S499 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
Bibliographic record
Abstract
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 1 study included double-dose, 2 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. Conclusion: 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.011 | 0.023 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.016 | 0.028 |
| Bibliometrics | 0.008 | 0.008 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".