This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. For questions and comments, please e-mail:

Testosterone replacement for men has come under scrutiny with the publication of a new study that suggests that men are at higher risk of myocardial infarction (MI) within 3 months of starting hormone therapy. In a cohort study of nearly 56,000 men who were started on testosterone therapy, the rate of MI was assessed in the first 90 days of therapy. The MI rates were compared to nearly 170,000 men started on sildenafil or tadalafil as comparators (similar age groups with similar complaints). In men ≥ 65 years of age, the relative risk (RR) for MI was 2.19 (1.27, 3.77) for testosterone therapy and 1.15 (0.83, 1.59) for sildenafil/tadalafil. The risk for MI with testosterone increased with age, with men > 75 years of age having the highest RR of 3.43. Men < 65 years of age only showed a risk for MI if they had preexisting heart disease. The authors suggest that with the “rapidly increasing use of testosterone therapy,” there is urgency to perform clinical trials adequately powered to assess benefits and risks. In the meantime, physicians should include serious cardiovascular events in the discussion of side effects of therapy, especially for men with existing cardiovascular disease (PLoS One, published online January 29, 2014, DOI: 10.1371/journal.pone.0085805).