Evidence map›Paper›PMID 21499703›Full record

Trial reportJournal of gastroenterology2011

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

Kentaro Sugano, Yasushi Matsumoto, Tsukasa Itabashi, Sumihisa Abe, Nobuhiro Sakaki, Kiyoshi Ashida, Yuji Mizokami, Tsutomu Chiba, Shigeyuki Matsui, Tatsuya Kanto and 4 more

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of gastroenterology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 10 pooled it
7.1field-weighted citation impact, top 3% 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

37 citing papers in PubMed, 10 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Guideline
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  6. [Clinical Guidelines for Drug-induced Peptic Ulcer, 2020 Revised Edition].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2020
    Guideline
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  8. Pooled it
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  18. Observational
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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

14 authors at 11 institutions in 1 country.

Kentaro SuganoDivision of Gastroenterology, Department of Internal Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan. sugano@jichi.ac.jp
Yasushi Matsumoto
Tsukasa Itabashi
Sumihisa Abe
Nobuhiro Sakaki
Kiyoshi Ashida
Yuji Mizokami
Tsutomu Chiba
Shigeyuki Matsui
Tatsuya Kanto
Kazuyuki Shimada
Shinichiro Uchiyama
Naomi Uemura
Naoki Hiramatsu
Jichi Medical University · JPOsaka University · JPEbara Hospital · JPKohnan Hospital · JPKyoto University · JPNational Center for Global Health and Medicine · JPSaiseikai Nakatsu Hospital · JPTakatsuki General Hospital · JPThe Institute of Statistical Mathematics · JPTokyo Women's Medical University · JPUniversity of Tsukuba Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of low-dose lansoprazole has not been established for the prevention of recurrent gastric or duodenal ulcers in those receiving long-term low-dose aspirin (LDA) for cardiovascular and cerebrovascular protection. This study sought to examine the efficacy of low-dose lansoprazole (15 mg once daily) for the secondary prevention of LDA-associated gastric or duodenal ulcers.

methodsPatients were randomized to receive lansoprazole 15 mg daily (n = 226) or gefarnate 50 mg twice daily (n = 235) for 12 months or longer in a prospective, multicenter, double-blind, randomized active-controlled trial, followed by a 6-month follow-up study with open-label lansoprazole treatment. The study utilized 94 sites in Japan and 461 Japanese patients with a history of gastric or duodenal ulcers who required long-term LDA therapy for cardiovascular and cerebrovascular disease.

resultsThe primary endpoint was the development of gastric or duodenal ulcers. The cumulative incidence of gastric or duodenal ulcers on days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 1.5, 2.1, and 3.7%, respectively, in the lansoprazole group versus 15.2, 24.0, and 31.7%, respectively, in the gefarnate group. The risk of ulcer development was significantly (log-rank test, P < 0.001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.099 (95% confidence interval [CI] 0.042-0.230).

conclusionLansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term LDA therapy.

Indexed as

2-PyridinylmethylsulfinylbenzimidazolesAgedAnti-Ulcer AgentsAspirinDouble-Blind MethodDuodenal UlcerFemaleFollow-Up StudiesGefarnateHumansIncidenceJapanKaplan-Meier EstimateLansoprazoleMaleMiddle Aged2-PyridinylmethylsulfinylbenzimidazolesAnti-Ulcer AgentsAspirinGefarnateLansoprazolePlatelet Aggregation Inhibitors

Identifiers

PMID21499703
PMCPMC3117278
OpenAlexW2167595087

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.