Borja Ruiz1, Urko Aguirre2, Ana Estany-Gestal3, Luca Rodella4, Pablo Ruiz5, Adolfo Figueiras3, Alfonso Carvajal6, Luisa Ibáñez7, Anita Conforti8, Marian M de Pancorbo9, Xavier Vidal7, Luis H Martin6, Carmelo Aguirre10,11. 1. Unidad de Farmacovigilancia del Pais Vasco, Galdakao-Usansolo Hospital, Barrio Labeaga 46A, 48960, Galdakao, Spain. 2. Research Unit, Research Network of Health Services in Chronic Diseases (REDISSEC), Galdakao-Usansolo Hospital, Galdakao, Spain. 3. Department of Preventive Medicine and Public Health, Consortium for Biomedical Research in Epidemiology and Public Health (CIBER Epidemiología y Salud Pública-CIBERESP), University of Santiago de Compostela, Santiago de Compostela, Spain. 4. 1st Department of Surgery, Surgical Endoscopy Unit, University of Verona, Verona, Italy. 5. Department of Digestive Diseases, Basurto University Hospital, Bilbao, Spain. 6. Pharmacoepidemiology Institute, Department of Pharmacology, School of Medicine, University of Valladolid, Valladolid, Spain. 7. Catalan Institute of Pharmacology, Clinical Pharmacology Service, University Hospital Vall d'Hebron, Department of Pharmacology, Therapeutics and Toxicology, Autonomous University, Barcelona, Spain. 8. Clinical Pharmacology Unit, Department of Medicine and Public Health, University of Verona, Verona, Italy. 9. General Service of Genomic Research: DNA Bank, School of Pharmacy, University of the Basque Country, Vitoria-Gasteiz, Spain. 10. Unidad de Farmacovigilancia del Pais Vasco, Galdakao-Usansolo Hospital, Barrio Labeaga 46A, 48960, Galdakao, Spain. carmelo.aguirregomez@osakidetza.eus. 11. Pharmacology Department, School of Medicine and Nursing, University of the Basque Country, Leioa, Spain. carmelo.aguirregomez@osakidetza.eus.
Abstract
PURPOSE: The use of gastroprotective agents has allowed significant progress in the prevention of upper gastrointestinal bleeding (UGIB) associated with non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents. Nevertheless, some concerns remain regarding the gastroprotective dosage and treatment duration. Our aim was to study the effect of gastroprotective agents in UGIB induced by NSAIDs and single- or dual-antiplatelet therapy. METHODS: A multicenter case-control study was conducted including 577 cases diagnosed with UGIB and 1343 sex-, age-, and hospital-matched controls. To estimate exposure to NSAIDs and gastroprotective agents, consumption was calculated for the 4 weeks prior to hospital admission in terms of defined daily doses (DDDs). Risk groups for UGIB induced by NSAIDs and single- or dual-antiplatelet therapy were defined as a function of each drug dose, use of gastrointestine-damaging drugs, and risk factors for UGIB. Odds ratios (ORs) with 95% confidence intervals (CIs) were adjusted for single- (model 1) and dual- (model 2) antiplatelet therapy. RESULTS: Full adherence (> 0.80DDD) to proton pump inhibitors (PPIs) was the only gastroprotective therapy that significantly reduced the risk of UGIB, considering NSAID risk (OR: 0.53; 95% CI: 0.30-0.95) and dose (OR: 0.48; 95% CI: 0.27-0.87) with ORs adjusted for single-antiplatelet therapy (model 1) and NSAID risk (OR: 0.55; 95% CI: 0.31-0.98) and dose (OR: 0.49; 95% CI: 0.28-0.89) with ORs adjusted for dual-antiplatelet therapy (model 2). CONCLUSIONS: These results reinforce the recommendation of adding a PPI at effective doses (full adherence) to prevent UGIB induced by NSAIDs, or single- or dual-antiplatelet therapy.
PURPOSE: The use of gastroprotective agents has allowed significant progress in the prevention of upper gastrointestinal bleeding (UGIB) associated with non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents. Nevertheless, some concerns remain regarding the gastroprotective dosage and treatment duration. Our aim was to study the effect of gastroprotective agents in UGIB induced by NSAIDs and single- or dual-antiplatelet therapy. METHODS: A multicenter case-control study was conducted including 577 cases diagnosed with UGIB and 1343 sex-, age-, and hospital-matched controls. To estimate exposure to NSAIDs and gastroprotective agents, consumption was calculated for the 4 weeks prior to hospital admission in terms of defined daily doses (DDDs). Risk groups for UGIB induced by NSAIDs and single- or dual-antiplatelet therapy were defined as a function of each drug dose, use of gastrointestine-damaging drugs, and risk factors for UGIB. Odds ratios (ORs) with 95% confidence intervals (CIs) were adjusted for single- (model 1) and dual- (model 2) antiplatelet therapy. RESULTS: Full adherence (> 0.80DDD) to proton pump inhibitors (PPIs) was the only gastroprotective therapy that significantly reduced the risk of UGIB, considering NSAID risk (OR: 0.53; 95% CI: 0.30-0.95) and dose (OR: 0.48; 95% CI: 0.27-0.87) with ORs adjusted for single-antiplatelet therapy (model 1) and NSAID risk (OR: 0.55; 95% CI: 0.31-0.98) and dose (OR: 0.49; 95% CI: 0.28-0.89) with ORs adjusted for dual-antiplatelet therapy (model 2). CONCLUSIONS: These results reinforce the recommendation of adding a PPI at effective doses (full adherence) to prevent UGIB induced by NSAIDs, or single- or dual-antiplatelet therapy.
Authors: G I Leontiadis; A Sreedharan; S Dorward; P Barton; B Delaney; C W Howden; M Orhewere; J Gisbert; V K Sharma; A Rostom; P Moayyedi; D Forman Journal: Health Technol Assess Date: 2007-12 Impact factor: 4.014