BOSTON — Testosterone therapy should not be offered to all older men with low testosterone levels, according to experts commissioned by the Endocrine Society to examine the treatment of androgen deficiency in adult men.
Guidelines issued by the task force members advise that physicians instead offer testosterone therapy on an individual basis to older men with consistently low testosterone levels on more than one occasion and clinically significant symptoms of androgen deficiency. The guidelines were published in June (J. Clin. Endocrinol. Metab. 2006;91:1995–2010).
But task force members disagreed about the serum testosterone threshold that should trigger therapy in older men with symptoms of androgen deficiency, Dr. Shalender Bhasin, chair of the task force, said at the annual meeting of the Endocrine Society. Some would initiate treatment in symptomatic older men with testosterone levels less than 300 ng/dL; others favored a threshold of 200 ng/dL and said the severity of symptoms should guide treatment.
The Endocrine Society decided to address the treatment of androgen deficiency because it's an area with rapid advances in basic science and product development. In addition, testosterone prescriptions are up; but at the same time, there is considerable misinformation and controversy surrounding the use of testosterone therapy, said Dr. Bhasin, chief of endocrinology at Boston University.
“We tried to do the right thing,” he said. “We anguished a great deal because of the realization that … we know so little.”
The new guidelines are based on systematic reviews of available evidence and discussions among the task force members. The guidelines outline recommendations for diagnosis, screening, treatment, and monitoring for testosterone therapy in adult men with androgen deficiency syndromes.
Diagnosis
The members of the task force opposed screening for androgen deficiency in the general population because of a lack of consensus on the case definition and a lack of data on the public health impact of androgen deficiency.
The experts recommended making the diagnosis of androgen deficiency only in individuals with consistent symptoms and signs of low serum testosterone levels. A diagnosis should not be made during an acute or subacute illness, Dr. Bhasin said.
The diagnosis can be challenging because the signs and symptoms of androgen deficiency are nonspecific and appropriate threshold testosterone levels are unknown and may depend on age, Dr. Bhasin said. Further, testosterone measures may vary because of circadian rhythms as well as accuracy problems with commercial assays, he said.
The task force advised using a reliable assay to measure the morning total testosterone level to establish the diagnosis and confirming it either by repeating the measurement of morning total testosterone or by measuring the free or bioavailable testosterone level.
Treatment
Testosterone therapy is appropriate in symptomatic men who have classic androgen deficiency syndromes and low testosterone levels, according to the guidelines. The therapy should be used to induce and maintain secondary sex characteristics. It can also be used to improve sexual function, sense of well-being, muscle mass, strength, and bone mineral density.
Testosterone therapy is not appropriate in patients who have metastatic prostate cancer, breast cancer, or a palpable prostate nodule or induration. Patients with a prostate-specific antigen (PSA) greater than 3 ng/mL without further urologic evaluation are not candidates for testosterone therapy. Other contraindications noted in the guidelines include erythrocytosis, hyperviscosity, untreated obstructive sleep apnea, severe benign prostatic hyperplasia symptoms, or uncontrolled severe heart failure.
Because of a lack of randomized controlled trial data, the task force did not make a recommendation on treating men with prostate cancer who have been disease free for 2 years or more.
For HIV-infected men who have low testosterone levels and weight loss, the task force members suggested short-term testosterone therapy as an adjunctive approach to promote weight maintenance and improvements in lean body mass and muscle strength.
Monitoring
The task force recommended a standardized monitoring plan with evaluation and measures of testosterone levels at 3 months after initiating treatment and annual assessments.
Hematocrit should be measured at baseline, 3 months, and annually, the task force recommended. If hematocrit exceeds 54%, therapy should be stopped until hematocrit decreases to a safe level. Therapy can be restarted at a lower dose, but evaluations for hypoxia and sleep apnea should be conducted.
The task force recommended urologic consultation if there is a verified serum or plasma PSA concentration of more than 4.0 ng/mL or an increase in serum or PSA concentration of more than 1.4 ng/mL in any 12-month period.