Putting the 'T'rouble in Testosterone Therapy?

Charles P. Vega, MD


January 30, 2014

In This Article

Does Testosterone Therapy Put Men at Risk?

Does the surge in enthusiasm for the diagnosis and treatment of "low T" have consequences? A new study suggests that it may be putting men's lives at risk.[16]

Study Synopsis

Study patients were male veterans who underwent coronary angiography between 2005 and 2011 in one of 76 Veterans Affairs (VA) medical centers. All patients had a serum total testosterone level examined, but patients who initiated testosterone therapy before coronary angiography were excluded from evaluation. Researchers also excluded patients who were prescribed testosterone therapy after having recently had a myocardial infarction (MI).

Patient data were obtained from the VA Clinical Assessment Reporting and Tracking Program, a database with high fidelity to actual clinical outcomes. Researchers recorded angiography results as well as demographic and disease data. The main study outcome was the relationship between testosterone therapy and the incidence of MI, stroke, or mortality. Researchers used stabilized inverse probability of treatment weighting to adjust for a wide variety of possible confounders.

A total of 8709 men had a total testosterone level less than 300 ng/dL. The mean age of patients was 63 years, and there was a high rate of comorbidity. More than 80% had evidence of coronary artery disease on angiography.

Testosterone therapy was initiated in 1223 of these 8709 men a median of 531 days after angiography. The transdermal patch was used in nearly two thirds of treated cases. Men who were treated with testosterone were likely to be healthier than untreated men with regard to coronary anatomy and comorbid illness. Testosterone therapy was effective in significantly increasing serum testosterone levels in the 60% of men who had follow-up laboratory testing.

The average follow-up period for study outcomes was 27.5 months. Over 3 years, the cumulative rates of the combined outcome of MI, stroke, and overall mortality in the testosterone treatment and untreated groups were 25.7% and 19.9%, respectively. The relative risk for these events increased with time in comparing the 2 groups.

In fully adjusted analyses, the hazard ratio for the combined outcome of MI, stroke, and mortality was 1.29 in the testosterone therapy group compared with the untreated group. The presence of coronary artery disease or prior revascularization disorders failed to alter this outcome.

All testosterone formulations appeared to increase risk for the composite outcome. Further analyses revealed that differences in blood pressure, low-density lipoprotein cholesterol levels, or treatment with beta-blockers or statins did not explain the difference in outcomes between the testosterone and untreated groups.


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