Author(s)

Akash Shukla¹, Anil Kumar Awasthi², Ramesh Rao³, Dawesh Prakash Yadav⁴, Nilesh Nolkha⁵, Rajesh Pendlimari⁶, Sanjiv Dua⁷, Shrish Bhatnagar⁸, Ravindra Mote^9*, Ashish Birla¹⁰, Jay Savai¹⁰, Kapil Mehta¹⁰, Shashank Salunke¹⁰

¹Department of Gastroenterology, Gastro Universe, Mumbai, India.
²Department of Medicine, Ajanta Research Centre, Ajanta Hospital & IVF Centre, Lucknow, India.
³Departmentof Nephrology, Sanjeevani Kidney Care, Mumbai, India.
⁴Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
⁵Department of Rheumatology, Wockhardt Hospitals, Mumbai, India.
⁶Department of Gastroenterology, Rajalakshmi Hospital and Research Center, Bangalore, India.
⁷Department of General Surgery, SaiKripa Hospital, Mumbai, India.
⁸Department of Gastroenterology, Sparsh Child Care and Gastro Centre, Lucknow, India.
⁹Department of Clinical Research, Mediclin Clinical Research, Mumbai, India.
¹⁰Department of Medical Affairs, JB Chemicals & Pharmaceuticals Ltd., Mumbai, India.

Purpose: Ranitidine hydrochloride (HCl) remains an important medication for treating acid-peptic ailments such as Gastroesophageal reflux disease (GERD). The main objective of this Post Marketing Surveillance (PMS) clinical study was to test the efficacy and safety of Ranitidine HCl in Indian patients suffering from GERD. Patients and Methods: Data of 2446 patients (1307 males; 1121 females) from 21 centers across India were analyzed. Patients received either of the three treatments: Ranitidine HCl 150 mg twice a day (BID) (ARM-A), Ranitidine HCl 300 mg once daily (OD) or BID (ARM-B), and Ranitidine HCl 300 mg OD (ARM-C). Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) score and Heartburn Severity score were used to assess the drug’s efficacy. The adverse events reported by patients or investigators were analyzed to assess the safety profile of Ranitidine. Results: Of the 2446 subjects screened, 2428 were enrolled. There was a significant reduction in GSAS scores from baseline to the end of the study visit in all three ARMs. The GSAS scores reduced from 2.02 to 0.23 in ARM-A, 2.01 to 0.24 in ARM-B, and 2.07 to 0.26 in ARM-C patients. In ARM A, 72.82% had 24 hours heartburn-free days, and 66.89% had 7 consecutive heartburn-free days, which was more significant than the other two ARMs. 128 (5.27%) patients reported ADRs due to Ranitidine HCl at different doses. The most frequently reported ADR was constipation (17.18%), followed by oliguria (14.06%), cold (13.28%), and dysuria (12.5%). Of 128 ADRs, 113 (88.28%) were mild, and only 11 (8.59%) ADRs were related to the study drug. No severe ADRs were reported during the study. Conclusion: Ranitidine HCl 150/300 mg tablet was found to be an effective and safe H2-receptor antagonist for treating GERD in Indian Patients.

Ranitidine Hydrochloride, GERD, Heartburn, H2-Receptor Antagonists

Shukla, A. , Awasthi, A. , Rao, R. , Yadav, D. , Nolkha, N. , Pendlimari, R. , Dua, S. , Bhatnagar, S. , Mote, R. , Birla, A. , Savai, J. , Mehta, K. and Salunke, S. (2023) A Prospective, Multicentric, Post Marketing Surveillance to Evaluate Efficacy & Safety of Ranitidine HCl (150 & 300 mg IR/CR) in Indian Patients with Gastroesophageal Reflux Disease (PROGRADE). Open Journal of Gastroenterology, 13, 237-249. doi: 10.4236/ojgas.2023.137022.