Hellstrom, W. J. G. (2017) · Urology · doi:10.1016/j.urology.2017.04.036 · Cited by 5
Ishay, A., Tzemah, S., Nitzan, R., Jehassi, A., & Cohen, M. (2019) · Sexual Medicine · doi:10.1016/j.esxm.2019.06.011 · Cited by 5
Hypogonadism management and cardiovascular health
Auerbach, J. M., & Khera, M. (2020) · Postgraduate Medicine · doi:10.1080/00325481.2020.1805917 · Cited by 5
The Implications of Low Testosterone on Mortality in Men
Shores, M. M. (2014) · Current Sexual Health Reports · doi:10.1007/s11930-014-0030-x · Cited by 5
Predicting Adverse Drug Effects from Literature- and Database-Mined Assertions
La, M. K., Sedykh, A., Fourches, D., Muratov, E. N., & Tropsha, A. (2018) · Drug Safety · doi:10.1007/s40264-018-0688-5 · Cited by 5
“[59, 60] that found an association between testosterone and negative cardiovascular outcomes, including myocardial”
Rai, S., & Ramasamy, R. (2015) · European Urology · doi:10.1016/j.eururo.2015.10.060 · Cited by 5
Changes in testosterone prescribing patterns after FDA warning
Lokeshwar, S. D., Bitran, J., & Ramasamy, R. (2019) · Translational Andrology and Urology · doi:10.21037/tau.2019.04.03 · Cited by 5
Tang, X., Xu, Y., Ou, N., Tang, Y., & Chen, H. (2025) · Sexual Medicine Reviews · doi:10.1093/sxmrev/qeaf043 · Cited by 4
Debate: Testosterone Therapy Reduces Cardiovascular Risk in Men with Diabetes. Against the Motion
Schooling, C. M., Xu, L., & Zhao, J. V. (2015) · Current Cardiovascular Risk Reports · doi:10.1007/s12170-015-0449-2 · Cited by 4
Does falling testosterone with age among men underlie the increase in ischaemic heart disease
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Health, Evolution, and Reproductive Strategies in Men: New Hypotheses and Directions
Bribiescas, R. G., & Burke, E. E. (2017) · Springer eBooks · doi:10.1007/978-1-4939-4038-7_6 · Cited by 4
Sexual Dysfunction in Diabetic Patients: Τhe Role of Advanced Glycation End Products
Peppa, Μ., & Manta, A. (2023) · Current Diabetes Reviews · doi:10.2174/1573399819666230407095522 · Cited by 4
Chen, J. Y., Ardissino, M., Reddy, R. K., Mason, A. M., Raisi‐Estabragh, Z., Angelantonio, E. D., Burgess, S., & Ng, F. S. (2023) · ESC Heart Failure · doi:10.1002/ehf2.14527 · Cited by 3
“14,15 The relationship is more complex in females.”
BackgroundTestosterone therapy and the risk of cardiovascular disease in older, hypogonadal men
Krishnan, S., Aldana-Bitar, J., Golub, I. S., Ichikawa, K., Shabir, A., Bagheri, M., Hamidi, H., Benzing, T., Kianoush, S., & Budoff, M. J. (2024) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2024.02.015 · Cited by 5
Mann, A., Strange, R. C., Hackett, G. I., König, C. S., & Ramachandran, S. (2024) · Exploration of Endocrine and Metabolic Diseases · doi:10.37349/eemd.2024.00010 · Cited by 4
The Role of Testosterone Therapy in Cardiovascular Mortality: Culprit or Innocent Bystander?
Tanna, M. S., Schwartzbard, A. Z., Berger, J. S., Alukal, J. P., & WEINTRAUB, H. S. (2015) · Current Atherosclerosis Reports · doi:10.1007/s11883-015-0490-0 · Cited by 4
Risks of Different Testosterone Preparations
Wierman, M. E. (2015) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2015.1580 · Cited by 4
Testosterone supplementation in men
Owen, R. C., Elkelany, O. O., & Kim, E. D. (2015) · Current Opinion in Obstetrics & Gynecology · doi:10.1097/gco.0000000000000192 · Cited by 4
Testosterone and androstanediol glucuronide among men in NHANES III
Duan, C. W., & Xu, L. (2018) · BMC Public Health · doi:10.1186/s12889-018-5255-6 · Cited by 4
“Second, there is some evidence that the association of testosterone administration with CVD vary with age, with the adverse effect being more pronounced in people aged 65 or more than those younger [19].”
BackgroundCardiovascular risk with androgen deprivation therapy
Rosenberg, M. T. (2019) · International Journal of Clinical Practice · doi:10.1111/ijcp.13449 · Cited by 4
Role of Androgens in Cardiovascular Diseases in Men: A Comprehensive Review
Mukherjee, D., Sen, K., Gupta, S., Chowdhury, P. D., Majumder, S., & Guha, P. (2020) · IntechOpen eBooks · doi:10.5772/intechopen.85852 · Cited by 5
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“TRT is not recommended in men prostatic cancer and lower urinary tract symptoms caused by an enlarged prostate (McGill et al., 2012).”
BackgroundInfluentialTestosterone deficiency in male organ transplant recipients
Omil-Lima, D., Jesse, E., Gupta, K., Sellke, N. C., Muncey, W. W., Burrelli, C. C., Ghayda, R. A., Loeb, A., & Thirumavalavan, N. (2022) · International Journal of Impotence Research · doi:10.1038/s41443-021-00513-9 · Cited by 4
Duro, T., McClain, M., Aragon, K. G., Casson, C., Choi, E. H. E., Bouchonville, M. F., & Kapsner, P. (2022) · Endocrine Practice · doi:10.1016/j.eprac.2022.12.007 · Cited by 4
Metadata
- Authors
- Finkle, W. D., Greenland, S., Ridgeway, G. K., Adams, J. L., Frasco, M. A., Cook, M. B., Fraumeni, J. F., & Hoover, R. N.
- Affiliations
- University of California, Los Angeles (US)
- National Cancer Institute (US)
- Corresponding author
- Finkle, William D.
- Hoover, Robert N.
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2014-01-29
- Volume
- 9
- Issue
- 1
- Pages
- e85805
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC3905977
- OpenAlex
- W2156204904
- Cited by
- 735
- References
- 31
- Citations by year
- 2026: 21 · 2025: 34 · 2024: 33 · 2023: 42 · 2022: 45 · 2021: 32 · 2020: 41 · 2019: 52 · 2018: 69 · 2017: 87 · 2016: 79 · 2015: 112 · 2014: 86
- FWCI
- 97.58
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, public-domain)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, public-domain)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion, public-domain)
- Figshare (submittedVersion, cc-by)
- Funders
- National Institutes of Health
- National Cancer Institute
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- testosterone replacement therapy, myocardial infarction, cardiovascular risk, phosphodiesterase-5 inhibitors, sildenafil, tadalafil, men, older men, heart disease history, drug safety, adverse drug reactions
- MeSH terms
- Tadalafil, Sildenafil Citrate, Age Factors, Aged, Carbolines, Humans, Male, Middle Aged, Myocardial Infarction, Piperazines, Purines, Risk, Sulfones, Testosterone, Prescription Drugs, Phosphodiesterase 5 Inhibitors
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