Coronary CT angiography (CCTA) shows older men who use testosterone gel have a significantly greater increase in coronary artery noncalcified plaque volume, according to a study published in the Journal of the American Medical Association.
Researchers from nine states in the U.S. undertook a double-blinded, placebo-controlled trial to determine if testosterone use among older men slowed progression of noncalcified coronary artery plaque volume or increased cardiovascular risk.
A total of 138 men completed the study out of 170 who enrolled. The men were aged 65 or older with an average of two serum testosterone levels lower than 275 ng/dL and had symptoms suggestive of hypogonadism. The subjects received testosterone gel dose adjusted to maintain the testosterone level in the normal range for young men (73 subjects), or placebo gel for 12 months (65 subjects).
The primary outcome was noncalcified coronary artery plaque volume, as determined by CCTA, and secondary outcomes included total coronary artery plaque volume and coronary artery calcium score (range of 0 to more than 400 Agatston units, with higher values indicating more severe atherosclerosis). At baseline, 70 men (50.7%) were found to have a coronary artery calcification score higher than 300 Agatston units, reflecting severe atherosclerosis.
Coronary CT angiogram results showed testosterone treatment compared with placebo was associated with a significantly greater increase in noncalcified plaque volume from baseline to 12 months, from median values of 204 mm3 to 232 mm3 versus 317 mm3 to 325 mm3, respectively, with an estimated difference of 41 mm3. For the secondary outcomes, the median total plaque volume increased from baseline to 12 months from 272 mm3 to 318 mm3 in the testosterone group versus from 499 mm3 to 541 mm3 in the placebo group, with an estimated difference of 47 mm3. The median coronary artery calcification score changed from 255 to 244 Agatston units in the testosterone group versus 494 to 503 Agatston units in the placebo group, with an estimated difference of −27 Agatston unit. No major adverse cardiovascular events occurred in either group.
The researchers concluded that older men with symptomatic hypogonadism who undergo treatment with testosterone gel for one year have a significantly greater increase in coronary artery noncalcified plaque volume. “Larger studies are needed to understand the clinical implications of this finding,” they wrote.