Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole
40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms.
Author(s): Moraes-Filho JP(1), Pedroso M, Quigley EM; PAMES Study Group.
Affiliation(s): Author information:
(1)Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao
Paulo, Brazil.
Publication date & source: 2014, Aliment Pharmacol Ther. , 39(1):47-56
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).
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