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Studies challenge standards to improve treatment outcomes for patients with clotting disorders
Date:12/8/2012

re liberal approach (keeping hematocrit levels between 45 and 50%), investigators from Italy conducted a study comparing the two strategies among 365 patients with newly diagnosed PV. Patients in Arm A were treated aggressively to maintain hematocrit levels at less than 45 percent, while the patients in Arm B were treated to maintain levels between 45 and 50 percent. The primary composite endpoint was major clots, including stroke, heart attack, transient ischemic attacks ("mini strokes"), clots in the veins in the abdomen, DVT or PE, and cardiovascular death.

The investigators observed that the risk of developing major clots was four times higher in those patients whose hematocrit levels were kept between 45 and 50 percent than in patients whose levels were kept below 45 percent. With the more intensive regimen in Arm A, 1.1 percent of the patients had a major clot versus 4.4 percent in the less aggressive regimen in Arm B. The median hematocrit levels during follow-up were 44 percent and 48 percent, respectively. Treatment with phlebotomy, anti-clotting drugs, and hydroxyurea were comparable.

There was no difference in the safety profile between the regimens. Six patients in Arm A and one patient in Arm B developed myelofibrosis, a blood disorder that causes the bone marrow to be replaced by scar tissue. Researchers observed no statistical difference in the frequency of acute leukemias that occurred in three patients in Arm A and one patient in Arm B.

"These data validate the notion that it is important to keep hematocrit levels below 45 percent for this population of patients who are at a high risk of developing clotting complications," said Tiziano Barbui, MD, lead author and Professor of Hematology and Scientific Director of the Research Foundation at Ospedali Riuniti di Bergamo in Italy. "The results from our study will be especially important in the development of new drugs for polycythemia vera, as we look to maintain these leve
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Contact: Andrea Slesinski
aslesinski@hematology.org
614-352-5096
American Society of Hematology
Source:Eurekalert

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