Effects of Testosterone Undecanoate on Cardiovascular Risk Factors and Atherosclerosis in Middle-Aged Men with Late-Onset Hypogonadism and Metabolic Syndrome: Results from a 24-month, Randomized, Double-Blind, Placebo-Controlled Study
Effects of Testosterone Undecanoate on Cardiovascular Risk Factors and Atherosclerosis in Middle-Aged Men with Late-Onset Hypogonadism and Metabolic Syndrome: Results from a 24-month, Randomized, Double-Blind, Placebo-Controlled Study
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DOI：
10.1111/j.1743-6109.2010.01931.x
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发表时间：
2010-10-01
影响因子：
3.5
通讯作者：
Spera, Giovanni
中科院分区：
文献类型：
--
作者：
Aversa, Antonio;Bruzziches, Roberto;Spera, Giovanni
简介：纵向研究表明，男性性腺功能减退症可被视为心血管疾病发生的替代标志。目的：评估肠外十一酸睾酮（TU）对代谢综合征（MS）和迟发性性腺功能减退症（总睾酮（T）等于或低于11 nmol/L或游离T等于或低于250）的临床患者的影响 pmol/L)。方法。这是一项随机、双盲、双模拟、安慰剂对照、平行组、单中心研究。 50 名患者（平均年龄 57 +/- 8）被随机 (4:1) 接受 TU 1,000 mg（每 12 周）或安慰剂 (PLB) 凝胶（3-6 g/每天）治疗 24 个月。主要结果指标：胰岛素抵抗 (HOMA-IR)、颈动脉内膜中层厚度 (CIMT) 和高敏 C 反应蛋白的稳态模型评估指数 (hsCRP)。结果。在基线时，所有患者均符合国家胆固醇教育计划第三成人治疗小组 (NCEP-ATPIII) 和国际糖尿病联盟 (IDF) 对 MS 定义的标准。 12个月时进行的中期分析显示，与PLB相比，TU显着改善了HOMA-IR（P < 0.001）、CIMT（P < 0.0001）和hsCRP（P < 0.001）；因此，所有患者均转至 TU 治疗。 24 个月后，分别有 35% (P < 0.0001) 和 58% (P < 0.001) 的患者仍出现 NCEP-ATPIII 和 IDF 标准定义的 MS。变化的主要决定因素是腰围减少 (P < 0.0001)、内脏脂肪量 (P < 0.0001) 和 HOMA-IR 改善，但体重指数 (BMI) 没有变化。结论。TU 降低了性腺功能减退男性 MS 的空腹血糖、腰围，并改善了动脉粥样硬化的替代标志物。年轻人 T 水平恢复并维持在正常范围可显着减少 MS 中的心血管危险因素，且不会出现明显的血液学和前列腺不良事件。 Aversa A、Bruzziches R、Francomano D、Rosano G、Isidori AM、Lenzi A 和 Spera G。十一烷酸睾酮对晚发性腺功能减退症和代谢综合征中年男性心血管危险因素和动脉粥样硬化的影响：一项为期 24 个月、随机、双盲、安慰剂对照研究的结果。 《性医学杂志》2010 年；7：3495-3503。
Introduction.Longitudinal studies have demonstrated that male hypogonadism could be considered a surrogate marker of incident cardiovascular disease.Aim.To evaluate the effects of parenteral testosterone undecanoate (TU) in outclinic patients with metabolic syndrome (MS) and late-onset hypogonadism (total testosterone (T) at or below 11 nmol/L or free T at or below 250 pmol/L).Methods.This is a randomized, double-blind, double-dummy, placebo-controlled, parallel group, single-center study. Fifty patients (mean age 57 +/- 8) were randomized (4:1) to receive TU 1,000 mg (every 12 weeks) or placebo (PLB) gel (3-6 g/daily) for 24 months.Main Outcome Measures.Homeostasis model assessment index of insulin resistance (HOMA-IR), carotid intima media thickness (CIMT), and high-sensitivity C-reactive protein (hsCRP).Results.At baseline, all patients fulfilled the National Cholesterol Education Program-Third Adult Treatment Panel (NCEP-ATPIII) and International Diabetes Federation (IDF) criteria for the definition of MS. An interim analysis conducted at 12 months showed that TU markedly improved HOMA-IR (P < 0.001), CIMT (P < 0.0001), and hsCRP (P < 0.001) compared with PLB; thus, all patients were shifted to TU treatment. After 24 months, 35% (P < 0.0001) and 58% (P < 0.001) of patients still presented MS as defined by NCEP-ATPIII and IDF criteria, respectively. Main determinants of changes were reduction in waist circumference (P < 0.0001), visceral fat mass (P < 0.0001), and improvement in HOMA-IR without changes in body mass index (BMI).Conclusions.TU reduced fasting glucose, waist circumference, and improved surrogate markers of atherosclerosis in hypogonadal men with MS. Resumption and maintenance of T levels in the normal range of young adults determines a remarkable reduction in cardiovascular risk factors clustered in MS without significant hematological and prostate adverse events. Aversa A, Bruzziches R, Francomano D, Rosano G, Isidori AM, Lenzi A, and Spera G. Effects of testosterone undecanoate on cardiovascular risk factors and atherosclerosis in middle-aged men with late onset hypogonadism and metabolic syndrome: Results from a 24-month, randomized, double-blind, placebo-controlled study. J Sex Med 2010;7:3495-3503.