November 17th, 2015
FDA (Food and Drug Administration of USA) has approved testosterone replacement therapy to address hormonal deficits in diagnosed individuals, but after the latest spike in the number of reported cases of adverse effects, experts are reviewing the pros and cons of testosterone therapy in high-risk candidates.
Safety issues with testosterone replacement is a matter of grave concern because:
Based on latest statistics, more than 3% of the male population over the age of 40 years use testosterone replacement therapy regularly. This corresponds to more than 2 million males (1).
Approximately 40% males in United States, initiate testosterone replacement without considering a baseline hormonal assessment (1).
Testosterone replacement therapy is recommended for individuals who complaints of low libido, depression, bone/ muscle weakness and other health issues due to abnormally low serum levels of testosterone. Based on the statistical studies, blood levels of testosterone declines with physiological aging. In other words, most males experience a decrease in the serum production of testosterone after 30 years of age, which does not always require any supplementation/ hormonal replacement.
Besides physiological causes, certain primary and secondary pathological disorders can also present with significant testosterone deficiency; such as testicular failure can lead to primary deficiency of testosterone. Likewise, hypothalamus and pituitary gland dysfunction can cause low testosterone levels due to secondary reasons.
This is a debatable topic; while testosterone replacement therapy can significantly improve the quality of life in individuals; it has also been observed that poorly managed regimen can aggravate the risk of certain complications in susceptible males. According to a new study, testosterone replacement is associated with a higher risk of developing serious cardiac complications in males.
Relationship between Heart Problems and Testosterone Replacement Therapy:
Journal PLOS ONE has recently published a research in which investigators revealed that men who receive testosterone therapy have a 2-fold increase risk of developing cardiac dysfunction within the initial 90 days of starting testosterone therapy (2). The risk is even higher in males who are age 65 years or more (3). The study also concluded that younger males with no risk of immediate cardiac dysfunction generally responds well to testosterone replacement, without developing any cardiac ailment.
Other risk factors that may makes you more vulnerable to develop cardiac dysfunction are:
Men who have a positive personal or family history of heart disease;
Males with very high serum testosterone levels due to poorly managed hormonal regimen are also at higher risk.
A study conducted on 1,223 men with history of testosterone replacement suggested that the risk of developing coronary heart diseases was 30% higher in individuals with very high levels of testosterone (compared to those with normal testosterone levels). Poorly managed testosterone regimens can also increase all-cause mortality due to other causes such as stroke.
The nature of formulation can also influence the cardiac risk profile by affecting testosterone bioavailability. For example, according to a study reported in the New England Journal of Medicine, investigators revealed that the serum levels of testosterone should be tightly regulated in males who are on gel testosterones (that is usually advised to improve the muscular strength in elderly males). Very high serum levels in elderly men is associated with respiratory, skin and cardiac problems that may reduce compliance rate and efficacy of therapy.
Individuals who are at risk of developing prostate cancer (or those who are experiencing urinary symptoms due to prostatic enlargement) should proceed with caution
Another study published in the peer reviewed American Medical Association Journal narrated the findings of FDA investigation on 8,709 veterans’ with clinically low testosterone levels to assess the cardiac risk profile and identified that testosterone replacement by itself does not have a direct effect on physical performance or sexual vigor. Therefore caution must be maintained and serial assessments are mandatory with testosterone replacement.
There are multiple formulations of testosterone replacement therapy that are currently approved by FDA for males with sub-normal testosterone levels (due to multiple causes, such as testicular failure, genetic issues and after effects of chemotherapy or radiotherapy as part of cancer management regimen). So far the investigations are underway to establish the association of spike in heart attacks with the use of testosterone therapies. But it is strongly advised to consider replacement only if you have significantly low levels of testosterone. The peak levels of testosterone can be measured by a simple blood test between 7 a.m. to 10 a.m.
In addition, those who are already consuming the hormones should not stop, change or increase the dose of hormone without consulting a healthcare professional. If you are concerned about the risk, make sure to speak to your primary doctor, regarding your risk profile.
2. Finkle, W. D., Greenland, S., Ridgeway, G. K., Adams, J. L., Frasco, M. A., Cook, M. B., … & Hoover, R. N. (2014). Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PloS one, 9(1), e85805.
3. Carson III, C. C., & Rosano, G. (2012). Exogenous testosterone, cardiovascular events, and cardiovascular risk factors in elderly men: a review of trial data. The journal of sexual medicine, 9(1), 54-67.
4. Basaria, S., Davda, M. N., Travison, T. G., Ulloor, J., Singh, R., & Bhasin, S. (2012). Risk factors associated with cardiovascular events during testosterone administration in older men with mobility limitation. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, gls138.
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