Study potentially linking Testosterone Therapy to an increased risk of Mortality, Myocardial Infarction and Stroke in Men with Low Testosterone Levels

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I am sure by now many of you have heard about a study potentially linking testosterone therapy to an increased risk of mortality, myocardial infarction and stroke in men with low testosterone levels. This recent study may be causing some of you concern about your personal health and questioning exactly what you need to do.

First, despite these claims, testosterone replacement therapy’s beneficial effects are well documented as to the prevention of cardiovascular disease. The overwhelming majority of medical research does not demonstrate any relationship to increased risk of mortality, myocardial infarction or stroke. There are however numerous studies that do indicate testosterone replacement therapy’s substantial benefits.

Testosterone replacement therapy in testosterone deficient, symptomatic patients improves:

  • Sexual function and interest
  • Quality of erections (what we all really want anyways)
  • Bone mineral density
  • Muscle Strength
  • Increased exercise capacity
  • Decreased hip to waist ratio
  • Fat free mass
  • Lean body mass
  • Lipid profiles
  • Insulin sensitivity
  • Increased time to ST segment depression during stress testing
  • Cardiac risk factors
  • Mood stability
  • Cognitive function
  • Quality of Life
  • Augments growth hormone secretion

Here are some of the issues with this recent study:

  • A retrospective cohort study of men with low testosterone levels who underwent coronary angiography and had low serum testosterone, categorized as initiating testosterone therapy if they filled a prescription for testosterone gel, patch, or injections following coronary angiography based on pharmacy-dispensing data. Once initiated, a patient was ASSUMED to have continued treatment until an outcome event occurred or the end of follow-up.
  • Poorly managed and inadequate Testosterone Replacement Therapy.  Raising testosterone levels to only 332 ng/dL will not deliver any health benefits.  Research has demonstrated that restoring levels to above 500ng/dL or higher is associated with significant cardiovascular health benefits.
  • There is no indication of appropriate follow up, monitoring of testosterone replacement therapy, or continuance of therapy among cohorts of this national retrospective study of men with low testosterone levels.  There was no indication of downstream by-product management for either estrogen or DHT.
  • Clinical trials have demonstrated that testosterone therapy improves a number of intermediate outcomes and cardiac risk factors. Aside from the TOM trial (Testosterone in Older Men with Mobility Limitations), a study conducted in older, frail men with a high prevalence of cardiovascular disease, these trials and subsequent meta-analyses did not demonstrate adverse cardiovascular outcomes in men on testosterone replacement therapy.
  • A clinical trial evaluating the effect of testosterone therapy on cardiovascular outcomes including mortality, MI, and stroke has not been conducted to my knowledge.
  • The association between testosterone therapy use and adverse outcomes observed in this study differs from the association observed in a prior retrospective VA study. In the study by Shores et al, investigators noted a 39% reduction in mortality risk among patients treated with testosterone therapy.
  • Elderly men with low serum testosterone levels have an increased risk of mortality and subjects with low values of both testosterone and estradiol levels have the highest risk of mortality (Journal of Clinical Endocrinology and Metabolism 94: 2482-2488, 2009)
  • Significant differences in baseline testosterone levels between the study groups.  Which means the treatment group may have had years of cardiovascular damage from low testosterone levels that was not accounted for in this study.


So here is the bottom line. We know definitively that optimized testosterone levels are associated improved health, higher quality of life and with lower rates of death. Additionally, testosterone replacement therapy improves sexual function, cognitive function, lipid profiles, muscle mass, free fat mass, exercise capacity, strength and endurance. Undoubtedly, the risk/benefit ratio analysis for the use of Testosterone Replacement Therapy in my opinion is unquestioned.

As with many stories adapted in the media, dramatization of the story and misguided interpretation leads to confusion and can potentially jeopardize your personal health. I will always strive to deliver clear and accurate information. If you are on Testosterone Replacement Therapy, I still strongly recommend the use of Testosterone Replacement Therapy in symptomatic, deficient patients to improve your overall health profile, accompanied by appropriate monitoring laboratory, follow up, and physician management.

All the Best in Your Health & Wellness,


Dr. Rob Kominiarek DO, FACOFP

Alpha Male Medical Institute

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