Association of Physicians of India Consensus Recommendations for Vonoprazan in Management of Acid Peptic Disorders

The Association of Physicians of India (API) has recently issued a consensus statement, highlighting vonoprazan as an effective option for managing acid peptic disorders (APDs). This 1st Indian consensus, which was supported by an educational grant from Macleods Pharmaceuticals Ltd has been published in the February 2025 issue of the Journal of Physician of India (JAPI) provides a unified framework for utilizing vonoprazan, a novel potassium-competitive acid blocker (P-CAB), in treating Indian patients with mild to severe APDs. 

The suppression of gastric acid secretion has been a fundamental approach in treating acid peptic disorders (APDs) for years. Proton pump inhibitors (PPIs) have been pivotal in managing these conditions. However, the effectiveness of PPIs can be limited by several factors such as treatment failure due to insufficient acid suppression in some GERD patients, non-adherence to complex dosing regimens, variability in response, nocturnal acid breakthrough, etc.

Vonoprazan is the first-in-class PCAB is recently approved in India. Although significant clinical studies on vonoprazan have been published worldwide, there is currently no published guidance document available for its use in Indian clinical settings. Recognizing these challenges, this consensus from the API was developed to provide expert recommendations on the appropriate use of vonoprazan to gain maximum therapeutic benefit in APD patients, thereby optimizing the existing therapeutic options and improving the care and management of APD patients.

Speaking to Medical Dialogues about the benefits of the consensus for Indian Doctors Dr Jyotirmoy Pal, President (Elect) of the Association of Physicians of India (API) and Dean, Indian College of Physicians said “Acid peptic ulcer disorder is widespread due to lifestyle changes, fast food, stress, and PPI misuse. Many patients remain unsatisfied with PPIs due to rebound acid secretion, leading to overuse, especially for night-time gastric distress. From that background, we at API felt the need for proper guidelines on the use of this newer drug (Vonoprazan), which can benefit patients, ensure their safety and maximize therapeutic benefits”

Vonoprazan, recently approved in India, represents a significant advancement in acid suppression therapy. It offers advantages over PPIs, including acid stability, rapid onset, reduced variability due to CYP2C19 polymorphisms, and an extended half-life, enhancing its clinical utility.

Dr Mangesh Tiwaskar, Editor in Chief Journal of Association of Physicians of India, senior consulting physician & Diabetologist from Mumbai spoke to Medical Dialogues team highlighting on the need for consensus on PCABs “Vonoprazan belongs to the new class of drug i.e., PCABs - which was earlier approved in developed countries such as the USA and Japan and is recently introduced in India in 2024. It offers significant benefits for PPI-resistant patients and those with nocturnal acid breakthrough. Unlike traditional PPIs, it works 24 hours with once-daily dosing, can be taken regardless of food timing, and provides effective acid suppression. This drug has shown wonderful results in published clinical studies. So, we thought—why not come together as Indian experts on the topic? Physicians, gastroenterologists, nephrologists, endocrinologists, ENT specialists, and orthopedics collaborated to publish this consensus document for consulting practitioners and healthcare providers”.

Consensus Development Process

A multidisciplinary panel of 19 experts was convened to establish evidence-based guidelines (multidisciplinary panel included experts from the field of - gastroenterology and hepatology, internal medicine, otorhinolaryngology, pulmonology, cardiology, rheumatology, and nephrology).

The consensus was developed using the DELPHI method, a well-established technique for structured expert discussions. A total of 13 key statements were formulated and presented in a working group meeting, where experts reviewed clinical data and rated their agreement using a 5-point Likert scale. Statements were accepted as consensus when 85% or more experts agreed or strongly agreed.

Medical Dialogues spoke to the experts from various therapy areas, who participated in the consensus statement about their views on the molecule.

Dr. N.K. Soni, Director Academics and Head, Department of Internal Medicine, Yatharth Super Specialty Hospital, Greater Noida, Uttar Pradesh shared insights on the clinical uses of Vonoprazan “PPIs fail in 30–40% of acid peptic disease cases, even with twice-daily use. Vonoprazan offers better relief (80–90%) by blocking both active and inactive proton pumps, ensuring 24-hour acid suppression and thereby effectively addressing Night-time Acid Breakthrough (NAB). In GERD, vonoprazan has shown better efficacy compared to PPIs and H2 receptor blockers. It plays a crucial role in Helicobacter pylori eradication, which is vital as H. pylori affects more than 60 % of the Indian population and is risk factor for peptic ulcers and gastric carcinoma. Several published studies across the globe and international guidelines suggests that vonoprazan is more effective and better tolerated than PPIs when used as a part of H. pylori eradication regimen”.

Below are the key statements achieved through this scientific consensus:

Prevalence of Acid Peptic Disorders (APDs) in India

• There is a substantial presence of APDs in India, with a significant burden of GERD, peptic ulcers, and H. pylori infections. (100% agreement)

Limitations of Proton Pump Inhibitors (PPIs)

• Currently, available PPIs have certain limitations in GERD management, including suboptimal acid suppression and variable patient response. (100% agreement)

Food and PPIs Administration Timing

• In real-world practice, most GERD patients do not follow the recommended dosing of PPIs (30–45 minutes before meals), leading to reduced effectiveness and increased treatment failures. (100% agreement)

Vonoprazan Pharmacology and Advantages Over PPIs

• Vonoprazan overcomes key clinical limitations of PPIs in APD management. (100% agreement)
• Vonoprazan may be an alternative to PPIs for GERD patients with nocturnal acid breakthrough. (100% agreement)
• Unlike PPIs, vonoprazan can be taken irrespective of meal timing, improving patient adherence. (100% agreement)

Vonoprazan in Refractory GERD

• Switching from PPIs to vonoprazan (20 mg once daily) is the most effective treatment approach in refractory GERD cases. (100% agreement)

Vonoprazan in Erosive Esophagitis (EE)

• For mild Erosive Esophagitis EE (Los Angeles Grades A & B), vonoprazan (20 mg once daily) may shorten treatment duration by 4 weeks. (91.7% agreement)
• Vonoprazan is a preferred alternative for patients with mild EE who struggle with adherence to PPI dosing schedule (100% agreement)
• Vonoprazan is the first-line treatment for severe EE (Los Angeles Grades C & D). (100% agreement)

Vonoprazan in Non-Erosive Reflux Disease (NERD)

• Vonoprazan may be considered as an alternative to PPIs in NERD patients with excessive esophageal acid exposure. (100% agreement)
• For long-term management of NERD, vonoprazan can be used as an on-demand therapy. (100% agreement)

Vonoprazan in H. pylori Eradication

• Vonoprazan is recommended over PPIs for H. pylori eradication regimens. (100% agreement)

Vonoprazan in NSAID-Induced Peptic Ulcers

• Vonoprazan is an effective alternative to PPIs in preventing peptic ulcers in patients at high risk due to chronic NSAID use. (100% agreement)

Vonoprazan in Laryngopharyngeal Reflux Disease (LPRD)

• Vonoprazan may be considered as an alternative treatment option to PPIs for LPRD. (100% agreement)

Long-Term (5-year) Safety of Vonoprazan

• Vonoprazan has been found safe for up to 5 year usage in GERD maintenance therapy, as per the clinical evidence published by (VISION trial). (100% agreement)
• In GERD patients on antiplatelet therapy, vonoprazan can be used with careful monitoring. (100% agreement)

Dr Rajesh Upadhyay, Senior Director and Head, Department of Gastroenterology and Hepatology, Max Super Specialty Hospital, Delhi, shared his experience with Vonoprazan “Having used vonoprazan for months, I find it very useful, particularly in patients who have not responded to standard therapy. Whenever I've used it, I have had success in most cases, and therefore I feel this will become the drug of choice for the eradication of H. pylori and for the treatment of GERD in the future. The best usage of this drug I find is in patients with severe or refractory esophagitis who have not responded to standard PPI treatment, and this is one indication where I would definitely use this drug. Apart from this, I am now using it for all cases of H. pylori infection for eradication instead of PPIs. As far as gastric/peptic ulcer treatment is concerned, I use it only for patients who have not responded to standard treatment. My experience in that area is limited, but I feel Vonoprazan is a very promising drug and is likely to replace the PPIs in the near future.”

On the question of Vonoprazan’s long-term safety, usage with comorbidities & with dual anti-platelet therapy (DAPT) Dr V.G Mohan Prasad, Founder & Chairman, VGM Gastro Centre, Coimbatore told Medical Dialogues team “Vonoprazan has been in use for over 9 years in Japan with no major safety concerns. The VISION trial confirmed its safety over five years, with no increased risk of gastric cancer or neuroendocrine tumors. Unlike PPIs, which compete with Clopidogrel for CYP2C19 metabolism, Vonoprazan follows the CYP3A4 pathway, avoiding drug interactions. This makes it a safer choice for co-prescription with Clopidogrel. In liver impairment (Child’s B/C) or kidney disease (eGFR <30), a reduced 10 mg dose is recommended. It has no significant drug interactions with diabetes or hypertension medications, ensuring safe use in comorbid conditions.”

Vonoprazan Use in Hepatic and Renal Impairment

• Vonoprazan can be considered in patients with renal impairment, with appropriate dose adjustments and monitoring. (Refer product label/prescribing information for dose adjustments - 100% agreement)
• Vonoprazan can also be considered in patients with hepatic impairment, with careful monitoring based on severity. (Refer product label/prescribing information for dose adjustments - 100% agreement)

Vonoprazan: New Approach to Acid Peptic Disorders

The API consensus highlights vonoprazan as an effective treatment alternative to PPIs in most of the clinical scenarios of acid peptic disorders. With its wide-ranging applications in GERD, H. pylori eradication, laryngopharyngeal reflux and NSAID-induced ulcers, vonoprazan is steadily and undoubtedly set to transform the management of acid peptic disorders in India.

Dr. Agam Vora, Hon. General Secretary of API, Pulmonologist and Chest Physician, Medical Director at Brahma Kumari's Global Hospital & Research Centre and Vora Clinic, Mumbai, shared his thoughts on the need for a new class of acid-suppressing drugs and their role in respiratory medicine practice, stating “When treating patients on tuberculosis therapy or antibiotics, achieving consistent acid suppression becomes even more challenging. There was a definite need for a new molecule, and fortunately, this one arrived with distinct advantages-offering effective acid suppression, as supported by data, and eliminating the need to take it 30–45 minutes before food”.

Conclusion

The API consensus highlights the appropriate clinical relevance of vonoprazan in several clinical scenarios, including refractory GERD, severe erosive esophagitis, H. pylori eradication and in mild erosive esophagitis (with freedom of meal dependent dosing unlike PPIs). Due to vonoprazan’s ability to provide faster onset of action, stronger and sustained acid suppression, superior H. pylori eradication rates and meal independent dosing - makes it a valuable addition to the management of acid peptic disorders in India.

APD: Acid Peptic Disease, NSAIDs: Nonsteroidal Anti-inflammatory Drugs, PPIs: proton pump inhibitor, GERD: Gastroesophageal Reflux Disease, H. pylori: Helicobacter pylori, CYP2C19 polymorphisms: Cytochrome P450 2C19

Reference:

Upadhyay R, Soni NK, Vora A, et al. Association of Physicians of India Consensus Recommendations for Vonoprazan in Management of Acid Peptic Disorders. J Assoc Physicians India 2025;73(2):68–77.