P0429 - The Efficacy and Safety of Vonoprazan, a Potassium-Competitive Acid Blocker, for the Treatment of Proton-Pump Inhibitor-Resistant Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis

Elvira Lesmana, MD¹, Daniel Martin Simadibrata, MD, MS², Ronnie Fass, MD^3
1Universitas Indonesia, New York, NY; ²University of Oxford, UK, Jakarta, Jakarta Raya, Indonesia; ³MetroHealth System, Case Western Reserve University, Cleveland, OH

Introduction: Up to 40% of Gastroesophageal Reflux Disease (GERD) patients experience inadequate symptom relief with Proton Pump Inhibitor (PPI), termed PPI-resistant or refractory GERD. Vonoprazan is a novel acid-suppressive medication (Potassium Competitive Acid Blocker) that inhibits the H+/K+ ATPase pump at the potassium binding site and has been shown to have better efficacy than a PPI in suppressing gastric acid secretion. This systematic review and meta-analysis summarize the efficacy and safety of Vonoprazan in the treatment of GERD (both erosive esophagitis [EE] and non-erosive reflux disease [NERD].

Methods: Four electronic databases (Medline, Embase, SCOPUS, and CENTRAL) were searched for studies indexed up to May 26, 2023. Both observational studies and clinical trials that assessed the efficacy and safety of Vonoprazan in PPI-resistant GERD, regardless of phenotypes, were included. Efficacy outcomes included healing and maintenance rates of EE and improvement of the Frequency Scale for the Symptoms of GERD (FSSG) scores. Safety outcomes were any adverse events (AE), drug-related AE, or serious AE (SAE). The modified Newcastle-Ottawa Scale (NOS) was used to assess study quality. The fixed-effect model was used to pool the efficacy and safety outcomes.

Results: Fourteen studies were included in this systematic review. Only one study included double-dose, two had both standard-dose and double-dose, and the remaining included only standard-dose PPI-resistant GERD. Healing rates of PPI-resistant EE of Vonoprazan were 91.7% (95%CI 86.8-94.8%; n-study: 5; 176/192) at Week 4 and 82.1% (95%CI 63.6-92.4%; n-study: 4; 23/28) at Week 8. For healed PPI-resistant EE, the overall maintenance rates of Vonoprazan were 79.5% (95% 65.1-89.0%; n-study: 2; 35/44) at Week 8, 86.0% (95%CI 72.1-94.7%; n-study: 1; 37/43) at Week 24, and 87.9% (95%CI 77.6-93.8%; n-study: 2; 58/66) at Week 48. FSSG scores were improved in 74.6% (95%CI 65.8-81.7%; n-study: 2; 85/114) of the patients at Week 4 and 51.9% (95%CI 37.8-65.7%) at Week 8. Any AE, drug-related AE, and SAE of Vonoprazan were low to none in PPI-resistant GERD patients.

Discussion: Vonoprazan demonstrated high efficacy for healing and maintenance of PPI-resistant EE and moderate efficacy for improvement of FSSG score. Vonoprazan appears to be well tolerated in patients with PPI-resistant GERD.


Disclosures:


Elvira Lesmana, MD¹, Daniel Martin Simadibrata, MD, MS², Ronnie Fass, MD³. P0429 - The Efficacy and Safety of Vonoprazan, a Potassium-Competitive Acid Blocker, for the Treatment of Proton-Pump Inhibitor-Resistant Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.