Back to Search
Start Over
Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin
- Source :
- 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, Yusuf, S & COMPASS Investigators 2019, ' Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin ', Gastroenterology, vol. 157, no. 3, pp. 682-691.e2 . https://doi.org/10.1053/j.gastro.2019.05.056
- Publication Year :
- 2019
- Publisher :
- Elsevier BV, 2019.
-
Abstract
- 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.
- Subjects :
- Male
0301 basic medicine
Time Factors
law.invention
0302 clinical medicine
Rivaroxaban
Randomized controlled trial
Risk Factors
law
Medicine
Prospective Studies
Pantoprazole
Enterocolitis, Pseudomembranous
Cardiovascular Diseases/diagnosis
Aspirin
Enterocolitis, Pseudomembranous/chemically induced
Gastroenterology
Middle Aged
Obstructive lung disease
Pantoprazole/administration & dosage
Proton Pump Inhibitors/administration & dosage
Treatment Outcome
Peripheral Arterial Disease/diagnosis
Cardiovascular Diseases
Factor Xa Inhibitors/administration & dosage
Female
030211 gastroenterology & hepatology
Gastrointestinal Hemorrhage
medicine.drug
medicine.medical_specialty
medicine.drug_class
Rivaroxaban/administration & dosage
Proton-pump inhibitor
Placebo
Risk Assessment
Drug Administration Schedule
Peripheral Arterial Disease
03 medical and health sciences
Double-Blind Method
Internal medicine
Humans
Aspirin/administration & dosage
Adverse effect
Platelet Aggregation Inhibitors/administration & dosage
Aged
Hepatology
business.industry
Proton Pump Inhibitors
medicine.disease
030104 developmental biology
business
Platelet Aggregation Inhibitors
Gastrointestinal Hemorrhage/chemically induced
Factor Xa Inhibitors
Kidney disease
Subjects
Details
- ISSN :
- 00165085
- Volume :
- 157
- Database :
- OpenAIRE
- Journal :
- Gastroenterology
- Accession number :
- edsair.doi.dedup.....481c1fd21968546b2f8a4758bcd0e8ff