The Canadian Medical [Association] Journal (CMAJ) has recently published a paper reviewing changes in the rates of upper gastrointestinal haemorrhage following the introduction of COX-2 selective non-steroidal anti-inflammatories (NSAIDs).
The paper compares changes in rates of GI bleeds in British Columbia and Ontario in comparison to changes in the use of NSAIDs following the introduction of COX-2 in patients aged 66 and over. In British Columbia, NSAID use rose by 2.2% (25% in relative terms) following the launch of COX-2 NSAIDs. This increase made no statistical difference to the rate of GI bleeds seen.
In Ontario, NSAID use rose by 5.6% (51% in relative terms), this increase may have contributed to the increased rate of GI bleeds observed. The observed number of GI bleeds was 26% greater than expected which is approximately 2 admissions be 10,000 patients.
In interpreting this paper the authors states that although COX-2 NSAIDs are associated with a lower risk of upper GI bleeding than traditional NSAIDs they still increase the risk compared to no treatment. It is therefore possible that a more cautious use of all NSAIDs may have avoided the increased number of GI bleeds seen in Ontario.
This study has some limitations it was observational, however there is a close temporal association seen between the introduction of COX-2 NSAIDs and the increased rate of upper GI bleeds. Additionally, the appropriateness of the treatment for individual patients and any benefits gained are unknown. Despite this it does appear that a more cautious use of new drugs may have may protect against adverse drug effects.
Action: Clinicians should consider the risks and benefits of possible treatments before recommending a particular therapy. This process should account for potentially unknown risks when drugs are new to the market.
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