Review Article
Are All Oral COX-2 Selective Inhibitors the Same? A Consideration of Celecoxib, Etoricoxib, and Diclofenac
Table 3
GI safety of celecoxib and etoricoxib compared with diclofenac in patients with OA and RA.
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In addition to GI safety, data from parts of the MEDAL clinical trial programs and the CLASS study demonstrated a significantly higher incidence of hepatic AEs with diclofenac than with either coxib comparator (celecoxib versus diclofenac: 0.6% and 2.3%, respectively, p ≤ 0.05; etoricoxib versus diclofenac: 4.3% and 9.4%, respectively, p ≤ 0.05) (Silverstein et al. 2000, Krueger et al. 2008). GI intolerability AEs: abdominal pain, diarrhea, dyspepsia, flatulence, and nausea. Celecoxib combined doses of 200 mg daily dose and 400 mg daily dose. GI intolerability AEs: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, and nausea. Clinical and laboratory GI AEs. Bleeding from the esophagus, stomach, or duodenum; perforation or obstruction from a nonmalignant gastric or duodenal ulcer; or an ulcer documented on clinically indicated workup. The MEDAL program consists of data from the MEDAL, EDGE I, and EDGE II trials. Perforation, obstruction, and witnessed ulcer or significant bleeding. Uncomplicated ulcer or bleeding. Bleeding, perforation, obstruction. Gastroduodenal, small-bowel, or large-bowel hemorrhage, gastric-outlet obstruction; gastroduodenal, small-bowel, or large-bowel perforation; clinically significant anemia of defined GI or presumed occult GI origin; acute GI hemorrhage of unknown origin. p ≤ 0.05. GI, gastrointestinal; OA, osteoarthritis; RA, rheumatoid arthritis; AEs, adverse events; PY, patient-years; HR, hazard ratio. |