Efficacy of pantoprazole in the prevention of peptic ulcers, induced by non-steroidal anti-inflammatory drugs: a prospective, placebo-controlled, double-blind, parallel-group study

Aim. To evaluate the efficacy of pantoprazole in preventing gastrointestina l lesions in patients with rheumatic diseases receiving continuous, long-te rm treatment with non-steroidal anti-inflammatory drugs. Material. This was a prospective, randomised, double-blind, unbalanced, pla cebo-controlled, parallel group study. Outpatients (n = 104, age range 22-8 0 years, mean age 59.5) with rheumatoid arthritis or osteoarthritis, requir ing chronic intake of NSAIDs (at least 8 weeks prior to the start of the st udy), were randomised and enrolled to receive either 40 mg pantoprazole (n= 70) or placebo (n=34) once daily, for 12 weeks. Patients had endoscopically confirmed gastric and duodenal lesions grade 0, 1 or 2 (Lanza classificati on grade 0: normal to hyperaemic mucosa; grade 1 : 1 to 3 erosions, submuco sal haemorrhage or petechiae, grade 2 : 4 to 10 erosions, submucosal haemor rhages or petechiae). Clinical and endoscopic evaluations were performed at baseline, after 4, and 12 weeks. The primary end-point of the study was th e incidence of gastric or duodenal ulcers after 4 and 12 weeks of treatment . Results. Patients (n=95) were evaluated: 65 in the pantoprazole group and 3 0 in the placebo group. When considering all patients (those with Lanza sco re grade 0, 1, 2 at baseline), the overall proportion of patients in remiss ion was 82% and 77% after 4 weeks, and 72% and 59% after 12 weeks in pantop razole and placebo groups, respectively (cumulative survival analysis accor ding to Kaplan-Meier). The difference between the treatment groups was even more marked when only those patients with normal mucose at baseline (grade 0) were considered. After 12 weeks, the proportion of patients in remissio n was 82% (95% confidence limits 70% - 94%) in the pantoprazole and 55% (95 % confidence limits 33%-77%) in the placebo treatment group, p=0.036. Adver se events were reported in 4% and 6% of patients in pantoprazole and placeb o treatment groups, respectively Conclusions. Pantoprazole 40 mg once daily was well tolerated and is more e ffective than placebo in the prevention of peptic ulcers in patients with r heumatic diseases who require continuous, long-term, treatment with NSAIDs.