Abstract
BackgroundConcerns have been raised as to the safety of bisphosphonates; in particular a possible link between bisphosphonate use and upper gastrointestinal (GI) cancer. Two published studies using different study populations but drawn from earlier versions of the same national UK database, reached differing conclusions: one finding no evidence for an increase in the risk of gastric or oesophageal cancer in bisphosphonate users and one finding a small but significantly increased risk of oesophageal cancer linked to duration of bisphosphonate use.Methodology/ Principal FindingsDesign-A case control study comparing bisphosphonate prescribing in cases of upper GI cancer from 1995 to 2007 using UK primary care electronic health records (GPRD).Main Outcome Measure-Relative Risk (approximated to Odds Ratio for rare events) for oesophageal and gastric cancer development in bisphosphonate users compared to non–users. The odds of being a case of oesophageal cancer, adjusted for smoking status, were significantly increased in women who had had one or more bisphosphonate prescriptions, odds ratio 1·54 (95% CI 1·27–1·88) compared to non-users. There was no significant effect on gastric cancer in women, odds ratio adjusted for smoking status, 1.06 (95% CI 0.83–1.37) and also no apparent risk in men for either oesophageal or gastric cancer, odds ratio adjusted for smoking status 0.78 (95%CI 0.56–1.09) and 0.87 (95% CI 0.55–1.36) respectively.Conclusions/ SignificanceOur results support a small but significant increased risk of oesophageal cancer in women prescribed bisphosphonates and is based on the largest number of exposed cases to date in the UK.
Highlights
There has been a 20-fold rise in the prescribing of bisphosphonates in general and alendronate in particular in recent years
Risk of all bisphosphonates on upper GI (UGI) cancer We initially investigated the effect of all bisphosphonates on UGI cancer in both men and women and found an Odds Ratio (OR) of 1?13 for men and women combined
The OR for the effect of all bisphosphonates on UGI cancer in women adjusted for smoking status was 1?34 and 0?81 for men
Summary
There has been a 20-fold rise in the prescribing of bisphosphonates in general and alendronate in particular in recent years. Bisphosphonates and alendronate are well known to cause both dyspepsia and inflammatory changes such as erosive oesophagitis, delayed healing, and mucosal abnormalities.[2] Multinucleated giant cells have been detected in oesophageal inflammatory exudates. Whether these can undergo malignant transformation is not known but concerns have been raised as to a possible link between bisphosphonate use and upper GI cancer.[3,4]. Concerns have been raised as to the safety of bisphosphonates; in particular a possible link between bisphosphonate use and upper gastrointestinal (GI) cancer. Two published studies using different study populations but drawn from earlier versions of the same national UK database, reached differing conclusions: one finding no evidence for an increase in the risk of gastric or oesophageal cancer in bisphosphonate users and one finding a small but significantly increased risk of oesophageal cancer linked to duration of bisphosphonate use
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