On-demand vonoprazan reduces nonerosive reflux disease symptoms ‘within first hour’
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Key takeaways:
- On-demand vonoprazan improved heartburn symptoms in nonerosive reflux disease within 1 hour of treatment.
- High rate of heartburn-free days was sustained after switch from daily therapy.
PHILADELPHIA — On-demand vonoprazan effectively reduced heartburn symptom severity in patients with nonerosive reflux disease within 1 hour of treatment, according to data presented at the ACG Annual Scientific Meeting.
“On-demand treatment for nonerosive reflux disease is suitable primarily for patients who do not have a high frequency of heartburn,” Ronnie Fass, MD, MACG, medical director at the Digestive Health Center and director of the division of gastroenterology and hepatology at MetroHealth Medical Center, told attendees. “Our current options for on-demand dosing are very limited as you all know, primarily antacids and H2 blockers that are somewhat effective, but with limited potency and they lack durable response.”
He added: “Potassium-competitive acid blockers, and specifically vonoprazan, are actually very good candidates for on-demand therapy because they meet the four important attributes: rapid onset, potent acid suppression, durable 24-hour acid control after a single dose and flexibility in administration as they are not food-dependent.”
To determine whether on-demand vonoprazan (Voquezna, Phathom Pharmaceuticals) was able to reduce the frequency of heartburn episodes following symptom control with daily vonoprazan, Fass and colleagues conducted a post-hoc analysis of the phase 2 NERD-201 study. After completing 4 weeks of daily 20 mg vonoprazan to control their symptoms, patients with endoscopy-proven NERD (n = 207) were randomly assigned to one of four 6-week on-demand treatments: 10 mg, 20 mg or 40 mg vonoprazan or placebo.
Heartburn severity was catalogued at the time of treatment as none, mild, moderate, severe or very severe, and rechecked at 30-minute intervals following drug receipt. The researchers defined improvement in heartburn severity as at least one grade reduction from the initial reported severity.
According to study results, the percentage of heartburn-free days improved from 16.1% during the initial screening to 82.9% among patients who received 20 mg vonoprazan daily. Fass noted that the percentage of heartburn-free days “only decreased slightly” after patients transitioned to the on-demand groups, and “remained well above pretreatment levels” (71% to 75% across treatment groups).
“The primary endpoint of our previously reported study was binary outcome of complete relief at 3 hours and sustained relief for 24 hours; however, this endpoint does not capture how quickly symptoms start to improve,” Fass told attendees. “Differences when comparing episodes treated with each vonoprazan dose to those treated with placebo were evident within first hour.”
In the first hour following treatment, patients who received vonoprazan exhibited significant improvement in heartburn symptoms: 10 mg (75.5%, P < .0001); 20 mg (69.1%, P = .001); 40 mg (75.5%, P < .0001) and placebo (57%). Additionally, the researchers reported more than 90% of episodes treated with vonoprazan improved after 2 hours.
“Overall, we observed significant improvement across all three doses tested compared to placebo, irrespective of the initial heartburn severity; although it appears that severe and very severe episodes may have a higher improvement rate,” Fass said. “We believe this is most likely a reflection that more severe episodes have greater room for improvement than episodes that were reported as mild at the time of improvement.”
He added: “Our findings support the potential use of vonoprazan as an on-demand option for patients with nonerosive reflux disease, although a confirmatory study in a larger patient population with a longer on-demand period is warranted.”
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Fass R, et al. Heartburn frequency and symptom improvement rates of treated episodes when switching from daily to on-demand vonoprazan treatment for nonerosive reflux disease. Presented at: ACG Annual Scientific Meeting; Oct. 25-30, 2024; Philadelphia (hybrid meeting).
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