Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Safety of Proton Pump Inhibitors Based on a Large, Multi-year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Antibody Responses to Immunization With HCV Envelope Glycoproteins as a Baseline for B cell-Based Vaccine Development

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Crohn's Disease With Progressive Renal Impairment

    Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

  3. Cancer Risk in Pediatric-Onset Inflammatory Bowel Disease: A Population-Based Danish Cohort Study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Prevalence and incidence of various Cancer subtypes in patients with heart failure vs matched controls

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Antihypertensive Drugs and Risk of Depression: A Nationwide Population-Based Study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Long-term impact of baseline anaemia on clinical outcomes following percutaneous coronary intervention in stable angina

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Self-reported health status and the associated risk of mortality in heart failure: The DANISH trial

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. Differences in mortality in patients undergoing surgery for infective endocarditis according to age and valvular surgery

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • COMPASS Investigators
Vis graf over relationer

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