On-demand vonoprazan may replace daily therapy for nonerosive reflux disease
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Key takeaways:
- On-demand vonoprazan relieved heartburn within 3 hours in up to 70% of patients vs. placebo.
- An exploratory analysis showed complete and sustained relief by 1 hour in up to 28.1% of patients.
Researchers reported that on-demand vonoprazan may be a “reasonable alternative” to daily therapy for heartburn, after demonstrating complete and sustained relief of more heartburn episodes than placebo.
“On-demand treatment is particularly attractive for the management of [nonerosive reflux disease (NERD)] because, although episodic symptoms are common, there is minimal concern for progression to more severe and erosive forms of GERD,” Ronnie Fass, MD, medical director of Digestive Health Center at MetroHealth, and colleagues wrote in Alimentary Pharmacology and Therapeutics. “Although proton pump inhibitors (PPIs) are approved by the FDA for continuous, once-daily use for the treatment of acid disorders, including NERD, they are not approved for on-demand therapy.”
They continued: “Vonoprazan, a potassium-competitive acid blocker, has been shown to provide greater and more prolonged acid suppression than PPIs in addition to a rapid onset of action.”
During a 4-week run-in period, 458 adults (mean age, 52 years; 64.8% women) with NERD, defined as a history of heartburn for at least 6 months at a frequency of 4 to 7 consecutive days, received once-daily vonoprazan 20 mg. Of those, 207 were eligible for the on-demand period after completing the run-in with at least 80% compliance and reporting no heartburn during the last 7 days.
Researchers randomized participants to vonoprazan 10 mg (n = 52), 20 mg (n = 52) or 40 mg (n = 51) or placebo (n = 52) for 6 weeks. The primary outcome was heartburn relief within 3 hours and no further heartburn for 24 hours following treatment.
Researchers reported significantly more heartburn episodes were relieved at 3 hours with sustained relief for 24 hours among patients in the vonoprazan 10 mg (56%), 20 mg (60.6%) and 40 mg (70%) groups compared with placebo (27.3%).
In addition, the ORs for achieving complete and sustained relief were 1.9 (95% CI, 1-3.62), 2.2 (95% CI, 1.14-4.15) and 3.2 (95% CI, 1.73-5.92) for vonoprazan 10 mg, 20 mg and 40 mg, respectively, vs. placebo.
Results from an exploratory analysis also showed significantly more heartburn episodes with complete and sustained relief 1 hour after dosing in the vonoprazan 10 mg (28.1%; 95% CI, 10.54-21.94), 20 mg (19.3%; 95% CI, 1.98-12.77) and 40 mg (22.9%; 95% CI, 5.37-16.66) groups vs. placebo (11.9%).
Patients reported no serious treatment-emergent adverse events.
“Treatment of patients with NERD with on-demand vonoprazan is efficacious and well-tolerated, resulting in a greater proportion of heartburn episodes with complete and sustained relief compared with placebo,” Fass and colleagues concluded. “On-demand (as-needed) vonoprazan treatment may be a reasonable alternative to continued daily therapy for patients with heartburn, completely relieving heartburn symptoms within 1hour of use in some patients.”
They continued: “The results of this study support further investigation of on-demand vonoprazan for the treatment of NERD symptoms in larger clinical trials.”
Perspective
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Scott Gabbard, MD
This study demonstrates the potential benefit of the potassium-competitive acid blocker (P-CAB) vonoprazan as an on-demand medication for patients with NERD. Vonoprazan was found to relieve heartburn within 3 hours in the majority of patients at all studied doses and had a low rate of adverse events.
The prospect of using on-demand vonoprazan is exciting, as proton pump inhibitors take 3 to 5 days to see full effect. Currently, vonoprazan 10 mg and 20 mg is FDA-approved to treat erosive esophagitis but not NERD.
I look forward to more studies regarding P-CABs and on-demand use for patients with NERD.
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