The Effect of Esomeprazole 40 mg Single Therapy in Patients with Non-Erosive Reflux Disease Who Are Resistant to Standard-Dose Proton Pump Inhibitor Therapy: An Open-Label Multicenter Study

ABSTRACT

BACKGROUND/AIMS: Despite the efficacy of proton pump inhibitor (PPI) treatment, a considerable number of patients with non-erosive reflux disease (NERD) are resistant to treatment with a PPI at the standard dose. In these patients, doubling the dose of PPI is one of the potential therapeutic strategies. However, only few studies support this therapeutic strategy. The aim of this study was to assess the efficacy and safety of 40 mg esomeprazole once daily in patients with persistent symptoms of NERD despite standard daily PPI therapy. MATERIALS AND METHODS: A total of 92 patients with NERD who had persistent symptoms of NERD despite standard dose (half dose) of PPI for more than 4 weeks, were enrolled in this multicenter (eight centers) open-label study. Efficacy and safety of a daily dose of 40 mg esomeprazole were evaluated after 4 weeks in all the patients. RESULTS: The sum score of two symptoms (heartburn and regurgitation) decreased significantly from 72.51 to 32.55 after 4 weeks of treatment (P<0.001). The percentage of patients with ≥50% improvement in symptom score (heartburn+acid regurgitation), during the study period was 66.7%. Patients with severe symptoms at baseline had significantly higher symptom improvement rate in comparison to patients who had milder symptoms. Adverse effects related to the treatment were reported by 3 (3.3%) patients. CONCLUSIONS: Esomeprazole 40 mg once daily is an effective and safe strategy to treat NERD patients with persistent symptoms despite standard daily PPI therapy.