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remain uncertain,” Matthew J. Budoff, MD, professor of medicine at David Geffen School of Medicine at UCLA and program director and director of cardiac CT at Harbor-UCLA Medical Center, and colleagues wrote. “Several observational studies show an inverse association between serum testosterone concentration and adverse [CV] outcomes, the metabolic syndrome, diabetes, and mortality, independent of traditional [CV] risk factors.”
In a double blind, placebo-controlled trial, Budoff and colleagues analyzed 170 men aged 65 years or older with an average of two serum testosterone levels lower than 275 ng/dL and symptoms suggestive of hypogonadism. Participants were enrolled between June 2010 and June 2014 and were randomly assigned testosterone gel (n = 82) or placebo gel (n = 88) for 12 months.
The primary outcome was noncalcified plaque volume and was determined by coronary CTA.
From baseline to 12 months, participants in the testosterone arm had a significantly greater increase in noncalcified plaque volume (from median value 204 mm3 to 232 mm3) compared with placebo (from median value 317 mm3 to 325 mm3) with an estimated difference of 41 mm3 (95% CI, 14-67; P = .003).
The median total plaque volume increased in the testosterone group from 272 mm3 to 318 mm3, compared with 499 mm3 to 541 mm3 for placebo (estimated difference, 47 mm3; 95% CI, 13-80; P = .006). The median CAC score decreased in in the testosterone group (from 255 to 244 Agatston units) and increased in the placebo group (from 494 to 503 Agatston units) from baseline to 12 months (estimated difference, –27 Agatston units; 95% CI, –80 to 26 Agatston units), according to the researchers.
No one in either group had a major adverse CV event.
“The increase in coronary artery noncalcified and total plaque volumes in men treated with testosterone is concerning because any limitation of the vascular lumen could be considered deleterious,” Budoff and colleagues wrote. “The clinical significance of these increases could depend on the differential effects of testosterone on the individual components of noncalcified plaque.”
The researchers concluded that larger studies are needed to understand the clinical implications. – by Cassie Homer