HSR&D Citation Abstract
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Shaikh K, Ellenberg SS, Nakanishi R, Snyder PJ, Lee J, Wenger NK, Lewis CE, Swerdloff RS, Preston P, Hamal S, Stephens-Sheilds A, Bhasin S, Cherukuri L, Cauley JA, Crandall JP, Cunningham GR, Ensrud KE, Matsumoto AM, Molich ME, Alla VM, Birudaraju D, Nezarat N, Rai K, Almeida S, Roy SK, Sheikh M, Trad G, Budoff M. Biomarkers and Non-Calcified Coronary Artery Plaque Progression in Older Men Treated with Testosterone. The Journal of clinical endocrinology and metabolism. 2019 Nov 30.
Recent results from the Cardiovascular (CV) Trial of the Testosterone(T) Trials showed that T treatment of older men with low T was associated with greater progression of non-calcified plaque (NCP). We evaluated the effect of anthropometric measures and cardiovascular biomarkers on plaque progression in individuals in the T Trial.
The CV part of the trial included 170 men aged 65 years or older with low T. Participants received T gel or placebo gel for 12 months. The primary outcome was change in NCP volume from baseline to 12 months, as determined by coronary computed tomography angiography (CCTA). We assayed several markers of CV risk and analyzed each marker individually in a model as predictive variables and change in NCP as the dependent variable.
Of 170 enrollees, 138 (73 T, 65 placebo) completed the study and were available for the primary analysis. Of 10 markers evaluated, none showed a significant association with the change in NCP volume, but a significant interaction between treatment assignment and waist-hip ratio p-0.0014) indicated that this variable impacted the testosterone effect on non-calcified plaque volume. The statistical model indicated that for every 0.1 change in the waist-hip ratio, the T-induced 12-month change in non-calcified plaque volume increased by 26.96 mm3 (95% confidence interval 7.72, 46.20).
Among older men with low T treated for one year, greater waist-hip ratio was associated with greater NCP progression, as measured by CCTA. Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.