Real-world-evidence, prospective-observational study to evaluate safety and effectiveness of rabeprazole dual-delayed-release capsules in patients with gastroesophageal reflux disease.

Background: Abnormal gastric acid reflux into the esophagus causes symptoms of gastroesophageal reflux disease (GERD) such as heartburn and regurgitation and also leads to mucosal damage. This damage can further lead to complications such as Barrett's esophagus and esophagitis. Conventional proton pump inhibitors (PPIs) often fail to reduce nocturnal acid production, leaving patients with unresolved symptoms that worsen at night and decreased satisfaction. Happi ER, a novel dual delayed-release (DDR) formulation of rabeprazole, aims to address these limitations by providing both immediate and prolonged acid suppression.

Aim: To evaluate the safety and effectiveness of rabeprazole DDR 20 mg capsule in patients with GERD.

Methods: This study involved a multicenter, real-world, prospective, observational design over an eight-week period. A total of 1022 GERD patients were treated with rabeprazole DDR 20 mg capsules (Happi ER), as prescribed by their physicians. We included adult patients with confirmed GERD and persistent heartburn symptoms despite prior PPI use. Outcome measures included heartburn severity, frequency of night-time awakenings, use of rescue medications, and overall patient satisfaction.

Results: Rabeprazole DDR 20 mg capsules (Happi ER) were shown to be highly effective in treating GERD symptoms. At the end of the study, the mean heartburn score improved significantly from 2.46 ± 0.67 at baseline to 0.16 ± 0.39 (P < 0.0001). The median number of night-time awakenings decreased to 0 (P < 0.0001). More than 93% of patients rated the therapy as "excellent" or "very good", reflecting high satisfaction. No significant adverse effects were reported, and the safety profile was comparable to that of traditional PPIs.

Conclusion: By providing both rapid and sustained acid suppression, Happi ER effectively treats GERD, particularly with respect to night-time symptoms. Its safety and efficacy profile make it a viable option for individuals with mild-to-moderate GERD, significantly improving the quality of life and symptom management.