Anagrelide noninferior to hydroxyurea in essential thrombocythemia
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Anagrelide was associated with similar thrombotic outcomes as hydroxyurea in a cohort of patients with essential thrombocythemia, according to results of a prospective phase 3 study.
The randomized noninferiority study included 259 patients with high-risk essential thrombocythemia. Patients had been diagnosed according to the WHO classification system.
Investigators compared anagrelide with hydroxyurea in this patient population in an a priori ordered hypothesis. There were 122 patients in the anagrelide group and 137 in the hydroxyurea group.
“Confirmatory proof of noninferiority of anagrelide was achieved after 6 months using the primary endpoint criteria and further confirmed after an observation time of 12 and 36 months for platelet counts, hemoglobin levels, leukocyte counts (P<.001) and [essential thrombocythemia]-related events (HR[95%CI]=1.19[0.61-2.30], 1.03[0.57-1.81] and 0.92[0.57-1.46] respectively),” the researchers wrote.
Observation time was calculated for 730 patient years. No significant differences between the two drugs were observed regarding major arterial thrombosis, venous thrombosis, severe bleeding events, minor arterial thrombosis, venous thrombosis and minor bleeding events. Discontinuation rates also were similar.
The research did not report incidence of disease transformation into myelofibrosis or secondary leukemia.