A clinical trial comparing pantoprazole and esomeprazole to explore the concept of achieving ‘complete remission’ in gastro‐oesophageal reflux disease

• Published in: Alimentary pharmacology & therapeutics Vol. 25; no. 12; pp. 1461 - 1469
• Main Authors: BARDHAN, K. D., ACHIM, A., RIDDERMANN, T., PFAFFENBERGER, B.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 15.06.2007; Blackwell
• Subjects: 2-Pyridinylmethylsulfinylbenzimidazoles - therapeutic use; Adolescent; Adult; Aged; Anti-Ulcer Agents - therapeutic use; Biological and medical sciences; Digestive system; Double-Blind Method; Esomeprazole - therapeutic use; Esophagus; Female; Gastroenterology. Liver. Pancreas. Abdomen; Gastroesophageal Reflux - drug therapy; Humans; Male; Medical sciences; Middle Aged; Other diseases. Semiology; Pharmacology. Drug treatments; Remission Induction - methods; Secondary Prevention; Treatment Outcome; Wound Healing - drug effects; Human; Gastroesophageal reflux; Pantoprazole; Enzyme; Esophageal disease; H; Enzyme inhibitor; Antiulcer agent; K; Proton pump inhibitor; Benzimidazole derivatives; Antisecretory agent; Esomeprazole; Digestive diseases; exchanging ATPase; Hydrolases; Clinical trial; Remission
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2007.03337.x

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.