Cardiovascular Safety of Anagrelide Hydrochloride versus Hydroxyurea in Essential Thrombocythaemia
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Cardiovascular Safety of Anagrelide Hydrochloride versus Hydroxyurea in Essential Thrombocythaemia Mirjana Gotic1 · Miklos Egyed2 · Liana Gercheva3 · Krzysztof Warzocha4 · Hans Michael Kvasnicka5 · Heinrich Achenbach6 · Jingyang Wu7 Received: 3 December 2019 / Accepted: 16 October 2020 © The Author(s) 2020
Abstract Essential thrombocythaemia (ET) is a rare myeloproliferative neoplasm. This multicentre, Phase 3b, randomised, openlabel, non-inferiority study investigated the cardiac safety, efficacy and tolerability of first-line treatment with anagrelide or hydroxyurea in high-risk ET patients for up to 3 years. Eligible patients aged ≥ 18 years with a diagnosis of high-risk ET confirmed by bone marrow biopsy within 6 months of randomisation received anagrelide (n = 75) or hydroxyurea (n = 74), administered twice daily. Treatment dose for either compound was titrated to the lowest dose needed to achieve a response. Planned primary outcome measures were change in left ventricular ejection fraction from baseline over time and platelet count at Month 6. Planned secondary outcome measures were platelet count change from baseline at Months 3 and 36; percentage of patients with complete or partial response; time to complete or partial response; number of patients with thrombohaemorrhagic events; and changes in white blood cell count or red blood cell count over time. Neither treatment altered cardiac function. There were no significant differences in adverse events between treatment groups, and no reports of malignant transformation. The incidence of disease-related thrombotic or haemorrhagic events was numerically higher in anagrelide-treated patients. Both treatments controlled platelet counts at 6 months, with the majority of patients experiencing complete or partial responses. In conclusion, these results suggest that long-term treatment with anagrelide is not associated with adverse effects on cardiac function. This is one of the few studies using left ventricular ejection fraction assessment and central biopsy reading to confirm the diagnosis of ET. Trial registration number: Clinicaltrials.gov NCT00202644 Keywords Cardiac safety · Anagrelide · Essential thrombocythaemia · Hydroxyurea · Platelet counts
Introduction
Communicated by Dipak K Dube. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12012-020-09615-0) contains supplementary material, which is available to authorised users. * Mirjana Gotic [email protected] 1
Clinic for Hematology Clinical Centre of Serbia Belgrade, Medical Faculty, University of Belgrade, Koste Todorovica 2, 11000 Belgrade, Serbia
2
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár 7400, Hungary
3
Clinic of Hematology, University Hospital St. Marina, 9010 Varna, Bulgaria
Essential thrombocythaemia (ET) is a rare myeloproliferative neoplasm characterised by elevated platelet counts, megakaryocyte hyperplasia and enlargement, and one of the following: JAK2, CALR or MPL mutations, a clonal marker, or lack of evidence for rea
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