Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole 40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms.

BACKGROUND

Pantoprazole magnesium (pantoprazole-Mg) may display extended inhibition of the proton pump with the potential for improved clinical efficacy in gastro-oesophageal reflux disease (GERD).

AIM

To compare the efficacy of pantoprazole-Mg and esomeprazole in GERD.

METHODS

Gastro-oesophageal reflux disease (Los Angeles grades A-D) patients were randomised to 4 weeks of treatment with pantoprazole-Mg (n = 290) or esomeprazole (n = 288), both 40 mg once daily, in this multicentre (14 Brazilian sites in 9 cities), double-blind study, with an additional 4 weeks' treatment in nonresponding patients. Severity of oesophagitis (at endoscopy) and GERD-related symptoms (ReQuest-GI) were assessed. The primary end point was the proportion of patients in complete remission (ReQuest-GI score <1.73 plus endoscopic healing) at week 4.

RESULTS

Complete remission occurred in 61% of patients in each treatment group at 4 weeks (primary endpoint) and in 81% and 79% of patients in the pantoprazole-Mg and esomeprazole groups at 8 weeks, with no significant differences. Mucosal healing rates were high and not significantly different. At 8 weeks, symptom relief with pantoprazole-Mg was significantly greater than that with esomeprazole (91.6% vs. 86.0%, P = 0.0370) because of continued improvement in symptoms with pantoprazole-Mg from week 4 to week 8 (P = 0.0206).

CONCLUSIONS

Pantoprazole-Mg 40 mg was at least as effective as esomeprazole 40 mg for complete remission and the mucosal healing rate was high. Symptom relief with pantoprazole-Mg continued to improve from 4 to 8 weeks and was greater than that with esomeprazole at week 8, suggesting an extended period of treatment effect (ClinicalTrials.gov identifier: NCT01132638).