Author: Pierre Angier DO – Florida’s Wellness Doctor
Recently, two studies were published that raised the possibility that testosterone replacement therapy could increase the risk of heart attacks and stroke in older men. The media has been having a field day with this, and attorneys are drooling in anticipation of the settlements they might receive.
But not so fast—there are major concerns about the way these studies were conducted and reported. Also, they directly conflict with previous studies that show normal testosterone levels reduce the risk of cardiovascular events.
To be specific, the PLOS ONE study was flawed in several ways. The data used were based on insurance claims and not on any clinical data. Also, it was an observational study—not a randomized, controlled trial—making the results more uncertain. They did use comparison drugs (Viagra and Cialis) but that only confused the picture, as these drugs may prevent heart attacks. Lastly, the difference in risk was so small as to be clinically insignificant. Based on the study’s own conclusions, testosterone therapy would result in an increase of only 1.27 heart attacks per 1000 patient years. That’s not enough to convince me and I don’t think it will convince many juries.
In the second study, published in JAMA, the raw data showed a reduction in heart attacks, strokes and deaths in VA patients who received testosterone compared to those who did not. But after statistical modeling the authors concluded that testosterone increased the risk of these events! What would account for this difference? Well, the authors used convoluted and complex statistical analysis (which often is more likely to confuse than clarify). Also, there were over a thousand patients excluded from the analysis that should not have been. This error drastically changed the statistical outcome to make testosterone replacement seem unsafe.
Immediately after its publication, the study’s many flaws were brought to light and many prominent physicians and scientists, including 25 different medical societies from around the world, have asked that it be retracted. While the study has been corrected several times, the data mismanagement was so serious that this study is no longer considered credible.
In short, these two studies do not conclude that testosterone therapy will increase your risk of a cardiac event. In contrast, nine scientific studies done since 2006 have shown that low testosterone puts you at increased risk for cardiac death. Other well done studies show improvement of cardiac risk factors with testosterone replacement.
Until we have better information, I will continue to use caution in prescribing testosterone replacement in older men with heart disease, but in most cases, and especially in middle-aged men, I believe the benefits outweigh the risks. Patients report enhanced libido and sexual function, increased energy, and improvement in mood and motivation. Treating low testosterone can also help patients lose weight, lower their blood sugar, and avoid osteoporosis.
If you have further questions about testosterone replacement therapy, call Dr. Angier today for a consult (904-217-7030).