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www.nature.com/clinicalpractice/gasthep
Original article Schnitzer TJ et al. (2004) Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet 2004; 364: 665674
Safety and efficacy of lumiracoxib compared with NSAIDs
SYNOPSIS
KEYWORDS COX-2 inhibitors, NSAIDs, ulcer
BACKGROUND
Long-term use of selective inhibitors of cyclooxygenase 2 (COX-2) could be associated with reduced rates of upper gastro intestinal (UGI) tract ulcer complications compared with the use of nonselective non-steroidal anti-inflammatory drugs (NSAIDs).
OBJECTIVES
To compare the rate of UGI ulcer and cardiovascular complications of lumiracoxib with two nonspecific NSAIDs, naproxen and ibuprofen, in patients with osteoarthritis.
DESIGN AND INTERVENTION
Patients with osteo arthritis were enrolled in this multicenter, double-blind trial. Eligible patients had at least moderate arthritis-related pain at the study start, which necessited anti-inflammatory therapy anticipated to be used for at least 52 weeks. Exclusion criteria included: patients taking proton-pump inhibitors, misoprostol, and full-dose H2 antagonists; those with active gastrointestinal ulceration in the 30 days before the study, or UGI bleeding in the previous year or any history of gastroduodenal perforation or obstruction. Patients were also excluded if they had a history of cardiovascular complications. In one substudy patients were randomly assigned to 52 weeks of 400 mg lumira coxib once daily or 500 mg naproxen twice daily. The other substudy compared the same dose of lumiracoxib with 800 mg ibuprofen three times a day. Gastrointestinal and cardio vascular complications were assessed at baseline and at weeks 4, 13, 20, 26, 39 and 52 during the study and at 4 weeks follow up.
OUTCOME MEASURES
The primary endpoint was the rate of UGI ulcer complications (bleeding, perforation or obstruction). Secondary endpoints included the rate of all ulcers (a combined endpoint of ulcer complications as above plus uncomplicated symptomatic ulcers found when endoscopy was done to evaluate patient reported symptoms), and cardiovascular endpoints (myocardial infarction, stroke or...