We have been discussing the unknown risks associated with testosterone replacement therapy. Unknown risk does not necessarily mean absence of risk. To illustrate, we reviewed the history of hormone replacement therapy for postmenopausal women and how that treatment went from the most frequently prescribed medication in the late 1990s to pariah by the early 2000s. Its fall from grace was a function of clinical trials demonstrating hormone replacement increased level of risk for breast cancer and cardiovascular disease among postmenopausal women.
We now move from the then to the present and change genders. To date, no large scale publicly funded clinical trials have been conducted on testosterone replacement therapy. However, smaller randomized clinical trials have been conducted and they do seem to drip with déjà vu.
For example, a recent study looking at testosterone replacement therapy was stopped mid-stream due to an unacceptable number of negative health events within that study’s treatment group. In this study, 22 percent of the participants receiving testosterone experienced one or more negative health events. Only 5 percent of participants in the placebo group, however, experienced any negative health events. Adverse health events in the treatment group included heart attack, stroke, and, in one case, death. Of most concern was the ratio of cardiac events in the treatment group versus the placebo group at 10 to 1. This ratio was deemed alarming enough to prematurely stop the study.
What can I say?
Meet the new drug, same as the old drug.
- Basaria, S., Coviello, A. D., Travison, T. G., Storer, T. W., Farwell, W. R., Jette, A. M., . . . Bhasin, S. (2010). Adverse events associated with testosterone administration. New England Journal of Medicine, 362, 109-122.