British Journal of Haematology / A phase III randomized, multicentre, double blind, active controlled trial to compare the efficacy and safety of two different anagrelide formulations in patients with essential thrombocythaemia the TEAMET 2·0 trial

Anagrelide is an established treatment option for essential thrombocythaemia (ET ). A prolonged release formulation was developed with the aim of reducing dosing frequency and improving tolerability, without diminishing efficacy. This multicentre, randomized, double blind, activecontrolled, noninferiority trial investigated the efficacy, safety and tolerability of anagrelide prolonged release (APR ) over a reference product in highrisk ET patients, either anagrelidenaïve or experienced. In a 6 to 12week titration period the individual dose for the consecutive 4week maintenance period was identified. The primary endpoint was the mean platelet count during the maintenance period (3 consecutive measurements, day 0, 14, 28). Of 112 included patients 106 were randomized. The mean screening platelet counts were 822 10/l (95% confidence interval (CI ) 707936 10/l) and 797 10/l (95% CI 708883 10/l) for APR and the reference product, respectively. Both treatments effectively reduced platelet counts, to mean 281 10/l for APR (95% CI 254311) and 305 10/l (95% CI 276337) for the reference product (P < 0·0001, for noninferiority). Safety and tolerability were comparable between both drugs. The novel prolongedrelease formulation was equally effective and well tolerated compared to the reference product. APR provides a more convenient dosing schedule and will offer an alternative to licensed immediaterelease anagrelide formulations.(VLID)510150