( ng the standard of care of patients at...)New Study Shows That Extending Prophylaxis With Clexane / Lovenox,(enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10,Days for Reducing the Risk of Venous Thromboembolism (VTE) in,Acutely ill Medical Patients With Reduced Mobility,Health
| HOME >> MEDICINE >> TECHNOLOGY |
ng the standard of care of patients at high risk for VTE and it further establishes enoxaparin as a reference treatment for VTE prophylaxis in acutely ill medical patients".
About EXCLAIM
The EXCLAIM trial is the first international, multicenter, prospective, randomized, double-blind, placebo-controlled study. It enrolled 5,105 acutely-ill patients with recent reduced mobility in 20 countries, comparing extended-duration (28 plus or minus 4 days) venous thromboembolism (VTE) prophylaxis with enoxaparin, a low-molecular-weight heparin (LMWH) with the standard regimen of enoxaparin (10 plus or minus 4 days) for the prophylaxis of VTE.
Patients recently immobilized for up to 3 days with level 1 mobility (total bed rest or sedentary patients) or with level 2 mobility (with bathroom privileges) with age > 75 years or history of VTE or diagnosis of cancer and predefined acute medical illness were randomized to received enoxaparin 40 mg subcutaneously once daily for 10 plus or minus 4 days and were then randomized to receive the same enoxaparin regimen or placebo for an additional 28 plus or minus 4 days.
The steering committee followed the Data Safety Monitoring Board (DSMB) suggestion that in addition to level 1 mobility patients to re-define the inclusion criteria by adding on level 2 mobility patients inclusion criteria : Age >75 years, or prior VTE or diagnosed cancer.
The objective of the Exclaim study was to assess the superiority of enoxaparin prophylaxis given for 28 plus or minus 4 days versus placebo, both following an initial treatment with enoxaparin for 10 plus or minus 4 days, to reduce VTE events
The primary efficacy endpoint was the incidence of asymptomatic
deep-vein thrombosis (DVT) detected by routine standardized
ultrasonography, symptomatic DVT, symptomatic pulmonary embolism
(PE), or fatal PE during the double-blind period. Secondary
efficacy endpoints include the incidence of VTE at 3 months and the
incidenc
'"/>
Related medicine technology :
1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
3. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
8. Protox Announces Positive Clinical Data from Prostate Cancer Study
9. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
10. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
11. New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV
| Copyright © 2003-2009 Bio-Medicine. All rights reserved. ABOUT | CONTACT US | DISCLAIMER | PRIVACY POLICY | TERMS AND CONDITIONS |  |