Large clinical trials to evaluate risks of testosterone treatment urgently needed

April 28, 2014, Lancet

Physicians do not have sufficient information from clinical trials to understand the risks associated with the prescription of testosterone in older men, according to a Comment in The Lancet Diabetes & Endocrinology, written by Professor Stephanie Page, of the University of Washington and Harborview Medical Center, Seattle, USA.

While the benefits of therapy in younger men with a deficiency of the hormone are well established, testosterone is now widely prescribed to , particularly in the USA.

Existing studies have produced conflicting findings over whether the prescription of testosterone is associated with increased cardiovascular risk in older men, and ongoing studies are unlikely to adequately address this question, meaning that even if an appropriately powered trial were to start today, reliable safety data are at least a decade away.

According to Professor Page, "In an era when millions of men are using testosterone every day, support is urgently needed from both the public and medical communities to fund an appropriate clinical study to assess the risks and benefits of testosterone treatment in older men. There is a danger that funding and regulatory agencies will overinterpret the evidence from existing and ongoing observational studies, and conclude that larger and longer are unnecessary and unwarranted. This conclusion would do men's health a disservice."

"Testosterone is a billion dollar industry, probably fuelled partly by direct to consumer advertising and some degree of overprescription," Professor Page adds. "Physicians need to discuss with their patients that we simply do not fully understand the risks associated with testosterone use in older men, and use conservative treatment guidelines – such as those provided by the Endocrine Society – to guide therapeutic decisions."

Explore further: Endocrine Society calls for large-scale studies to evaluate testosterone therapy risks

More information: Paper: www.thelancet.com/journals/lan … (14)70082-8/abstract

Related Stories

Endocrine Society calls for large-scale studies to evaluate testosterone therapy risks

February 7, 2014
According to a statement issued today by the Endocrine Society, the risks and benefits of testosterone therapy for older men with declining levels of the hormone need to be fully evaluated.

More specialists question safety of testosterone therapy for older men

February 17, 2014
(HealthDay)—Following the recent announcement from the U.S. Food and Drug Administration about the potential hazards of using testosterone supplements in older men, another group of experts is raising concerns about the ...

Many men start testosterone therapy without clear medical need

January 9, 2014
Although testosterone use has sharply increased among older men in the past decade, many patients appear to have normal testosterone levels and do not meet the clinical guidelines for treatment, according to new research ...

Midrange testosterone levels better for older men

January 10, 2014
(Medical Xpress)—Optimal levels of testosterone - meaning neither low nor high - in older men are associated with better survival, according to a study recently published by a team of UWA researchers in the Journal of Clinical ...

US regulators probing cardio risks in testosterone products

February 1, 2014
US federal regulators said Friday they were investigating products containing testosterone after recent studies suggested a higher risk of strokes and heart attacks in men being treated with the hormone.

Excessive testosterone raises mortality risk in older men

November 20, 2013
Older men whose testosterone levels were neither low nor high tended to live longer, according to new research accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism.

Recommended for you

Neuroimaging reveals lasting brain deficits in iron-deficient piglets

February 21, 2018
Iron deficiency in the first four weeks of a piglet's life - equivalent to roughly four months in a human infant - impairs the development of key brain structures, scientists report. The abnormalities remain even after weeks ...

Iron triggers dangerous infection in lung transplant patients, study finds

February 21, 2018
Researchers at the Stanford University School of Medicine have identified elevated tissue iron as a risk factor for life-threatening fungal infections in lung transplant recipients.

Products derived from plants offer potential as dual-targeting agents for experimental cerebral malaria

February 21, 2018
Malaria, a life-threatening disease usually caused when parasites from the Plasmodium family enter the bloodstream of a person bitten by a parasite-carrying mosquito, is a severe health threat globally, with 200 to 300 million ...

Scientists in Germany improve malaria drug production

February 21, 2018
Scientists in Germany who developed a new way to make a key malaria drug several years ago said Wednesday they have come up with a technique to make the process even more efficient, which should increase global access and ...

Early results from clinical trials not all they're cracked up to be, shows new research

February 21, 2018
When people are suffering from a chronic medical condition, they may place their hope on treatments in clinical trials that show early positive results. However, these results may be grossly exaggerated in more than 1 in ...

Clues to obesity's roots found in brain's quality control process

February 20, 2018
Deep in the middle of our heads lies a tiny nub of nerve cells that play a key role in how hungry we feel, how much we eat, and how much weight we gain.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.