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    TRT, blood clot risk evaluated in large analysis

    Middle-aged and older men undergoing testosterone replacement therapy aren’t at increased risk of venous thromboembolism (VTE), the results of a large comparative case-control analysis published online in Mayo Clinic Proceedings (July 15, 2015) suggest.

    A leading sexual dysfunction expert praised the researchers’ efforts but noted that a prospective long-term clinical trial would be most effective at determining the risk.

    Researchers studied 30,572 men 40 years of age and older who were enrolled in one of the country’s largest commercial insurance programs between Jan. 1, 2007 and Dec. 31, 2012. They identified 7,643 cases, defined as men diagnosed with VTE (deep vein thrombosis or pulmonary embolism) at any time during the study period who received at least one prescription for an anticoagulant or had an intravascular vena cava filter inserted within 60 days after the VTE diagnosis.

    Read: What do you think of new warning labels on TRT products?

    Cases were matched with three control subjects on event/index month, age, geographic region, diagnosis of hypogonadism, and diagnosis of any underlying prothrombic condition. The analysis adjusted for potential confounding factors, including age, geographic region, calendar year, underlying medical conditions, and medications.

    Exposure to testosterone therapy within 15 days of the event/index date wasn’t associated with increased risk of VTE (adjusted odds ratio, 0.90), nor were any of the routes of administration that the authors examined—topical, transdermal, or intramuscular. The finding extended to men who received therapy 30 or 60 days before the VTE diagnosis.

    NEXT: “These findings may provide clinically relevant information about the benefit-risk assessment for men with testosterone deficiency considering treatment."

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