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Lumiracoxib is a cyclooxygenase (COX)-2–selective nonsteroidal anti-inflammatory drug (NSAID) that is associated with substantially fewer ulcer complications than are nonselective NSAIDs (Lancet 2004; 364:665). The industry-sponsored TARGET study of lumiracoxib included more than 18,000 patients (age, ≥50) with osteoarthritis who were followed for 1 year; it is the largest study published to date in which selective and nonselective NSAIDs were compared. Investigators used the data from this study to identify risk factors for complicated and uncomplicated ulcers in patients who took lumiracoxib or nonselective NSAIDs (naproxen or ibuprofen).
Researchers identified 14 potential risk factors, and then they used backward elimination in a Cox proportional hazards model to detect factors that were associated significantly with ulcer risk. They identified four risk factors for definite or probable complicated ulcers in patients who took nonselective NSAIDs: history of gastrointestinal bleeding or peptic ulcer (hazard ratio, 3.61; 95% CI, 1.86–7.00), age ≥65 (HR, 2.30; 95% CI, 1.48–3.59), nonwhite race (HR, 2.10; 95% CI, 1.35–3.27), and male sex (HR, 1.70; 95% CI, 1.08–2.68). Risk factors in patients who took lumiracoxib were age ≥65 (HR, 3.18; 95% CI, 1.40–7.20), concomitant aspirin use (HR, 2.89; 95% CI, 1.40–5.97), male sex (HR, 2.60; 95% CI, 1.25–5.40), and nonwhite race (HR, 2.16; 95% CI, 1.02–4.59). Lumiracoxib was associated with lower risk than were nonselective NSAIDs in each of these risk groups, except among patients who took aspirin. The numbers needed to treat with lumiracoxib instead of a nonselective NSAID to prevent 1 confirmed or probable ulcer complication were 47 for patients with histories of GI bleeding or ulcer, 106 for nonwhite patients, 128 for older patients (age, ≥65), and 135 for male patients. Helicobacter pylori infection did not increase risk for complicated ulcers. The authors concluded that the identified groups are at greater risk for complicated ulcers when taking NSAIDs and that lumiracoxib can lower that risk.
Hawkey CJ et al. Effect of risk factors on complicated and uncomplicated ulcers in the TARGET lumiracoxib outcomes study. Gastroenterology 2007 Jul; 133:57-64.
Comment
This secondary analysis of the very large TARGET trial provides data similar to those from other large NSAID trials, such as VIGOR (Journal Watch Gastroenterology Dec 12 2000) and CLASS (Journal Watch Gastroenterology Nov 6 2000). Age, history of GI bleeding or ulcer, and male sex have been identified previously as risk factors for ulcer complications. The finding that lumiracoxib did not lower risk in patients who took aspirin mirrors results for celecoxib in the CLASS trial. Overall, the data suggest that, compared with nonselective NSAIDs, COX-2–selective NSAIDs lower risk for complicated ulcers in the general population and in patients who have risk factors. Risk for adverse cardiovascular events has limited the use of these drugs, but the initial lumiracoxib study analysis suggested no increased cardiovascular risk was conferred when the drug was taken for 1 year. Of course, these data must be confirmed in studies with longer treatment periods.