Risk of Venous Thromboembolism in Men Receiving Testosterone Therapy

Jacques Baillargeon, Randall Urban, Abraham Morgentaler, Charles J. Glueck, Gwen Baillargeon, Gulshan Sharma, Yong Fang Kuo

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Objective To examine the risk of venous thromboembolism (VTE) associated with exposure to testosterone therapy in middle-aged and older men. Patients and Methods We conducted a case-control study of 30,572 men 40 years and older who were enrolled in one of the nation's largest commercial insurance programs between January 1, 2007, and December 31, 2012. Cases were defined as men who had a primary diagnosis of VTE and received an anticoagulant drug in the 60 days after their diagnoses. Cases were matched with 3 controls on event/index month, age, geographic region, diagnosis of hypogonadism, and diagnosis of any underlying prothrombotic condition. Conditional logistic regression analysis was used to calculate adjusted odds ratios (aORs) and 95% CIs for the risk of VTE associated with previous exposure to testosterone therapy. Results Exposure to testosterone therapy in the 15 days before the event/index date was not associated with an increased risk of VTE (aOR, 0.90; 95% CI, 0.73-1.12). None of the specific routes of administration examined were associated with an increased risk of VTE (topical [aOR, 0.80; 95% CI, 0.61-10.41], transdermal [aOR, 0.91; 95% CI, 0.38-2.16], and intramuscular [aOR, 1.15; 95% CI, 0.80-1.64]). These findings persisted using exposure windows that extended to 30 and 60 days before the event/index date. Conclusion Having filled a prescription for testosterone therapy was not associated with an increased risk of VTE in commercially insured middle-aged and older men. These findings may provide clinically relevant information about the benefit-risk assessment for men with testosterone deficiency considering treatment.

Original languageEnglish (US)
Pages (from-to)1038-1045
Number of pages8
JournalMayo Clinic Proceedings
Volume90
Issue number8
DOIs
StatePublished - Aug 1 2015

Fingerprint

Venous Thromboembolism
Testosterone
Therapeutics
Hypogonadism
Insurance
Anticoagulants
Prescriptions
Case-Control Studies
Logistic Models
Odds Ratio
Regression Analysis

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Risk of Venous Thromboembolism in Men Receiving Testosterone Therapy. / Baillargeon, Jacques; Urban, Randall; Morgentaler, Abraham; Glueck, Charles J.; Baillargeon, Gwen; Sharma, Gulshan; Kuo, Yong Fang.

In: Mayo Clinic Proceedings, Vol. 90, No. 8, 01.08.2015, p. 1038-1045.

Research output: Contribution to journalArticle

Baillargeon, Jacques ; Urban, Randall ; Morgentaler, Abraham ; Glueck, Charles J. ; Baillargeon, Gwen ; Sharma, Gulshan ; Kuo, Yong Fang. / Risk of Venous Thromboembolism in Men Receiving Testosterone Therapy. In: Mayo Clinic Proceedings. 2015 ; Vol. 90, No. 8. pp. 1038-1045.
@article{734f8c0f33394f4994b8e1ae81b5a3ec,
title = "Risk of Venous Thromboembolism in Men Receiving Testosterone Therapy",
abstract = "Objective To examine the risk of venous thromboembolism (VTE) associated with exposure to testosterone therapy in middle-aged and older men. Patients and Methods We conducted a case-control study of 30,572 men 40 years and older who were enrolled in one of the nation's largest commercial insurance programs between January 1, 2007, and December 31, 2012. Cases were defined as men who had a primary diagnosis of VTE and received an anticoagulant drug in the 60 days after their diagnoses. Cases were matched with 3 controls on event/index month, age, geographic region, diagnosis of hypogonadism, and diagnosis of any underlying prothrombotic condition. Conditional logistic regression analysis was used to calculate adjusted odds ratios (aORs) and 95{\%} CIs for the risk of VTE associated with previous exposure to testosterone therapy. Results Exposure to testosterone therapy in the 15 days before the event/index date was not associated with an increased risk of VTE (aOR, 0.90; 95{\%} CI, 0.73-1.12). None of the specific routes of administration examined were associated with an increased risk of VTE (topical [aOR, 0.80; 95{\%} CI, 0.61-10.41], transdermal [aOR, 0.91; 95{\%} CI, 0.38-2.16], and intramuscular [aOR, 1.15; 95{\%} CI, 0.80-1.64]). These findings persisted using exposure windows that extended to 30 and 60 days before the event/index date. Conclusion Having filled a prescription for testosterone therapy was not associated with an increased risk of VTE in commercially insured middle-aged and older men. These findings may provide clinically relevant information about the benefit-risk assessment for men with testosterone deficiency considering treatment.",
author = "Jacques Baillargeon and Randall Urban and Abraham Morgentaler and Glueck, {Charles J.} and Gwen Baillargeon and Gulshan Sharma and Kuo, {Yong Fang}",
year = "2015",
month = "8",
day = "1",
doi = "10.1016/j.mayocp.2015.05.012",
language = "English (US)",
volume = "90",
pages = "1038--1045",
journal = "Mayo Clinic Proceedings",
issn = "0025-6196",
publisher = "Elsevier Science",
number = "8",

}

TY - JOUR

T1 - Risk of Venous Thromboembolism in Men Receiving Testosterone Therapy

AU - Baillargeon, Jacques

AU - Urban, Randall

AU - Morgentaler, Abraham

AU - Glueck, Charles J.

AU - Baillargeon, Gwen

AU - Sharma, Gulshan

AU - Kuo, Yong Fang

PY - 2015/8/1

Y1 - 2015/8/1

N2 - Objective To examine the risk of venous thromboembolism (VTE) associated with exposure to testosterone therapy in middle-aged and older men. Patients and Methods We conducted a case-control study of 30,572 men 40 years and older who were enrolled in one of the nation's largest commercial insurance programs between January 1, 2007, and December 31, 2012. Cases were defined as men who had a primary diagnosis of VTE and received an anticoagulant drug in the 60 days after their diagnoses. Cases were matched with 3 controls on event/index month, age, geographic region, diagnosis of hypogonadism, and diagnosis of any underlying prothrombotic condition. Conditional logistic regression analysis was used to calculate adjusted odds ratios (aORs) and 95% CIs for the risk of VTE associated with previous exposure to testosterone therapy. Results Exposure to testosterone therapy in the 15 days before the event/index date was not associated with an increased risk of VTE (aOR, 0.90; 95% CI, 0.73-1.12). None of the specific routes of administration examined were associated with an increased risk of VTE (topical [aOR, 0.80; 95% CI, 0.61-10.41], transdermal [aOR, 0.91; 95% CI, 0.38-2.16], and intramuscular [aOR, 1.15; 95% CI, 0.80-1.64]). These findings persisted using exposure windows that extended to 30 and 60 days before the event/index date. Conclusion Having filled a prescription for testosterone therapy was not associated with an increased risk of VTE in commercially insured middle-aged and older men. These findings may provide clinically relevant information about the benefit-risk assessment for men with testosterone deficiency considering treatment.

AB - Objective To examine the risk of venous thromboembolism (VTE) associated with exposure to testosterone therapy in middle-aged and older men. Patients and Methods We conducted a case-control study of 30,572 men 40 years and older who were enrolled in one of the nation's largest commercial insurance programs between January 1, 2007, and December 31, 2012. Cases were defined as men who had a primary diagnosis of VTE and received an anticoagulant drug in the 60 days after their diagnoses. Cases were matched with 3 controls on event/index month, age, geographic region, diagnosis of hypogonadism, and diagnosis of any underlying prothrombotic condition. Conditional logistic regression analysis was used to calculate adjusted odds ratios (aORs) and 95% CIs for the risk of VTE associated with previous exposure to testosterone therapy. Results Exposure to testosterone therapy in the 15 days before the event/index date was not associated with an increased risk of VTE (aOR, 0.90; 95% CI, 0.73-1.12). None of the specific routes of administration examined were associated with an increased risk of VTE (topical [aOR, 0.80; 95% CI, 0.61-10.41], transdermal [aOR, 0.91; 95% CI, 0.38-2.16], and intramuscular [aOR, 1.15; 95% CI, 0.80-1.64]). These findings persisted using exposure windows that extended to 30 and 60 days before the event/index date. Conclusion Having filled a prescription for testosterone therapy was not associated with an increased risk of VTE in commercially insured middle-aged and older men. These findings may provide clinically relevant information about the benefit-risk assessment for men with testosterone deficiency considering treatment.

UR - http://www.scopus.com/inward/record.url?scp=84938750645&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84938750645&partnerID=8YFLogxK

U2 - 10.1016/j.mayocp.2015.05.012

DO - 10.1016/j.mayocp.2015.05.012

M3 - Article

C2 - 26205547

AN - SCOPUS:84938750645

VL - 90

SP - 1038

EP - 1045

JO - Mayo Clinic Proceedings

JF - Mayo Clinic Proceedings

SN - 0025-6196

IS - 8

ER -