An open non-comparative clinical study for the evaluation of safety and efficacy of esomeprazole in patients of reflux oesophagitis in Indian population.

ABSTRACT

The proton pump inhibitors have consistently been shown to be far more effective than the others are in gastro-oesophageal reflux disease (GERD) as proton pump inhibitors (PPIs) block the final and rate-limiting step of parietal acid production. The primary objective of the study was to assess the efficacy and tolerability of esomeprazole 40 mg given once a day for 4 weeks in patients with reflux oesophagitis. An open, non-comparative study was done with 103 patients in 4 centres with endoscopic erosive oesophagitis. Symptoms of reflux oesophagitis such as heartburn/retrosternal pain and regurgitation recorded on a 4-point scale, dysphagia being marked as present or absent. Oesophagitis was graded as 5-point scale. There was a significant decrease in mean score of heartburn (60.8% and 86%), retrosternal pain (60.84% and 86.75%), mean score of regurgitation (65% and 90%) at second and fourth week respectively. Global assessment of overall symptoms by patients showed complete resolution of symptoms in 86.4% patients at week 4. At the end of treatment 93 out of 103 patients showed complete healing, 13.6% of total cases had side effects. Esomeprazole was found effective and safe in the treatment of GERD.