@article{Gunnar Birgegård_Carlos Besses_Martin Griesshammer_Luigi Gugliotta_Claire N. Harrison_Mohamed Hamdani_Jingyang Wu_Heinrich Achenbach_Jean-Jacques Kiladjian_2017, place={Pavia, Italy}, 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}, volume={103}, url={https://haematologica.org/article/view/8321}, DOI={10.3324/haematol.2017.174672}, abstractNote={Evaluation of Anagrelide (Xagrid<sup>®</sup>) 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<sup>®</sup>) (n=804), other cytoreductive therapy (n=2666), or anagrelide + other cytoreductive therapy (n=141). The median age was 56 <em>vs.</em> 70 years for anagrelide <em>vs.</em> other cytoreductive therapy. Event rates (patients with events/100 patient-years) were 1.62 <em>vs.</em> 2.06 for total thrombosis and 0.15 <em>vs.</em> 0.53 for venous thrombosis. Anagrelide was more commonly associated with hemorrhage (0.89 <em>vs.</em> 0.43), especially with anti-aggregatory therapy (1.35 <em>vs.</em> 0.33) and myelofibrosis (1.04 <em>vs.</em> 0.30). Other cytoreductive therapies were more associated with acute leukemia (0.28 <em>vs.</em> 0.07) and other malignancies (1.29 <em>vs.</em> 0.44). <em>Post hoc</em> 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%). <em><a href="http://clinicaltrials.gov">clinicaltrials.gov</a> Identifier: 00567502.</em&gt;}, number={1}, journal={Haematologica}, author={Gunnar Birgegård and Carlos Besses and Martin Griesshammer and Luigi Gugliotta and Claire N. Harrison and Mohamed Hamdani and Jingyang Wu and Heinrich Achenbach and Jean-Jacques Kiladjian}, year={2017}, month={Dec.}, pages={51-60} }