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

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 ReQuestTM-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.
Aliment Pharmacol Ther 25, 1461–1469