EXCLAIM Study Publication in Annals of Internal Medicine Shows that Extended Anticoagulant Prophylaxis with Enoxaparin is Beneficial in Acutely Ill Medical Patients
NEW YORK, July 6, 2010 /PRNewswire/ -- The Steering Committee of the EXCLAIM study that explored the benefit of extended prophylaxis of venous thrombo embolism (VTE) with enoxaparin in acutely ill medical patients, announced today the publication of the comprehensive study results in the peer-reviewed journal Annals of Internal Medicine.
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The study showed that in recently immobilized patients, who received usual short-term prophylaxis of 10 days (+/- 4) with the standard of care enoxaparin (Lovenox/Clexane), an additional 28 days (+/- 4) prophylaxis with enoxaparin further reduced the risk of VTE events (2.5% for enoxaparin arm vs. 4% for placebo comparator [absolute risk reduction 1.5%; 95.8% CI -2.54% to -0.52%]);
The populations who benefited most from the extended anticoagulation prophylaxis with enoxaparin included patients with restricted mobility (Level 1 immobilisation, confined to bed), elderly patients (older than 75 years) and women. This reduction in VTE risk was largely attributable to the reduction of some of the most serious forms of deep vein thrombosis, the symptomatic manifestations.
The EXCLAIM randomized trial enrolled 6085 acutely ill medical patients, with recently reduced mobility, in 370 sites in 20 countries across North America, South America, Europe and Asia. Patients where classified according to immobility criteria: Level 1 (bed rest or sedentary without bathroom privilege), Level 2 (as previously with bathroom privilege). After an interim analysis, eligibility criteria for patients with Level 2 immobility were amended to include only those who had at least one of three additional risk factors (i.e., age > 75 years, history of VTE, cancer)
In the extended prophylaxis phase, the bleeding risk was generally manageable with a major bleeding rate of 0.8% in the enoxaparin arm and 0.3% in the placebo arm. This difference was similar to what was generally observed in placebo-controlled trials of standard-duration VTE anticoagulant prophylaxis.
"EXCLAIM study gathered momentous information that will help improve the understanding of VTE risk in acutely ill populations, and is opening a new path for the individualised anticoagulation management of recently immobilised patients according to their individual risk profile" said Pr Russell Hull from the Calgary University, Canada, lead author of the publication and chair of the Steering Committee.
"EXCLAIM landmark trial is the largest study that established that the heterogeneous group of acutely ill patients continue to be exposed to VTE risk after the usual short term anticoagulant prophylaxis, similarly to the patients undergoing high risk major orthopedic surgery " said Pr Turpie, from McMaster University, Canada, and member of the study Steering Committee.
"A decade after MEDENOX study that established the benefit of enoxaparin based short term prophylaxis in acutely ill medical patients, EXCLAIM is building in this paradigm and highlighting even further the necessity to optimising enoxaparin thromboprophylaxis according to patients' venothrombotic risks" added Pr Samama, from Hotel-Dieu Hospital Paris, member of the EXCLAIM study Steering Committee
EXCALAIM study was sponsored by sanofi-aventis, the company that discovered and developed enoxaparin, the worldwide standard low molecular weight heparin that is available under the brand name Lovenox /Clexane.
About the EXCLAIM Study Steering Committee:
Russell D. Hull, MBBS; Sebastian M. Schellong, MD; Victor F. Tapson, MD; Manuel Monreal, MD; Meyer-Michel Samama, MD PharmD; Philippe Nicol, PhD; Eric Vicaut, MD, PhD; Alexander G.G. Turpie, MD; Roger D. Yusen, MD, MPH
University of Calgary, Foothills Hospital, Calgary, Alberta, Canada (Dr Hull); Hospital Carl Gustav Carus, Dresden, Germany (Dr Schellong); Duke University Medical Center, Durham, NC, USA (Dr Tapson); Hospital Germans Trias i Pujol, Barcelona, Spain (Dr Monreal); Service d'Hematologie Biologique Hotel-Dieu, Paris, France (Dr Samama); sanofi-aventis, Paris, France (Dr Nicol); McMaster University; HHSC McMaster Clinic, Hamilton, Ontario, Canada (Dr Turpie); and Washington University School of Medicine, St. Louis, MO, USA (Dr Yusen).
About Venous Thromboembolism (VTE)
Venous thromboembolism is a general term describing the formation of a blood clot (thrombus) that blocks a vessel. The thrombus may occur in any part of the venous system, but the most common manifestations are deep-vein thrombosis (DVT), usually in the leg, and pulmonary embolism (PE, occurs when all or part of the blood clot dislodges from the vessel wall and travels through the venous system to the lungs).
SOURCE EXCLAIM Study Steering Committee