Evidence map›Paper›PMID 23315161›Full record

Trial reportBlood2013

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

Heinz Gisslinger, Mirjana Gotic, Jerzy Holowiecki, Miroslav Penka, Juergen Thiele, Hans-Michael Kvasnicka, Robert Kralovics, Petro E Petrides, ANAHYDRET Study Group

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01065038 (A Single Blind, Multi-centre, Randomised Multinational Phase III Study to Compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients With Essential Thrombocythaemia), which is not on this map. Cited by 125 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
125citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01065038 phase3completednot on this map

A Single Blind, Multi-centre, Randomised Multinational Phase III Study to Compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients With Essential Thrombocythaemia

TypeinterventionalSponsorAOP Orphan Pharmaceuticals AGRan2002ConditionsEssential ThrombocythaemiaArmsAnagrelide, Hydroxyurea
3 · Its place in the literature

Who cites it

125 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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65 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Heinz GisslingerMedical University of Vienna, Department of Internal Medicine I, Division of Hematology and Blood Coagulation, Vienna, Austria. heinz.gisslinger@meduniwien.ac.at
Mirjana Gotic
Jerzy Holowiecki
Miroslav Penka
Juergen Thiele
Hans-Michael Kvasnicka
Robert Kralovics
Petro E Petrides
ANAHYDRET Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. This trial was registered at http://www.clinicaltrials.gov as #NCT01065038.

Indexed as

AdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansHydroxyureaMaleMaximum Tolerated DoseMiddle AgedNucleic Acid Synthesis InhibitorsPlatelet Aggregation InhibitorsPrognosisProspective StudiesQuinazolinesRetrospective StudiesanagrelideHydroxyureaNucleic Acid Synthesis InhibitorsPlatelet Aggregation InhibitorsQuinazolines

Identifiers

PMID23315161
PMCPMC3591796

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.