Safety of proton pump inhibitors based on a large, multi-year, randomized trial of patients receiving rivaroxaban or aspirin

Moayyedi, P. et al. (2019) Safety of proton pump inhibitors based on a large, multi-year, randomized trial of patients receiving rivaroxaban or aspirin. Gastroenterology, 157(3), 682-691.e2. (doi: 10.1053/j.gastro.2019.05.056) (PMID:31152740)

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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. We performed a 3x2 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. 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% CI, 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. 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. identifier: NCT01776424 ( [Abstract copyright: Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.]

Item Type:Articles
Keywords:CVD, bacteria, reflux, thrombosis.
Glasgow Author(s) Enlighten ID:Guzik, Professor Tomasz
Authors: Moayyedi, P., Eikelboom, J. W., Bosch, J., Connolly, S. J., Dyal, L., Shestakovska, O., Leong, D., Anand, S. S., Störk, S., Branch, K. R. H., Bhatt, D. L., Verhamme, P. B., O'Donnell, M., Maggioni, A. P., Lonn, E. M., Piegas, L. S., Ertl, G., Keltai, M., Bruns, N. C., Muehlhofer, E., Dagenais, G. R., Kim, J.-H., Hori, M., Steg, P. G., Hart, R. G., Diaz, R., Alings, M., Widimsky, P., Avezum, A., Probstfield, J., Zhu, J., Liang, Y., Lopez-Jaramillo, P., Kakkar, A. K., Parkhomenko, A. N., Ryden, L., Pogosova, N., Dans, A. L., Lanas, F., Commerford, P. J., Torp-Pedersen, C., Guzik, T. J., Vinereanu, D., Tonkin, A. M., Lewis, B. S., Felix, C., Yusoff, K., Metsarinne, K. P., Fox, K. A. A., and Yusuf, S.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Gastroenterology
ISSN (Online):1528-0012
Published Online:29 May 2019

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