Original articleRisk of Venous Thromboembolism in Men Receiving Testosterone Therapy
Section snippets
Data Source
This case-control study used administrative health data from Clinformatics Data Mart (CDM; OptumInsight), a database of one of the nation’s largest commercial health insurance programs. CDM data have been used to examine drug toxicity and health services in numerous studies.15, 16, 17, 18 Persons enrolled in this insurance program may be included in either a fee-for-service plan or a managed care plan, which includes health maintenance organizations, preferred provider organizations, and
Results
Table 1 shows that 4 of the 5 matching variables—year of diagnosis/index date, age, region, and diagnosis of hypogonadism—were distributed evenly across cases and controls. The fifth matching variable, diagnosis of any prothrombotic disease, was more prevalent among cases (84; 1.1%) than controls (183; 0.8%). Examination of comorbid diseases exhibited that cases had a higher prevalence of cardiac arrhythmia, congestive heart failure, pulmonary circulation disease, paralysis, neurological
Discussion
In this case-control study of 30,572 middle aged and older men, we found that having filled a prescription for testosterone therapy was not associated with an increased risk of VTE. In addition, none of the specific routes of administration examined—topical, transdermal, or intramuscular—were associated with an increased risk of VTE. The association between testosterone therapy and VTE did not appear to vary by the presence of underlying prothrombotic disease. However, our exclusion of all men
Conclusion
Middle-aged and older men who filled a prescription for testosterone therapy were not at increased risk of VTE. This finding persisted across specific routes of administration—topical, transdermal, and intramuscular—and across different exposure windows—15, 30, 60 days before the event/index date. These findings may provide clinically relevant information about the benefit-risk assessment for men with testosterone deficiency considering treatment.
Acknowledgments
We are grateful to Leonard Pechacek for his editorial assistance.
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Grant Support: The work was supported by the Institute for Translational Sciences at the University of Texas Medical Branch, which was supported in part by a Clinical and Translational Science Award (UL1TR000071) from the National Center for Advancing Translational Sciences, National Institutes of Health. The funding organizations had no role in the design or conduct of the study; in the collection, analysis, or interpretation of data; or in the preparation, review, or approval of the article.
Potential Competing Interests: Dr Morgentaler has received payments for consulting, scientific advisory boards, research grants, and/or lecture honoraria from AbbVie, Antares, Auxilium, Bayer, Clarus, Eli Lilly, Lipocine, Merck, Pfizer, and TesoRx.