New guideline aims to improve testosterone prescribing
CHICAGO — New evidence, recent improvements in testosterone measurements and growing public interest encouraged the Endocrine Society to update its testosterone treatment guideline, which was last released in 2010.
A primary recommendation of the new Clinical Practice Guideline is avoidance of testing and treating healthy men for whom the risks and benefits of testosterone therapy are unclear, an emphasis on shared decision-making, and a focus on androgen deficiency syndromes related to opioid and anabolic steroid use.
“In a reflection of the growing attention paid to men’s health issues, men’s health clinics have mushroomed all over the country,” task force chair Shalender Bhasin, MD, director of the Center for Clinical Investigation and of Men’s Health: Aging and Metabolism at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said in a press release. “Yet recent surveys indicate many men are prescribed testosterone treatment without an appropriate diagnostic workup or monitoring plan. Some men receiving testosterone therapy do not have adequately documented hypogonadism, while others who have hypogonadism are not receiving the needed treatment.”
The Endocrine Society recommends diagnosing hypogonadism “only in men with symptoms and signs consistent with testosterone deficiency and unequivocally and consistently low serum [testosterone] concentrations.”
The society endorses measurement of fasting morning total testosterone concentrations via an accurate, reliable assay as the initial diagnostic test for hypogonadism. The new guideline places “substantially greater” emphasis on accurate assays, especially liquid chromatography-mass spectrometry and/or mass spectrometry (LC-MS/MS) assays, which Bhasin noted “have become more widely available since the last iteration of the guidelines.” The update explicitly recommends use of laboratories certified by the CDC’s Hormone Standardization Program (HoSt) for testosterone or one verified by an external quality control program.
Confirming measurements is key, as an individual’s testosterone levels can vary greatly over time and among different testing methods and laboratories. The society recommends a free testosterone concentration using equilibrium dialysis or estimation via an accurate formula among men with total testosterone near the lower limit of normal.
An addition to the new guideline is greater emphasis on androgen deficiency syndromes — in particular, androgen deficiency associated with opioid use and androgenic-anabolic steroid withdrawal hypogonadism — which have increased in prevalence since the 2010 guideline. In an analysis of the VA database, Bhasin noted that 20% of testosterone prescriptions were in men who were using chronic opioids. Similarly, in many men’s health clinics, 25% to 30% of men with testosterone prescriptions have a diagnosis of anabolic steroid withdrawal hypogonadism, according to Bhasin.
“Ascertaining history of opioid use and anabolic steroid use has received greater emphasis in the diagnostic workup,” he said.
In recent years, high-quality efficacy data from large controlled trials have enabled a stronger treatment recommendation for men with hypogonadism. The Endocrine Society continues to recommend testosterone therapy for hypogonadal men, with the goal to induce and maintain secondary sex characteristics and/or to correct symptoms of testosterone deficiency.
Therapy is not recommended for men aged 65 years and older with low testosterone concentrations. However, for those with symptoms or conditions that suggest testosterone deficiency, such as low libido or unexplained anemia, coupled with consistently low testosterone concentrations, the decision to treat should be made on an individualized basis after discussion between the patient and provider about potential risks and benefits.
The Endocrine Society also advises against testosterone therapy initiation in men with breast or prostate cancer, elevated prostate-specific antigen levels, severe obstructive sleep apnea, uncontrolled heart failure or recent myocardial infarction/stroke, and those planning to begin fertility treatment, among others.
The guideline acknowledges adverse events associated with testosterone therapy, with erythrocytosis cited most frequently. However, the task force noted that there remains no clear evidence that therapy raises the risks for major adverse cardiac events or prostate cancer, as the trials have not been large enough or long enough to evaluate these effects.
Providers are encouraged to follow a standardized plan for monitoring that includes evaluation of symptoms, adverse effects, compliance, serum testosterone and hematocrit concentrations, and prostate cancer risk during the first year after treatment initiation.
Prostate monitoring in this population continues to be a controversial issue, Bhasin said. For men aged 55 to 69 years and for those aged 40 to 69 years with increased risk for prostate cancer, the current recommendation is to perform a digital rectal exam and check prostate-specific antigen (PSA) before testosterone initiation, at 3 to 12 months after initiation, and then in accordance with guidelines for prostate cancer screening based on age and race. A urologic consultation should be obtained if PSA increases by more than 1.4 ng/mL within 1 year of initiation, PSA is greater than 4 ng/mL at any time, prostatic abnormalities emerge and/or lower urinary tract symptoms worsen.
The guideline update is intended to be a roadmap for diagnosis, treatment and monitoring of hypogonadal men, but “not intended to dictate the treatment of a particular patient,” Bhasin said.
“We recognize that different patients and different physicians may weigh risks and benefits differently, and therefore, in this version of the guidelines, there is much greater emphasis on shared decision-making, particularly in the decision to treat and perform prostate monitoring,” he said. – by Katie Kalvaitis
Reference s :
Bhasin S, et al. Men with hypogonadism: An Endocrine Society Clinical Practice Guideline. Presented at: The Endocrine Society Annual Meeting; March 17-20, 2018; Chicago.
Disclosures: Bhasin reports he receives research support from Abbott, AbbVie, Alivegen, Metro International Biotechnology, the National Institute on Aging, the National Institute of Nursing Research, PCORI and Transition Therapeutics; is a consultant for AbbVie; and has equity interest in Function Promoting Therapies, LLC. See the guideline for all other authors’ relevant financial disclosures.