Androgens/Female Clinical/Female Basic Science

Screening and monitoring in men prescribed testosterone therapy in the U.S., 2001–2010. J Baillargeon, RJ Urban, YF Kuo, HM Holmes, MA Raji, A Morgentaler, BT Howrey, YL Lin, KJ Ottenbacher. PublicHealth Rep 2015;130:143–52. Editorial Comment: Testosterone therapy for late-onset hypogonadism is a controversial practice. What is not controversial is the need for appropriate patient selection and careful monitoring for treatment emergency adverse events in those patients who do choose to initiate testosterone therapy. While individual practitioners may vary in the details of their follow-up protocols, all experts agree that patients should be followed. This follow-up must include physical examination and routine laboratory testing. This insurance claims database makes clear a distressing reality; there exist a substantial number of U.S. men being treated with testosterone without proper testing before initiation of therapy and/or absence of follow-up serum after therapy has been initiated. As would be expected, clinicians with particular expertise in hypogonadism were more likely to adhere to established guidelines. The issue of PSA screening is itself controversial, and hence, some providers may opt to defer this testing altogether. While deferral of PSA testing may be appropriate in properly counseled patients, it is counter-intuitive, and perhaps medico-legally risky, to avoid PSA testing in a patient receiving a therapy that has been associated withPSAchanges andprostate cancer. Setting aside the issue of PSA, it is clearly inappropriate not to test serum testosterone level before starting treatment and/or after therapy has been initiated.While there is controversy about appropriate cutoff levels for “low testosterone,” very few studies support any benefit from supplementation in men with total serum testosterone levels greater than 400 ng/dL; indeed, most studies recommend a much lower cut point around 300 ng/dL. Supplementing men who may have serum levels greater than these cutoffs is potentially risky and of unclear clinical benefit. Unfortunately, providers who are not knowledgeable about established cut-offs are likely less prone to read literature such as this paper. It behooves medical practices and regulatory agencies to ensure that their practitioners adhere to the best available evidence-based guidelines; at a minimum, this should mean pretreatment assessment of serum testosterone levels and follow-up to ensure appropriate supplementation is achieved. Alan W. Shindel, MD, MAS