Effective Management of H. pylori Infection in Peptic Ulcer Disease: An Indian Perspective
Post Marketing Surveillance of Kit containing Pantoprazole + Clarithromycin + Amoxycillin
Abstract
Background: Infection with Helicobacter Pylori (H.pylori) remains a major healthcare burden, with persistently high prevalence rates, especially in developing countries like India. H.pylori is the cause of most cases of Peptic Ulcer Disease and is a primary risk factor for gastric cancer. This infection if not treated effectively can lead
to recurrence of Peptic Ulcer Disease. Numerous consensus groups around the world recommend a standard triple therapy as first-line therapy, including a proton pump inhibitor and a combination of Amoxicillin and Clarithromycin for eradication of H. pylori infections. The purpose of this study was to evaluate safety and efficacy
of kit containing Pantoprazole + Clarithromycin + Amoxycillin in H. pylori infected patients with Peptic Ulcer Disease.
Methods: A prospective, open-label, non-comparative multicentric study was conducted. A pool of 500 patients was involved in the study and the duration of study was 14 days. Kit containing tablets of Pantoprazole 40mg + Clarithromycin 500mg + Amoxycillin 750mg was administered for 14 consecutive days as one tablet each twice
a day.
Results: At the end of the study, a significant difference was observed in various parameters from baseline. A significant reduction in abdominal pain was observed at the end of the treatment (the mean score of abdominal pain at the base line was 2.21 which reduced to 0.17 on the 14th day). Significant decrease in the symptoms of
heartburn was observed (the mean score of heart burn at the base line was 2.19 which reduced to 0.15 on the 14th day). Similarly significant decrease in symptoms of bloating & dysphagia was observed at the end of the therapy. As per investigator’s assessment about efficacy and tolerability, 96.2% of patients reported excellent
efficacy and 92.4% of patients reported excellent tolerability. The therapy was well tolerated with few adverse events (AEs).
Conclusion: The results of this study confirm that Kit containing tablets of Pantoprazole + Clarithromycin + Amoxycillin is well tolerated and it showed significant improvement in the symptoms of H. pylori infected patients with Peptic Ulcer Disease at the end of treatment.
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