Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin.
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Moayyedi Paul, Eikelboom John W, Bosch Jackie, Connolly Stuart J, Dyal Leanne, Shestakovska Olga, Leong Darryl, Anand Sonia S, Störk Stefan, Branch Kelley R H, Bhatt Deepak L, Verhamme Peter B, O'Donnell Martin, Maggioni Aldo P, Lonn Eva M, Piegas Leopoldo S, Ertl Georg, Keltai Matyas, Bruns Nancy Cook, Muehlhofer Eva, Dagenais Gilles R, Kim Jae-Hyung, Hori Masatsugu, Steg P Gabriel, Hart Robert G, Diaz Rafael, Alings Marco, Widimsky Petr, Avezum Alvaro, Probstfield Jeffrey, Zhu Jun, Liang Yan, Lopez-Jaramillo Patricio, Kakkar Ajay K, Parkhomenko Alexander N, Ryden Lars, Pogosova Nana, Dans Antonio L, Lanas Fernando, Commerford Patrick J, Torp-Pedersen Christian, Guzik Tomek J, Vinereanu Dragos, Tonkin Andrew M, Lewis Basil S, Felix Camilo, Yusoff Khalid, Metsarinne Kaj P, Fox Keith A A, Yusuf Salim, COMPASS Investigators
Аннотация
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.