Testosterone Replacement Therapy

The next (March 3, 2014) issue of The Medical Letter will include a short article on the cardiovascular risks of testosterone replacement therapy. The impetus for this piece was a Drug Safety Communication from the FDA announcing that the agency was investigating the risk of stroke, heart attack, and death in men taking FDA-approved replacement products.

Testosterone is popular. A 2011 article in The Medical Letter mentioned 4 transdermal products (3 gels and a patch), one buccal tablet, and 2 injectable formulations. A 2013 editorial in The New England Journal of Medicine estimated that nearly $2 billion per year are spent on these products. Undoubtedly some of those dollars are spent on the FDA-approved indication, which is hypogonadism (defined by testosterone serum concentrations <300 ng/dL), but I suspect that many or most of them come from young men seeking to enhance their appearance or their athletic prowess and older men trying to regain the energy and sexual prowess of youth, without regard for their serum testosterone levels.

Testosterone actually can increase feelings of wellbeing, strength, physical performance, muscle mass, and libido. But is it safe? The main concern with prescribing the hormone has been whether it could promote the growth of prostate cancer. Androgen deprivation through surgical or medical castration is a standard treatment for the disease, but there is no convincing evidence that testosterone replacement therapy increases the risk of prostate cancer. A 2006 study published in the Journal of the American Medical Association described prostate biopsies obtained at baseline and after 6 months of testosterone replacement therapy in 40 elderly men with hypogonadism; no treatment-related change was observed in prostate histology.

Now we have a cardiovascular signal. Is it weak or is it strong? The next issue of The Medical Letter will shed some light on that question, but the large long-term controlled trial we need to really know the answers to all of our questions about testosterone replacement therapy is nowhere in sight.

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  1. I agree with the need for a study. However, I can recall a huge meta-analysis of a similar hormone replacement study in women that erroneously concluded it was causing an increase in cardiovascular related deaths. The terribly designed study did not take into account the simple fact that age is associated with the need for hormone replacement and is also a primary risk factor in CVD. The result of this biased review was millions of women forgoing medication that could revitalize them. Let’s not rush to the same thing again. The need for testosterone replacement increases with age, along with the incidence of BPH and CVD.

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