International expert consensus on testosterone safety

[Nelson Vergel]

To address widespread concerns regarding the medical condition of testosterone (T) deficiency (TD) (male hypogonadism) and its treatment with T therapy, an international expert consensus conference was convened in Prague, Czech Republic, on October 1, 2015. Experts included a broad range of medical specialties including urology, endocrinology, diabetology, internal medicine, and basic science research. A representative from the European Medicines Agency participated in a nonvoting capacity. Nine resolutions were debated, with unanimous approval: (1) TD is a well-established, clinically significant medical condition that negatively affects male sexuality, reproduction, general health, and quality of life; (2) symptoms and signs of TD occur as a result of low levels of T and may benefit from treatment regardless of whether there is an identified underlying etiology; (3) TD is a global public health concern; (4) T therapy for men with TD is effective, rational, and evidence based; (5) THERE IS NO T CONCENTRATION THRESHOLD THAT RELIABLY DISTINGUISHES THOSE WHO WILL RESPOND TO TREATMENT FROM THOSE WHO WILL NOT; (6) THERE IS NO SCIENTIFIC BASIS FOR ANY AGE-SPECIFIC RECOMMENDATIONS AGAINST THE USE OF T THERAPY IN MEN; (7) THE EVIDENCE DOES NOT SUPPORT INCREASED RISKS OF CARDIOVASCULAR EVENTS WITH T THERAPY; (8) THE EVIDENCE DOES NOT SUPPORT INCREASED RISK OF PROSTATE CANCER WITH T THERAPY; AND (9) the evidence supports a major research initiative to explore possible benefits of T therapy for cardiometabolic disease, including diabetes. These resolutions may be considered points of agreement by a broad range of experts based on the best available scientific evidence. Morgentaler A, Zitzmann M, Traish AM, et al. Fundamental Concepts Regarding Testosterone Deficiency and Treatment: International Expert Consensus Resolutions. Mayo Clin Proc. http://www.ncbi.nlm.nih.gov/pubmed/27313122