Dyspepsia tolerability from the patients' perspective: a comparison of celecoxib with diclofenac

Aim: To compare celecoxib (800 mg/day, n =1997) with diclofenac (150 mg/day, n =1996) on dyspepsia‐related tolerability. Methods: In one of the two protocols comprising the Celecoxib Long‐Term Arthritis Safety Study, a randomized double‐blind trial, patients completed the Severity of Dyspepsia Assessment Questionnaire at baseline and at weeks 4, 13, 26 and 52 for the following three scales: Pain Intensity, Non‐Pain Symptoms and Satisfaction with Dyspepsia‐Related Health. Results: For the Pain Intensity scale, patients given diclofenac had significantly higher (worsening dyspepsia) mean changes, defined as follow‐up minus baseline, than patients given celecoxib ( P < 0.001, at all assessments). The mean changes in the Pain Intensity scale (scale, 2–47; higher score is higher pain intensity) were 0.99 (95% confidence interval (CI): 0.50, 1.48) for celecoxib and 2.76 (95% CI: 2.28, 3.25) for diclofenac at 4 weeks. Satisfaction was superior with celecoxib at all assessments ( P < 0.001). At 4 weeks, the mean changes in the Satisfaction scale (scale, 7–35; higher score is higher satisfaction) were 0.02 (95% CI: − 0.26, 0.29) for celecoxib and − 0.72 (95% CI: − 1.00, − 0.45) for diclofenac. Diclofenac patients had significantly higher Non‐Pain Symptoms at 4 weeks ( P =0.005). Conclusions: Celecoxib, at two to four times the recommended dose, demonstrated a superior dyspepsia‐related tolerability and satisfaction compared with standard dosages of diclofenac.