S559 Heartburn Frequency and Symptom Improvement Rates of Treated Episodes when Switching From Daily to On-Demand Vonoprazan Treatment for Non-erosive Reflux Disease
Bibliographic record
Abstract
Introduction: The efficacy and safety of on-demand vonoprazan, a potassium-competitive acid blocker, was evaluated against placebo in patients with endoscopy-proven non-erosive reflux disease (NERD). The aim of this study is to evaluate the frequency of heartburn (HB) when switching to on-demand treatment after symptom control and the rate of symptom improvement of treated episodes. Methods: This was a post hoc analysis of a double-blind, randomized, placebo-controlled trial (NCT04799158). Patients completing a run-in period of daily vonoprazan 20 mg for 4-weeks were eligible for the 6-week on-demand period if they were 80% compliant with open-label study drug and electronic diary entries and reported no HB during the last 7 days of the run-in period. Patients were randomized to one of 4 treatment arms (vonoprazan 10 mg, 20 mg, or 40 mg, placebo) and prompted to take study drug when experiencing HB. HB severity (none, mild, moderate, severe, very severe) was reported at time of treatment and 0.5, 1, 1.5, 2 and 3 hours after taking study drug. Improvement in severity was defined as a minimum of one grade reduction from the initial severity. Results: Patients eligible for the on-demand period (n=207) reported a mean of 16.1% [95% CI: (13.5%, 18.7%)] HB-free days during screening. HB-free days increased during the run-in period to a mean of 82.9% [95% CI: (80.4%, 85.4%)]. When transitioning to on-demand treatment, the percentage of HB-free days remained well above pre-treatment levels for all treatments, ranging from 71% to 75%. These results were consistent through the 6-week treatment period. The difference in percentage of treated HB episodes that improved between the active and placebo groups was evident within the first hour (10 mg [75.5%, P<0.0001], 20 mg [69.1%, P = 0.0010], 40 mg [75.5%, P<0.0001], placebo [57.0%], Figure 1). Over 90% of episodes treated with vonoprazan improved at 2 hours. Discussion: Following effective symptom management with daily vonoprazan treatment, a high rate of HB-free days was sustained over 6-weeks of on-demand treatment. Upon treatment of episodes, improvement of HB occurred rapidly with differences observed within one hour in vonoprazan-treated episodes compared to placebo. These results suggest that the initial daily run-in treatment was effective and that on-demand vonoprazan may be a suitable option in patients who respond to continuous treatment, with improvement in severity occurring within one hour.Figure 1.: Percentage of heartburn episodes improved at each time point over 3 hours after treatment. * P < 0.1, ** P < 0.05, *** P < 0.0001, compared with placebo.
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".