title: Association between Use of Exogenous Testosterone Therapy and Risk of Venous Thrombotic Events among Exogenous Testosterone Treated and Untreated Men with Hypogonadism.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana. Electronic address: LI_HU_HL@lilly.com.
authors.forename: Hu
authors.initials: H
authors.lastname: Li
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.
authors.forename: Karin
authors.initials: K
authors.lastname: Benoit
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana.
authors.forename: Stephen
authors.initials: S
authors.lastname: Motsko
mesh_terms: D000728:Androgens / Q000009:adverse effects* / Q000627:therapeutic use; D016022:Case-Control Studies; D015331:Cohort Studies; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012306:Risk; D013739:Testosterone / Q000009:adverse effects* / Q000627:therapeutic use; D020246:Venous Thrombosis / Q000139:chemically induced* / Q000453:epidemiology*
chemical_list: D000728:Androgens; D013739:Testosterone
keywords: hypogonadism; pulmonary embolism; testis; testosterone; venous thrombosis