Safety of proton pump inhibitors based on a large, multi-year, randomized trial of patients receiving rivaroxaban or aspirin
Gastroenterology
; 157(3): 682-691, ago., 30 2019. ilus, tab
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1015771
Biblioteca responsável:
BR79.1
Localização: BR79.1
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 x 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 (5mg 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. (AU)
Texto completo:
Disponível
Coleções:
Bases de dados nacionais
/
Brasil
Contexto em Saúde:
Doenças Negligenciadas
/
ODS3 - Meta 3.4 Reduzir as mortes prematuras devido doenças não transmissíveis
Problema de saúde:
Zoonoses
/
Doença Cardiovascular
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Bactérias
/
Doenças Cardiovasculares
/
Aspirina
Tipo de estudo:
Ensaio clínico controlado
/
Estudo observacional
Idioma:
Inglês
Revista:
Gastroenterology
Ano de publicação:
2019
Tipo de documento:
Artigo
Instituição/País de afiliação:
Amphia Ziekenhuis and Werkgroep Cardiologische Centra Nederland/NL
/
Associazione Nazionale Medici Cardiologi Ospedalieri/IT
/
Bayer/DE
/
Catholic University of Korea/KR
/
Estudios Clinicos Latino America and Instituto Cardiovascular de Rosario/AR
/
Facultad de Ciencias de la Salud Eugenio Espejo-Universidad Tecnoligica Equinoccial/EC
/
FuWai Hospital/CN
/
Harvard Medical School/US
/
Hospital do Coração/BR
/
Institut Universitaire de Cardiologie et Pneumologie de Quebec/CA