Filling a testosterone prescription was not associated with increased risk for venous thromboembolism in middle-aged and older men, according to a new case-control study.
In June 2014, the FDA mandated a general warning on labels of testosterone products about the risk for VTE after receiving postmarket reports of an association between the products and VTE unrelated to polycythemia.
Jacques Baillargeon, PhD
Jacques Baillargeon
“We believe that this study addresses a critical deficit in the published literature and may provide clinically relevant information regarding the risk–benefit assessment for men with testosterone deficiency considering treatment,” Jacques Baillargeon, PhD, professor of epidemiology in the department of preventive medicine and community health at the University of Texas Medical Branch at Galveston, told Cardiology Today. “We hope that the current study provides a basis for patients and physicians to have an evidence-based discussion about benefit-risk assessment for this particular outcome.”
Benefit–risk assessment
Baillargeon and colleagues conducted a case-control study of 30,572 men aged 40 years or older in the Clinformatics Data Mart commercial health insurance database. The researchers analyzed 7,643 cases diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) who received an anticoagulant or a vena cava filter within 60 days of diagnosis from 2007 to 2012 and 22,929 controls who were not diagnosed with DVT or PE. Each case was matched with three controls based on index month, age, geographic region, diagnosis of hypogonadism and diagnosis of any prothrombotic condition.
The researchers used conditional logistic regression analysis to calculate odds of risk for VTE associated with previous exposure to testosterone therapy.
No elevated VTE risk
Exposure to testosterone therapy in the 15 days before the event or index date was not associated with increased risk for VTE (adjusted OR = 0.9; 95% CI, 0.73-1.12). In addition, the researchers also found no increased risk for VTE associated with administration route, including topical (adjusted OR = 0.8; 95% CI, 0.61-10.41), transdermal (adjusted OR = 0.91; 95% CI, 0.38-2.16) and intramuscular (adjusted OR = 1.15; 95% CI, 0.8-1.64).
Extending the exposure windows to 30 days and 60 days before the event or index date did not change the results.
“It is important to acknowledge that, for a man who is truly hypogonadal, there are clear risks to not taking testosterone therapy, including osteoporosis, sexual dysfunction, increased adiposity, decreased lean muscle mass, fatigue, and even possible metabolic syndrome and [CVD],” Baillargeon told Cardiology Today. “Certainly with the big increase in testosterone prescribing over the last 10 years coinciding with increased direct-to-consumer marketing and the big increase in commercial specialty men’s hormone clinics, there are likely to be many men without hypogonadism who are taking testosterone. And for these men, given the still unknown long-term risks of testosterone therapy, the benefit–risk ratio is not favorable. But for men with hypogonadism, this study provides the first real evidence on this particular outcome, VTE.” – by Erik Swain
www.healio.com
In June 2014, the FDA mandated a general warning on labels of testosterone products about the risk for VTE after receiving postmarket reports of an association between the products and VTE unrelated to polycythemia.
Jacques Baillargeon, PhD
Jacques Baillargeon
“We believe that this study addresses a critical deficit in the published literature and may provide clinically relevant information regarding the risk–benefit assessment for men with testosterone deficiency considering treatment,” Jacques Baillargeon, PhD, professor of epidemiology in the department of preventive medicine and community health at the University of Texas Medical Branch at Galveston, told Cardiology Today. “We hope that the current study provides a basis for patients and physicians to have an evidence-based discussion about benefit-risk assessment for this particular outcome.”
Benefit–risk assessment
Baillargeon and colleagues conducted a case-control study of 30,572 men aged 40 years or older in the Clinformatics Data Mart commercial health insurance database. The researchers analyzed 7,643 cases diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) who received an anticoagulant or a vena cava filter within 60 days of diagnosis from 2007 to 2012 and 22,929 controls who were not diagnosed with DVT or PE. Each case was matched with three controls based on index month, age, geographic region, diagnosis of hypogonadism and diagnosis of any prothrombotic condition.
The researchers used conditional logistic regression analysis to calculate odds of risk for VTE associated with previous exposure to testosterone therapy.
No elevated VTE risk
Exposure to testosterone therapy in the 15 days before the event or index date was not associated with increased risk for VTE (adjusted OR = 0.9; 95% CI, 0.73-1.12). In addition, the researchers also found no increased risk for VTE associated with administration route, including topical (adjusted OR = 0.8; 95% CI, 0.61-10.41), transdermal (adjusted OR = 0.91; 95% CI, 0.38-2.16) and intramuscular (adjusted OR = 1.15; 95% CI, 0.8-1.64).
Extending the exposure windows to 30 days and 60 days before the event or index date did not change the results.
“It is important to acknowledge that, for a man who is truly hypogonadal, there are clear risks to not taking testosterone therapy, including osteoporosis, sexual dysfunction, increased adiposity, decreased lean muscle mass, fatigue, and even possible metabolic syndrome and [CVD],” Baillargeon told Cardiology Today. “Certainly with the big increase in testosterone prescribing over the last 10 years coinciding with increased direct-to-consumer marketing and the big increase in commercial specialty men’s hormone clinics, there are likely to be many men without hypogonadism who are taking testosterone. And for these men, given the still unknown long-term risks of testosterone therapy, the benefit–risk ratio is not favorable. But for men with hypogonadism, this study provides the first real evidence on this particular outcome, VTE.” – by Erik Swain
Testosterone therapy not linked to VTE
Filling a testosterone prescription was not associated with increased risk for venous thromboembolism in middle-aged and older men, according to a new case-control study. In June 2014, the FDA mandated a general warning on labels of testosterone products about the risk for VTE after receiving...
www.healio.com
