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Pracoviště: International Cancer Institute Osaka Japan

1 záznamů v PubMed Filtry

Článek

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

Moayyedi, Paul
Autor Moayyedi, Paul The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: moayyep@mcmaster.ca
Eikelboom, John W
Autor Eikelboom, John W The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
Bosch, Jackie
Autor Bosch, Jackie The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
Connolly, Stuart J
Autor Connolly, Stuart J The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
Dyal, Leanne
Autor Dyal, Leanne The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
Shestakovska, Olga
Autor Shestakovska, Olga The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
Leong, Darryl
Autor Leong, Darryl The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
Anand, Sonia S
Autor Anand, Sonia S The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
Störk, Stefan
Autor Störk, Stefan University of Würzburg and University Hospital, Würzburg, Germany
Branch, Kelley R H
Autor Branch, Kelley R H University of Washington Medical Center, Seattle, Washington

Gastroenterology. 2019 Sep ; 157 (3) : 682-691.e2. [epub] 20190529

ISSN 1528-0012 | 0016-5085
Zdroj

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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