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Testosterone use higher in men with coronary artery disease

While testosterone use among men declined overall, use was higher in men with coronary artery disease despite potential increased cardiovascular risk, according to findings published in JAMA Internal Medicine.

“Signals of cardiovascular risk from off-label prescription testosterone use began with the early termination of a placebo-controlled trial in frail, older men,” Nancy E. Morden, MD, MPH, from the Dartmouth Institute for Health Policy and Clinical Practice, and colleagues wrote.

“In 2014, the FDA issued a safety communication about testosterone drugs, and the Endocrine Society expressed particular concern about testosterone use by men with heart disease,” they added. “In 2015, the FDA revised testosterone labels, highlighting the lack of efficacy evidence for age-related hypogonadism and adding a warning about possible increased cardiovascular risk.”

Morden and colleagues analyzed Medicare fee-for-service administrative data to examine how trends in testosterone use and prescribing among men with and without coronary artery disease changed in response to concerns.

The researchers established annual cohorts of men aged 50 years or older with and without a same-year coronary artery disease diagnosis who were enrolled in Medicare fee-for-service from Jan. 1, 2007, to Dec. 31, 2016. The cohorts included 1.8 million to 3.1 million men which represented 10% to 12% of all male Medicare fee-for-service enrollees. The percentage of men with coronary artery disease ranged from 33.9% of the full cohort in 2007 (n = 629,823) to 32.3% of the full cohort in 2016 (n = 1,017,484).

Testosterone prescription fills under Medicare Parts B and D were documented. On-label use was defined as prescription during the same-year of diagnosis for any indicated condition and off-label use was defined as prescription to patients who did not have a same-year diagnosis.

Adjusted data showed that 0.2% (n = 3,681) to 0.3% (n = 8,861) of all men received on-label prescription testosterone. In 2013, off-label prescription testosterone use peaked in both the cohort with coronary artery disease (3.2%; n = 29,144) and without coronary artery disease (2.4%; n = 45,029). Men with coronary artery disease used testosterone consistently more often than those without the disease (2% vs. 1.6% in 2016).

Sensitivity analyses were consistent with the main analyses.

Annual testosterone spending increased from $108 million in 2007 to $402 million in 2016.

About 21% of men with Part D prescription testosterone fills were subject to prior authorization in 2012 (n = 13,685), compared to 49% of men in 2016 (n = 31,462). Testosterone use substantially varied by region.

“After the publication of safety warnings from the FDA and observational studies that found testosterone harmful, use among Medicare beneficiaries declined after 2013 but remained higher than in 2007, and was largely off-label,” Morden and colleagues concluded.

“Persistently higher testosterone use among patients with coronary artery disease suggests the need for more effective dissemination of label changes,” they added. “A robust prior authorization process could also help, as could rigorous evidence-based safety-review processes, richer shared-risk contracts, and patient education.” – by Alaina Tedesco

Disclosures: Morden reports no relevant financial disclosures. Please see study for all other authors’ relevant financial disclosures.