Cardiovascular Events and Intensity of Treatment in Polycythemia Vera
Roberto Marchioli,Guido Finazzi,Giorgina Specchia,Rossella R. Cacciola,Riccardo Cavazzina,Daniela Cilloni,Valerio De Stefano,Elena Maria Elli,Alessandra Iurlo,Roberto Latagliata,Francesca Lunghi,Monia Lunghi,Rosa Maria Marfisi,Pellegrino Musto,Arianna Masciulli,Caterina Musolino,Nicola Cascavilla,Giovanni Quarta,Maria Luigia Randi,Davide Rapezzi,Marco Ruggeri,Elisa Rumi,Anna Rita Scortechini,Simone Santini,Marco Scarano,Sergio Siragusa,Antonio Spadea,Alessia Tieghi,Emanuele Angelucci,Giuseppe Visani,Alessandro M. Vannucchi,Tiziano Barbui +31 more
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TLDR
In patients with polycythemia vera, those with a hematocrit target of less than 45% had a significantly lower rate of cardiovascular death and major thrombosis than did those with an intended target of 45 to 50%.Abstract:
A b s t r ac t Background Current treatment recommendations for patients with polycythemia vera call for maintaining a hematocrit of less than 45%, but this therapeutic strategy has not been tested in a randomized clinical trial. Methods We randomly assigned 365 adults with JAK2-positive polycythemia vera who were being treated with phlebotomy, hydroxyurea, or both to receive either more intensive treatment (target hematocrit, <45%) (low-hematocrit group) or less intensive treatment (target hematocrit, 45 to 50%) (high-hematocrit group). The primary composite end point was the time until death from cardiovascular causes or major thrombotic events. The secondary end points were cardiovascular events, cardiovascular hospitalizations, incidence of cancer, progression to myelofibrosis, myelodysplasia or leukemic transformation, and hemorrhage. An intention-to-treat analysis was performed. Results After a median follow-up of 31 months, the primary end point was recorded in 5 of 182 patients in the low-hematocrit group (2.7%) and 18 of 183 patients in the highhematocrit group (9.8%) (hazard ratio in the high-hematocrit group, 3.91; 95% confidence interval [CI], 1.45 to 10.53; P = 0.007). The primary end point plus superficial-vein thrombosis occurred in 4.4% of patients in the low-hematocrit group, as compared with 10.9% in the high-hematocrit group (hazard ratio, 2.69; 95% CI, 1.19 to 6.12; P = 0.02). Progression to myelofibrosis, myelodysplasia or leukemic transformation, and bleeding were observed in 6, 2, and 2 patients, respectively, in the low-hematocrit group, as compared with 2, 1, and 5 patients, respectively, in the high-hematocrit group. There was no significant between-group difference in the rate of adverse events. Conclusions In patients with polycythemia vera, those with a hematocrit target of less than 45% had a significantly lower rate of cardiovascular death and major thrombosis than did those with a hematocrit target of 45 to 50%. (Funded by the Italian Medicines Agency and others; ClinicalTrials.gov number, NCT01645124, and EudraCT number, 2007–006694-91.)read more
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Ruxolitinib versus Standard Therapy for the Treatment of Polycythemia Vera
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References
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Journal ArticleDOI
Efficacy and Safety of Low-Dose Aspirin in Polycythemia Vera
Raffaele Landolfi,Roberto Marchioli,Jack Kutti,Heinz Gisslinger,Gianni Tognoni,Carlo Patrono,Tiziano Barbui +6 more
TL;DR: Low-dose aspirin can safely prevent thrombotic complications in patients with polycythemia vera who have no contraindications to such treatment, and reduced the risk of the combined end point of nonf fatal myocardial infarction, nonfatal stroke, pulmonary embolism, major venous thromBosis, or death from cardiovascular causes.
Journal ArticleDOI
A Comparison of Two Intensities of Warfarin for the Prevention of Recurrent Thrombosis in Patients with the Antiphospholipid Antibody Syndrome
Mark Crowther,Jeffrey S. Ginsberg,Jim A. Julian,Judah A. Denburg,Jack Hirsh,James D. Douketis,Carl A. Laskin,Paul R. Fortin,David C. Anderson,Clive Kearon,Ann E. Clarke,William Geerts,Melissa A. Forgie,David Green,Lorrie Costantini,Wendy Yacura,Sarah E. Wilson,Michael Gent,Michael J. Kovacs +18 more
TL;DR: The low rate of recurrent thrombosis among patients in whom the target INR was 2.0 to 3.0 suggests that moderate-intensity warfarin is appropriate for patients with the antiphospholipid antibody syndrome.
Journal ArticleDOI
Philadelphia-Negative Classical Myeloproliferative Neoplasms: Critical Concepts and Management Recommendations From European LeukemiaNet
Tiziano Barbui,Giovanni Barosi,Gunnar Birgegård,Francisco Cervantes,Guido Finazzi,Martin Griesshammer,Claire N. Harrison,Hans Carl Hasselbalch,Rüdiger Hehlmann,Ronald Hoffman,Jean-Jacques Kiladjian,Kröger N,Ruben A. Mesa,Mary Frances McMullin,Animesh Pardanani,Francesco Passamonti,Alessandro M. Vannucchi,Andreas Reiter,Richard T. Silver,Srdan Verstovsek,Ayalew Tefferi +20 more
TL;DR: A review of critical concepts and recommendations on the management of Philadelphia-negative classical myeloproliferative neoplasms, including monitoring, response definition, first- and second-line therapy, and therapy for special issues are presented.
Journal ArticleDOI
Vascular and Neoplastic Risk in a Large Cohort of Patients With Polycythemia Vera
Roberto Marchioli,Guido Finazzi,Raffaele Landolfi,Jack Kutti,Heinz Gisslinger,Carlo Patrono,Raphael Marilus,Ana Villegas,Gianni Tognoni,Tiziano Barbui +9 more
TL;DR: The persistently high mortality rate from hematologic malignancies characterizes the unmet therapeutic need of polycythemic patients and suggests a priority for future studies in this disease.
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