Key result
Lumiracoxib reduces ulcers and complications versus nonselective NSAIDs in patients not taking aspirin.
Why the study?
The TARGET study previously demonstrated a significant gastrointestinal benefit with lumiracoxib versus naproxen or ibuprofen, but the timing of early ulcer complication reduction was unclear.
Does lumiracoxib reduce upper gastrointestinal ulcer complications compared to nonselective NSAIDs in patients with arthritis?
RCT (n=18,325)
Does lumiracoxib reduce upper gastrointestinal ulcer complications compared to nonselective NSAIDs in patients with arthritis?
Lumiracoxib provides gastrointestinal safety benefits over nonselective NSAIDs even with short-term use.
Early GI benefit with lumiracoxib detectable by day 16 for ulcer complications; extends TARGET evidence to short-term use in non-aspirin patients.
BACKGROUND: The large (n = 18 325) Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) study demonstrated a significant gastrointestinal benefit with lumiracoxib 400 mg o.d. (4x the recommended dose in osteoarthritis) vs. naproxen 500 mg b.d. or ibuprofen 800 mg t.d.s. AIM: To investigate how early a reduction in ulcer complications could be detected with lumiracoxib vs. nonselective nonsteroidal anti-inflammatory drugs in TARGET. METHODS: Pointwise 95% confidence intervals were generated for the between-treatment differences in Kaplan-Meier estimates for definite or probable upper gastrointestinal ulcer complications (ulcer complications) and for all ulcers. RESULTS: In patients not on aspirin, there was a significant reduction in all ulcers by day 8 and in ulcer complications by day 16 with lumiracoxib compared with both nonselective nonsteroidal anti-inflammatory drugs combined, by day 6 (all ulcers) and day 14 (ulcer complications) vs. naproxen and by day 32 (all ulcers) and day 33 (ulcer complications) vs. ibuprofen. CONCLUSION: Even with short-term use, there are gastrointestinal safety benefits for lumiracoxib vs. nonselective nonsteroidal anti-inflammatory drugs.
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Hawkey et al. (2008) conducted an RCT in Arthritis (n=18,325). Lumiracoxib vs. Naproxen 500 mg b.d. or ibuprofen 800 mg t.d.s. was evaluated on Definite or probable upper gastrointestinal ulcer complications and all ulcers. Lumiracoxib significantly reduced all ulcers by day 8 and ulcer complications by day 16 compared with combined nonselective NSAIDs in patients not taking aspirin.
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