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Randomized Controlled Trial
. 2018 Feb 1;103(2):681-688.
doi: 10.1210/jc.2017-02243.

The Effect of Testosterone on Cardiovascular Biomarkers in the Testosterone Trials

Emile R Mohler 3rd  1 , Susan S Ellenberg  2 , Cora E Lewis  3 , Nanette K Wenger  4 , Matthew J Budoff  5 , Michael R Lewis  6 , Elizabeth Barrett-Connor  7 , Ronald S Swerdloff  8 , Alisa Stephens-Shields  2 , Shalender Bhasin  9 , Jane A Cauley  10 , Jill P Crandall  11 , Glenn R Cunningham  12 , Kristine E Ensrud  13   14 , Thomas M Gill  15 , Alvin M Matsumoto  16   17 , Mark E Molitch  18 , Marco Pahor  19 , Peter E Preston  2 , Xiaoling Hou  2 , Denise Cifelli  2 , Peter J Snyder  20
Affiliations
Randomized Controlled Trial

The Effect of Testosterone on Cardiovascular Biomarkers in the Testosterone Trials

Emile R Mohler 3rd et al. J Clin Endocrinol Metab. .

Erratum in

Abstract

Context: Studies of the possible cardiovascular risk of testosterone treatment are inconclusive.

Objective: To determine the effect of testosterone treatment on cardiovascular biomarkers in older men with low testosterone.

Design: Double-blind, placebo-controlled trial.

Setting: Twelve academic medical centers in the United States.

Participants: In all, 788 men ≥65 years old with an average of two serum testosterone levels <275 ng/dL who were enrolled in The Testosterone Trials.

Intervention: Testosterone gel, the dose adjusted to maintain the testosterone level in the normal range for young men, or placebo gel for 12 months.

Main outcome measures: Serum markers of cardiovascular risk, including lipids and markers of glucose metabolism, fibrinolysis, inflammation, and myocardial damage.

Results: Compared with placebo, testosterone treatment significantly decreased total cholesterol (adjusted mean difference, -6.1 mg/dL; P < 0.001), high-density lipoprotein cholesterol (adjusted mean difference, -2.0 mg/dL; P < 0.001), and low-density lipoprotein cholesterol (adjusted mean difference, -2.3 mg/dL; P = 0.051) from baseline to month 12. Testosterone also slightly but significantly decreased fasting insulin (adjusted mean difference, -1.7 µIU/mL; P = 0.02) and homeostatic model assessment‒insulin resistance (adjusted mean difference, -0.6; P = 0.03). Testosterone did not change triglycerides, d-dimer, C-reactive protein, interleukin 6, troponin, glucose, or hemoglobin A1c levels more than placebo.

Conclusions and relevance: Testosterone treatment of 1 year in older men with low testosterone was associated with small reductions in cholesterol and insulin but not with other glucose markers, markers of inflammation or fibrinolysis, or troponin. The clinical importance of these findings is unclear and requires a larger trial of clinical outcomes.

Trial registration: ClinicalTrials.gov NCT00799617.

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References

    1. Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, Cook MB, Fraumeni JF Jr, Hoover RN. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One. 2014;9(1):e85805. - PMC - PubMed
    1. Vigen R, O’Donnell CI, Barón AE, Grunwald GK, Maddox TM, Bradley SM, Barqawi A, Woning G, Wierman ME, Plomondon ME, Rumsfeld JS, Ho PM. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013;310(17):1829–1836. - PubMed
    1. Baillargeon J, Urban RJ, Kuo YF, Ottenbacher KJ, Raji MA, Du F, Lin YL, Goodwin JS. Risk of myocardial infarction in older men receiving testosterone therapy. Ann Pharmacother. 2014;48(9):1138–1144. - PMC - PubMed
    1. Shores MM, Smith NL, Forsberg CW, Anawalt BD, Matsumoto AM. Testosterone treatment and mortality in men with low testosterone levels. J Clin Endocrinol Metab. 2012;97(6):2050–2058. - PubMed
    1. Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010;363(2):109–122. - PMC - PubMed

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