Celecoxib compared with lansoprazole and naproxen to prevent gastrointestinal ulcer complications.
OBJECTIVE
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Lai
Kam-Chuen
KC
Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China. kclai@hku.hk
Chu
Kent-Man
KM
Hui
Wai-Mo
WM
Wong
Benjamin Chun-Yu
BC
Hu
Wayne Hsing-Ching
WH
Wong
Wai-Man
WM
Chan
Annie On-On
AO
Wong
John
J
Lam
Shiu-Kum
SK
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy; D016480:Helicobacter pylori; D006801:Humans; D015994:Incidence; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D010438:Peptic Ulcer Hemorrhage / Q000139:chemically induced; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D011720:Pyrazoles / Q000009:adverse effects* / Q000627:therapeutic use; D012008:Recurrence; D012307:Risk Factors; D013449:Sulfonamides / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D052246:Cyclooxygenase 2 Inhibitors; D054328:Proton Pump Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D064747:Lansoprazole; D009288:Naproxen; D000068579:Celecoxib; D009853:Omeprazole