1. Impact of age on the efficacy and safety of extended-duration thromboprophylaxis in medical patients
- Author
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Sebastian Schellong, Victor F. Tapson, Meyer-Michel Samama, Manuel Monreal, Alexander G.G. Turpie, Min Chen, Russell D. Hull, Roger D. Yusen, Bruno Deslandes, Washington University School of Medicine (WUSM), University of Washington [Seattle], Thrombosis Research Unit, University of Calgary, Duke University Medical Center, Department of Internal Medicine, Hospital Universitari Germans Trias I Pujol, Serv. Hématologie Biologie Hôtel Dieu, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Oxford e-Research Center, University of Oxford [Oxford], Department of Medicine (DM - McMaster), and McMaster University [Hamilton, Ontario]
- Subjects
Male ,Canada ,medicine.medical_specialty ,Pediatrics ,Time Factors ,medicine.drug_class ,[SDV]Life Sciences [q-bio] ,Hemorrhage ,Subgroup analysis ,030204 cardiovascular system & hematology ,Placebo ,03 medical and health sciences ,0302 clinical medicine ,Population Groups ,Risk Factors ,Internal medicine ,medicine ,Humans ,In patient ,030212 general & internal medicine ,Enoxaparin ,Aged ,business.industry ,Anticoagulant ,Age Factors ,Anticoagulants ,Thrombosis ,Venous Thromboembolism ,Hematology ,Middle Aged ,medicine.disease ,United States ,Confidence interval ,Europe ,Female ,business ,Venous thromboembolism ,Major bleeding ,Follow-Up Studies - Abstract
SummaryThe EXCLAIM study enrolled hospitalised acutely ill medical patients with age >40 years and recently-reduced mobility into a trial of extended-duration anticoagulant thromboprophylaxis. This post-hoc analysis evaluated the impact of age on patient outcomes. After completion of open-label therapy with enoxaparin 40 mg once-daily (10 ± 4 days), eligible patients underwent randomisation to receive double-blind therapy of enoxaparin (n=2,975) or placebo (n=2,988) for 28 ± 4 days. During follow-up, the venous thromboembolism (VTE) risk increased with age in both treatment groups. In patients with age >75 years, those who received extended-duration enoxaparin had lower incidence of VTE (2.5% vs 6.7%; absolute difference [AD] [95% confidence interval]: −4.2% [−6.5, −2.0]), proximal deep-vein thrombosis (2.5% vs 6.6%; AD −4.1 % [−6.2, −2.0]), and symptomatic VTE (0.3% vs 1.5%; AD −1.2% [−2.2, −0.3]), in comparison to those who received placebo. In patients with age ≤75 years, those who received enoxaparin had reduced VTE (2.4% vs 2.8%; AD −0.4% [−1.5, 0.7]) and symptomatic VTE (0.2% vs 0.7%; AD −0.6% [−1.0, −0.1]) in comparison to those who received placebo. In both age subgroups, patients who received enoxaparin had increased rates of major bleeding versus those who received placebo: age >75 years (0.6% vs 0.2%; AD +0.3% [−0.2, 0.9], respectively); age ≤75 years (0.7% vs 0.2%; AD +0.5% [0.1, 0.9]). Patients in both age subgroups that received enoxaparin had similar low bleeding rates (0.6% and 0.7%, respectively). VTE risk increased with age, though the bleeding risk did not. Patients with age >75 years had a more favourable benefit-to-harm profile than younger patients.
- Published
- 2013