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Several Options Available for Androgen Replacement Therapy: Presented at ACP

By Daniel Keller

SAN DIEGO, CA -- April 8, 2003 -- Androgen replacement therapy can improve the lives of men who are clinically hypogonadal. By restoring them to a eugonadal state, it can increase muscle mass and strength, help maintain bone density, increase cognition and mood, improve libido and sexual function, and lead to a generalized state of well-being.

Speaking here at the Annual Session of the American College of Physicians on April 5^th, Jacob Rajfer, MD, a professor of urology, Harbor-University of California at Los Angeles Medical Center, in Torrance, California, said that no data have proven that exogenous androgen promotes cardiovascular disease (CVD).

"So the fear of exacerbating cardiovascular disease should not be an issue," he said. The relative risks and benefits of testosterone on CVD will remain an open question until its effects on specific cardiovascular end points are evaluated in clinical trials.

Studies suggest that bringing a hypogonadal man back to a normal level of testosterone with exogenous androgen does not affect the prostate negatively. "There is essentially no significant change in the PSA [prostate specific antigen], in prostate volume, and in urinary symptoms," according to Dr. Rajfer.

For these men, he recommends measuring the PSA level at baseline and 6 weeks after starting therapy. If PSA levels move into the abnormal range, an ultrasound and a biopsy of the prostate gland should be obtained with patient consent, he said. PSA should be monitored every 6 months thereafter. Similarly, hematocrit and liver function tests should be performed every 6 months.

Androgen preparations consist of oral, parenteral, transdermal patches, and topical gels. Dr. Rajfer strongly recommended against using the oral medications now available in the United States because of hepatotoxicity as well as because of low drug levels from first-pass inactivation through the liver. He said a form of testosterone lacking the methyl group that leads to hepatotoxicity is available in Europe but not in the United States.

Injectable preparations cause wide swings in testosterone levels, and sometimes patients cannot tolerate the accompanying mood changes. These preparations are, however, the most cost effective, Dr. Rajfer said. Patches provide more constant doses, but many patients complain of dermatologic side effects.

A currently available testosterone gel is AndroGel®, applied once daily to the shoulder or upper arms, resulting in a steady state testosterone level. Dosing should be titrated according to serum testosterone levels as well as PSA and hematocrit levels.

Side effects of exogenous androgen therapies are mood changes, polycythemia, gynecomastia, exacerbation of sleep apnea, and in some patients, acne. Most symptomatic hypogonadal men can find a tolerable medication and will benefit from it, Dr. Rajfer said.

"So [testosterone] treatment in aged men is here to stay," Dr. Rajfer concluded. "The data proves that it enhances their mood, prevents fractures… [and] improves strength, muscle mass, and cognition."

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