Clinical Question:
In patients with previous peptic ulcer, is celecoxib safer than naproxen
taken with an proton pump inhibitor?
Bottom Line:
Celecoxib was as effective as lansoprazole co-therapy in the prevention of
recurrences of ulcer complications in subjects with a history of NSAID-related
complicated peptic ulcers. However, celecoxib, similar to lansoprazole
co-therapy, was still associated with a significant proportion of ulcer
complication recurrences. In addition, more patients receiving celecoxib
developed dyspepsia than patients receiving lansoprazole and naproxen.
Reference:
Lai KC, Chu KM, Hui WM, et al. Celecoxib compared with lansoprazole and
naproxen to prevent gastrointestinal ulcer complications. Am J Med
2005;118:1271-78.
Study Design:
Randomized controlled trial (nonblinded)
Synopsis:
Selective cyclooxygenase-2 (COX-2) inhibitors cause significantly fewer
peptic ulcers than conventional nonselective nonsteroidal anti-inflammatory
drugs (NSAIDs) in patients at low risk or high risk for peptic ulcers. On
the other hand, proton pump inhibitor co-therapy has also been shown to be
effective in preventing relapse of peptic ulcers in high-risk patients using
nonselective NSAIDs. We compared the efficacy of a selective COX-2 inhibitor
with that of proton pump inhibitor co-therapy in the reduction in the
incidence of ulcer relapse in patients with a history of NSAID-related
peptic ulcers. For this study, we recruited 224 patients who developed ulcer
complications after NSAID use. We excluded patients who required concomitant
aspirin treatment and who had renal impairment. After healing of ulcers and
eradication of Helicobacter pylori, patients were randomly assigned to
treatment with celecoxib 200 mg daily (n = 120) or naproxen 750 mg daily and
lansoprazole 30 mg daily (n = 122) for 24 weeks. The primary endpoint was
recurrent ulcer complications. During a median follow-up of 24 weeks, 4
(3.7%, 95% confidence interval [CI] 0.0%-7.3%) patients in the celecoxib
group, compared with 7 patients (6.3%, 95% CI 1.6%-11.1%) in the
lansoprazole group, developed recurrent ulcer complications (absolute
difference -2.6%; 95% CI for the difference -9.1%-3.7%). Celecoxib was
statistically non-inferior to lansoprazole co-therapy in the prevention of
recurrent ulcer complications. Concomitant illness (hazard ratio 4.72, 95%
CI 1.24-18.18) and age 65 years or more (hazard ratio 18.52, 95% CI
2.26-142.86) were independent risk factors for ulcer recurrences.
Significantly more patients receiving celecoxib (15.0%, 95% CI 9.7-22.5)
developed dyspepsia than patients receiving lansoprazole (5.7%, 95% CI
2.8-11.4. P = .02). |