June 25, 2010
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Guidelines updated for evaluation, treatment of adult androgen deficiency syndromes

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The Endocrine Society has revamped its guidelines for the evaluation and treatment of androgen deficiency syndromes in adult men. The recommendations serve an update to the previously released 2006 guidelines.

“While many sections of the guidelines have not seen sweeping changes in the update, there have been several additional clinical trials in the interim which have strengthened the previous recommendations,” Glenn R. Cunningham, MD, guideline task force member and professor of molecular and cellular biology at Baylor College of Medicine, told Endocrine Today.

One such area is updates in research for the assessment of prostate cancer prostate risk.

“The guidelines emphasize that there are other factors beyond the prostate-specific antigen and digital rectal examination of the prostate that should be taken into assessment when considering testosterone treatment,” said Cunningham, who is also a member of the Endocrine Today Editorial Board. “This includes age, family history, race and if the patient has had a previous biopsy.” The task force also recommended use of a prostate risk calculator that may provide a better assessment of risk than prostate-specific antigen and digital rectal examination.

Diagnosis, therapy

The diagnosis of androgen deficiency should be made only in men who display regular symptoms and signs consistent with androgen deficiency and “unequivocally low serum testosterone levels,” according to the guidelines.

The goal is to have physicians treat only symptomatic patients with low testosterone levels, and not only one or the other, Cunningham said.

“There is sometimes an inclination to treat the numbers without necessarily confirming that the patient has symptoms,” he said.

The guidelines provide further advice for using a consistent, reliable assay as the preliminary diagnostic test to measure a morning total testosterone level; a repeat morning testosterone level to confirm the diagnosis; and validated calculated free or bioavailable testosterone assays for patients with total testosterone levels near the lower limit of normal or if sex-hormone binding globulin abnormality is suspected.

Testosterone therapy is recommended “for men with symptomatic androgen deficiency to induce and maintain secondary sex characteristics and to improve their sexual function, sense of well-being, muscle mass and strength, and bone mineral density,” according to the guidelines.

The recommendations advise against starting testosterone therapy in the following groups: patients with breast or prostate cancer; a palpable prostate nodule or induration of the prostate or a prostate-specific antigen ≥4 ng/mL; a palpable prostate nodule or induration or prostate-specific antigen ≥3 ng/mL in men at high risk for prostate cancer, including black men and those with a first-degree relative who has prostate cancer; hematocrit >50%; untreated severe obstructive sleep apnea; severe lower urinary tract symptoms; or poorly uncontrolled heart failure.

The task force suggested that clinicians aim to achieve mid-normal range testosterone levels using any of the official, approved formulations. This choice can be based on the patient’s preference, careful consideration of pharmacokinetics, deliberation of treatment burden and cost. A uniform plan should be utilized to monitor patients who receive therapy.

“The take-away message is to make sure that men who have symptoms of low testosterone are screened for androgen deficiency and men who are in the higher-risk category should be questioned for symptoms, and if they have them they should be screened,” Cunningham said. – by Matthew Brannon

Bhasin S. J Clin Endocrinol Metab. 2010;95:2536-2559.

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