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Treatment of essential thrombocythemia in Europe: a prospective long-term observational study of 3649 high-risk patients in the Evaluation of Anagrelide Efficacy and Long-term Safety study

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dc.contributor.author Birgegård, Gunnar
dc.contributor.author Besses Raebel, Carles
dc.contributor.author Griesshammer, Martin
dc.contributor.author Gugliotta, Luigi
dc.contributor.author Harrison, Claire N.
dc.contributor.author Hamdani, Mohamed
dc.contributor.author Wu, Jackie
dc.contributor.author Achenbach, Heinrich
dc.contributor.author Kiladjian, Jean-Jacques
dc.date.accessioned 2018-06-01T07:27:26Z
dc.date.available 2018-06-01T07:27:26Z
dc.date.issued 2018
dc.identifier.citation Birgegård G, Besses C, Griesshammer M, Gugliotta L, Harrison CN, Hamdani M. et al. Treatment of essential thrombocythemia in Europe: a prospective long-term observational study of 3649 high-risk patients in the Evaluation of Anagrelide Efficacy and Long-term Safety study. Haematologica. 2018 Jan;103(1):51-60. DOI: 10.3324/haematol.2017.174672
dc.identifier.issn 0390-6078
dc.identifier.uri http://hdl.handle.net/10230/34774
dc.description.abstract Evaluation of Anagrelide (Xagrid®) Efficacy and Long-term Safety, a phase IV, prospective, non-interventional study performed in 13 European countries enrolled high-risk essential thrombocythemia patients treated with cytoreductive therapy. The primary objectives were safety and pregnancy outcomes. Of 3721 registered patients, 3649 received cytoreductive therapy. At registration, 3611 were receiving: anagrelide (Xagrid®) (n=804), other cytoreductive therapy (n=2666), or anagrelide + other cytoreductive therapy (n=141). The median age was 56 vs. 70 years for anagrelide vs. other cytoreductive therapy. Event rates (patients with events/100 patient-years) were 1.62 vs. 2.06 for total thrombosis and 0.15 vs. 0.53 for venous thrombosis. Anagrelide was more commonly associated with hemorrhage (0.89 vs. 0.43), especially with anti-aggregatory therapy (1.35 vs. 0.33) and myelofibrosis (1.04 vs. 0.30). Other cytoreductive therapies were more associated with acute leukemia (0.28 vs. 0.07) and other malignancies (1.29 vs. 0.44). Post hoc multivariate analyses identified increased risk for thrombosis with prior thrombohemorrhagic events, age ≥65, cardiovascular risk factors, or hypertension. Risk factors for transformation were prior thrombohemorrhagic events, age ≥65, time since diagnosis, and platelet count increase. Safety analysis reflected published data, and no new safety concerns for anagrelide were found. Live births occurred in 41/54 pregnancies (76%). clinicaltrials.gov Identifier: 00567502.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher Ferrata Storti Foundation
dc.rights Material published in Haematologica is covered by copyright. All rights are reserved to the Ferrata Storti Foundation. Use of published material is allowed under the following terms and conditions: https://creativecommons.org/licenses/by-nc/4.0/legalcode. Copies of published material are allowed for personal or internal use. Sharing published material for non-commercial purposes is subject to the following conditions: https://creativecommons.org/licenses/by-nc/4.0/legalcode, sect. 3. Reproducing and sharing published material for commercial purposes is not allowed without permission in writing from the publisher.
dc.subject.other Trombocitopènia -- Tractament -- Europa
dc.title Treatment of essential thrombocythemia in Europe: a prospective long-term observational study of 3649 high-risk patients in the Evaluation of Anagrelide Efficacy and Long-term Safety study
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.3324/haematol.2017.174672
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion


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