Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
31152740
DOI
10.1053/j.gastro.2019.05.056
PII: S0016-5085(19)40974-8
Knihovny.cz E-zdroje
- Klíčová slova
- Bacteria, CVD, Reflux, Thrombosis,
- MeSH
- Aspirin aplikace a dávkování škodlivé účinky MeSH
- časové faktory MeSH
- dvojitá slepá metoda MeSH
- gastrointestinální krvácení chemicky indukované prevence a kontrola MeSH
- hodnocení rizik MeSH
- inhibitory agregace trombocytů aplikace a dávkování škodlivé účinky MeSH
- inhibitory faktoru Xa aplikace a dávkování škodlivé účinky MeSH
- inhibitory protonové pumpy aplikace a dávkování škodlivé účinky MeSH
- kardiovaskulární nemoci diagnóza farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- onemocnění periferních arterií diagnóza farmakoterapie MeSH
- pantoprazol aplikace a dávkování škodlivé účinky MeSH
- prospektivní studie MeSH
- pseudomembranózní enterokolitida chemicky indukované mikrobiologie MeSH
- rivaroxaban aplikace a dávkování škodlivé účinky MeSH
- rizikové faktory MeSH
- rozvrh dávkování léků MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- Aspirin MeSH
- inhibitory agregace trombocytů MeSH
- inhibitory faktoru Xa MeSH
- inhibitory protonové pumpy MeSH
- pantoprazol MeSH
- rivaroxaban MeSH
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 3 × 2 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% confidence interval, 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 Number: 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
Cardiologists Research Center Associazione Nazionale Medici Cardiologi Ospedalieri Florence Italy
Catholic University of Korea Seoul South Korea
Centre for Cardiovascular Science University of Edinburgh Edinburgh UK
Estudios Clinicos Latino America and Instituto Cardiovascular de Rosario Rosario Argentina
Facultad de Ciencias de la Salud Eugenio Espejo Universidad Tecnoligica Equinoccial Quito Ecuador
Hospital do Coracao Sao Paulo Brazil
Institut Universitaire de Cardiologie et de Pneumologie de Québec Québec City Québec Canada
Institute of Cardiology Kiev Ukraine
Instituto Dante Pazzanese de Cardiologia Sao Paulo Brazil
International Cancer Institute Osaka Japan
Karolinska Institutet Stockholm Sweden
Lady Davis Carmel Medical Center Haifa Israel
Monash University Melbourne Victoria Australia
National Research Center for Preventative Medicine Moscow Russia
National University of Ireland Galway Ireland
Semmelweis University Budapest Hungary
Thrombosis Research Institute and University College London London UK
Turku University Central Hospital and Turku University Turku Finland
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
University Paris Diderot Hôpital Bichat Assistance Publique Hôpitaux de Paris Paris France
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT01776424
