Real-World Effectiveness and Safety of Esomeprazole/Magnesium Hydroxide in Gastroesophageal Reflux Disease: Results from a Multicenter Prospective Observational Study

Background/Objectives: Proton pump inhibitors (PPIs) are the mainstay treatment for gastroesophageal reflux disease (GERD); however, variability in treatment response and suboptimal symptom control pose clinical challenges. This study aimed to evaluate the real-world effectiveness and safety of esomeprazole/magnesium hydroxide in patients with GERD using a structured symptom assessment. Methods: This multicenter, prospective, non-interventional study included patients with GERD who were prescribed esomeprazole/magnesium hydroxide in routine clinical practice. Symptoms were assessed at baseline and at weeks 4 and 8. The prespecified primary endpoint was the protocol-defined responder rate at week 4; a post hoc sensitivity analysis required a decrease in total symptom score. Results: A total of 5228 patients were included in the effectiveness analysis. Protocol-defined responder rates were 98.4% and 96.2% at weeks 4 and 8, respectively. In the stricter sensitivity analysis, responder rates were 91.1% and 93.4%, respectively. The median total symptom score decreased from 6.0 at baseline to 3.0 at week 4 and 1.0 at week 8 (nominal p < 0.0001). Symptom improvement was observed across erosive esophagitis, non-erosive GERD, and maintenance-therapy subgroups. Adverse events occurred in 0.7% of patients. Conclusions: Esomeprazole/magnesium hydroxide use was associated with symptom improvement over 8 weeks in routine practice. Because this uncontrolled observational study cannot establish causality, the findings should be interpreted as descriptive real-world evidence.