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Research Highlights New Approaches to Prevent Blood Clots in Several High-Risk Patient Populations Including Largest Study Ever to Examine Use of Blood-Thinning Medication in Patients With Cancer
Date:12/7/2008

hemotherapy. The primary outcome of the study was the combined occurrence of clinically overt venous or arterial thromboembolic events (i.e., deep-vein thrombosis of the lower and upper limbs, visceral and cerebral venous thrombosis, pulmonary embolism, acute myocardial infarction, ischemic stroke, acute peripheral arterial thromboembolism, and unexplained death of possible thromboembolic origin). Major bleeding was the main safety parameter.

In this study, 1,166 patients with advanced lung (279), colon (235), breast (165), ovarian (143), stomach (98), rectal (87), pancreatic (53), head and neck (36), and other cancers (54) were randomized to one of two treatment arms: once-daily subcutaneous injections of nadroparin (3,000 IU) or placebo. Twice as many patients were enrolled into the nadroparin group than the placebo group. Treatment was started on the first day of the current cycle of chemotherapy and was maintained for the overall duration of chemotherapy treatment or up to a maximum of four months.

Only 16 of the 769 patients treated with nadroparin had a thromboembolic event (2.1 percent) compared with 15 of the 381 patients (3.9 percent) in the placebo group, a 47.2 percent reduction in the risk of developing a thromboembolic event for the patients in the treatment arm. The drug also appeared to be safe as only five patients in the nadroparin group (0.7 percent) experienced a major bleeding episode, and the incidence of minor bleeding in the treatment arm was similar to that of the placebo group.

Venous thromboembolism occurred 11 times in both the nadroparin and placebo groups. Fifteen of these events occurred in patients with lung cancer (4 percent in the nadroparin arm and 8.8 percent in the placebo arm). Patients with pancreatic cancer also experienced a high overall rate of thromboembolic events (7.5 percent). While this study confirms that nadroparin reduces the incidence of thromboembolic ev
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SOURCE American Society of Hematology
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