Evidence map›Paper›PMID 31183813›Full record

Trial reportInternational journal of hematology2019

Hematologic recovery induced by eltrombopag in Japanese patients with aplastic anemia refractory or intolerant to immunosuppressive therapy.

Hirohito Yamazaki, Kensuke Ohta, Hiroatsu Iida, Kazunori Imada, Naoshi Obara, Yukihiro Tokumine, Yoshiaki Tomiyama, Kensuke Usuki, Kenji Imajo, Koichi Miyamura and 6 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02148133 (A Non-randomized, Open-label, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% of its field
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.

NCT02148133 phase2completednot on this map

A Non-randomized, Open-label, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2017Enrolled21ConditionsCytopaeniaArmsEltrombopag 12.5 mg, Eltrombopag 25 mg
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

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  18. [A real-world study of 176 cases with aplastic anemia treated in outpatient].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2021
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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

16 authors at 14 institutions in 1 country.

Hirohito YamazakiDivision of Transfusion Medicine, Kanazawa University Hospital, 13-1 Takaramachi, Kanazawa, Ishikawa, 920-8641, Japan. h-yama@staff.kanazawa-u.ac.jp.ORCID http://orcid.org/0000-0003-3018-2098
Kensuke OhtaHematology Ohta Clinic, Osaka, Japan.
Hiroatsu IidaNational Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan.
Kazunori ImadaJapanese Red Cross Osaka Hospital, Osaka, Japan.
Naoshi ObaraUniversity of Tsukuba, Tsukuba, Ibaraki, Japan.
Yukihiro TokumineItami City Hospital, Itami, Hyogo, Japan.
Yoshiaki TomiyamaOsaka University Hospital, Osaka, Japan.
Kensuke UsukiNTT Medical Center Tokyo, Tokyo, Japan.
Kenji ImajoOkayama City Hospital, Okayama, Japan.
Koichi MiyamuraJapanese Red Cross Nagoya Daiichi Hospital, Nagoya, Aichi, Japan.
Osamu SasakiMiyagi Cancer Center, Natori, Miyagi, Japan.
Zhang FanghongNovartis Pharma K.K, Tokyo, Japan.
Toshihiro HattoriNovartis Pharma K.K, Tokyo, Japan.
Takeshi TajimaNovartis Pharma K.K, Tokyo, Japan.
Akira MatsudaInternational Medical Center, Saitama Medical University, Saitama, Japan.
Shinji NakaoKanazawa University Institute of Medical Pharmaceutical and Health Sciences, Kanazawa, Ishikawa, Japan.
Novartis (Japan) · JPItami City Hospital · JPJapanese Red Cross Nagoya Daiichi Hospital · JPKanazawa University · JPKanazawa University Hospital · JPMiyagi Prefectural Hospital Organization · JPNational Hospital Organization · JPNTT Medical Center · JPOkayama Prefecture · JPOsaka Hospital · JPOsaka Nishi Clinic · JPOsaka University Hospital · JPSaitama International Medical Center · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Eltrombopag, an oral thrombopoietin-receptor agonist, stimulates hematopoiesis in patients with acquired aplastic anemia (AA) and has higher exposure in patients of East Asian origin. We evaluated the pharmacokinetics, efficacy, and safety of eltrombopag in Japanese patients with AA refractory or intolerant to immunosuppressive therapy (IST). Twenty-one patients (15 with non-severe AA, six with severe AA) with platelet counts < 30,000/µL received eltrombopag in a dose-escalation fashion (25, 50, 75, or 100 mg once daily) depending on individual platelet responses; the responders continued eltrombopag treatment beyond 6 months. The primary endpoint was hematologic response at 6 months, defined as improvements in blood counts or transfusion requirements. Ten (48%) patients achieved hematologic responses in at least one lineage at 6 months. Six patients achieved tri- and/or bi-lineage responses with continuation of eltrombopag treatment, with two patients no longer requiring eltrombopag treatment. The most common adverse events were nasopharyngitis and abnormal hepatic function, with the majority being grade 1 or 2. Cytogenetic abnormalities were observed in three patients; however, no progression to myelodysplastic syndrome/other malignancy was observed. Eltrombopag can safely restore multi-lineage hematopoiesis in Japanese patients with AA refractory or intolerant to IST.Clinical Trial registration NCT02148133.

Indexed as

AdultAgedAnemia, AplasticBenzoatesBlood TransfusionCell LineageChemical and Drug Induced Liver InjuryCombined Modality TherapyDrug ResistanceDrug SubstitutionFemaleHematopoiesisHumansHydrazinesImmunosuppressive AgentsJapanBenzoateseltrombopagHydrazinesImmunosuppressive AgentsMPL protein, humanPyrazolesReceptors, ThrombopoietinAplastic anemiaEltrombopagInter-ethnic differenceJapanese patients

Identifiers

PMID31183813
OpenAlexW2949611873

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.