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Older men experience a decline in testosterone levels as a normal response to aging. Many treat this change by taking testosterone supplementation in the form of a gel, pill, or injection. This has led to an exponential increase in prescriptions for testosterone treatment, though the FDA has not approved replacement therapy for a normal age-related testosterone decline.
Seven placebo-controlled, double-blind trials in 788 men with a mean age of 72 years have been performed to assess the impact of such treatment. In one trial, testosterone supplementation improved sexual function, and in another, the distance participants could walk. In two other trials, testosterone supplementation did not increase energy or improve cognitive function. A potential downside of treatment, found in a fifth trial, was an increase in the size (volume) of plaques without calcium in them found in the coronary arteries. Plaques can obstruct the artery if they become large enough and cause a heart attack. However, in this study, no adverse cardiovascular outcomes were noted, perhaps because the number of participants was too few to find a change.
More recent findings on the effect of treatment with 1 percent topical testosterone gel in 123 men older than 65 years found that their heart muscle mass increased by 3.5 percent. Whether the increase was “good” heart muscle, such as might occur with exercise, or “bad” heart muscle, such as might occur with hypertension, is not known.
The question is whether testosterone supplementation is bad for the heart.
Information from several retrospective studies and randomized trials have suggested that testosterone replacement therapy increases the risk of cardiovascular disease. This conclusion led the FDA to issue a warning statement about the potential cardiovascular risks of such replacement therapy. However, because no trials of testosterone replacement in older men have been specifically designed to assess cardiovascular events, a recent publication concluded that the cardiovascular safety of such therapy remains unclear.
Until further information surfaces, I would suggest that older men contemplating testosterone supplementation discuss this with a health care expert before starting treatment. Those men who have established coronary artery disease should probably avoid testosterone supplements.
Note: Dr. Zipes has been a consultant and has testified in deposition as a plaintiff expert witness in testosterone litigation.
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