ASH News Daily 2012 - Monday, December 10, 2012 - (Page A-3)

Monday, December 10, 2012 MYELOPROLIFERATIVE DISORDERS Vera Veritas: Identifying Hematocrit Targets in P Vera BY MARC J. KAHN, MD, MBA T he abnormal increased production of red blood cells associated with polycythemia vera (PV) leads to an increased risk of thromboembolism and cardiovascular events. Although expert opinion suggests that patients with PV should have their hematocrit values maintained at levels less than 45 percent in order to decrease the risk of cardiovascular events and thromboembolism, this recommendation has not been previously tested in a prospective fashion. Analysis of at least two large studies of PV patients, PVSG-1 and ECLAP, suggested that there was no difference in major thrombosis when the hematocrit was kept in the 40 to 50 percent range. Yesterday, during the Plenary session, Tiziano Barbui, MD, from Bergamo, Italy, presented the first randomized study to date comparing hematocrit values in PV patients. Dr. Barbui is professor of hematology and scientific director of the Research Foundation at Ospedali Riuniti de Bergamo. He had previously served as head of the Department of Hematology in Bergamo. Further, as former president of the Italian Society of Hematology and leader of the GIMEMA group on myeloproliferative disorders, Dr. Barbui’s research interests have recently focused on the optimization of PV and essential thrombocythemia care and therapy. The session was introduced by Claire Harrison, DM, from Guy’s Hospital, London. She reminded us of an observational study published in 1978 that correlated a hematocrit over 45 percent with increased cardiovascular events in patients with PV. Dr. Harrison also reminded us that this study, which appeared in the Lancet, was coincidentally published by investigators from her current institution. Dr. Harrison introduced the session with the notion that despite the advent of JAK2 inhibitors for the treatment of PV, the fundamental question regarding the role of venisection and target hematocrit remains unanswered. Dr. Barbui and his co-investigators presented the results of a large-scale randomized trial involving 21 Italian hematologic centers and included 365 patients. The patients were randomized into two groups. Patients randomly assigned to arm A had their hematocrits maintained at less than 45 percent; patients assigned to arm B had a more permissive approach, maintaining hematocrits of 45 to 50 percent. Patients in both arms were equally treated with antiplatelet drugs or warfarin. Patients in arm A To fi nd out how to download your customizable free app, packed with educational resources to benefi t you and your patients, speak to a representative at our booth. had median hematocrit values of 44 percent, whereas those randomized to arm B had median values of 48 percent. Hematocrit values were maintained by either phlebotomy, cytoreductive therapy, or a combination of both. Target hemoglobin values were reached at six months. Interestingly, the white count was also significantly lower in the group targeted to a lower hematocrit, suggesting the increased use of cytoreductive therapy in that group. The primary endpoint, total cardiovascular events, was four-fold higher in the group with hematocrit values in the 45 to 50 percent range. Additionally, major thrombotic events were significantly decreased in the group with a lower hematocrit. There was no difference in the two groups regarding evolution to myelofibrosis, evolution of myelodysplasia, or incidence of leukemia. Dr. Barbui was quick to assert that these data are relevant for patients with an intrinsic marrow process and should not be generalized to patients with secondary polycythemia due to congenital heart disease or pulmonary disease. Supporting the clinical importance ASH NEWS DAILY Page A–3 ® of Dr. Barbui’s work, the results of this study were just published in the New England Journal of Medicine simultaneously with the ASH presentation. Dr. Barbui and his colleagues have shown the truth in the treatment of PV and truth is beauty. Namely, a target hematocrit value of less than 45 percent is significantly associated with prevention of cardiovascular deaths and major thrombotic complications in patients with PV. Dr. Kahn indicated no relevant conflicts of interest. Visit us at Booth 2219 A free educational app is waiting for you © 2011 Bristol-Myers Squibb All rights reserved. SPRYCEL is a registered trademark of Bristol-Myers Squibb. 729US11AB06309 09/11 729US11AB06309_ASH_DailyNewsAd_7x10.indd 1 Item# 729US11AB06309 TrimSize: 7”x10” 12/5/12 12:15 PM Publication:

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ASH News Daily 2012 - Monday, December 10, 2012

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