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Incidence of gastroduodenal ulcers during treatment with celecoxib or diclofenac: pooled results from three 12-week trials in Chinese patients with osteoarthritis or rheumatoid arthritis.
Int J Rheum Dis. 2010 May; 13(2):151-7.IJ

Abstract

AIM

To test whether treatment with celecoxib reduces the incidence of gastroduodenal ulcers compared to diclofenac in Asian patients with osteoarthritis (OA) or rheumatoid arthritis (RA) with minimal significant risk factors.

METHODS

Patients with a clinical diagnosis of OA or RA of at least 3 months were randomized to 12 weeks of double-blind treatment with celecoxib 100 mg twice daily (n = 440) or diclofenac 50 mg twice daily (n = 440). The primary outcome was the gastric and/or duodenal ulcer rate at endpoint as determined by upper gastrointestinal endoscopy performed during the screening week, and at endpoint.

RESULTS

There was no significant difference in the overall incidence of gastroduodenal ulcers at 12-week endpoint for celecoxib compared to diclofenac (2.8% vs. 5.1%; Cochran-Mantel-Haenszel [CMH] chi(2) P = 0.083). However, there was a significantly lower incidence of gastric ulcers on celecoxib versus diclofenac (0.5% vs. 3.6%; CMH chi(2) P = 0.002). Approximately 59% of patients in both treatment groups had no visible gastric lesions at endpoint; and a similar proportion were found to have one or more erosions on celecoxib (n = 85; 21.4%) and diclofenac (N = 91; 23.3%). A survival analysis of time to ulcer was significant for gastric ulcers (log-rank P = 0.004), but not for duodenal ulcers, or for gastroduodenal ulcers combined. Fewer patients reported at least one adverse event on celecoxib compared to diclofenac (42.4% vs. 50.3%; chi(2), 5.52; P = 0.019).

CONCLUSIONS

In Asian patients with minimal significant risk factors, treatment with celecoxib was associated with a modest but significantly reduced incidence of gastric ulcers at the end of 12 weeks.

Authors+Show Affiliations

Pfizer Inc, New York, NY 10017, USA. raymond.y.cheung@pfizer.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20536600

Citation

Cheung, Raymond, et al. "Incidence of Gastroduodenal Ulcers During Treatment With Celecoxib or Diclofenac: Pooled Results From Three 12-week Trials in Chinese Patients With Osteoarthritis or Rheumatoid Arthritis." International Journal of Rheumatic Diseases, vol. 13, no. 2, 2010, pp. 151-7.
Cheung R, Cheng TT, Dong Y, et al. Incidence of gastroduodenal ulcers during treatment with celecoxib or diclofenac: pooled results from three 12-week trials in Chinese patients with osteoarthritis or rheumatoid arthritis. Int J Rheum Dis. 2010;13(2):151-7.
Cheung, R., Cheng, T. T., Dong, Y., Lin, H. Y., Lai, K., Lau, C. S., Feng, H., & Parsons, B. (2010). Incidence of gastroduodenal ulcers during treatment with celecoxib or diclofenac: pooled results from three 12-week trials in Chinese patients with osteoarthritis or rheumatoid arthritis. International Journal of Rheumatic Diseases, 13(2), 151-7. https://doi.org/10.1111/j.1756-185X.2010.01463.x
Cheung R, et al. Incidence of Gastroduodenal Ulcers During Treatment With Celecoxib or Diclofenac: Pooled Results From Three 12-week Trials in Chinese Patients With Osteoarthritis or Rheumatoid Arthritis. Int J Rheum Dis. 2010;13(2):151-7. PubMed PMID: 20536600.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Incidence of gastroduodenal ulcers during treatment with celecoxib or diclofenac: pooled results from three 12-week trials in Chinese patients with osteoarthritis or rheumatoid arthritis. AU - Cheung,Raymond, AU - Cheng,Tien-Tsai, AU - Dong,Yi, AU - Lin,Hsiao-Yi, AU - Lai,Kamchuen, AU - Lau,Chak-sing, AU - Feng,Huang, AU - Parsons,Bruce, PY - 2010/6/12/entrez PY - 2010/6/12/pubmed PY - 2010/9/24/medline SP - 151 EP - 7 JF - International journal of rheumatic diseases JO - Int J Rheum Dis VL - 13 IS - 2 N2 - AIM: To test whether treatment with celecoxib reduces the incidence of gastroduodenal ulcers compared to diclofenac in Asian patients with osteoarthritis (OA) or rheumatoid arthritis (RA) with minimal significant risk factors. METHODS: Patients with a clinical diagnosis of OA or RA of at least 3 months were randomized to 12 weeks of double-blind treatment with celecoxib 100 mg twice daily (n = 440) or diclofenac 50 mg twice daily (n = 440). The primary outcome was the gastric and/or duodenal ulcer rate at endpoint as determined by upper gastrointestinal endoscopy performed during the screening week, and at endpoint. RESULTS: There was no significant difference in the overall incidence of gastroduodenal ulcers at 12-week endpoint for celecoxib compared to diclofenac (2.8% vs. 5.1%; Cochran-Mantel-Haenszel [CMH] chi(2) P = 0.083). However, there was a significantly lower incidence of gastric ulcers on celecoxib versus diclofenac (0.5% vs. 3.6%; CMH chi(2) P = 0.002). Approximately 59% of patients in both treatment groups had no visible gastric lesions at endpoint; and a similar proportion were found to have one or more erosions on celecoxib (n = 85; 21.4%) and diclofenac (N = 91; 23.3%). A survival analysis of time to ulcer was significant for gastric ulcers (log-rank P = 0.004), but not for duodenal ulcers, or for gastroduodenal ulcers combined. Fewer patients reported at least one adverse event on celecoxib compared to diclofenac (42.4% vs. 50.3%; chi(2), 5.52; P = 0.019). CONCLUSIONS: In Asian patients with minimal significant risk factors, treatment with celecoxib was associated with a modest but significantly reduced incidence of gastric ulcers at the end of 12 weeks. SN - 1756-185X UR - https://www.unboundmedicine.com/medline/citation/20536600/Incidence_of_gastroduodenal_ulcers_during_treatment_with_celecoxib_or_diclofenac:_pooled_results_from_three_12_week_trials_in_Chinese_patients_with_osteoarthritis_or_rheumatoid_arthritis_ L2 - https://doi.org/10.1111/j.1756-185X.2010.01463.x DB - PRIME DP - Unbound Medicine ER -