Evidence map›Paper›PMID 31388437›Full record

ArticleJournal of pharmaceutical health care and sciences2019

Retrospective cohort study of the efficacy and safety of dabigatran: real-life dabigatran use including very low-dose 75 mg twice daily administration.

Yuuki Akagi, Tatsuo Chiba, Shusuke Uekusa, Hiroyoshi Kato, Shigeo Yamamura, Yukiko Aoki, Mizuho Enoki, Yuka Ogawara, Takanori Kasahara, Yuki Kimura and 5 more

Open access · goldAbstract read
In one paragraph

Article in Journal of pharmaceutical health care and sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 24% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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 8 institutions in 1 country.

Yuuki Akagi1Department of Pharmacy, National Hospital Organization, Yokohama Medical Center, 3-60-2 Harajuku, Totsuka, Yokohama, Kanagawa 245-8575 Japan.ORCID 0000-0001-9015-2507
Tatsuo Chiba2Department of Pharmacy, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro, Tokyo, 153-8515 Japan.
Shusuke Uekusa2Department of Pharmacy, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro, Tokyo, 153-8515 Japan.
Hiroyoshi Kato3Faculty of Pharmaceutical Sciences, Toho University, 2-2-1 Miyama, Funabashi, Chiba, 274-8510 Japan.
Shigeo Yamamura4Faculty of Pharmaceutical Sciences, Josai International University, 1 Gumyo, Togane, Chiba, 283-8555 Japan.
Yukiko Aoki5Department of Pharmacy, National Hospital Organization, Tokyo Medical Center, 2-5-1 Higashigaoka, Meguro, Tokyo, 152-8902 Japan.
Mizuho EnokiDepartment of Pharmacy, Tamagawa Hospital, 4-8-1 Seta, Setagaya, Tokyo, 158-0095 Japan.
Yuka OgawaraDepartment of Pharmacy, Tamagawa Hospital, 4-8-1 Seta, Setagaya, Tokyo, 158-0095 Japan.
Takanori Kasahara5Department of Pharmacy, National Hospital Organization, Tokyo Medical Center, 2-5-1 Higashigaoka, Meguro, Tokyo, 152-8902 Japan.
Yuki Kimura5Department of Pharmacy, National Hospital Organization, Tokyo Medical Center, 2-5-1 Higashigaoka, Meguro, Tokyo, 152-8902 Japan.
Tadahiro ShimizuDepartment of Pharmacy, Mishuku Hospital, 5-33-12 Kami-meguro, Meguro, Tokyo, 153-0051 Japan.
Aiko Takeishi2Department of Pharmacy, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro, Tokyo, 153-8515 Japan.
Yuko NakajimaDepartment of Pharmacy, Kohsei Chuo General Hospital, 1-11-7 Mita, Meguro, Tokyo, 153-8581 Japan.
Hideki Kobayashi2Department of Pharmacy, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro, Tokyo, 153-8515 Japan.
Kaoru SugiDepartment of Cardiovascular Medicine, Odawara Cardiovascular Hospital, 6-1-14 Yahagi, Odawara, Kanagawa 250-0873 Japan.
Toho University · JPTokyo Medical Center · JPNissan Tamagawa Hospital · JPJosai International University · JPKoto Hospital · JPMeguro Parasitological Museum · JPNational Hospital Organization · JPOdawara Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDabigatran is a direct thrombin inhibitor and an anticoagulant that is prescribed to prevent ischemic stroke and systemic embolism in non-valvular atrial fibrillation. Dabigatran (150 mg twice daily) is non-inferior to warfarin for the prevention of stroke and systemic embolism. A dose reduction to 110 mg twice daily should be considered for patients with decreased renal function, elderly patients, and those with a history of gastrointestinal bleeding. A small number of patients are prescribed 75 mg twice daily; however, excessive dose reduction below that indicated on the package insert may decrease the effectiveness of dabigatran. In this study, we investigated the incidence of thromboembolic events and hemorrhagic complications in patients receiving different doses of dabigatran, including patients receiving the very low-dose of 75 mg twice daily.

methodsFive hospitals in Meguro and Setagaya areas of Tokyo were included in this study. The subjects were patients receiving dabigatran in the hospitals from March 2011 to February 2014. Thromboembolic events (stroke, systemic embolism, and transient cerebral ischemic attack) and hemorrhagic complications occurring before December 2014 were retrospectively evaluated.

resultsA total of 701 subjects received dabigatran during the study period: 187 patients (26.7%) received 150 mg twice daily (normal dose), 488 patients (69.6%) received 110 mg twice daily (low-dose), and 26 patients (3.7%) received 75 mg twice daily (very low-dose). Thromboembolism occurred in 4 (2.1%), 11 (2.3%), and 3 patients (11.5%), in the normal dose, low-dose, and very low-dose groups, respectively. The odds ratio of the 75 mg dose to the 150 and 110 mg doses was 5.73 (95% CI, 1.55-21.2;

conclusionsThe results suggest that sufficient anticoagulation efficacy may not be maintained when the dabigatran dose is excessively reduced to 75 mg twice daily.

Indexed as

AnticoagulantDabigatranExcessive dose reductionNon-valvular atrial fibrillationRetrospective studyThromboembolism

Identifiers

PMID31388437
PMCPMC6670142
OpenAlexW2965990610

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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.