An open non-comparative clinical study for the evaluation of safety and efficacy of esomeprazole in patients of reflux oesophagitis in Indian population.
J Indian Med Assoc
; 2002 Oct; 100(10): 624-6
Article
in En
| IMSEAR
| ID: sea-100232
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.
Full text:
1
Index:
IMSEAR
Main subject:
Severity of Illness Index
/
Omeprazole
/
Female
/
Humans
/
Male
/
Esophagitis, Peptic
/
Adolescent
/
Treatment Outcome
/
Adult
/
Enzyme Inhibitors
Type of study:
Diagnostic_studies
/
Evaluation_studies
Country/Region as subject:
Asia
Language:
En
Journal:
J Indian Med Assoc
Year:
2002
Type:
Article