To investigate tolerability and efficacy of pantoprazole 20 mg, once daily (o.d.), pantoprazole 40 mg o.d., and omeprazole 20 mg o.d., in patients taking nonsteroidal anti-inflammatory drug(s) (NSAIDs).
Included in this randomized, double-blind, multicenter, parallel-group study were rheumatic patients (>55 yr) on continual NSAIDs and with at least one more recognized risk factor that contributes to the development of gastrointestinal (GI) injury. Study duration was 6 months, and the treatment consisted of pantoprazole 20 mg o.d. (N = 196), pantoprazole 40 mg o.d. (N = 199), or omeprazole 20 mg o.d. (N = 200). Patients took NSAID(s) (except COX-2 inhibitors), had no more than five erosions/petechiae in the upper GI tract, no current peptic ulcers or reflux esophagitis, and had at most moderate intensity GI symptoms. Endoscopy was performed at baseline, 3, and 6 months. The primary end points were lack of "therapeutic failure" and lack of "endoscopic failure" at 6 months.
After 6 months, the probabilities to remain in remission were 90% pantoprazole 20 mg o.d., 93% pantoprazole 40 mg o.d., and 89% omeprazole 20 mg o.d. for lack of "therapeutic failure;" 91% pantoprazole 20 mg o.d., 95% pantoprazole 40 mg o.d., and 93% omeprazole 20 mg o.d. for lack of "endoscopic failure."
For patients taking NSAIDs continually, pantoprazole 20 mg o.d., pantoprazole 40 mg o.d., or omeprazole 20 mg o.d. provide equivalent, effective, and well-tolerated prophylaxis against GI lesions, including peptic ulcers.