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Endocrine Society updates testosterone treatment guidelines

Blackboard with the chemical formula of testosteroneNew scientific evidence has strengthened the case for reserving testosterone therapy for well-documented cases of hypogonadism, a condition where the body does not produce enough testosterone, Endocrine Society experts concluded in an updated Clinical Practice Guideline.

The availability of new information from some of the largest randomised trials of testosterone, recent improvements in testosterone measurements, combined with the growing public interest in issues related to men's health encouraged the Endocrine Society's initiative to update its testosterone treatment guideline, which was last released in 2010.

The Society debuted the guideline on the opening day of ENDO 2018, its 100th Annual Meeting & Expo. "In a reflection of the growing attention paid to men's health issues, men's health clinics have mushroomed all over the country," said Dr Shalender Bhasin, of Brigham and Women's Hospital in Boston, and chair of the task force that authored the guideline. "Yet recent surveys indicate many men are prescribed testosterone treatment without an appropriate diagnostic work up 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."

Testosterone therapy is recommended for hypogonadal men to correct symptoms of testosterone deficiency. Men who are otherwise healthy do not need to be screened for hypogonadism. The guideline calls for avoiding testing and treating healthy men for whom the risks and benefits of testosterone therapy are unclear.

The Society recommends against routinely prescribing testosterone therapy to all men age 65 or older with low testosterone concentrations. The treatment decisions should be individualised and guided by the intensity of symptoms, the presence of other co-morbid conditions, and an explicit discussion with the patient of the long-term risks and benefits of testosterone treatment in older men. The scientific evidence for this recommendation has grown stronger since the 2010 guideline was released.

Men should only be diagnosed with hypogonadism if they display symptoms of a testosterone deficiency and their measurements of total or free testosterone are unequivocally and consistently low. Diagnosing hypogonadism can be challenging because the symptoms are nonspecific and may vary, depending on the individual's age, other medical conditions and factors such as how long the testosterone deficiency has persisted.

Society experts note an individual's testosterone levels can vary greatly over time, so it is important to confirm measurements. About 30% of men whose testosterone is measured in the hypogonadal range will have normal concentrations when their levels are retested. In addition, there can be great variability among different testing methods and laboratories. Clinicians should ideally measure total testosterone levels using an assay certified by the US Centres for Disease Control and Prevention's accuracy-based standardisation programme or one verified by an external quality control programme.

"We hope these recommendations will help clarify and dispel much of the misinformation about testosterone therapy," Bhasin said. "With this updated guideline, we were able to incorporate data from some of the most important randomised trials on testosterone conducted during the past three years. Relying on the latest and highest quality scientific evidence will help men and their healthcare providers determine when testosterone treatment is appropriate and when it is unlikely to benefit an individual's health."

Other members of the Endocrine Society task force that developed this guideline include: Juan P Brito of the Mayo Clinic in Rochester; Glenn R Cunningham of Baylor College of Medicine in Houston; Frances J Hayes of Massachusetts General Hospital in Boston; Howard N Hodis of the Keck School of Medicine at the University of Southern California in Los Angeles; Alvin M Matsumoto of Seattle VA Puget Sound Health Care System; Peter J Snyder of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia; Ronald S Swerdloff of Harbour UCLA Medical Centre in Torrance; Frederick C Wu of the University of Manchester; and Maria A Yialamas of Brigham and Women's Hospital in Boston.

The Society established the Clinical Practice Guideline Programme to provide endocrinologists and other clinicians with evidence-based recommendations in the diagnosis and treatment of endocrine-related conditions. Each guideline is created by a task force of topic-related experts in the field. Task forces rely on evidence-based reviews of the literature in the development of guideline recommendations.

Abstract
Objective: To update the “Testosterone Therapy in Men With Androgen Deficiency Syndromes” guideline published in 2010.
Participants: The participants include an Endocrine Society–appointed task force of 10 medical content experts and a clinical practice guideline methodologist.
Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies.
Consensus Process: One group meeting, several conference calls, and e-mail communications facilitated consensus development. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline.
Conclusions: We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test. We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone–binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. We recommend against starting T therapy in patients who are planning fertility in the near term or have any of the following conditions: breast or prostate cancer, a palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, prostate-specific antigen > 3 ng/mL in men at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer) without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia. We suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy.

Authors
Shalender Bhasin, Juan P Brito, Glenn R Cunningham, Frances J Hayes, Howard N Hodis, Alvin M Matsumoto, Peter J Snyder, Ronald S Swerdloff, Frederick C Wu, Maria A Yialamas

[link url="https://www.endocrine.org/news-room/2018/experts-issue-recommendations-to-improve-testosterone-prescribing-practices"]The Endocrine Society material[/link]
[link url="https://academic.oup.com/jcem/advance-article/doi/10.1210/jc.2018-00229/4939465"]Journal of Clinical Endocrinology & Metabolism abstract[/link]

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