Testosterone Treatment and Coronary Artery Plaque Volume in Older Men With Low Testosterone.
Testosterone Treatment and Coronary Artery Plaque Volume in Older Men With Low Testosterone.
复制标题
DOI：
10.1001/jama.2016.21043
复制
发表时间：
2017-02-21
期刊：
影响因子：
--
通讯作者：
Snyder PJ
中科院分区：
文献类型：
--
作者：
Budoff MJ;Ellenberg SS;Lewis CE;Mohler ER 3rd;Wenger NK;Bhasin S;Barrett-Connor E;Swerdloff RS;Stephens-Shields A;Cauley JA;Crandall JP;Cunningham GR;Ensrud KE;Gill TM;Matsumoto AM;Molitch ME;Nakanishi R;Nezarat N;Matsumoto S;Hou X;Basaria S;Diem SJ;Wang C;Cifelli D;Snyder PJ
关于睾酮治疗是否会增加心血管风险，最近的研究得出了相互矛盾的结果。验证睾酮治疗老年男性低睾酮患者可减缓非钙化冠状动脉斑块体积进展的假设。在美国9个学术医学中心进行的双盲、安慰剂对照试验。参与者是788名年龄在65岁或以上的男性中的170名，平均2个血清睾酮水平低于275 ng/dL（82名男性分配到安慰剂组，88名男性分配到睾酮组），并且在2010年6月24日至2014年6月9日期间入组了Teplasty试验。Teastrin凝胶，调整剂量以维持年轻男性的睾酮水平在正常范围内，或安慰剂凝胶12个月。主要结果是冠状动脉计算机断层血管造影确定的非钙化冠状动脉斑块体积。次要结果包括总冠状动脉斑块体积和冠状动脉钙评分（范围为0至>400 Agatston单位，数值越高表明动脉粥样硬化越严重）。在入组的170名男性中，138名（73名接受睾酮治疗，65名接受安慰剂治疗）完成了研究，并可用于主要分析。在138名男性中，平均（SD）年龄为71.2（5.7）岁，81%为白色。基线时，70名男性（50.7%）的冠状动脉钙化评分高于300 Agatston单位，反映了严重的动脉粥样硬化。对于主要结局，睾酮治疗组与安慰剂组相比，非钙化斑块体积从基线至12个月显著增加（中位数分别为204 mm 3至232 mm 3 vs 317 mm 3至325 mm 3;估计差异为41 mm 3; 95%CI为14至67 mm 3; P = 0.003）。对于次要结局，睾酮组中位总斑块体积从基线至12个月从272 mm 3增加至318 mm 3，安慰剂组从499 mm 3增加至541 mm 3（估计差异，47 mm 3; 95%CI，13至80 mm 3; P = .006），睾酮组的冠状动脉钙化评分中位数从255到244 Agatston单位变化，安慰剂组为494到503 Agatston单位（估计差异，−27 Agatston单位; 95%CI，−80至26 Agatston单位）。两组均未发生重大心血管不良事件。在患有症状性性腺功能减退症的老年男性中，与安慰剂相比，使用睾酮凝胶治疗1年与冠状动脉计算机断层血管造影测量的冠状动脉非钙化斑块体积显着增加相关。需要更大规模的研究来了解这一发现的临床意义。clinicaltrials.gov标识符：NCT 00799617
Recent studies have yielded conflicting results as to whether testosterone treatment increases cardiovascular risk. To test the hypothesis that testosterone treatment of older men with low testosterone slows progression of noncalcified coronary artery plaque volume. Double-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. Testosterone gel, with the dose adjusted to maintain the testosterone level in the normal range for young men, or placebo gel for 12 months. The primary outcome was non calcified 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). Of 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. Among 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. clinicaltrials.gov Identifier: NCT00799617