Testosterone replacement therapy in the elderly has increased more than 300% in 15 years

The use of testosterone replacement therapy (TRT) has increased substantially during the past 15 years, despite the lack of long-term efficacy and safety data among the elderly according to a study by researchers at the Institute for Clinical Evaluative Sciences (ICES) and St. Michael’s Hospital.

The study, published today in PLOS ONE, found that one in every 90 men aged 66 and older in Ontario is currently being treated with TRT but only 6.3 per cent of these men have a documented diagnosis of hypogonadism – a condition in which the body doesn't produce enough testosterone – the main clinical criteria for TRT treatment and reimbursement by the government drug plan.

“We’re seeing huge rises in use, particularly in topical formulations of TRTs, and it appears as though the majority of this use is among older men without clinically diagnosed hypogonadism. Given the lack of evidence of long-term safety of these products in the elderly, this high prevalence of use is concerning,” said Tara Gomes, a scientist at ICES and the Li Ka Shing Knowledge Institute of St. Michael’s Hospital.

In the study, a total of 28,477 men aged 66 and older were dispensed testosterone between January 1, 1997 and March 31, 2012. The study found:

• During the last 15 years, rates of TRT use in elderly men in Ontario have increased by 310 per cent.
• Currently, one in every 90 elderly men in Ontario is currently being treated with TRT. Only 6.3 per cent of men newly starting TRT have a documented diagnosis of hypogonadism.
• Restricting the public drug funding criteria for TRT reimbursement in Ontario in early 2006 led to a sharp 27.9 per cent decline in use; however this decline was temporary and TRT utilization quickly resumed its upward trend.
• Increased TRT prescribing rates have been driven largely by topical testosterone, which quickly became the most popular form of TRT after becoming listed on the provincial formulary in 2005.

“As the aging process continues to be medicalized, these drugs are being increasingly marketed for ‘andropause’ and male sexual dysfunction, which has led to considerable uptake of testosterone in older men. We are finding that these men also have multiple comorbidities, including cardiovascular risk factors such as hypertension, diabetes and dyslipidemia which is concerning considering emerging evidence of the an association between testosterone replacement and cardiovascular events,” added Gomes.

Authors: Jolanta Piszczek,  Muhammad Mamdani, Tony Antoniou, David N. Juurlink and Tara Gomes.

The study “The impact of drug reimbursement policy on rates of testosterone replacement therapy among older men,” is being published today by PLOS ONE.

ICES is an independent, non-profit organization that uses population-based health information to produce knowledge on a broad range of healthcare issues. Our unbiased evidence provides measures of health system performance, a clearer understanding of the shifting healthcare needs of Ontarians, and a stimulus for discussion of practical solutions to optimize scarce resources. ICES knowledge is highly regarded in Canada and abroad, and is widely used by government, hospitals, planners, and practitioners to make decisions about care delivery and to develop policy.

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The Ontario Drug Policy Research Network (ODPRN) is an independent, province-wide network of researchers who provide timely, high quality, drug policy relevant research to decision makers in Ontario. For the latest news from the ODPRN, follow us on Twitter: @ODPRN_Research

St. Michael’s Hospital provides compassionate care to all who enter its doors. The hospital also provides outstanding medical education to future healthcare professionals in 27 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, care of the homeless and global health are among the hospital’s recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing International Healthcare Education Centre, which make up the Li Ka Shing Knowledge Institute, research and education at St. Michael's Hospital are recognized and make an impact around the world. Founded in 1892, the hospital is fully affiliated with the University of Toronto.

FOR FURTHER INFORMATION PLEASE CONTACT:

• Deborah Creatura
• Communications, ICES
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• Geoff Koehler
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• St. Michael’s Hospital
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