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Region Hovedstaden - en del af Københavns Universitetshospital
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Safety of Proton Pump Inhibitors Based on a Large, Multi-year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin

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  1. Crohn's Disease With Progressive Renal Impairment

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Remission of bile acid malabsorption symptoms following treatment with the glucagon-like peptide 1 receptor agonist liraglutide

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Postprandial Nutrient Handling and Gastrointestinal Hormone Secretion After Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Dysregulated Lncrnas in Inflammatory Bowel Disease Demonstrate Immune System Related Association Through Guilt-By Association Analysis

    Publikation: Bidrag til tidsskriftKonferenceabstrakt i tidsskriftForskningpeer review

  5. Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Regional variation in out-of-hospital cardiac arrest: incidence and survival - a nationwide study of regions in Denmark

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Genome-wide association and Mendelian randomisation analysis provide insights into the pathogenesis of heart failure

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Socioeconomic position and one-year mortality risk among patients with heart failure: A nationwide register-based cohort study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are effective at treating acid-related disorders. These drugs are well tolerated in the short term, but long-term treatment was associated with adverse events in observational studies. We aimed to confirm these findings in an adequately powered randomized trial.

METHODS: We performed a 3x2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease randomly assigned to groups given pantoprazole (40 mg daily, n=8791) or placebo (n=8807). Participants were also randomly assigned to groups that received rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg) alone. We collected data on development of pneumonia, Clostridium difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months. Patients were followed up for a median of 3.01 years, with 53,152 patient years of follow up.

RESULTS: There was no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs 1.0% in the placebo group; odds ratio, 1.33; 95% CI, 1.01-1.75). For all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole vs the placebo group, although there were only 13 events, so this difference was not statistically significant.

CONCLUSIONS: In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections. Clinicaltrials.gov identifier: NCT01776424 (https://clinicaltrials.gov/ct2/show/NCT01776424).

OriginalsprogEngelsk
TidsskriftGastroenterology
Vol/bind157
Udgave nummer3
Sider (fra-til)682-691.e2
ISSN0016-5085
DOI
StatusUdgivet - sep. 2019
Eksternt udgivetJa

Bibliografisk note

Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.

ID: 57550548