Anagrelide compared with hydroxyurea in WHO-classified
essential thrombocythemia: the ANAHYDRET Study, a randomized
controlled trial

J 2013

Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial

GISSLINGER, Heinz; Mirjana GOTIC; Jerzy HOLOWIECKI; Miroslav PENKA; Juergen THIELE et al.

Základní údaje

Originální název

Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial

Autoři

GISSLINGER, Heinz; Mirjana GOTIC; Jerzy HOLOWIECKI; Miroslav PENKA; Juergen THIELE; Hans-Michael KVASNICKA; Robert KRALOVICS a Petro E. PETRIDES

Vydání

Blood, WASHINGTON, American Society of Hematology, 2013, 0006-4971

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30200 3.2 Clinical medicine

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 9.775

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/13:00071320

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1182/blood-2012-07-443770

UT WoS

000321751800009

Klíčová slova anglicky

CHRONIC IDIOPATHIC MYELOFIBROSIS; RISK ESSENTIAL THROMBOCYTHEMIA; BONE-MARROW BIOPSIES; MYELOPROLIFERATIVE DISORDERS; POLYCYTHEMIA-VERA; VASCULAR COMPLICATIONS; THROMBOSIS; LEUKOCYTOSIS; DIAGNOSIS; CRITERIA

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 24. 1. 2014 11:25, Soňa Böhmová

Anotace

V originále

High platelet counts in essential thrombocythemia (ET) can be effectively lowered by treatment with either anagrelide or hydroxyurea. In 259 previously untreated, high-risk patients with ET, diagnosed according to the World Health Organization classification system, the efficacy and tolerability of anagrelide compared with hydroxyurea were investigated in a prospective randomized noninferiority phase 3 study in an a priori-ordered hypothesis. Confirmatory proof of the noninferiority of anagrelide was achieved after 6 months using the primary end point criteria and was further confirmed after an observation time of 12 and 36 months for platelet counts, hemoglobin levels, leukocyte counts (P < .001), and ET-related events (HR, 1.19 [95% CI, 0.61-2.30], 1.03 [95% CI, 0.57-1.81], and 0.92 [95% CI, 0.57-1.46], respectively). During the total observation time of 730 patient-years, there was no significant difference between the anagrelide and hydroxyurea group regarding incidences of major arterial (7 vs 8) and venous (2 vs 6) thrombosis, severe bleeding events (5 vs 2), minor arterial (24 vs 20) and venous (3 vs 3) thrombosis and minor bleeding events (18 vs 15), or rates of discontinuation (adverse events 12 vs 15 or lack of response 5 vs 2). Disease transformation into myelofibrosis or secondary leukemia was not reported. Anagrelide as a selective platelet-lowering agent is not inferior compared with hydroxyurea in the prevention of thrombotic complications in patients with ET diagnosed according to the World Health Organization system.

Citovat

GISSLINGER, Heinz; Mirjana GOTIC; Jerzy HOLOWIECKI; Miroslav PENKA; Juergen THIELE; Hans-Michael KVASNICKA; Robert KRALOVICS a Petro E. PETRIDES. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. WASHINGTON: American Society of Hematology, 2013, roč. 121, č. 10, s. 1720-1728. ISSN 0006-4971. Dostupné z: https://doi.org/10.1182/blood-2012-07-443770.

@article{1160708,
   author = {Gisslinger, Heinz and Gotic, Mirjana and Holowiecki, Jerzy and Penka, Miroslav and Thiele, Juergen and Kvasnicka, HansandMichael and Kralovics, Robert and Petrides, Petro E.},
   article_location = {WASHINGTON},
   article_number = {10},
   doi = {https://doi.org/10.1182/blood-2012-07-443770},
   keywords = {CHRONIC IDIOPATHIC MYELOFIBROSIS; RISK ESSENTIAL THROMBOCYTHEMIA; BONE-MARROW BIOPSIES; MYELOPROLIFERATIVE DISORDERS; POLYCYTHEMIA-VERA; VASCULAR COMPLICATIONS; THROMBOSIS; LEUKOCYTOSIS; DIAGNOSIS; CRITERIA},
   language = {eng},
   issn = {0006-4971},
   journal = {Blood},
   title = {Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial},
   volume = {121},
   year = {2013}
}

TY  - JOUR
ID  - 1160708
AU  - Gisslinger, Heinz - Gotic, Mirjana - Holowiecki, Jerzy - Penka, Miroslav - Thiele, Juergen - Kvasnicka, Hans-Michael - Kralovics, Robert - Petrides, Petro E.
PY  - 2013
TI  - Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial
JF  - Blood
VL  - 121
IS  - 10
SP  - 1720-1728
EP  - 1720-1728
PB  - American Society of Hematology
SN  - 00064971
KW  - CHRONIC IDIOPATHIC MYELOFIBROSIS
KW  - RISK ESSENTIAL THROMBOCYTHEMIA
KW  - BONE-MARROW BIOPSIES
KW  - MYELOPROLIFERATIVE DISORDERS
KW  - POLYCYTHEMIA-VERA
KW  - VASCULAR COMPLICATIONS
KW  - THROMBOSIS
KW  - LEUKOCYTOSIS
KW  - DIAGNOSIS
KW  - CRITERIA
N2  - High platelet counts in essential thrombocythemia (ET) can be effectively lowered by treatment with either anagrelide or hydroxyurea. In 259 previously untreated, high-risk patients with ET, diagnosed according to the World Health Organization classification system, the efficacy and tolerability of anagrelide compared with hydroxyurea were investigated in a prospective randomized noninferiority phase 3 study in an a priori-ordered hypothesis. Confirmatory proof of the noninferiority of anagrelide was achieved after 6 months using the primary end point criteria and was further confirmed after an observation time of 12 and 36 months for platelet counts, hemoglobin levels, leukocyte counts (P < .001), and ET-related events (HR, 1.19 [95% CI, 0.61-2.30], 1.03 [95% CI, 0.57-1.81], and 0.92 [95% CI, 0.57-1.46], respectively). During the total observation time of 730 patient-years, there was no significant difference between the anagrelide and hydroxyurea group regarding incidences of major arterial (7 vs 8) and venous (2 vs 6) thrombosis, severe bleeding events (5 vs 2), minor arterial (24 vs 20) and venous (3 vs 3) thrombosis and minor bleeding events (18 vs 15), or rates of discontinuation (adverse events 12 vs 15 or lack of response 5 vs 2). Disease transformation into myelofibrosis or secondary leukemia was not reported. Anagrelide as a selective platelet-lowering agent is not inferior compared with hydroxyurea in the prevention of thrombotic complications in patients with ET diagnosed according to the World Health Organization system.
ER  -

GISSLINGER, Heinz; Mirjana GOTIC; Jerzy HOLOWIECKI; Miroslav PENKA; Juergen THIELE; Hans-Michael KVASNICKA; Robert KRALOVICS a Petro E. PETRIDES. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. \textit{Blood}. WASHINGTON: American Society of Hematology, 2013, roč.~121, č.~10, s.~1720-1728. ISSN~0006-4971. Dostupné z: https://doi.org/10.1182/blood-2012-07-443770.

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