AAFP-endorsed practice guideline supports limiting testosterone prescriptions

Is age-related low testosterone normal or a disease? If it is a disease, what are the benefits and harms of testosterone therapy? A previous AFP Community Blog post reviewed the controversy surrounding screening for low testosterone in older men and the U.S. Food and Drug Administration's requirement that prescription testosterone product labeling include warnings about a possible increased risk of heart attacks and strokes. A recent analysis of Medicare data found that testosterone prescribing peaked in 2013 and has since declined, but that prescribing rates were actually higher for men with coronary artery disease (CAD) than men without CAD. Meanwhile, another study suggested that men prescribed testosterone therapy have an increased risk of developing venous thromboembolism in the first 6 months of use.

Today the American College of Physicians (ACP) published a clinical practice guideline, endorsed by the American Academy of Family Physicians (AAFP), to provide evidence-based recommendations for primary care and subspecialist clinicians on treatment of men with age-related low testosterone. Based on an independent systematic review of the efficacy and safety of testosterone treatment, the ACP and AAFP suggested that clinicians discuss potential benefits, harms and costs of therapy with patients with age-related low testosterone and sexual dysfunction. The guideline recommended against initiating testosterone treatment for the purpose of improving energy, vitality, physical function, or cognition, due to the lack of benefits in randomized trials. Since some men will not respond to treatment, the guideline suggested re-evaluating symptoms within 12 months of initiating testosterone therapy, and discontinuing treatment if sexual function does not improve.

Studies assessing patient preferences reviewed by the ACP showed mixed preferences for injectable versus topical testosterone; the most bothersome symptoms were erectile dysfunction, decreased sex drive, and loss of energy; and moderately high therapy discontinuation rates in two studies (30 and 62 percent). Since transdermal testosterone costs an average of 14 times as much as intramuscular ($2135 vs. $156 for a year's supply in 2016, respectively) and has similar clinical effects and harms, the ACP and AAFP suggested considering intramuscular rather than transdermal formulations.

Although the guideline did not directly address the relatively common phenomenon of testosterone treatment in men without low testosterone levels, the American Society of Clinical Pathology, the American Urological Association, and the Endocrine Society have all advised against this type of prescribing to improve erectile dysfunction or any other symptom.