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

P. Moayyedi, JW. Eikelboom, J. Bosch, SJ. Connolly, L. Dyal, O. Shestakovska, D. Leong, SS. Anand, S. Störk, KRH. Branch, DL. Bhatt, PB. Verhamme, M. O'Donnell, AP. Maggioni, EM. Lonn, LS. Piegas, G. Ertl, M. Keltai, NC. Bruns, E. Muehlhofer, GR....

. 2019 ; 157 (3) : 682-691.e2. [pub] 20190529

Language English Country United States

Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc19034529

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

Bayer Leverkusen Germany

Brigham and Women's Hospital Heart and Vascular Center Harvard Medical School Boston Massachusetts

Cardiocenter University Hospital Kralovske Vinohrady and 3rd Faculty of Medicine Charles University Prague Czech Republic

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

Collegium Medicum Jagiellonian University Krakow Poland

Estudios Clinicos Latino America and Instituto Cardiovascular de Rosario Rosario Argentina

Facultad de Ciencias de la Salud Eugenio Espejo Universidad Tecnoligica Equinoccial Quito Ecuador

FuWai Hospital Beijing China

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 Association of Hospital Research Institute Fundaciun Oftalmoligica de Santander Bucaramanga Bucaramanga Colombia

National Research Center for Preventative Medicine Moscow Russia

National University of Ireland Galway Ireland

Semmelweis University Budapest Hungary

The Population Health Research Institute McMaster University and Hamilton Health Sciences Hamilton Ontario Canada

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

University of Leuven Leuven Belgium

University of Medicine and Pharmacology Carol Davila University and Emergency Hospital Bucharest Romania

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

References provided by Crossref.org

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$a Moayyedi, Paul $u The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: moayyep@mcmaster.ca.
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$a Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin / $c P. Moayyedi, JW. Eikelboom, J. Bosch, SJ. Connolly, L. Dyal, O. Shestakovska, D. Leong, SS. Anand, S. Störk, KRH. Branch, DL. Bhatt, PB. Verhamme, M. O'Donnell, AP. Maggioni, EM. Lonn, LS. Piegas, G. Ertl, M. Keltai, NC. Bruns, E. Muehlhofer, GR. Dagenais, JH. Kim, M. Hori, PG. Steg, RG. Hart, R. Diaz, M. Alings, P. Widimsky, A. Avezum, J. Probstfield, J. Zhu, Y. Liang, P. Lopez-Jaramillo, AK. Kakkar, AN. Parkhomenko, L. Ryden, N. Pogosova, AL. Dans, F. Lanas, PJ. Commerford, C. Torp-Pedersen, TJ. Guzik, D. Vinereanu, AM. Tonkin, BS. Lewis, C. Felix, K. Yusoff, KP. Metsarinne, KAA. Fox, S. Yusuf, COMPASS Investigators,
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$a 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.
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$a Eikelboom, John W $u The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
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