Evidence mapPaperPMID 39340686Full record

Trial reportAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2025

Long-Term Effects of Low-Dose Aspirin on Gastrointestinal Symptoms and Bleeding Complications in Patients with Type 2 Diabetes.

Naoko Masutani, Hisao Ogawa, Hirofumi Soejima, Sadanori Okada, Izuru Masuda, Masako Waki, Hideaki Jinnouchi, Yoshihiko Saito, Takeshi Morimoto

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
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.

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

2 citing papers in PubMed.

  1. Article
  2. Review
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.

Naoko MasutaniDepartment of Data Science, Hyogo Medical University, 1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501, Japan.
Hisao OgawaKumamoto University, Kumamoto, Japan.
Hirofumi SoejimaDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences and Health Care Center, Kumamoto University, Kumamoto, Japan.
Sadanori OkadaCenter for Postgraduate Training, Nara Medical University, Kashihara, Japan.
Izuru MasudaDepartment of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.
Masako WakiFood Safety Commission of Japan, Tokyo, Japan.
Hideaki JinnouchiDepartment of Internal Medicine, Jinnouchi Hospital Diabetes Care Center, Kumamoto, Japan.
Yoshihiko SaitoDepartment of Cardiovascular Medicine, Nara Prefecture Seiwa Medical Center, Ikoma, Japan.
Takeshi MorimotoDepartment of Data Science, Hyogo Medical University, 1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501, Japan. morimoto@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0002-6844-739X

Funding

Ministry of Health, Labour and Welfare H16-Junkanki-004Ministry of Health, Labour and Welfare H26-Iryo-Ippan-012Ministry of Health, Labour and Welfare H27-Junkanki-Ippan-001
6 · The paper itself

Abstract

backgroundLow-dose aspirin for primary prevention is determined by the balance of risks of cardiovascular events and adverse effects. We assessed the long-term gastrointestinal symptoms or bleeding with low-dose aspirin in diabetic patients.

methodsThe Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial was a randomized clinical trial to evaluate the efficacy and safety of low-dose aspirin in patients with type 2 diabetes. As a post hoc analysis, we investigated the incidence of upper gastrointestinal symptoms or bleeding in aspirin (100 mg enteric-coated aspirin or 81 mg buffered aspirin daily) and no-aspirin groups within and beyond 3 years.

resultsOf 2535 patients (mean age 65 years, 55% male) followed for a median of 11.2 years, 1258 were included in the aspirin group (951 enteric-coated, 208 buffered, 99 unknown) and 1277 were included in the no-aspirin group. The cumulative incidence of upper gastrointestinal symptoms or bleeding was higher in the aspirin group than the no-aspirin group (8.8% vs. 5.7% at 18 years; p < 0.0001). The increased risk in the aspirin group was prominent within 3 years, and the hazard ratio (HR) [95% confidence interval (CI)] of the aspirin group was 7.10 [3.21-15.7], but attenuated beyond 3 years (HR 1.20 [0.76-1.89]). In 1159 patients in the aspirin group, the cumulative incidence was lower in the enteric-coated than in the buffered aspirin groups (2.9% vs. 7.3%; p = 0.003) within 3 years, and the adjusted HR of enteric-coated aspirin was 0.38 [0.20-0.72] compared with the buffered aspirin group.

conclusionThe upper gastrointestinal symptoms or bleeding of low-dose aspirin within 3 years, and the aspirin formulations, were relevant for decision making of initiation and continuation of low-dose aspirin for primary prevention.

Indexed as

AspirinDiabetes Mellitus, Type 2Gastrointestinal DiseasesGastrointestinal HemorrhagePlatelet Aggregation InhibitorsAgedDose-Response Relationship, DrugFemaleHumansIncidenceJapanMaleMiddle AgedPrimary PreventionTablets, Enteric-CoatedAspirinPlatelet Aggregation InhibitorsTablets, Enteric-Coated

Identifiers

PMID39340686

What Socratic holds

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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 Socratic graph.