Abstract

EVALUATION OF THE EFFICACY, TOLERABILITY AND SAFETY OF A COMBINATION OF ESOMEPRAZOLE AND DOMPERIDONE IN GERD.

*Dr. R. Vedamanickam, Dr. D. Arunprasath, Dr. R. Vinothkumar, Dr. Sakthi Dasan

Abstract

Background: Gastroesophageal reflux disease (GERD) represents spectra of symptoms and of reflux damage to the esophagus. The burden of GERD results from its widespread prevalence and the unfavorable impact of its symptoms on well-being and quality-of –life. Aim of the study: To evaluate the clinical efficacy, tolerability and safety of a fixed – dose combination of Esomeprazole 20 mg + sustained release (SR) Domperdone 30mg administered once daily in adult Indian patients for the symptomatic relief of dyspepsia associated with GERD. Material and methods: This prospective studywas conducted between JUNE 2015 and JUNE 2016 in 137 patients in department of medicine, Sree Balaji Medical College & Hospital, Chennai, India with dyspepsia associated with GERD. Patients were treated with a fixed – dose combination on Esomeprazole 20 mg + sustained release (SR) Domperidone 30 mg administered once daily for a period of 2 weeks. Efficacy was assessed on the basis of improvement in the symptoms and patients’ satisfaction with the treatment. Tolerability and safety was assessed by physical examination, laboratory parameters and monitoring of treatment – emergent adverse events. Results: Of the 137 patients enrolled in the study, 6 patients were lost to follow – up. Thus, the data of 131 patients was available for evaluation of efficacy. As per the patient’s assessment of treatment response, 92.4% of the total cases expressed extreme – to-good satisfaction with the treatment. Conclusion: The present study suggests that a fixed – dose combination of Esomeprazole 20 mg and sustained release (SR) Domperidone 30 mg is an effective and well tolerated therapeutic option in the management of symptomatic relief of dyspepsia associated with GERD in adult Indian patients.

Keywords: Gastroesophageal reflux disease (GERD), Domperidone.