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Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone.

ABSTRACT: OBJECTIVE:Recent results from the Cardiovascular Trial of the Testosterone Trials showed that testosterone treatment of older men with low testosterone was associated with greater progression of noncalcified plaque (NCP). We evaluated the effect of anthropometric measures and cardiovascular biomarkers on plaque progression in individuals in the Testosterone Trial. METHODS:The Cardiovascular part of the trial included 170 men aged 65 years or older with low testosterone. Participants received testosterone 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 cardiovascular risk and analyzed each marker individually in a model as predictive variables and change in NCP as the dependent variable. RESULTS:Of 170 enrollees, 138 (73 testosterone, 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 (WHR) (P = 0.0014) indicated that this variable impacted the testosterone effect on NCP volume. The statistical model indicated that for every 0.1 change in the WHR, the testosterone-induced 12-month change in NCP volume increased by 26.96 mm3 (95% confidence interval, 7.72-46.20). CONCLUSION:Among older men with low testosterone treated for 1 year, greater WHR was associated with greater NCP progression, as measured by CCTA. Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.

SUBMITTER: Shaikh K

PROVIDER: S-EPMC7209773 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone.

Shaikh Kashif K Ellenberg Susan S SS Nakanishi Rine R Snyder Peter J PJ Lee Juhwan J Wenger Nanette K NK Lewis Cora E CE Swerdloff Ronald S RS Preston Peter P Hamal Sajad S Stephens-Sheilds Alisa A Bhasin Shalender S Cherukuri Lavanya L Cauley Jane A JA Crandall Jill P JP Cunningham Glenn R GR Ensrud Kristine E KE Matsumoto Alvin M AM Molich Mark E ME Alla Venkata M VM Birudaraju Divya D Nezarat Negin N Rai Kelash K Almeida Shone S Roy Sion K SK Sheikh Mohammad M Trad George G Budoff Mathew J MJ

The Journal of clinical endocrinology and metabolism 20200701 7

<h4>Objective</h4>Recent results from the Cardiovascular Trial of the Testosterone Trials showed that testosterone treatment of older men with low testosterone was associated with greater progression of noncalcified plaque (NCP). We evaluated the effect of anthropometric measures and cardiovascular biomarkers on plaque progression in individuals in the Testosterone Trial.<h4>Methods</h4>The Cardiovascular part of the trial included 170 men aged 65 years or older with low testosterone. Participan ...[more]

PMID: 31784747

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Project description:ImportanceRecent studies have yielded conflicting results as to whether testosterone treatment increases cardiovascular risk.ObjectiveTo test the hypothesis that testosterone treatment of older men with low testosterone slows progression of noncalcified coronary artery plaque volume.Design, setting, and participantsDouble-blinded, placebo-controlled trial at 9 academic medical centers in the United States. The participants were 170 of 788 men aged 65 years or older with an average of 2 serum testosterone levels lower than 275 ng/dL (82 men assigned to placebo, 88 to testosterone) and symptoms suggestive of hypogonadism who were enrolled in the Testosterone Trials between June 24, 2010, and June 9, 2014.InterventionTestosterone gel, with the dose adjusted to maintain the testosterone level in the normal range for young men, or placebo gel for 12 months.Main outcomes and measuresThe primary outcome was noncalcified coronary artery plaque volume, as determined by coronary computed tomographic angiography. Secondary outcomes included total coronary artery plaque volume and coronary artery calcium score (range of 0 to >400 Agatston units, with higher values indicating more severe atherosclerosis).ResultsOf 170 men who were enrolled, 138 (73 receiving testosterone treatment and 65 receiving placebo) completed the study and were available for the primary analysis. Among the 138 men, the mean (SD) age was 71.2 (5.7) years, and 81% were white. At baseline, 70 men (50.7%) had a coronary artery calcification score higher than 300 Agatston units, reflecting severe atherosclerosis. For the primary outcome, 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 vs 317 mm3 to 325 mm3, respectively; estimated difference, 41 mm3; 95% CI, 14 to 67 mm3; P = .003). 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 vs from 499 mm3 to 541 mm3 in the placebo group (estimated difference, 47 mm3; 95% CI, 13 to 80 mm3; P = .006), and the median coronary artery calcification score changed from 255 to 244 Agatston units in the testosterone group vs 494 to 503 Agatston units in the placebo group (estimated difference, -27 Agatston units; 95% CI, -80 to 26 Agatston units). No major adverse cardiovascular events occurred in either group.Conclusions and relevanceAmong older men with symptomatic hypogonadism, treatment with testosterone gel for 1 year compared with placebo was associated with a significantly greater increase in coronary artery noncalcified plaque volume, as measured by coronary computed tomographic angiography. Larger studies are needed to understand the clinical implications of this finding.Trial registrationclinicaltrials.gov Identifier: NCT00799617.

Project description:BackgroundIn coronary artery disease (CAD), plaque progression and plaque composition are associated with cardiovascular risk. Whether compositional plaque progression in non-obstructive CAD differs between women and men is less studied.MethodsWe included 31 patients (42% women) with chronic non-obstructive CAD from the Norwegian Registry of Invasive Cardiology, undergoing serial coronary computed tomography angiography (CCTA) on clinical indication (median inter-scan interval 1.8 [1.5-2.2] years). We performed quantitative and qualitative plaque analysis of all coronary artery segments.ResultsWomen were older compared to men (65 ± 8 years vs. 55 ± 12 years, p = 0.019), while there was no difference in the prevalence of hypertension, diabetes, smoking or statin treatment between groups. At baseline, women had a higher total plaque burden, more calcified plaques, and less fibro-fatty and necrotic core plaques compared to men (all p < 0.05). During follow-up, men showed faster progression of fibro-fatty plaques (4.0 ± 5.4 % per year vs. -0.6 ± 3.1 % per year, p = 0.019) and a greater reduction of fibrous plaques (-7.3 ± 6.1 % per year vs. 2.1 ± 7.2 % per year, p = 0.003) compared to women even after age adjustment. At follow-up, total plaque burden remained higher in women compared to men (24.9 ± 3.3 % vs. 21.1 ± 2.6 %, p = 0.001), while men had an increase in fibro-fatty (21.2 ± 9.3 % vs. 28.6 ± 9.8 %, p = 0.004) and necrotic core plaques (5.6 ± 3.6 % vs. 10.8 ± 7.2 %, p = 0.006), and a decrease in fibrous plaques (69.0 ± 11.9 % vs. 54.7 ± 13.7 %, p < 0.001). Women's plaque composition remained unaltered.ConclusionIn non-obstructive CAD, serial CCTA demonstrated a higher total plaque burden and a stable plaque composition in women, while men had a faster progression of unstable low-attenuating fibro-fatty plaques.Clinical trial registration: ClinicalTrials.gov: Identifier NCT04009421.

Dataset Information

Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone.

Publications

Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone.

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