Oral bisphosphonates do not increase the risk of severe upper gastrointestinal complications: a nested case–control study

BMC Gastroenterology

Research Article

Rosaria Gesuita¹  Achille P Caputi²  Giampiero Mazzaglia³  Francesco Cipriani³  Francesco Lapi⁴  Gianluca Della Vedova⁵  Tommaso Staniscia⁶  Annarita Vestri⁷  Dario Gregori⁸  Lorenza Scotti⁹  Giovanni Corrao⁹  Arianna Ghirardi^1,10  Luca Cavalieri D’Oro^1,11  Alberto Vaccheri^1,12 

[1] Center of Epidemiology, Biostatistics, and Medical Information Technology, Polytechnic University of Marche, Ancona, Italy;Department of Clinical and Experimental Medicine and Pharmacology, University of Messina, Messina, Italy;Department of Epidemiology, Regional Agency for Healthcare Services of Tuscany, Florence, Italy;Department of Epidemiology, Regional Agency for Healthcare Services of Tuscany, Florence, Italy;Department of Preclinical and Clinical Pharmacology, University of Florence, Florence, Italy;Centre for Clinical Epidemiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada;Department of Informatics, Systems and Communications, University of Milano-Bicocca, Milan, Italy;Department of Medicine and Aging, University “G. d’Annunzio”, Chieti-Pescara, Italy;Department of Public Health and Infectious Diseases, University “La Sapienza”, Rome, Italy;Department of Public Health and Microbiology, University of Turin, Turin, Italy;Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Via Bicocca degli Arcimboldi 8, 20126, Milan, Italy;Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Via Bicocca degli Arcimboldi 8, 20126, Milan, Italy;the AIFA-BEST Investigators, Italy;Operative Unit of Epidemiology, Local Health Unit of Monza and Brianza, Monza, Italy;Regional Centre for Drug Evaluation and Information (CREVIF), Department of Pharmacology, University of Bologna, Bologna, Italy;

关键词: Bisphosphonates;    Drug safety;    Healthcare utilization database;    Upper gastrointestinal complications;   

DOI  :  10.1186/1471-230X-14-5

 received in 2012-10-08, accepted in 2013-12-18,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundData on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting. We conducted a large population-based study from a network of Italian healthcare utilization databases aimed to assess the UGIC risk associated with use of BPs in the setting of secondary prevention of osteoporotic fractures.MethodsA nested case–control study was carried out within a cohort of 68,970 patients aged 45 years or older, who have been hospitalized for osteoporotic fracture from 2003 until 2005. Cases were the 804 patients who experienced hospitalization for UGIC until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current and past use of BPs (i.e. for drug dispensation within 30 days and over 31 days prior the outcome onset, respectively) after adjusting for several covariates.ResultsCompared with patients who did not use BPs, current and past users had OR (and 95% confidence interval) of 0.86 (0.60 to 1.22) and 1.07 (0.80 to 1.44) respectively. There was no difference in the ORs estimated according with BPs type (alendronate or risedronate) and regimen (daily or weekly), nor with co-therapies and comorbidities.ConclusionsFurther evidence that BPs dispensed for secondary prevention of osteoporotic fractures are not associated with increased risk of severe gastrointestinal complications is supplied from this study. Further research is required to clarify the role BPs and other drugs of co-medication in inducing UGIC.

【 授权许可】

Unknown   
© Ghirardi et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.