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

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

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  3. Crohn's Disease With Progressive Renal Impairment

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

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

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  1. Risk Factors for Morbidity and Mortality Following Hospitalization for Pericarditis

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  2. Incidence of acute myocardial infarction-related cardiogenic shock during corona virus disease 19 (COVID-19) pandemic

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  3. Incidence of infective endocarditis during the coronavirus disease 2019 pandemic: A nationwide study

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  4. Hypertension, cardiovascular disease and cause of death in Danish living kidney donors: matched cohort study

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  5. Catheter ablation and mortality, stroke and heart failure readmission with atrial fibrillation

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  • COMPASS Investigators
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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).

Original languageEnglish
JournalGastroenterology
Volume157
Issue number3
Pages (from-to)682-691.e2
ISSN0016-5085
DOIs
Publication statusPublished - Sep 2019
Externally publishedYes

    Research areas

  • Bacteria, CVD, Reflux, Thrombosis

ID: 57550548