Assessment of Burden of Partial Response to Standard Doses of Proton Pump Inhibitors in Patients with Clinically Diagnosed Gastroesophageal Reflux Disease: A Real-World Evidence Study in India.

Abstract

Background: Partial response to standard-dose proton pump inhibitors (PPIs) in gastroesophageal reflux disease (GERD) is common, yet real-world data on its burden and management in Indian settings remain limited.

Objective: This study aimed to understand the burden, clinical profile, drug utilization patterns across specialties, the effectiveness of Pantoprazole 80 mg dual delayed-release (DDR) formulation, and management strategies used in the treatment of partial responders with clinically diagnosed GERD in Indian settings.

Methods: This was a multicentric, retrospective observational study. Data on adult patients with GERD with a follow-up duration of at least 4 weeks from baseline were extracted from electronic medical records (EMR) of outpatient settings from five centers, which included drug utilization patterns, clinical and treatment profiles, and effectiveness of PPIs.

Results: Among EMRs of 5205 patients with GERD, 38.0% were on rabeprazole and 36.6% on pantoprazole (mean age: 53.3 years; standard deviation: 14.3 years), and 55.0% were male. Heartburn was the primary complaint in 76.0% of cases. Cardiovascular co-morbidities with dyslipidemia were reported in 66.7% (1742/2610) patients. Pantoprazole and rabeprazole were preferred across specialties, where 31.1% (592/1906) and 17.7% (350/1979) adhered to treatment, respectively. Total burden of partial responders was 41.7%, including patients who switched PPIs, changed PPI dosage, or added other medications. Pantoprazole 40 mg twice daily (BD) showed 49.1% improvement in heartburn and 50.9% in abdominal pain. Pantoprazole 80 mg DDR once daily demonstrated significantly higher symptom relief, with a 60.2% reduction in heartburn (p < 0.001) and a 66.1% reduction in abdominal pain (p < 0.001). These findings suggest that higher-dose pantoprazole therapy may be a clinically effective strategy for managing partial responders to standard-dose PPIs.

Conclusions: A significant proportion of patients with GERD were partial responders to PPIs. Pantoprazole and rabeprazole had high patient adherence across disciplines. Both pantoprazole DDR 80 mg once daily (OD) and 40 mg BD demonstrated significant symptom reduction in partial responders, supporting their use in optimizing GERD management in Indian clinical settings.