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Testosterone injections, not gels, increase CV event risk
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Greater risks for cardiovascular events, hospitalization and death were found with testosterone injections compared with gels, according to study findings published in JAMA Internal Medicine.
Similar risk patterns were found between patches and gels, the researchers wrote.
J. Bradley Layton, PhD, of the department of epidemiology at the University of North Carolina at Chapel Hill, and colleagues evaluated data from administrative claims from a commercially insured (2000 -2012) and Medicare (2007-2010) population in the United States and general practitioner records from the United Kingdom (2000 to June 2012) on 544,115 men aged 18 years or older who began using testosterone gels (55.8%), injections (37.4%) or patches (6.9%) after 180 days of no testosterone use. The researchers conducted the analysis from Dec. 11, 2013, to Nov. 12, 2014, and sought to determine the CV safety of testosterone injections, patches and gels.
J. Bradley Layton
Fifty-one percent of participants in the Medicare cohort were injection initiators, whereas those from the U.S. commercially insured populations were mostly gel initiators (56.5%), and those from the United Kingdom were equally injection and gel users (approximately 41%).
Researchers found higher risks for CV events (HR = 1.26; 95% CI, 1.18-1.35), hospitalization (HR = 1.16; 95% CI, 1.13-1.19) and death (HR = 1.34; 95% CI, 1.15-1.56), but not venous thromboembolism (HR = 0.92; 95% CI, 0.76-1.11), among participants using injections compared with those using gels. No increased risks for CV events (HR = 1.1; 95% CI, 0.94-1.29), hospitalization (HR = 1.04; 95% CI, 1-1.08), death (HR = 1.02; 95% CI, 0.77-1.33) or VTE (HR = 1.08; 95% CI, 0.79-1.47) were found for patch users compared with gel users.
“Our analysis suggests that testosterone injections may increase the short-term risk of [CV] events, stroke, death and hospitalization compared with gels,” the researchers wrote. “The risks associated with patches and gels appeared to be similar and lower than the risk with injections. With potential long-term effects of testosterone on lipid levels, further exploration of [CV] risk associated with longer-term treatment is warranted. With continuing concern about the safety and effectiveness of testosterone treatment in men with primary and age-related hypogonadism and the trend of treatment in men with normal testosterone levels or without recent baseline testing, it is important to understand the potential hazards of testosterone treatment.”
In an accompanying editorial, Margaret E. Wierman, MD, of the University of Colorado School of Medicine and Denver Veterans Affairs Medical Center, wrote that the results “can reassure physicians who rationally provide treatment for men with true hypogonadism with approaches that result in physiologic levels of testosterone, which is a safe and effective therapy.”
“Finally, the study raises the issue of whether injectable depo-testosterone or other formulations that consistently result in levels outside the physiologic range should be restricted or at least more carefully monitored for [CV] risk,” she wrote. – by Amber Cox
Disclosure: Layton and Wierman report no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
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