Endocrine News talks with Shalender Bhasin, MD, chair of the task force that created the latest Endocrine Society Clinical Practice Guideline on testosterone treatment. He discusses why it was important for the Society to update such a guideline now and why he thinks it will improve the care these patients receive in the future.
In March, the Endocrine Society issued a Clinical Practice Guideline on testosterone therapy, the first such guideline since 2010, and it focuses specifically on hypogonadism.
Titled “Testosterone Therapy in Men with Hypogonadism: An Endocrine Society Clinical Practice Guideline,” the guideline was published online March 17 and will appear in the May 2018 print issue of The Journal of Clinical Endocrinology & Metabolism.
Over the last few years, testosterone treatments have become part of the common lexicon as more and more products are being released to the market and advertised on television. Unfortunately, some of the information that so many patients tend to find on their own via various websites may not be very reliable. “The patients — and the clinicians caring for them —would find the updated guideline particularly helpful,” Bhasin says, “Especially because of the large amount of inaccurate and often contradictory information about testosterone available on the Internet.”
Endocrine News spoke with Shalender Bhasin MD, of the Brigham and Women’s Hospital in Boston, and the chair of the task force that authored the guideline to find out how this guideline will provide accurate information about testosterone treatments for hypogonadal patients as well as serve as a helpful tool for general practitioners, urologists, and other specialists who treat these patients.
“We hope that the guidance offered by the Endocrine Society guidelines will enhance the overall quality of medical care and outcomes of hypogonadal men.”
Endocrine News: What was the main reason for the development of a guideline on hypogonadism and testosterone. What drove the decision and why now?
Shalender Bhasin: This updated guideline is very timely for many reasons. In a reflection of the growing attention on issues related to men’s health, men’s health clinics have mushroomed all over the country. The men who attend men’s health clinics do so largely for sexual, reproductive, and urologic health concerns involving common conditions. Among these, androgen deficiency is a leading motivation for men to seek medical attention. Second, some of the most important, high quality, randomized trials of testosterone have been published during the past three years, enabling a more rigorous appraisal of testosterone’s efficacy and safety than had been possible without these data in previous versions of the guideline. Thus, a confluence of these scientific and societal factors – availability of novel, high-quality evidence; continuing uncertainty about the benefits and risks of testosterone therapy; suboptimal testosterone prescribing practices; and rapid growth of testosterone prescriptions in the U.S. all motivated this timely update of the testosterone guideline.
EN: What impact do you anticipate the guideline recommendations will make on endocrine standards of care of the patient with hypogonadism?
SB: This evidence-based guideline should enhance the standards of care for the patient with hypogonadism. Recent surveys of testosterone-prescribing practices indicate that many men get prescribed testosterone treatment without an appropriate diagnostic workup or a monitoring plan. Some men receiving testosterone treatment do not have adequately documented hypogonadism, while others with hypogonadism are not receiving the needed treatment. The treatment discontinuation rates are high among men receiving testosterone prescription. In one study, as many as 50% of men prescribed testosterone discontinued treatment within three months and only a quarter of men who received a testosterone prescription were still on testosterone treatment after one year. We hope that the guidance offered by the Endocrine Society guidelines will enhance the overall quality of medical care and outcomes of hypogonadal men.
The Guideline addresses some of the controversies in the androgen field related to the prostate and cardiovascular safety of testosterone, and offers guidance on how to consider these uncertainties in making the clinical decision to treat.
EN: How do you see the guideline influencing medical specialties other than endocrinology?
SB: Endocrinologists play an important role in the diagnostic work-up, treatment initiation, and monitoring of hypogonadal men receiving testosterone treatment. However, many hypogonadal men receive their care in primary care clinics or in urology clinics. The testosterone guideline would be of value to primary care providers as well as to other specialists who care for hypogonadal men.
Some of the most important, high quality, randomized trials of testosterone have been published during the past three years, enabling a more rigorous appraisal of testosterone’s efficacy and safety than had been possible without these data in previous versions of the guideline.
EN: What are the key take home messages for patients in this guideline?
SB: The updated guideline offers several helpful suggestions for the patient and the clinician on what symptoms and signs should prompt screening for testosterone deficiency; how to diagnose and treat hypogonadal men; and, how to optimize benefit to risk ratio using a standardized monitoring plan. The guideline emphasizes the use of accurate assays for the measurement of total and free testosterone and rigorously derived reference ranges for the interpretation of testosterone levels. The diagnosis should not be made based on a single testosterone level or without appropriate consideration of symptoms and signs, and overall health of the patient. The guideline provides an up-to-date perspective on the potential benefits and risks of testosterone therapy using rigorous analyses of the newly available, high-quality, randomized clinical trials evidence. The Guideline addresses some of the controversies in the androgen field related to the prostate and cardiovascular safety of testosterone, and offers guidance on how to consider these uncertainties in making the clinical decision to treat. The guideline emphasizes the importance of patient engagement in a shared decision-making process, especially with respect to the choice of treatment regimens and prostate monitoring.