Is it Better to Prescribe a Cyclooxygenase-2 Inhibitor or Conventional NSAIDs to Prevent Adverse Gastrointestinal Events?
Is it Better to Prescribe a Cyclooxygenase-2 Inhibitor or Conventional NSAIDs to Prevent Adverse Gastrointestinal Events?
Abstract & Commentary
By Joseph Varon, MD, FACP, FCCP, FCCM, Professor, University of Texas Health Science Center, Houston; St. Luke's Episcopal Hospital, Houston. Dr. Varon reports no financial relationship to this field of study.
Synopsis: Cyclooxygenase 2 (COX 2) inhibitors may not be as safe as previously thought. These agents have a considerable risk of adverse gastrointestinal events. The concurrent use of ulcer-healing drugs appears to decrease this risk.
Source: Hippisley-Cox J, et al. Risk of adverse gastrointestinal outcomes in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. BMJ. 2005;331:1310-1316.
This British study was aimed at evaluating the risk of an adverse upper gastrointestinal event among patients taking different cyclooxygenase-2 (COX 2) inhibitors and comparing it with those taking non-selective non-steroidal anti-inflammatory drugs (NSAIDs). The study was designed as a nested case-control analysis utilizing a large British database of 367 general practices. Analysis was done for those patients with an adverse upper gastrointestinal episode such as hematemesis, gastritis, or peptic ulcer disease. For each adverse episode, 10 controls were matched for age, gender, time of year, and type of practice.
Over the 4-year study period, 10,892 patients had a first-ever diagnosis of an adverse upper gastrointestinal event, with an overall incidence for all ages of 1.36 per 1000 person years. The incidence was higher in men than in women and increased with age. The incidence for patients aged 65 years and older was 4.03 per 1000 person years. After correcting for other variables, 9,407 patients were analyzed and compared with 88,867 controls. Of these 9407 patients, 45.2% had been prescribed NSAIDs in the prior 3 years and 9.9% had been prescribed a COX 2 inhibitor. Odds ratios (OR) for the development of an adverse gastrointestinal event were adjusted for other medications, co-morbidity, and smoking status.
Once adjustments were made, the highest OR was associated with current use of naproxen (OR, 2.12), followed by current use of diclofenac (OR, 1.96), other COX 2 inhibitors (OR, 1.72), other non-selective NSAIDs (OR, 1.67), aspirin (OR, 1.60), and ibuprofen (OR, 1.59). Previous utilization of diclofenac and aspirin was associated with significantly higher odds ratios. Among those patients taking ulcer-healing medications, current use of all NSAIDs showed no significantly increased risk of adverse gastrointestinal events. However, the risk remained elevated for those patients taking diclofenac despite the concurrent use of ulcer-healing medications.
Commentary
The use of NSAIDs and COX 2 inhibitors has increased significantly over the past decade.1 The increase in the use of COX 2 drugs, in particular, was attributed to the "lower risk" of adverse gastrointestinal events.2
The most important finding in this study was that the investigators found no strong evidence of enhanced safety with the newer COX 2 inhibitor compared with traditional non-selective NSAIDs. Moreover, the concurrent use of ulcer-healing drugs in patients taking COX 2 inhibitors appeared to reduce the risk for adverse gastrointestinal events.
This study suggests that COX 2 inhibitors may not be as safe as originally thought. One could even justify prescribing ulcer-healing medications to any patient that will require long-term use of COX 2 inhibitors.
References
1. Micklewright R, et al. Review article: NSAIDs, gastroprotection and cyclooxygenase-II-selective inhibitors. Aliment Pharmacol Ther. 2003;17:321-322.
2. Williams GW. An update on nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors. Curr Pain Headache Rep. 2005;9:377-389.
Cyclooxygenase 2 (COX 2) inhibitors may not be as safe as previously thought. These agents have a considerable risk of adverse gastrointestinal events. The concurrent use of ulcer-healing drugs appears to decrease this risk.Subscribe Now for Access
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