ACP issues guideline on testosterone treatment for age-related low testosterone levels

Clinicians should prescribe testosterone for men with this condition only to treat sexual dysfunction, not to improve energy, vitality, physical function, or cognition, the guideline said.

Physicians should prescribe testosterone for age-related low testosterone levels only in men experiencing sexual dysfunction and should discontinue treatment if sexual function does not improve, ACP said in a new evidence-based clinical practice guideline.

The guideline and evidence review were published Jan. 7 by Annals of Internal Medicine.

The guideline suggested that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone levels and sexual dysfunction who want to improve sexual function. It also suggested that physicians consider intramuscular rather than transdermal formulations when starting testosterone treatment to improve sexual function because the costs are considerably lower for the former, with similar clinical effectiveness and harms. The annual cost in 2016 per beneficiary for testosterone replacement therapy was $2,135.32 for the transdermal formulation versus $156.24 for the intramuscular formulation, according to paid pharmaceutical claims provided in the 2016 Medicare Part D Drug Claims data.

Physicians should discuss preferences for treatment with patients, as well as the potential benefits, harms, and costs, the guideline suggested. Physicians should re-evaluate symptoms within 12 months and periodically thereafter and should stop testosterone treatment if sexual function does not improve. Testosterone treatment should not be started to improve energy, vitality, physical function, or cognition because evidence shows it is not effective for these indications, the guideline said.

ACP's guideline is endorsed by the American Academy of Family Physicians and applies to adult men with age-related low testosterone levels. It does not address screening or diagnosis of hypogonadism or monitoring of testosterone levels.

An editorial stated that many clinicians will question the recommendation of intramuscular over transdermal administration and noted that the need for repeated injections is a potential barrier to adherence and may increase costs if the patient cannot inject the drug himself. “Also, peak-and-valley blood levels after each injection may cause irregularity of symptom relief and difficulty achieving the desired blood level,” the editorialist wrote. “Individual preference may vary widely in the choice of testosterone therapy.”