Vonoprazan offers ‘complete, rapid, sustained’ relief in nonerosive reflux disease
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CHARLOTTE, N.C. — Vonoprazan bested placebo for on-demand treatment of episodic heartburn in patients with nonerosive reflux disease and may offer an alternative to daily therapy, noted a presenter at the ACG Annual Scientific Meeting.
“There is a need for noncontinuous therapy for GERD, especially by those with [nonerosive reflux disease (NERD)] and episodic heartburn,” Ronnie Fass, MD, head of the Esophageal and Swallowing Center and director of the division of gastroenterology and hepatology at MetroHealth Medical Center, told Healio. “On-demand is a noncontinuous therapeutic approach for GERD, where patients determine when they need to take the medication and for how long.”
The on-demand approach enables patients to assert more control on their therapy, while alleviating concerns about chronic treatment with anti-reflux medications and providing a more cost-effective option to chronic treatment, he noted.
“Vonoprazan, a [potassium-competitive acid inhibitor], has pharmacokinetic and pharmacodynamic properties that make it an excellent candidate for an on-demand drug for NERD patients,” Fass said. “It reaches maximum effect on intragastric pH within 30 minutes after administration. In contrast, none of the currently available [proton pump inhibitors] have a similar effect on intragastric pH, or in such a short period of time.”
To assess efficacy and safety of vonoprazan compared with placebo for treatment of symptomatic NERD, Fass and colleagues enrolled patients with NERD (n = 458) all of whom had normal endoscopy, heartburn episodes for more than 6 months, heartburn on more than 4 of the last 7 consecutive days into a 4-week run-in period of once-daily 20 mg vonoprazan. In addition, patients without heartburn in the previous 7 days were randomized 1:1:1:1 to receive 10 mg, 20 mg or 40 mg vonoprazan or on-demand placebo for 6 weeks.
Patients were instructed to only use a single dose of the study drug for 24 hours following a heartburn episode and to use no rescue antacids within 3 hours of taking the study drug. Heartburn symptoms, as well as drug and antacid use, were recorded in an electronic diary.
According to study results, complete and sustained relief of heartburn episodes was achieved by 56% of the 10 mg vonoprazan group, 60.6% of the 20 mg group and 70% of the 40 mg group compared with 27.3% of the placebo group (P < .0001).
“Vonoprazan on demand at all investigated doses was significantly better than placebo in providing complete (within 3 hours after drug consumption), rapid (within 1 hour after drug consumption) and sustained (during the first 24 hours after drug consumption) relief from heartburn in NERD patients,” Fass said. “Vonoprazan 10 mg and 20 mg on demand were equally efficacious, while vonoprazan 40 mg on demand provided limited extra benefit over the lower doses.”
During the on-demand phase of the study, 21.3% of patients who received placebo reported a treatment-emergent adverse event compared with 16.3% of patients who received 10 mg vonoprazan, 18.4% who received 20 mg and 16.7% on 40 mg. No treatment-emergent adverse event was reported by more than 1 patient in each treatment group, and no serious adverse events were observed.
“Vonoprazan, unlike PPIs, could potentially serve as an on-demand medication for NERD patients with episodic heartburn,” Fass said.
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Fass R. Abstract S390: Efficacy and Safety of On-Demand Vonoprazan versus Placebo in the Treatment of Heartburn in Symptomatic Nonerosive Reflux Disease (NERD) Patients. Presented at: ACG Annual Scientific Meeting; Oct. 21-26, 2022; Charlotte, NC (hybrid meeting).
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