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NJBMS - Volume 9 Issue 4, April - June 2019

Pages: 154-159
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A Comparative Study to Assess the Tolerability of Proton Pump Inhibitors and Prokinetic agents as a Combination therapy Versus Monotherapy

in patients with Gastroesophageal Reflux Disease

Author: Pradeep Kumar BT, Mamatha KR, Nagesh NS, Bharath Kumar VD

Category: Pharmacology


Background: Gastroesophageal reflux disease (GERD) is a chronic condition that develops when the reflux of gastric contents into the esophagus in significant quantities causes troublesome symptoms with or without mucosal erosions and relevant complications. Proton Pump Inhibitors (PPIs) remains the mainstay in the treatment of GERD but addition of Prokinetic drugs like Itopride helps in relieving the symptoms of GERD which in turn leads to improvement in quality of life of patient.

Aim &Objective: To assess tolerability among the patients with GERD with or without Prokinetic supplementation along with Proton Pump Inhibitors.

Materials & Methods: Hundred patients diagnosed with GERD were randomly assigned into two groups, Group A and Group B. Group A received tablet Pantoprazole 40 mg twice daily alone and group B received tablet Pantoprazole 40 mg twice daily and tablet Itopride 50 mg thrice daily 30 minutes before food for 4 weeks. Incidence of Adverse Drug Reaction (ADR) and tolerability was assessed using a standardized questionnaire given to the patient at the time of enrolment.

Results: The total incidence of ADR was less in group B compared to group A (22% vs 30%, p= 0.172). Group B patients experienced less incidence of ADR in terms of Nausea (2/50 vs. 3/50), diarrhoea (1/50 vs 3/50), abdominal pain (5/50 vs 7/50), and headache (3/50 vs 4/50) relative to Group A patients. Tolerability was better in Group B compared to Group A at the end of 4 weeks but was not statistically significant.

Conclusion: Addition of a Prokinetic agent like Itopride along with PPIs increase patient compliance by decreasing drug related side effects and by improving tolerability in patients with GERD.

Keywords: Pantoprazole, GERD, Itopride, PPIs, Prokinetics, ADR, tolerability.

DOI: 10.31975/NJBMS.2019.9402