Speaker: Benjamin Brenner, MD, Associate Professor of Hematology, The Bruce Rappaport Faculty of Medicine, Tech-nicon-Israel Institute of Technology, Haifa, Israel.
Enoxaparin (Lovenox®, Aventis), a well-known, low-molecular-weight heparin, has been shown to be safe and comparatively effective in preventing miscarriages in thrombophilic women with a history of recurrent pregnancy loss.
It is estimated that recurrent pregnancy loss affects 2% to 5% of all couples desiring children. Maternal thrombo-philia, a blood disorder that poses an increased risk of thrombosis, has been associated with recurrent pregnancy loss. Researchers performed a multicenter, prospective, randomized trial to investigate the use of an anticoagulant therapy with enoxaparin for improving pregnancy outcomes in these women.
In all, 183 patients were enrolled in the study at five to 10 weeks of gestation. The women were grouped according to type of thrombophilia, trimester distribution, and number of previous pregnancy losses, including three or more losses in the first trimester, two or more in the second trimester, and one or more in the third trimester. Treatment with enoxaparin 40 mg/day and 80 mg/day (40 mg twice daily) was given throughout the pregnancy and the postpartum period. The primary efficacy endpoint was delivery of a live, healthy infant. Safety endpoints included bleeding episodes in the newborns and thrombocytopenia in the mothers.
Enoxaparin therapy significantly increased the rate of live births, compared with the patients’ historical rates of live birth (81.4% vs. 28.2% for enoxaparin 40 mg and 76.5% vs. 28.3% for enoxaparin 80 mg). Treatment with enoxaparin also decreased the rate of pre-eclampsia and placental abruption. It is also noteworthy that no instances of maternal or neonatal bleeding were observed.
Aspirin for Polycythemia Vera
Speaker: Raffaele Landofi, MD, PhD, Professor of Medicine, Istituto di Medicina Interna e Geriatria, Universita Cattolica, and Director, Clinical Service for Coagulation Disorders, A. Gemelli Hospital, Rome, Italy.
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The use of low-dose aspirin has been found to significantly reduce the risk of thrombosis in patients with polycythemia vera, a disorder marked by an abnormal increase in red blood cells (RBCs) resulting from excess production by the bone marrow. Patients with polycythemia have an increased tendency to form blood clots that can lead to heart attacks or strokes.
In an attempt to find a treatment to improve upon the present method of cytoreduction—removing some of the patient’s blood periodically—the Efficacy and Safety of Low Dose Aspirin in Polycythemia Vera (ECLAP) Study was designed to test the effect of low-dose aspirin (100 mg daily) in patients with polycythemia vera. Initially, 1,630 patients were enrolled in this multicenter, parallel, double-blind, randomized clinical trial from 12 countries, including 11 patients from Europe and Israel. Of these, 512 patients were judged to have no clear contraindication to aspirin treatment and were randomly assigned to receive a 100-mg daily dose of aspirin or placebo. Sixty percent of the study participants were men, with a mean age of 61 years, who had the disease for an average of seven years. The follow-up duration was about three years.
For the primary study endpoints, treatment with low-dose aspirin significantly lowered the risk of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and all major arterial and venous thromboses. In addition, the risk of minor thrombotic events was significantly decreased. Major, total, and gastrointestinal bleeding episodes were slightly but not significantly increased.