Endocrinologist Groups Reject FDA's Testosterone Therapy Position

Signs and symptoms and testosterone levels, not the presence of disorders that cause low testosterone, should guide treatment decisions.
Signs and symptoms and testosterone levels, not the presence of disorders that cause low testosterone, should guide treatment decisions.

Two endocrinologist societies have issued a joint position statement recommending that the decision to prescribe testosterone replacement therapy (TRT) to hypogonadal men should be guided by signs and symptoms and testosterone levels rather than the underlying cause, as recommended by the FDA in response to concerns about cardiovascular risks associated with TRT.

In the position statement, the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) say the evidence for increased cardiovascular risks associated with testosterone use is weak. Two retrospective studies raised concern that testosterone therapy increases cardiovascular risk, but these studies have major flaws “precluding meaningful conclusions to be drawn,” according to the statement.

The statement, which was published recently in Endocrine Practice (2015;21:1066-1073), was prepared by Neil Goodman, MD, of the University of Miami Miller School of Medicine, and other members of the AACE Reproductive Endocrinology Scientific Committee.

“Epidemiologic studies strongly support the association of low testosterone concentrations and hypogonadism with cardiovascular events and all-cause mortality, especially in elderly men,” the position statement reads. “However, low testosterone could be a marker of illness and not a causal factor.”

The statement also pointed out that TRT “favorably changes many cardiovascular risk factors. It decreases fat mass, increases muscle mass, decreases insulin resistance and can reverse metabolic syndrome in some men.”

In March, the FDA issued a statement that read, “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.” According to the FDA, testosterone “should not be used to relieve symptoms in men who have low testosterone for no reasons other than aging.”

The AACE/ACE statement recommends that TRT be considered “for symptomatic men who have unequivocally low total and/or free testosterone levels that are assayed on at least 2 samples drawn before 10 am.” All men being considered for TRT must undergo a thorough diagnostic work-up.

“Since the risk/benefit ratio of TRT is not well established in aging-associated hypogonadism, we advise the practicing clinician to be extra cautious in the symptomatic elderly with demonstrably low testosterone levels prior to embarking on replacement therapy and to avoid treatment of the frail elderly altogether.”

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