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More on VTE in cancer…

http://www.pfizer.ca/english/newsroom/press%20releases/default.asp?s=1&year=2005&releaseID=1...

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New Fragmin Indication Fights Second Leading Cause of Death in Cancer Patients, Cancer-Associated Thrombosis

Pfizer drug shown effective in preventing cancer-associated blood clots

Kirkland, Quebec - March 29, 2005 – Pfizer Oncology today announced that its low molecular weight heparin FRAGMIN (dalteparin sodium) has been approved by Health Canada as therapy to reduce the recurrence of cancer-associated venous thromboembolism (VTE or clots in the blood vessels). FRAGMIN is the first and only drug in Canada to have this indication.

Venous thromboembolism, which includes deep vein thrombosis (DVT) and resulting pulmonary emboli (PE) is the second leading cause of death in people affected by cancer, after death from the cancer itself.1 Thrombosis (or blood clots) is a common complication in patients with malignant disease, with up to 15 percent of patients developing a clot with major symptoms and serious outcomes. The occurrence of a blood clot can have a significant impact on a cancer patient's quality of life and in some instances can be life-threatening.

"VTE poses a substantial risk for patients with cancer," said Dr. Agnes Lee, MD, Associate Professor of Medicine, McMaster University. "In fact, cancer patients have a three times higher risk of recurrent thromboembolism than patients without cancer. In these patients with cancer, FRAGMIN has been shown to reduce the risk of recurrent VTE by more than 50 percent compared to the current standard of care using Warfarin."

Formation of a clot within a blood vessel or thrombosis may be damaging as it can block blood flow to vital organs. Also, part of the clot may break away and cause a blockage further along the blood vessel (an embolism) or in the lung (PE).

Thrombosis is one of the most common complications in cancer patients - up to 1 in 7 patients will develop thromboembolism at some point. One in seven hospitalized people affected by cancer will die from a pulmonary embolism.

FRAGMIN is a clot-preventing agent in a class of drugs known as low molecular weight heparins. In Canada, FRAGMIN is now indicated for the following:

• Thromboprophylaxis (prevention of thrombosis) in conjunction with surgery
• Treatment of acute deep vein thrombosis
• Unstable coronary artery disease (UCAD), i.e., unstable angina and non-Q-wave myocardial infarction
• Prevention of clotting in the extracorporeal system during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency
• Extended treatment of symptomatic VTE to prevent recurrence of venous thromboembolism in patients with cancer.

A multinational, Canadian-led randomized, open-label clinical trial known as CLOT (short for "Randomized Comparison of Low Molecular Weight Heparin versus Oral Anticoagulant Therapy for Long Term Anticoagulation in Cancer Patients with Venous Thromboembolism) evaluated the efficacy of FRAGMIN against the current standard therapy, warfarin, in people affected by cancer who required treatment for acute VTE, or clots in blood vessels.4

The study showed FRAGMIN reduced the risk of recurrent VTE by 52 percent compared with warfarin in the long-term treatment of VTE. The cumulative rate of recurrent VTE events over a 6-month period was reduced from 17.4 percent in the warfarin group to 8.8 percent in the FRAGMIN group.

Additional clinical studies with FRAGMIN are being conducted in cancer to evaluate its impact on patient survival.
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