Aliment Pharmacol Ther

Is on-demand vonoprazan effective for non-erosive reflux disease?

December 1, 2023

On-demand vonoprazan, especially at the 40 mg dose, was more effective in providing complete and sustained relief from heartburn compared with placebo. Thus, as-needed dosing of voprazan may be a reasonable alternative to continued daily therapy for patients with heartburn.

• Patients with NERD, defined as having experienced heartburn for at least 6 months and who had episodes on at least 4 out of 7 consecutive days received once-daily vonoprazan 20 mg during a 4-week run-in period.
• Patients without heartburn during the last 7 days and had good study drug and diary compliance were randomised 1:1:1:1 to vonoprazan 10, 20, 40 mg or placebo on-demand for 6 weeks.
• Primary outcome was the percentage of evaluable heartburn episodes completely relieved within 3 hours of on-demand dosing and sustained for 24 hours.
• Of 458 patients in the run-in period, 207 entered the on-demand phase.
• 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 vs placebo for each vonoprazan group).
• By 1 hour post-dose, vonoprazan was associated with complete relief of significantly more heartburn episodes compared with placebo.
• No serious treatment-emergent adverse events were reported.

Source:

Fass R, et al. (2023, November 5). Aliment Pharmacol Ther. Randomised clinical trial: Efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease. https://pubmed.ncbi.nlm.nih.gov/37750406/