Abstract

A COMPARITIVE EVALUATION OF EFFECTIVENESS OF ACOTIAMIDE ER 300MG OD VERSUS ACOTIAMIDE 100MG TID IN THE TREATMENT OF GERD

*Dr. Syed Ibrahim Hassan, M.B.B.S., MD., Dr. Asif Rasheed, M. Pharm., Ph.D., Mohammed Akram Rayan Ahmed, Pharm. D., Mohd. Abdul Mughani, Pharm. D., Sadia Sultana, Pharm. D. and Sara Subuhi Pharm. D.

ABSTRACT

Background: Gastroesophageal reflux disease (GERD) is the most prevalent gastrointestinal disorder, and leads to substantial morbidity, though associated mortality is rare. It is present with heartburn and effortless regurgitation. Coexistent dysphagia is considered an alarm symptom, prompting evaluation. There is considerable overlap between symptoms of GERD and those of eosinophilic esophagitis, functional dyspepsia, and gastroparesis, posing a challenge for patient management. GERD is exceedingly common, ranking as the most frequent gastrointestinal diagnosis associated with outpatient clinic visits. Methods: This prospective, single - center, comparative, clinical trial was conducted in department of Gastroenterology at Multispecialty Hospital in Hyderabad, India for the period of sixmonths. Subjects data was drawn out from medical records. Treatment was given for 4weeks /1month. Therapeutic responses of treatment were assessed using FSSG and GERD HRQL scale. Subject compliance was analyzed using MMAS. Results: In our study, a total of 60 patients were included who met the inclusion criteria and they were randomly allocated into two groups namely Group – 1 and Group – 2. Each group consists of 30 patients. Group – 1 patients are treated with acotiamide 300mg OD and Group – 2 patients are treated with acotiamide 100mg TID. They were 40% males and 60% female participants. They were 65% subjects from age group 36-55 follwed by 20% subjects in age group 18-35 and 15% in subject in age group 56-65. Subjects BMI (Kg/m2) were also taken into consideration 1.67% subjects were underweight, 50% subjects were normal weight, 40% subjects were overweight and 8.33 patients were obese according WHO classification of BMI. Our data showed that majority of patients had heartburn (Group 1: n=18, 60% and group 2: n=20, 66.67%), regurgitation (Group 1: n=18, 60% and group 2: n=16, 53.33%) and abdominal discomfort (Group 1: n=16, 53.33% and group 2: n=18, 60%). Our data also showed that majority of patients had hypertension (Group 1: n=14, 46.67% and group 2: n=13, 43.33%), and diabetes mellitus (Group 1: n=10, 33.33% and group 2: n=6, 20%). The personal habits data revealed that patients diet history showed use of fried food (Group 1: n=16, 53.33% and group 2: n=15, 50%), spicy food (Group 1: n=12, 40% and group 2: n=13, 43.33%), and caffeine intake (Group 1: n=13, 43.33% and group 2: n=17, 56.67%). Minor ADRs such as GI upset, headache and dizziness were reported in our study which doesn’t required treatment withdrawal. The study outcome parameters showed significant improvement in FSSG and GERD HRQL scores from baseline to end of treatment. Conclusions: In our study, it illustrates that acotiamide in both the doses and frequencies that is 300mg once daily and 100mg thrice daily are effective in treatment of GERD. Still further research is require with large sample size to authenticate the results.

Keywords: Gastroesophageal Reflux Disease (GERD), Acotiamide, FSSG, GERD HRQL, MMAS.