title: 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.
authors.affiliation: Bombay Hospital & Medical Research Centre, Digestive Disease Centre, Mumbai.
authors.forename: N H
authors.initials: NH
authors.lastname: Dinakaran
authors.forename: J S
authors.initials: JS
authors.lastname: Rajkumar
authors.forename: Nandkishor P
authors.initials: NP
authors.lastname: Potdar
authors.forename: Anish
authors.initials: A
authors.lastname: Desai
mesh_terms: D000293:Adolescent; D000328:Adult; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D064098:Esomeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D004791:Enzyme Inhibitors; D064098:Esomeprazole