Galveston, TX—It will come as no surprise to pharmacists who were filling the prescriptions, but testosterone use in the United States tripled between 2001 and 2011, mostly in men who did not meet the criteria for use.

A new study published in JAMA demonstrates how, after a link between testosterone use and cardiovascular risk factors was reported, use of the supplements has dropped precipitously. In 2014, the FDA issued a drug safety communication saying it was investigating the risks.

To determine how much usage dropped, researchers from the University of Texas Medical Branch (UTMB) at Galveston tracked testosterone use data between 2002-2016 of nearly 10 million men, aged 30 years and older who were treated with the product.

“Between 2013 and 2016, there was a 48 percent decrease in testosterone prescriptions in established users and a 62 percent decrease in new users,” explained lead author Jacques Baillargeon, PhD, a UTMB professor in preventive medicine and community health. “The most substantial periods of decrease occurred following published reports linking testosterone to cardiovascular adverse events and an FDA safety communication.”

Results indicate that the decline in new testosterone users occurred in all age groups and regions of the country, he said.

To reach the conclusions, the study team used data from Clinformatics Data Mart (CDM), one of the nation’s largest commercial health insurance databases with more than 18,000,000 enrollees.

While total testosterone use increased among men from 0.52% (95% CI, 0.51%-0.53%) in 2002 to 3.20% (95% CI, 3.18%-3.22%) in 2013, it decreased to 1.67% (95% CI, 1.66%-1.69%) in 2016, according to the report.

For new users, the rate increased from 0.28% in 2002 to 1.26% in 2013, then decreased to 0.48% in 2016. In comparison, the study team notes, the relative decrease between 2013 and 2016 was 48% in established users and 62% in new users, according to the study.

Researchers point to a “22% (95% CI, 19% to 26%) relative decrease in new testosterone users from October 2013 to December 2013, following a publication linking testosterone to cardiovascular adverse events and an additional 50% (95% CI, 47% to 53%) relative decrease over the next 8 months following a similar study and an FDA safety communication.”

The study also states that the decline in new testosterone users occurred in all age groups, ranging from 0.88% in 2016 among men aged 30 to 39 years (relative decrease, 53% [95% CI, 51%-56%]) to 0.86% in 2013 to 0.26% (95% CI, 0.25%-0.27%) in 2016 among men aged 65 years and older (relative decrease, 69% [95% CI, 68%-71%]).

In addition, the median age for usage increased—46 years in 2002 to 53 years in 2016— as did the percentage living in the South—39.5% in 2002 to 42.1% in 2016, researchers note.

“After a decade of growth, the percentage of U.S. men receiving testosterone prescriptions decreased from 2013 through 2016,” study authors conclude. “The steepest decrease coincided with 2 published reports of testosterone-associated adverse cardiovascular events and an FDA communication.”

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