EXCLAIM Study Publication in Annals of Internal Medicine Shows that Extended Anticoagulant Prophylaxis with Enoxaparin is Beneficial in Acutely Ill Medical Patients

July 6, 2010

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
, 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

“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
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,
(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

Source: newswire

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