Evidence map›Paper›PMID 30105510›Full record

Trial reportJournal of gastroenterology2019

A randomized controlled trial of lusutrombopag in Japanese patients with chronic liver disease undergoing radiofrequency ablation.

Ryosuke Tateishi, Masataka Seike, Masatoshi Kudo, Hideyuki Tamai, Seiji Kawazoe, Takayuki Katsube, Toshimitsu Ochiai, Takahiro Fukuhara, Takeshi Kano, Katsuaki Tanaka and 5 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 5 pooled it
8.8field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 80 citations in OpenAlex.

  1. Pooled it
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  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. [Clinical research progress of lusutrombopag for the treatment of thrombocytopenia in chronic liver disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    Review
  14. Review
  15. Observational
  16. Review
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  20. Bleeding events in lusutrombopag-treated thrombocytopenic patients.European journal of clinical investigation · 2021
    Article
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

15 authors at 10 institutions in 1 country.

Ryosuke TateishiDepartment of Gastroenterology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. tateishi-tky@umin.ac.jp.
Masataka SeikeDepartment of Gastroenterology, Oita University Hospital, 1-1 Hasamamachi-idaigaoka, Yufu, 879-5593, Japan.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ono-higashi, Osaka-sayama, 589-8511, Japan.
Hideyuki TamaiSecond Department of Internal Medicine, Wakayama Medical University Hospital, 811-1 Kimiidera, Wakayama, 641-0012, Japan.
Seiji KawazoeDepartment of Hepatobiliary and Pancreatology, Saga-ken Medical Centre Koseikan, 1-12-9 Mizugae, Saga, 840-0054, Japan.
Takayuki KatsubeShionogi and Co., Ltd., 1-4, Shibata 1-chome, Kita-ku, Osaka, 530-0012, Japan.
Toshimitsu OchiaiShionogi and Co., Ltd., 1-4, Shibata 1-chome, Kita-ku, Osaka, 530-0012, Japan.
Takahiro FukuharaShionogi and Co., Ltd., 1-4, Shibata 1-chome, Kita-ku, Osaka, 530-0012, Japan.
Takeshi KanoShionogi and Co., Ltd., 1-4, Shibata 1-chome, Kita-ku, Osaka, 530-0012, Japan.
Katsuaki TanakaYokohama City University Medical Center, Gastroenterological Center, 4-57 Urafune, Minami-ku, Yokohama, 232-0024, Japan.
Mineo KurokawaDepartment of Hematology and Oncology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Kazuhide YamamotoGastroenterology and Hepatology Department, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
Yukio OsakiDepartment of Gastroenterology and Hepatology, Japanese Red Cross Society Osaka Hospital, 5-30 Fudegasakicho, Tennoji-ku, Osaka, 543-8555, Japan.
Namiki IzumiJapanese Red Cross Society Musashino Hospital, 1-26-1 Kyonancho, Musashino, Tokyo, 180-8610, Japan.
Michio ImawariInstitute for Gastrointestinal and Liver Diseases, Shin-yurigaoka General Hospital, 255 Furusawa, Asao-ku, Kawasaki, 215-0026, Japan.
Shionogi (Japan) · JPUniversity of Tokyo Hospital · JPKindai University · JPMusashino Red Cross Hospital · JPOita University Hospital · JPOkayama University Hospital · JPOsaka Hospital · JPSaga-Ken Medical Centre Koseikan · JPWakayama Medical University · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThrombocytopenia represents an obstacle for invasive procedures in chronic liver disease (CLD) patients. We aimed to estimate the appropriate dose and evaluate the efficacy and safety of lusutrombopag for the treatment of thrombocytopenia before percutaneous liver radiofrequency ablation (RFA) for primary hepatic cancer in patients with CLD.

methodsIn this multicenter, randomized, double-blind, placebo-controlled study conducted in Japan, 61 CLD patients with platelet count < 50 × 10

resultsThe proportion of patients who did not require platelet transfusion before RFA and that of responders were significantly higher (p < 0.01) in the 2-mg (80.0, 66.7%), 3-mg (81.3, 68.8%), and 4-mg groups (93.3, 80.0%) compared with the placebo group (20.0, 6.7%) and showed a dose-dependent effect. The incidence of AEs was 97.8 and 100% in the lusutrombopag (all groups) and placebo groups, respectively; no dose-related increase was observed. Four patients experienced thrombosis-related events (one each in the placebo and 2-mg groups, and two in the 4-mg group). A total of 16 (18%) adverse drug reactions occurred in the safety analysis set.

conclusionsLusutrombopag 3 mg once daily for 7 days was effective without raising concerns about excessive increases in platelet count. CLINICAL

trial registrationThe study is registered at JapicCTI-121944.

Indexed as

Platelet TransfusionAgedAged, 80 and overCarcinoma, HepatocellularChronic DiseaseCinnamatesDouble-Blind MethodFemaleHalf-LifeHumansJapanLiver DiseasesLiver NeoplasmsMaleMiddle AgedPlatelet CountCinnamateslusutrombopagReceptors, ThrombopoietinThiazolesChronic liver diseaseLusutrombopagRadiofrequency ablationThrombocytopeniaThrombopoietin receptor agonist

Identifiers

PMID30105510
PMCPMC6349796
OpenAlexW2887140939

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.