Anticoagulants Comparable for Venous Thromboembolism Prevention in Myeloma Patients Receiving Thalidomide Regimens: Presented at EHA
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Anticoagulants Comparable for Venous Thromboembolism Prevention in Myeloma Patients Receiving Thalidomide Regimens: Presented at EHA

By Emma Hitt, PhD

COPENHAGEN, Denmark -- June 18, 2008 -- Warfarin, aspirin, and enoxaparin provide comparable prevention of venous thromboembolism (VTE) in patients with multiple myeloma receiving thalidomide regimens, each achieving an overall rate of VTE of less than 10% in a ongoing study.

Antonio Palumbo, MD, Division of Haematology, University of Torino, Turin, Italy, reported the findings here on June 15 at the 13th Congress of the European Hematology Association (EHA).

Patients in the Italian Group for Haematological Illnesses in Adults (GIMEMA) randomised trial are receiving thalidomide-containing regimens: bortezomib, thalidomide, dexamethasone (VTD); thalidomide, dexamethasone (TD); bortezomib, melphalan, prednisone, and thalidomide (VMPT); and bortezomib, melphalan, prednisone (VMP).

Subsequently, patients were randomised in a substudy to receive VTE prophylaxis during induction therapy. The anticoagulants used were the low-molecular-weight heparin enoxaparin 40 mg/day, aspirin 100 mg/day, and warfarin 1.25 mg/day. Patients treated with VMP did not receive prophylaxis and served as controls.

Dr. Palumbo presented results on 539 patients; the study's final analysis will include 950 patients.

Grade 3/4 thromboembolic events occurred in 1.8% of patients receiving no prophylaxis, 4.5% of patients receiving enoxaparin, 3.9% of patients receiving warfarin, and 5.5% of patients receiving aspirin.

Bleeding occurred in approximately 3.8% of patients receiving no prophylaxis. The lowest incidence of bleeding occurred in patients receiving enoxaparin (0.6%); 1.1% of patients in the warfarin arm and 3.3% of patients in the aspirin arm had any grade of bleeding.

When the incidence of thrombosis and bleeding were combined, rates were 5.1% in the enoxaparin arm, 5.0% in the warfarin arm, and 8.8% in the aspirin arm, which were comparable to the group that received no prophylaxis (5.5%).

According to Dr. Palumbo, the time to onset of thromboembolic events was shortest in the aspirin arm. Of the patients, 40% of patients had at least 2 risk factors for thromboembolic events.

"The overall incidence of VTE was less than 10%. Aspirin, warfarin, and low-molecular-weight heparin are all effective options for prophylaxis," he concluded.

[Presentation title: Enoxaparin Versus Aspirin Versus Low-Fixed-Dose of Warfarin in Newly Diagnosed Myeloma Patients Treated With Thalidomide-Containing Regimens: A Randomized, Controlled Trial. Abstract 910]

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