Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.
Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.
J Urol. 2016 Apr;195(4 Pt 1):1065-72. doi: 10.1016/j.juro.2015.10.134. Epub 2015 Oct 31.
Limited information exists about whether exogenous testosterone therapy is associated with a risk of venous thrombotic events. We investigated via cohort and nested case-control analyses whether exogenous testosterone therapy is associated with the risk of venous thrombotic events in men with hypogonadism.
Databases were reviewed to identify men prescribed exogenous testosterone therapy and/or men with a hypogonadism diagnosis. Propensity score 1:1 matching was used to select patients for cohort analysis. Cases (men with venous thrombotic events) were matched 1:4 with controls (men without venous thrombotic events) for the nested case-control analysis. Primary outcome was defined as incident idiopathic venous thrombotic events. Cox regression and conditional logistic regression were used to assess HRs and ORs, respectively. Sensitivity analyses were also performed.
A total of 102,650 exogenous testosterone treated and 102,650 untreated patients were included in cohort analysis after matching, and 2,785 cases and 11,119 controls were included in case-control analysis. Cohort analysis revealed a HR of 1.08 for all testosterone treated patients (95% CI 0.91, 1.27, p = 0.378). Case-control analysis resulted in an OR of 1.02 (95% CI 0.92, 1.13, p = 0.702) for current exogenous testosterone therapy exposure and an OR of 0.92 (95% CI 0.82, 1.03, p = 0.145) for past exogenous testosterone therapy exposure. These results remained nonstatistically significant after stratifying by exogenous testosterone therapy administration route and age category. Most sensitivity analyses yielded consistent results.
No significant association was found between exogenous testosterone therapy and incidents of idiopathic or overall venous thrombotic events in men with hypogonadism. However, some discrepant findings exist for the association between injectable formulations and the risk of overall venous thrombotic events.
关于外源性睾丸激素治疗是否与静脉血栓栓塞事件的风险相关，现有信息有限。我们通过队列研究和巢式病例对照分析，调查了睾丸功能减退症男性中，外源性睾丸激素治疗与静脉血栓栓塞事件风险之间的关系。
检索数据库以确定接受外源性睾丸激素治疗的男性和/或患有性腺功能减退症的男性。使用倾向评分 1:1 匹配选择队列分析的患者。对于巢式病例对照分析，将病例（静脉血栓栓塞事件患者）与对照（无静脉血栓栓塞事件患者）以 1:4 的比例匹配。主要结局定义为偶发性特发性静脉血栓栓塞事件。使用 Cox 回归和条件逻辑回归分别评估 HR 和 OR。还进行了敏感性分析。
匹配后，队列分析共纳入 102650 例接受外源性睾丸激素治疗和 102650 例未接受治疗的患者，巢式病例对照分析共纳入 2785 例病例和 11119 例对照。队列分析显示，所有接受睾丸激素治疗的患者的 HR 为 1.08（95%CI 0.91，1.27，p=0.378）。病例对照分析显示，当前外源性睾丸激素治疗暴露的 OR 为 1.02（95%CI 0.92，1.13，p=0.702），过去外源性睾丸激素治疗暴露的 OR 为 0.92（95%CI 0.82，1.03，p=0.145）。这些结果在按外源性睾丸激素治疗途径和年龄类别分层后仍然没有统计学意义。大多数敏感性分析得出了一致的结果。
在性腺功能减退症男性中，外源性睾丸激素治疗与特发性或总体静脉血栓栓塞事件的发生之间未发现显著关联。然而，对于注射制剂与总体静脉血栓栓塞事件风险之间的关联，存在一些不一致的发现。
