COMMENTARY

When Men Want Testosterone, Show Them the Evidence

Henry R. Black, MD

Disclosures

January 24, 2014

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Hi. I am Dr. Henry Black, Adjunct Professor of Medicine at the Langone New York University School of Medicine and former President of the American Society of Hypertension.

The "low T [testosterone] syndrome" has become a major marketing gimmick these days. I use the term "gimmick" because it has led many men to think that with a little more testosterone they would have more muscle mass, be stronger, be more alert, and gain a variety of other benefits that we would all like to have.

The trouble is that there is no proof that additional testosterone prevents anything. It may make you feel better, so it is a quality-of-life drug, but it is only recommended for men with low testosterone levels (< 300 ng/dL).

The Veteran's Administration recently looked at their database to create what appeared to be a clinical trial.[1] A huge number of patients had their testosterone levels measured in addition to having cardiac catheterizations. Therefore, this was a very specific group of men who had coronary heart disease (or were thought to, at least) and had their testosterone levels measured before they had a myocardial infarction, rather than after. These men received an appropriate prescription and filled it at least once to see what would happen. The investigators ended up with approximately 8700 men, about 1275 of whom had been given testosterone, and they examined the outcomes.

The groups were well matched at the outset, and in the analysis, the investigators tried to adjust for 55 possible confounders. That is why we do clinical trials, after all. We know of certain variables that could be confounders but we don't know about variables that we haven't measured that might, in fact, be important.

They looked at all-cause mortality, strokes, and heart attacks. They found that giving testosterone at recommended levels to men who were candidates for it actually raised their testosterone levels, as might be expected. Giving testosterone did not, however, prevent cardiovascular events or reduce mortality, myocardial infarctions, or strokes. In fact, stroke rates were exactly the same.

If anything, receiving testosterone made outcomes worse. There was a higher rate of abnormal outcomes -- specifically myocardial infarctions (not strokes) -- in the men who received testosterone.

Patients will ask you about testosterone supplementation because there is an ongoing marketing campaign. Sales are nearly $2 billion in the United States alone.[2] [Editor’s note: An earlier version of this transcript incorrectly stated the sales figure as nearly $2 million.] It makes sense that if you have a low testosterone level, taking testosterone might improve how you feel, but it doesn’t seem to have any impact on outcomes, and that is the key.

Before we give a drug that hasn't been adequately tested, we should be aware that the only attempt to do a clinical trial in older men actually showed harm rather than benefit. We have to be very careful about this. Although some men will benefit from testosterone, we are not yet sure who they are. Thank you very much.

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