Hypogonadism: Expert panel adopts nine resolutions

October 13, 2016

A panel of experts, including several urologists, has approved nine resolutions on what they say is evidence-based clarity on male hypogonadism and how to manage it.

An international group of physician and scientific experts, including several urologists, recently approved nine resolutions that offer physicians and patients what they say is evidence-based clarity on the topic of male hypogonadism and its management. 

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"The medical and scientific communities are still largely unaware of the major negative impact of testosterone deficiency on general health. The media-driven focus on unproven risks has obscured the known health risks of untreated testosterone deficiency: obesity, reduced bone mineral density, and increased mortality,” panel member Abdulmaged Traish, MBA, PhD, of Boston University Medical Center, Boston said in a press release.

The nine resolutions, published in Mayo Clinic Proceedings (2016; 91:881-96), begin with defining testosterone deficiency (TD) as a “well-established, clinically significant medical condition that negatively affects male sexuality, reproduction, general health and quality of life.” The others include:

  • Symptoms and signs of TD occur as a result of low levels of testosterone and may benefit from treatment regardless of whether there is an identified underlying origin.

  • There is no scientific basis for any age-specific recommendations against the use of testosterone therapy in adult males.

  • The evidence does not support increased risks of cardiovascular events or prostate cancer with testosterone therapy.

  • The evidence supports a major research initiative to explore possible benefits of testosterone therapy for cardiometabolic disease, including diabetes.

Next: Dr. Morgentaler discusses resolutions

 

Experts representing urology, endocrinology, diabetology, internal medicine, and basic science research weighed in for what the consensus panel hopes will replace misinformation with what’s scientifically sound and in the interests of quality patient care, according to Abraham Morgentaler, MD, of Men’s Health Boston, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, who served as chairman of the consensus conference.

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“The goal of this meeting was to establish a set of fundamental concepts that could serve as a basis for future discussions,” Dr. Morgentaler told Urology Times. “The panel consisted of 18 experts from 11 countries, all of whom had extensive research and/or clinical experience with testosterone. Since it is challenging for experts to agree on anything, the unanimous agreement we achieved on nine major points should be understood to mean those points are fundamental, not controversial among experts, and scientifically sound.

“Foremost among these, readers should know we found that the evidence simply does not support the two big fears regarding T therapy-namely, that treatment increases risks of prostate cancer or cardiovascular disease.”

The hope is that these resolutions will have a far-reaching impact, according to Dr. Morgentaler.

“Insurers and regulators have taken a hard stance to limit the use of T therapy, even in men for whom it is medically indicated. This is contrary to good medicine. The evidence is clear that older men respond as well to T therapy as younger men, and that men without an identified cause for T deficiency also do well. Restrictions based on age (‘age-related hypogonadism’) or the presence of an incomplete list of rare conditions causing T deficiency are not supported by evidence or reason,” he said.

The expert panel, which convened last fall in Prague, Czech Republic to draft the resolutions, concluded that men with characteristic symptoms and low levels of testosterone may be candidates for treatment regardless of age or underlying etiology. They agreed there is no total T blood level that accurately and reliably indicates who may benefit from treatment and who will not. For this reason, current insurance policies that rigidly limit coverage only to men who meet arbitrary and restrictive T level criteria are unscientific and contrary to good medical practice, according to Dr. Morgentaler.

“T deficiency may affect men profoundly, causing sexual problems, depression, reduced strength, and reduced bone density,” he said. “The prevalent beliefs that T therapy is associated with increased CV risk and prostate cancer are scientifically unfounded, and these media-driven fears should not be used to justify withholding an effective evidence-based treatment with substantial benefits for many men.”

None of the panel received honoraria for their participation. Dr. Morgentaler has been a consultant for AbbVie, Auxilium Pharmaceuticals, Antares Pharma, Clarus Therapeutics, Endo, and TesoRx; has received honoraria from Bayer, Merck, and Pfizer, and has received research grants from Eli Lilly. Several of his co-authors have a financial or other relationship with several pharmaceutical companies.

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