EXCLAIM Study Publication in Annals of Internal Medicine Shows that Extended Anticoagulant Prophylaxis with Enoxaparin is Beneficial in Acutely Ill Medical Patients
Patients with Restricted Mobility, Elderly and Women Subgroups Drive the Patients' Benefit
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
Author Affiliations:
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).
Video: http://multivu.prnewswire.com/mnr/prne/exclaim/44182/
Source: EXCLAIM Study Steering Committee
Media Contact: Salah Mahyaoui, salah.mahyaoui@sanofi-aventis.com Telephone: +33-6-73-68-78-88
Posted: July 2010
