Randomised clinical trial : Efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease
© 2023 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd..
BACKGROUND: Non-erosive reflux disease (NERD) symptoms are often episodic, making on-demand treatment an attractive treatment approach.
AIMS: We compared the efficacy and safety of on-demand vonoprazan versus placebo in patients with NERD.
METHODS: 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.
RESULTS: 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.
CONCLUSION: On-demand vonoprazan may be a potential alternative to continued daily acid suppression therapy for the relief of episodic heartburn in patients with NERD.
CLINICALTRIALS: gov: NCT04799158.
| Errataetall: |
CommentIn: Aliment Pharmacol Ther. 2023 Dec;58(11-12):1230. - PMID 37986601 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:58 |
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| Enthalten in: |
Alimentary pharmacology & therapeutics - 58(2023), 10 vom: 18. Nov., Seite 1016-1027 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Fass, Ronnie [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 30.10.2023 Date Revised 11.12.2023 published: Print-Electronic ClinicalTrials.gov: NCT04799158 CommentIn: Aliment Pharmacol Ther. 2023 Dec;58(11-12):1230. - PMID 37986601 Citation Status MEDLINE |
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| doi: |
10.1111/apt.17728 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Randomised clinical trial |b Efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease |
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| 500 | |a Date Completed 30.10.2023 | ||
| 500 | |a Date Revised 11.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04799158 | ||
| 500 | |a CommentIn: Aliment Pharmacol Ther. 2023 Dec;58(11-12):1230. - PMID 37986601 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Non-erosive reflux disease (NERD) symptoms are often episodic, making on-demand treatment an attractive treatment approach | ||
| 520 | |a AIMS: We compared the efficacy and safety of on-demand vonoprazan versus placebo in patients with NERD | ||
| 520 | |a METHODS: 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 | ||
| 520 | |a RESULTS: 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 | ||
| 520 | |a CONCLUSION: On-demand vonoprazan may be a potential alternative to continued daily acid suppression therapy for the relief of episodic heartburn in patients with NERD | ||
| 520 | |a CLINICALTRIALS: gov: NCT04799158 | ||
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| 650 | 4 | |a GERD | |
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| 650 | 7 | |a Pyrroles |2 NLM | |
| 650 | 7 | |a Sulfonamides |2 NLM | |
| 650 | 7 | |a Proton Pump Inhibitors |2 NLM | |
| 700 | 1 | |a Vaezi, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Sharma, Prateek |e verfasserin |4 aut | |
| 700 | 1 | |a Yadlapati, Rena |e verfasserin |4 aut | |
| 700 | 1 | |a Hunt, Barbara |e verfasserin |4 aut | |
| 700 | 1 | |a Harris, Tom |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Neila |e verfasserin |4 aut | |
| 700 | 1 | |a Leifke, Eckhard |e verfasserin |4 aut | |
| 700 | 1 | |a Armstrong, David |e verfasserin |4 aut | |
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