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

Arianna Ghirardi,Gianluca Della Vedova,Achille P Caputi,Luca Cavalieri D’Oro,Giovanni Corrao,Rosaria Gesuita,Lorenza Scotti,Dario Gregori,Alberto Vaccheri,Tommaso Staniscia,Francesco Lapi,Giampiero Mazzaglia,Annarita Vestri,Francesco Cipriani

doi:10.1186/1471-230x-14-5

Abstract

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.

Highlights

Data on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting
Data source The data used for the present study were retrieved from the health service databases of all the 13 Italian territorial units participating at the AIFA-BEST (Bisphosphonates Effectiveness-Safety Tradeoff) project
This program is administered by an automated system of databases on the use of health services supplied free of charge from National Health Service (NHS) and including: (i) an archive of beneficiaries of NHS, inclusive of demographic and administrative data; (ii) details of hospitalizations in private and public hospitals, inclusive of diagnosis at discharge; and (iii) outpatients medicament prescriptions reimbursable from the NHS [according to Italian rules, outpatients medicaments supplied free of charge from NHS may be dispensed only from pharmacies and only by prescription]

Summary

Introduction

Data on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting. The lifetime risk of typical osteoporotic fracture (i.e., of the wrist, hip, or vertebra) has been reported to be around 40% [1,2,3]. An important clinical strategy is to identify patients who have already had a typical osteoporotic fracture and institute treatments aimed at secondary prevention [4,5,6,7]. Oral bisphosphonates (BPs), such as alendronate and risedronate, are considered the mainstay therapy for the prevention of osteoporotic fractures. Randomised clinical trials (RCTs) have consistently shown that long-term treatment with these medicaments improves bone mineral density (BMD) and reduces the risk of fracture [12,13,14,15,16,17,18,19]. Therapy must be generally safe, besides being effective, in a long-term fashion

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