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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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Testosterone replacement therapy and the risk of adverse cardiovascular outcomes and mortality
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“The importance to address this is meta-analysis of retrospective cohort studies is that two studies that received significant media attention by reporting an increased risk of CVD events among men who used TTh are considered retrospective cohort studies (40,41).”
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“Furthermore, an observational study suggests an association between testosterone supplementation and increased cardiac events [17].”
BackgroundGaba, A., Mairhofer, M., Zhegu, Z., Leditznig, N., Szabo, L., Tschugguel, W., Schneeberger, C., & Yotova, I. (2018) · Molecular and Cellular Endocrinology · doi:10.1016/j.mce.2018.05.007 · Cited by 13
Monitoring testosterone replacement therapy with transdermal gel: when and how?
Sansone, A., Sansone, M., Selleri, R., Schiavo, A., Gianfrilli, D., Pozza, C., Zitzmann, M., Lenzi, A., & Romanelli, F. (2019) · Journal of Endocrinological Investigation · doi:10.1007/s40618-019-01082-x · Cited by 13
López, D. S., Huang, D., Tsilidis, K. K., Khera, M., Williams, S. B., Urban, R. J., Panagiotou, O. A., Kuo, Y., Baillargeon, J., Farias, A. J., et al. (2019) · Clinical Endocrinology · doi:10.1111/cen.14093 · Cited by 12
Handelsman, D. J., Grossmann, M., Yeap, B. B., Stuckey, B. G. A., Shankara‐Narayana, N., Conway, A. J., Inder, W. J., McLachlan, R. I., Allan, C. A., Jenkins, A. J., et al. (2023) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgad485 · Cited by 12
Blackwell, K., Blackwell, M., & Blackwell, T. (2023) · Current Cardiology Reports · doi:10.1007/s11886-023-01935-1 · Cited by 12
Gosiker, B. J., Moutchia, J., Nguyen, N., Getahun, D., & Goodman, M. G. (2024) · Journal of Clinical & Translational Endocrinology · doi:10.1016/j.jcte.2024.100349 · Cited by 13
“[65 – 67] While the underlying mechanism is not clear, some hypotheses propose that lower testosterone levels may activate lipoprotein lipase, thereby increasing triglyceride uptake.”
Management of male obesity-related secondary hypogonadism: A clinical update
Shenoy, M. T., Mondal, S., Fernandez, C. J., & Pappachan, J. M. (2024) · World Journal of Experimental Medicine · doi:10.5493/wjem.v14.i2.93689 · Cited by 12
“In a retrospective review of men with low T undergoing angiography, TRT was found to be associated with an increased risk of composite CV outcome of MI, stroke and death (HR: 1.29), as also reported in an insurance database-based study [102,103].”
InfluentialAssociation of testosterone replacement therapy with atrial fibrillation and acute kidney injury
Greenberg, D. R., Kohn, T. P., Asanad, K., Brannigan, R. E., & Halpern, J. A. (2024) · The Journal of Sexual Medicine · doi:10.1093/jsxmed/qdae138 · Cited by 13
Martínez-Jabaloyas, J. M. (2014) · The Journal of Sexual Medicine · doi:10.1111/jsm.12596 · Cited by 11
Morgentaler, A., Zitzmann, M., Traish, A. M., & Fox, A. W. (2015) · The Aging Male · doi:10.3109/13685538.2015.1106469 · Cited by 11
“That controversy was precipitated by a number of events, including reactions to the rise in testosterone prescriptions [1], two reports of increased cardiovascular (CV) risks [2,3] and regulatory actions to limit the use of T therapy [4].”
BackgroundWu, B. W., Berger, M., Sum, J. C., Hatch, G. F. R., & Schroeder, E. T. (2014) · BMC Surgery · doi:10.1186/1471-2482-14-102 · Cited by 11
“The potential detrimental cardiovascular side effects of testosterone have recently been featured in both the literature and the media [40].”
BackgroundBlood donation and testosterone replacement therapy
Chin-Yee, B. H., Lazo‐Langner, A., Butler‐Foster, T., Hsia, C. C., & Chin-Yee, I. H. (2017) · Transfusion · doi:10.1111/trf.13970 · Cited by 10
Does long-term androgen deficiency lead to metabolic syndrome in middle-aged rats?
Borbélyová, V., Renczés, E., Bábíčková, J., Tóthová, Ľ., Kačmárová, M., Uličná, O., Ostatníková, D., Hodosy, J., & Celec, P. (2017) · Experimental Gerontology · doi:10.1016/j.exger.2017.08.016 · Cited by 11
“Beyond many benefits of testosterone replacement therapy, adverse effects were also reported and include increased cardiovascular risk (Basaria et al., 2010; Finkle et al., 2014; Vigen et al., 2013).”
EPHB6 and testosterone in concert regulate epinephrine release by adrenal gland chromaffin cells
Wang, Y., Shi, W., Blanchette, A., Peng, J., Qi, S., Luo, H., Ledoux, J., & Wu, J. (2018) · Scientific Reports · doi:10.1038/s41598-018-19215-2 · Cited by 11
Injection testosterone and adverse cardiovascular events: A case‐crossover analysis
Layton, J. B., Li, D., Meier, C. R., Sharpless, J. L., Stürmer, T., & Brookhart, M. A. (2018) · Clinical Endocrinology · doi:10.1111/cen.13574 · Cited by 11
Hypogonadotropic Hypogonadism in Non-Functioning Pituitary Adenomas: Impact of Intervention
Monteiro, D., Freitas, P., Vieira, R., & Carvalho, D. M. (2017) · Experimental and Clinical Endocrinology & Diabetes · doi:10.1055/s-0042-124355 · Cited by 11
Swerdloff, R. S., & Wang, C. (2020) · Andrology · doi:10.1111/andr.12901 · Cited by 11
Improvement of endothelial function following initiation of testosterone replacement therapy
Shoskes, D. A., Tucky, B. H., & Polackwich, A. S. (2016) · Translational Andrology and Urology · doi:10.21037/tau.2016.08.04 · Cited by 11
“Three recent studies which suggested an increase risk of cardiovascular events following TRT (1-3) led to an FDA review and updated labeling that indicates a possible increased risk of heart attacks and strokes following TRT.”
BackgroundInfluentialProvider and Site-Level Determinants of Testosterone Prescribing in the Veterans Healthcare System
Jasuja, G. K., Bhasin, S., Rose, A. J., Reisman, J. I., Hanlon, J. T., Miller, D. R., Morreale, A. P., POGACH, L. M., Cunningham, F. E., Park, A. Y. S., et al. (2017) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2017-00468 · Cited by 11
“vascular events in men taking testosterone (5, 6).”
BackgroundIntapad, S., Dasinger, J., Fahling, J., Backstrom, M. A., & Alexander, B. (2017) · PLoS ONE · doi:10.1371/journal.pone.0187843 · Cited by 9
Transformation or replacement - Effects of hormone therapy on cardiovascular risk
Kielb, J., Saffak, S., Weber, J., Baensch, L., Shahjerdi, K., Celik, A., Farahat, N., Riek, S., Chávez‐Talavera, O., Grandoch, M., et al. (2024) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2024.108592 · Cited by 10
Braga, M. A. P., Rivera, A., Marinheiro, G., Felix, N. S., Carvalho, P. E. P., Gewehr, D. M., Teixeira, L., Clemente, M. R. C., Reis, P. C. A., de Amorim, L. G. C. R., et al. (2025) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-025-00737-w · Cited by 10
“…study publication year, main exclusion criteria, sample size, follow-up period, baseline patient characteristics, TRT characteristics (drug, dosage, and treatment duration), endpoint definitions, and testosterone cutoffs (Supplemental Methods 6 and 7; see the electronic supplementary material ) .”
Does Testosterone Increase the Risk of a Cardiovascular Event?
Seftel, A. D., & Morgentaler, A. (2014) · The Journal of Urology · doi:10.1016/j.juro.2014.04.021 · Cited by 10
Trials of testosterone replacement reporting cardiovascular adverse events
Basaria, S. S., & Gagliano‐Jucá, T. (2018) · Asian Journal of Andrology · doi:10.4103/aja.aja_28_17 · Cited by 10
Arinno, A., Apaijai, N., Kaewthep, P., Pratchayasakul, W., Jaiwongkam, T., Kerdphoo, S., Chattipakorn, S. C., & Chattipakorn, N. (2019) · Journal of Endocrinology · doi:10.1530/joe-18-0673 · Cited by 10
Menakuru, S. R., Atta, M., Dhillon, V. S., & Salih, A. M. (2023) · Hematology Reports · doi:10.3390/hematolrep15020029 · Cited by 10
Testosterone threshold – does one size fit all?
Maganty, A., Shoag, J. E., & Ramasamy, R. (2015) · The Aging Male · doi:10.3109/13685538.2015.1004047 · Cited by 10
Pagano, M. J., Fazio, A. D., Levy, A. C., RoyChoudhury, A., & Stahl, P. J. (2015) · Urology · doi:10.1016/j.urology.2015.12.030 · Cited by 9
Chrysant, S. G., & Chrysant, G. S. (2018) · Hospital Practice · doi:10.1080/21548331.2018.1445405 · Cited by 11
“[33] Cohort 55,593 ≤65 Gel CV events 1.”
BackgroundInfluentialTestosterone therapy in hypogonadal patients and the associated risks of cardiovascular events
Kharaba, Z. J., Buabeid, M. A., Ibrahim, N. A., Jirjees, F., Al-Obaidi, H. J., Kaddaha, A., Khajehkarimoddini, L., & Alfoteih, Y. (2020) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2020.110423 · Cited by 10
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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