Journal article
Extended-Duration Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients With Recently Reduced Mobility
Annals of Internal Medicine, Vol.153(1)
2010
Abstract
BACKGROUND:
Extended-duration low-molecular-weight heparin has been shown to prevent venous thromboembolism (VTE) in high-risk surgical patients.
OBJECTIVE:
To evaluate the efficacy and safety of extended-duration enoxaparin thromboprophylaxis in acutely ill medical patients.
DESIGN:
Randomized, parallel, placebo-controlled trial. Randomization was computer-generated. Allocation was centralized. Patients, caregivers, and outcome assessors were blinded to group assignment. (ClinicalTrials.gov registration number: NCT00077753) SETTING: 370 sites in 20 countries across North and South America, Europe, and Asia.
PATIENTS:
Acutely ill medical patients 40 years or older with recently reduced mobility (bed rest or sedentary without [level 1] or with [level 2] bathroom privileges). Eligibility criteria for patients with level 2 immobility were amended to include only those who had additional VTE risk factors (age >75 years, history of VTE, or active or previous cancer) after interim analyses suggested lower-than-expected VTE rates.
INTERVENTION:
Enoxaparin, 40 mg/d subcutaneously (2975 patients), or placebo (2988 patients), for 28 +/- 4 days after receiving open-label enoxaparin for an initial 10 +/- 4 days.
MEASUREMENTS:
Incidence of VTE up to day 28 and of major bleeding events up to 48 hours after the last study treatment dose.
RESULTS:
Extended-duration enoxaparin reduced VTE incidence compared with placebo (2.5% vs. 4%; absolute risk difference favoring enoxaparin, -1.53% [95.8% CI, -2.54% to -0.52%]). Enoxaparin increased major bleeding events (0.8% vs. 0.3%; absolute risk difference favoring placebo, 0.51% [95% CI, 0.12% to 0.89%]). The benefits of extended-duration enoxaparin seemed to be restricted to women, patients older than 75 years, and those with level 1 immobility.
LIMITATION:
Estimates of efficacy and safety for the overall trial population are difficult to interpret because of the change in eligibility criteria during the trial.
CONCLUSION:
Use of extended-duration enoxaparin reduces VTE more than it increases major bleeding events in acutely ill medical patients with level 1 immobility, those older than 75 years, and women.
Details
- Title
- Extended-Duration Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients With Recently Reduced Mobility
- Authors/Creators
- Russell D. Hull (Author/Creator) - University of CalgaryS.M Schellong (Author/Creator)M. Monreal (Author/Creator)M.M. Samama (Author/Creator)P Nicol (Author/Creator)E Vicaut (Author/Creator)A.G. Turpie (Author/Creator)R.D. Yusen (Author/Creator)R. Baker (Author/Creator)
- Publication Details
- Annals of Internal Medicine, Vol.153(1)
- Publisher
- American College of Physicians
- Identifiers
- 991005544872707891
- Murdoch Affiliation
- Institute for Immunology and Infectious Diseases
- Language
- English
- Resource Type
- Journal article
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Citation topics
- 1 Clinical & Life Sciences
- 1.75 Blood Clotting
- 1.75.271 Venous Thromboembolism
- Web Of Science research areas
- Medicine, General & Internal
- ESI research areas
- Clinical Medicine