Men with documented testosterone deficiency should be allowed to take testosterone replacement therapy if they have cardiovascular disease (CVD) or localized prostate cancer, according to new guidelines issued by the Canadian Men’s Health Foundation. In addition, testosterone therapy was said to be appropriate for testosterone deficiency associated with alterations in body composition and metabolic issues, as well as in other chronic illnesses, for example, HIV infection and depression.
Studies of testosterone replacement therapy and the CV effects in men have shown mixed results. Earlier this year, the FDA required manufacturers of all approved testosterone products to add information on the labels about possible increased risks of heart attacks and strokes in patients taking testosterone.
The use of testosterone therapy has increased significantly, according to the FDA, with more than 2 million patients having received a prescription for testosterone replacement in 2013.
The new Canadian guidelines recommend that testosterone replacement therapy in men with CVD be restricted to those who have stable disease, only after a discussion of the potential risks and benefits.
The Foundation assembled a multidisciplinary Task Force to develop a clinical practice guideline for the management of testosterone deficiency syndrome. The Task Force, a range of specialists—clinical biochemists, endocrinologists, epidemiologists, family physicians, and urologists—who conducted a literature search and systematic review through April 2015, used an evidence-based approach to generate its recommendations.
The main recommendations, and the quality of evidence, include the following:
• Men with documented testosterone deficiency syndrome and no contraindications should receive treatment with testosterone (strong recommendation; high-quality evidence).
• Men with testosterone deficiency syndrome and stable CVD are candidates for testosterone treatment (weak recommendation; low-quality evidence).
• Men with testosterone deficiency syndrome and localized prostate cancer and no evidence of active disease should receive testosterone therapy (weak recommendation; low-quality evidence).
• Testosterone treatment for men with testosterone deficiency syndrome and mild-to-moderate symptoms resulting from benign prostatic hypertrophy (weak recommendation; very-low-quality evidence).
• Testosterone replacement therapy in men with metastatic prostate cancer (strong recommendation; moderate- to high-quality evidence).
• Men with a history of breast cancer are not candidates for testosterone replacement therapy (weak recommendation; moderate level of evidence).
• A recommendation against testosterone replacement therapy in men more interested in maintaining fertility over symptomatic improvement (strong recommendation; high-quality evidence).
• Treatment with a phosphodiesterase type 5 inhibitor in men with testosterone deficiency syndrome and persistent erectile dysfunction that is adequately treated with testosterone (strong recommendation; high-quality evidence).
• Men with a clinical picture strongly suggestive of testosterone deficiency syndrome but testosterone levels in the low-normal range should have a therapeutic trial with testosterone (weak recommendation; very-low-quality evidence).
The Task Force noted in conclusion that the management of testosterone deficiency syndrome is contentious. “The current evidence conclusively shows the importance of an adequate diagnostic approach followed by testosterone supplementation when the diagnosis is reached,” they stated. “The evidence also points to the importance of regular follow-up, frequently within the first year after the start of treatment and less stringent thereafter but uninterrupted for the duration of treatment.”