Randomised clinical trial: Efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease
Non-erosive reflux disease (NERD) symptoms are often episodic, making on-demand treatment an attractive treatment approach. We compared the efficacy and safety of on-demand vonoprazan versus placebo in patients with NERD. Patients with NERD, defined as heartburn for ≥6 months and for ≥4/7 consecutiv...
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Published in | Alimentary pharmacology & therapeutics Vol. 58; no. 10; pp. 1016 - 1027 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Wiley Subscription Services, Inc
01.11.2023
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Subjects | |
Online Access | Get full text |
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Summary: | Non-erosive reflux disease (NERD) symptoms are often episodic, making on-demand treatment an attractive treatment approach.
We compared the efficacy and safety of on-demand vonoprazan versus placebo in patients with NERD.
Patients with NERD, defined as heartburn for ≥6 months and for ≥4/7 consecutive days with normal endoscopy, received once-daily vonoprazan 20 mg during a 4-week run-in period. Patients without heartburn during the last 7 days and with ≥80% study drug and diary compliance were randomised 1:1:1:1 to vonoprazan 10, 20, 40 mg or placebo on-demand for 6 weeks. The primary endpoint was the percentage of evaluable heartburn episodes completely relieved within 3 h of on-demand dosing and sustained for 24 h.
Of 458 patients in the run-in period, 207 entered the on-demand period. In the vonoprazan 10 mg group, 56.0% (201/359) of evaluable heartburn episodes met the criteria for complete and sustained relief; 60.6% (198/327) in the 20 mg group; and 70.0% (226/323) in the 40 mg group, compared with 27.3% (101/370) in the placebo group (p < 0.0001 versus placebo for each vonoprazan group). By 1 h post-dose, vonoprazan was associated with complete relief of significantly more heartburn episodes compared with placebo. No serious treatment-emergent adverse events were reported.
On-demand vonoprazan may be a potential alternative to continued daily acid suppression therapy for the relief of episodic heartburn in patients with NERD.
gov: NCT04799158. |
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Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 |
ISSN: | 0269-2813 1365-2036 |
DOI: | 10.1111/apt.17728 |