Open Access Research article

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

Arianna Ghirardi1, Lorenza Scotti1, Gianluca Della Vedova2, Luca Cavalieri D’Oro3, Francesco Lapi456, Francesco Cipriani4, Achille P Caputi7, Alberto Vaccheri8, Dario Gregori9, Rosaria Gesuita10, Annarita Vestri11, Tommaso Staniscia12, Giampiero Mazzaglia4, Giovanni Corrao1* and on behalf of the AIFA-BEST Investigators

Author Affiliations

1 Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Via Bicocca degli Arcimboldi 8, 20126 Milan, Italy

2 Department of Informatics, Systems and Communications, University of Milano-Bicocca, Milan, Italy

3 Operative Unit of Epidemiology, Local Health Unit of Monza and Brianza, Monza, Italy

4 Department of Epidemiology, Regional Agency for Healthcare Services of Tuscany, Florence, Italy

5 Department of Preclinical and Clinical Pharmacology, University of Florence, Florence, Italy

6 Centre for Clinical Epidemiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada

7 Department of Clinical and Experimental Medicine and Pharmacology, University of Messina, Messina, Italy

8 Regional Centre for Drug Evaluation and Information (CREVIF), Department of Pharmacology, University of Bologna, Bologna, Italy

9 Department of Public Health and Microbiology, University of Turin, Turin, Italy

10 Center of Epidemiology, Biostatistics, and Medical Information Technology, Polytechnic University of Marche, Ancona, Italy

11 Department of Public Health and Infectious Diseases, University “La Sapienza”, Rome, Italy

12 Department of Medicine and Aging, University “G. d’Annunzio”, Chieti-Pescara, Italy

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BMC Gastroenterology 2014, 14:5  doi:10.1186/1471-230X-14-5

Published: 7 January 2014

Abstract

Background

Data 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.

Methods

A 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.

Results

Compared 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.

Conclusions

Further 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.

Keywords:
Bisphosphonates; Drug safety; Healthcare utilization database; Upper gastrointestinal complications