Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
31054846
DOI
10.1053/j.gastro.2019.04.041
PII: S0016-5085(19)36764-2
Knihovny.cz E-resources
- Keywords
- Drug, Heart Disease Prevention, Stomach, Thrombosis,
- MeSH
- Anticoagulants administration & dosage adverse effects MeSH
- Administration, Oral MeSH
- Aspirin administration & dosage adverse effects MeSH
- Double-Blind Method MeSH
- Gastrointestinal Hemorrhage chemically induced epidemiology prevention & control MeSH
- Proton Pump Inhibitors administration & dosage MeSH
- Cardiovascular Diseases prevention & control MeSH
- Drug Therapy, Combination adverse effects methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Pantoprazole administration & dosage MeSH
- Peptic Ulcer chemically induced epidemiology prevention & control MeSH
- Rivaroxaban administration & dosage adverse effects MeSH
- Drug Administration Schedule MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Anticoagulants MeSH
- Aspirin MeSH
- Proton Pump Inhibitors MeSH
- Pantoprazole MeSH
- Rivaroxaban MeSH
BACKGROUND & AIMS: Antiplatelets and anticoagulants are associated with increased upper gastrointestinal bleeding. We evaluated whether proton pump inhibitor therapy could reduce this risk. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease. Participants were randomly assigned to groups given pantoprazole 40 mg daily or placebo, as well as rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, or aspirin 100 mg alone. The primary outcome was time to first upper gastrointestinal event, defined as a composite of overt bleeding, upper gastrointestinal bleeding from a gastroduodenal lesion or of unknown origin, occult bleeding, symptomatic gastroduodenal ulcer or ≥5 erosions, upper gastrointestinal obstruction, or perforation. RESULTS: There was no significant difference in upper gastrointestinal events between the pantoprazole group (102 of 8791 events) and the placebo group (116 of 8807 events) (hazard ratio, 0.88; 95% confidence interval [CI], 0.67-1.15). Pantoprazole significantly reduced bleeding of gastroduodenal lesions (hazard ratio, 0.52; 95% confidence interval, 0.28-0.94; P = .03); this reduction was greater when we used a post-hoc definition of bleeding gastroduodenal lesion (hazard ratio, 0.45; 95% confidence interval, 0.27-0.74), although the number needed to treat still was high (n = 982; 95% confidence interval, 609-2528). CONCLUSIONS: In a randomized placebo-controlled trial, we found that routine use of proton pump inhibitors in patients receiving low-dose anticoagulation and/or aspirin for stable cardiovascular disease does not reduce upper gastrointestinal events, but may reduce bleeding from gastroduodenal lesions. ClinicalTrials.gov ID: NCT01776424.
Amphia Ziekenhuis and Werkgroep Cardiologische Centra Nederland Utrecht the Netherlands
Brigham and Women's Hospital Heart and Vascular Center Harvard Medical School Boston Massachusetts
Catholic University of Korea Seoul South Korea
Centre for Cardiovascular Science University of Edinburgh Edinburgh UK
College of Medicine University of the Philippines Manila Ermita Manila Philippines
Estudios Clinicos Latino America and Instituto Cardiovascular de Rosario Rosario Argentina
Facultad de Ciencias de la Salud Eugenio Espejo Universidad Tecnoligica Equinoccial Quito Ecuador
Hopitaux de Paris Paris France
Hospital do Coracao Sao Paulo Brazil
Institut Universitaire de Cardiologie et de Pneumologie de Quebec Quebec Canada
Institute of Cardiology Kiev Ukraine
Instituto Dante Pazzanese de Cardiologia Sao Paulo Brazil
Karolinska Institutet Stockholm Sweden
Lady Davis Carmel Medical Center Haifa Israel
Monash University Melbourne Victoria Australia
National Association of Hospital Cardiologists Research Center Florence Italy
National Research Center for Preventative Medicine Moscow Russia
National University of Ireland Galway Ireland
Osaka International Cancer Institute Osaka Japan
Research Institute Fundaciun Oftalmoligica de Santander Bucaramanga Bucaramanga Colombia
Semmelweis University Budapest Hungary
Thrombosis Research Institute and University College London London UK
Universidad de La Frontera Temuco Chile
Universiti Teknologi Mara Selangor Malaysia
University of Aalborg Copenhagen Denmark
University of Cape Town Cape Town South Africa
University of Glasgow Glasgow UK; Collegium Medicum Jagiellonian University Krakow Poland
University of Leuven Leuven Belgium
University of Philippines Manila Philippines
University of Washington Medical Center Seattle Washington
University of Washington Seattle Washington
University of Würzburg and University Hospital Würzburg Germany
References provided by Crossref.org
ClinicalTrials.gov
NCT01776424
