Evaluation of efficacy and safety of Vonoprazan in comparison to Pantoprazole in healing of erosive esophagitis in a tertiary care centre in North India: A pilot study

Erosive esophagitis (EE) is a condition characterized by inflammation and visible erosions of the esophageal mucosa, primarily caused by prolonged exposure to gastric acid as seen in gastroesophageal reflux disease (GERD). While occasional reflux is physiologic, persistent reflux overwhelms mucosal defenses and leads to complications such as esophagitis, strictures, and Barrett’s esophagus. In India, EE constitutes a smaller fraction of GERD presentations, with a prevalence of less than 10 percent among symptomatic patients undergoing endoscopy. Despite its relatively lower prevalence, EE is clinically significant due to its potential to cause chronic discomfort, impaired quality of life, and long-term complications like ulceration, bleeding, and even esophageal carcinoma.

Current management of EE relies heavily on proton pump inhibitors (PPIs), which have been the mainstay of acid suppression therapy. However, PPIs have notable limitations: delayed onset of action, incomplete 24-hour acid control, and variable efficacy in rapid metabolizers due to CYP2C19 polymorphisms. These limitations are particularly relevant in the Indian population, which may have different genetic and dietary influences affecting drug response. While PPIs like Pantoprazole are widely used and effective, the variability in therapeutic outcomes has led to the exploration of newer agents. Vonoprazan, a potassium-competitive acid blocker (PCAB), offers a promising alternative with faster onset, potent acid suppression, and minimal influence from CYP2C19 polymorphism. It received FDA approval in year 2022 and CDSCO approval on 8th May 2024. However, there is currently a lack of published clinical studies evaluating its efficacy and safety in the Indian population.

The research question guiding this study is: “Whether Vonoprazan is as effective and safe as Pantoprazole in healing of erosive esophagitis in Indian population?”. The rationale for this study lies in addressing a critical knowledge gap—there is no current Indian data assessing Vonoprazan’s role in EE management, despite its proven potential elsewhere. The hypothesis is that Vonoprazan will demonstrate superior or comparable efficacy with a faster response and better tolerability than Pantoprazole in Indian patients.

The study will involve adult Indian patients diagnosed with EE via upper GI endoscopy, addressing a population for whom region-specific treatment data is lacking. EE will be defined as the presence of mucosal breaks, erosions, or ulceration in the distal esophagus, confirmed by endoscopy and graded using the Los Angeles classification system.

To address this research gap, the proposed study will compare Vonoprazan and Pantoprazole in a randomized, controlled design, evaluating efficacy & safety based on using the GERD-HRQL score and adherence using the Brief Medication Questionnaire(BMQ). The results will provide clinically relevant data to inform future GERD management protocols in the Indian context.

Answering this question could influence future therapeutic guidelines and lead to more personalized, effective management of GERD & its complications in this region based on endoscopic findings, assessment of symptom control, compliance with medication and improvement in quality of life (QoL) of patients with the medication.