who is the seller/s, page-6

more good arixtra news For anybody interested, Arixtra (the drug that acl is developing a generic version of) did well in a VTE study.
Synthetic Heparin continues to show that it is safer and better than other forms of heparin:

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ARIXTRA® was effective and well tolerated in acutely ill medical patients — treatment reduced risk of venous thromboembolism (VTE)


Pivotal Study Published in British Medical Journal Reports:


London, UK/Philadelphia, PA, 13 February, 2006 - Results from the ARTEMIS study of ARIXTRA® (fondaparinux sodium) demonstrated that treatment with the antithrombotic reduced patients’ risk of overall VTE by nearly half (46.7%), with no increased risk of major bleeds compared with placebo. The ARTEMIS study (ARixtra® for ThromboEmbolism prevention in a Medical Indications Study), was published in the 11 February issue of the British Medical Journal and evaluated the overall efficacy and safety of ARIXTRA® in older acutely medically ill patients. Treatment with ARIXTRA® also was associated with a significant reduction in fatal pulmonary embolism.1


"VTE presents a significant risk to this patient population, however we have had limited understanding of the effectiveness of clot prevention to address VTE in this group,” said Alexander Cohen MD, Honorary Consultant Vascular Physician, King's College Hospital, London and Chairman of the Steering Committee of the ARTEMIS study. “These results show that ARIXTRA® is an effective and well tolerated treatment that can reduce the risk of VTE for these patients, further helping us to define the role of antithromboticsin this setting.”


VTE in the Acutely Ill

VTE refers to a common disease state comprising deep vein thrombosis and pulmonary embolism. It is a major cause of morbidity and death among hospitalised patients.2


VTE is a potential risk for many acutely ill medical patients admitted to the hospital. Acutely ill medical patients may be those with congestive heart failure, respiratory illness, and infectious or inflammatory disease.1 Each of these acute medical conditions are strong independent risk factors for VTE, and may also cause prolonged immobilization, another risk factor for VTE.3-5


Each year an increased number of patients are admitted to the hospital for acute medical illnesses and the number of VTE cases is expected to increase.6 Hospitalisation for an acute medical illness is itself independently associated with an increased relative risk of VTE.7


“Results from ARTEMIS support the growing body of evidence demonstrating the efficacy of ARIXTRA® with no increased risk of major bleeding in venous thrombosis, “ said Dr. Lawson Macartney, senior vice-president, Cardiovascular and Metabolic Medicine Development Centre, GlaxoSmithKline. “GSK is excited about these results that support ARIXTRA® in the treatment of this population, and may help to expand the application of ARIXTRA® in clinical practice.”


ARTEMIS

ARTEMIS is a double blind, randomised, placebo-controlled trial that included 849 patients in 35 sites across 8 countries. Patients were at least 60 years old and were admitted to hospital for congestive heart failure, acute respiratory illness (in the presence of chronic lung disease) or acute infections or inflammatory disease. Patients were expected to remain in bed for at least four days.1


Patients were randomised to receive ARIXTRA® 2.5 mg or placebo once daily subcutaneous injections for 6 to 14 days. Study treatment began within 48 hours of admission. Treatment lasted for a median of 7 days (range 1-15 days) in the fondaparinux group and 7 days (range 1-13 days) in the placebo group. A total of 644 patients (75.9%) were available for the primary efficacy analysis. Baseline characteristics were similar between the two groups.1


The primary efficacy outcome was VTE detected by routine bilateral venography along with symptomatic VTE up to day 15. Results showed that VTE was detected in 5.6% (18/321) of patients treated with ARIXTRA® versus 10.5% (34/323) of patients on placebo, demonstrating a significant reduction in relative risk (46.7%; p=0.029).1


Safety outcomes were bleeding and death. Major bleeding occurred in one patient (0.2%) in each group and minor bleeds were observed in 11 patients (2.6%) in the fondaparinux group and four (1.0%) in the placebo group. No patients in the fondaparinux group and five in the placebo group had fatal pulmonary embolism (P = 0.029).1


Patients were followed up at one month.


ARIXTRA®

ARIXTRA® is the first in a new class of antithrombotics that selectively inhibits Factor Xa, a central protein in the coagulation process. In the treatment of thrombosis, Factor Xa plays a central role in the generation of thrombin, a protease in blood that facilitates blood clotting. There have been no reported cases of heparin-induced thrombocytopenia (HIT) in patients receiving ARIXTRA. HIT is a potentially fatal side effect of heparin. For more information about ARIXTRA, please visit www.arixtra,com


ARIXTRA is not currently approved in the US for acutely medically ill patients.


References:

1. BMJ, doi: 10.1136/bmj.38733.466748.7C (published 26 January 2006).

2. Deep-Vein Thrombosis: Advancing Awareness to Protect Patient Lives. White Paper, American Public Health Association, 26 February 2003.

3. THRIFT Consensus Group. Risk of and prophylaxis for venous thromboembolism in hospital patients. BMJ. 1992; 305: 567–574.

4. Geerts WH, Heit JA, Clagett GP, et al. Prevention of venous thromboembolism. Chest. 2001; 119 (suppl 1): 132S–175S.

5. Kearon C. Epidemiology of venous thromboembolism. Semin Vasc Med. 2001; 1: 7–25.

6. Heit JA, Silverstein MD, Mohr DN, et al. The epidemiology of venous thromboembolism in the community. Thromb Haemost. 2001; 86: 452–463.

7. Heit J, O'Fallon W, Petterson T, et al. Relative impact of risk factors for deep vein thrombosis and pulmonary embolism: a population-based study. Arch Intern Med 2002;162:1245–1248.