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A clinical trial comparing pantoprazole and esomeprazole to explore the concept of achieving ‘complete remission’ in gastro‐oesophageal reflux disease
Author(s) -
BARDHAN K. D.,
ACHIM A.,
RIDDERMANN T.,
PFAFFENBERGER B.
Publication year - 2007
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2007.03337.x
Subject(s) - esomeprazole , pantoprazole , medicine , reflux , gastroenterology , randomized controlled trial , gastro , disease , symptom relief , clinical endpoint , clinical trial , complete remission , proton pump inhibitor , esophageal disease , surgery , esophagus , omeprazole , chemotherapy
Summary Background and Aim The outcome of gastro‐oesophageal reflux disease treatment is traditionally assessed by measuring endoscopically confirmed healing and symptom relief separately. Both terms together, indicating complete remission, are intuitively a more realistic clinical endpoint but are assessed less often. Aim To explore this concept, we formally compared the efficacy of the proton pump inhibitors (PPIs) pantoprazole and esomeprazole using rates of complete remission judged against rates of healing and symptom relief separately. Methods Five hundred and eighty‐two patients with erosive gastro‐oesophageal reflux disease were randomized to treatment for 4, 8, or 12 weeks with either pantoprazole or esomeprazole 40 mg daily. Symptom relief was assessed with the validated ReQuest™‐GI subscale. Results Approximately 75% of patients were free of symptoms or had no oesophageal lesions after 4 weeks’ treatment, rising to about 93% and 96%, respectively, at 12 weeks. Complete remission rates were, however, lower at these time points; approximately 60% and about 90%, respectively. Both PPIs had similar efficacy. Conclusions Endoscopically confirmed healing and symptom relief assessed separately over‐estimated the benefits of both drugs. In contrast, complete remission indicates that patients may be treated inadequately when given the standard 4‐ to 8‐week treatment. We suggest that complete remission is a more reliable and clinically relevant endpoint of treatment.