Randomised clinical trial: Efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease.

Abstract

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.

• Authors: Ronnie Fass, Michael Vaezi, Prateek Sharma, Rena Yadlapati, Barbara Hunt, Tom Harris, Neila Smith, Eckhard Leifke, David Armstrong
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 58 Issue 10 Pg. 1016-1027 (11 2023) ISSN: 1365-2036 [Electronic] England
• PMID: 37750406 (Publication Type: Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Chemical References

• 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
• Pyrroles
• Sulfonamides
• Proton Pump Inhibitors

Topics

• Humans
• Heartburn (drug therapy, diagnosis)
• Gastroesophageal Reflux (drug therapy, diagnosis)
• Pyrroles (adverse effects)
• Sulfonamides (adverse effects)
• Treatment Outcome
• Proton Pump Inhibitors (adverse effects)