PROGRADE Study Results: Ranitidine HCl Safe & Efficacious among Indian Patients with GERD

PROGRADE trial confirms the safety and efficacy of ranitidine among Indian GERD patients

PROGRADE Trial, a recent multicentric, multi-specialty PAN-India Post Marketing Surveillance study that enrolled 2428 GERD patients, across 21 centers in India, has reaffirmed the safety and efficacy of Ranitidine for GERD management in Indian practice settings.

This study has been published in the latest July 2023 issue of Open Journal of Gastroenterology

The PROGRADE study grouped the patients into three treatment arms: 1601 subjects received Ranitidine HCl 150 mg BID (ARM-A), 753 received Ranitidine 300 mg OD or BID (ARM-B), and 74 were administered once-daily controlled release formulation of Ranitidine 300 mg (ARM-C).

All patients were assessed for complete relief of the eight key GERD symptoms after 2 and 4 weeks of treatment. The Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) score and Heartburn Severity score were used to assess the efficacy of the drug. In addition, the safety of ranitidine was evaluated too, by monitoring the adverse events, serious adverse events, withdrawal due to adverse events, and mortality at the end of the study period.

The results of the PROGRADE study were highly promising, with

• 75.95% of patients experiencing relief from the 8 key GERD symptoms (heartburn, food regurgitation, flatulence, belching, dysphagia, nausea, vomiting, and acid regurgitation)
• The GSAS scores significantly decreased from baseline after 4 weeks of treatment.
• Furthermore, there was a significant increase in the percentage of patients who achieved sustained resolution of heartburn, with 7 consecutive heartburn-free days.
• The heartburn-free days were assessed for both 24 hours and 7 consecutive days. In ARM-A, 72.82% of patients had 24 hours heartburn-free days, and 66.89% had 7 consecutive heartburn-free days, showing the most significant improvement among the three treatment arms.
• Additionally, patients receiving Ranitidine HCl consumed significantly fewer antacid tablets, further supporting its efficacy in managing GERD symptoms.

The most important point noted in the study was that Ranitidine was found to be well tolerated, with only 5.3% of patients experiencing non-severe adverse events. All the adverse events related to Ranitidine were mild and completely resolved requiring no intervention. Also, no adverse event led to serious adverse events.

PROGRADE study reaffirmed that Ranitidine HCl safely & effectively reduces heartburn frequency and severity among Indian patients and remains a clinically valuable treatment consideration for the management of acid-peptic diseases.

Ranitidine - a H2-receptor antagonist, through reversible inhibition of H2-receptors in gastric parietal cells, results in a reduction in both gastric acid volume and concentration.

The estimated burden of GERD in India ranges up to 30%. GERD is commonly characterized by several distressing symptoms, including heartburn, food regurgitation, flatulence, belching, dysphagia, nausea, vomiting, and acid regurgitation. GERD significantly hampers the quality of life across the adult population groups.

References

Adapted from

1. Shukla, A., et. al 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. https://doi.org/10.4236/ojgas.2023.137022
2. Bhatia SJ, Makharia GK, et al, Indian consensus on gastroesophageal reflux disease in adults: A position statement of the Indian Society of Gastroenterology. Indian J Gastroenterol. 2019 Oct;38(5):411-440. doi: 10.1007/s12664-019-00979-y. Epub 2019 Dec 5. PMID: 31802441.