The impact of H. pylori status on healing of erosive and non-erosive GERD with Esomeprazole: an analysis based on the ProGERD Study initiative

Malfertheiner, P.; Leodolter, A.; Vieth, M.; Jaspersen, D.; Labenz, J.; Meyer-Sabellek, W.; Willich, S.N.; Lind, T.; Stolte, M.
September 2002
Gut;Sep2002 Supplement 2, Vol. 51, pA65
Academic Journal
Background: The ProGERD study initiative is based on a large multicenter clinical trial conducted in Germany. The aim is to follow, over a 5 year period, the clinical evolution of patients with non-erosive and erosive gastroesophageal reflux disease (GERD) after treatment with esomeprazole 20 mg and 40 mg respectively. Here we report the results of the acute treatment phase and the impact of H. pylori status on healing of GERD. Patients and Methods: 6509 patients have been included in this analysis. All patients presenting with heartburn underwent upper gastrointestinal endoscopy and were divided into non-erosive or erosive GERD according to the Los Angeles classification system. H. pylori status was assessed by histology from two antral and two corpus biopsies. Patients with nonerosive GERD received esomeprazole 20 mg for 2 weeks. If symptoms persisted, treatment continued for a further 2 weeks to a total of 4 weeks (endpoint symptom free by investigator assesment). Patients with erosive GERD received esomeprazole 40 mg for 4 weeks. If healing did not occur, treatment continued for a further 4 weeks to a total of 8 weeks (endpoint endoscopic healing). Results: In the overall treatment evaluation 91.5% of patients with non-erosive GERD and 91.9% of the patients with erosive GERD reported improvement. In the table the treatment responses are shown according to H. pylori status. In the multivariate analysis H. pylori was only in the NERD group an independent factor for better response to esomeprazole therapy. Conclusion: Esomeprazole leads to rapid symptomatic relief and anatomical healing of GERD. In the overall population, a positive H. pylori status was associated with a better response to esomeprazole. However, in the subpopulation of erosive GERD patients without Barrett's esophagus, a positive H. pylori status did not result in a significant better therapeutic response.


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