Vonoprazan reduces heartburn symptoms as early as day 1 in nonerosive reflux disease
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Key takeaways:
- The least-squares mean percentage of 24-hour heartburn-free days for placebo, vonoprazan 10 mg and vonoprazan 20 mg were 27.7%, 44.8% and 44.4%.
- The treatment effect persisted over the 20-week extension period.
WASHINGTON — Vonoprazan effectively relieved heartburn symptoms in patients with nonerosive reflux disease as early as day 1 of treatment, with results persisting after a 4-week placebo-controlled period through 20 weeks, according to data.
“Proton pump inhibitors are the main therapy used for GERD, including [nonerosive reflux disease (NERD)],” Loren Laine, MD, chief of the section of digestive diseases and professor of medicine at Yale School of Medicine, told Healio. “Potassium-competitive acid blockers (PCABs) are a new form of antisecretory therapy but there are few randomized controlled trials assessing the efficacy of PCABs for NERD — and they are all from Asia. We did a double-blind RCT in the U.S. to assess efficacy of the PCAB vonoprazan in patients diagnosed with NERD.”
In a study presented at Digestive Disease Week, Laine and colleagues randomly assigned 772 adults (mean age, 51 years; 68% women; 16% Black; 32% Latino) without erosive esophagitis who were experiencing heartburn at least 4 days per week to placebo (n = 258), vonoprazan 10 mg (n = 257) or vonoprazan 20 mg (n = 257). The mean BMI of participants was 30.3 kg/m2. All individuals completed electronic diaries twice daily for heartburn and use of rescue antacids.
After 4 weeks, participants on placebo were rerandomized to vonoprazan 10 mg or 20 mg, and those already assigned to vonoprazan continued their dose for another 20 weeks.
The primary outcome was percentage of 24-hour heartburn-free days, while the secondary outcome was percentage of days without using rescue antacids.
Over the placebo-controlled period, the least-squares (LS) mean percentage of 24-hour heartburn-free days was 27.7% for placebo compared with 44.8% for vonoprazan 10 mg (difference = 17.1%) and 44.4% for 20 mg (difference from placebo = 16.7%).
“We found that vonoprazan was efficacious for NERD,” Laine said. “We found a reduction in the primary endpoint — percentage of 24-hour heartburn-free days — with vonoprazan vs. placebo.”
Researchers reported similar findings in LS mean percentage of days without rescue antiacids: 47.6% with placebo vs. 63.3% with vonoprazan 10 mg (difference = 15.8%) and 61.2% with vonoprazan 20 mg (difference = 13.7%).
Further, the differences in the percentage of individuals with a 24-hour heartburn-free day for vonoprazan 10 mg compared with placebo and vonoprazan 20 mg compared with placebo were 8.3% and 11.6% on day 1 and 18.1% and 23.2% on day 2, respectively.
Results from the extension period showed the mean percentages for participants first assigned to placebo were 61.9% for those rerandomized to vonoprazan 10 mg at 4 weeks (n = 119) and 62.9% for those rerandomized to vonoprazan 20 mg (n = 122).
Among those on vonoprazan throughout the study, mean percentages of 24-hour heartburn-free days were 62.6% for the 10 mg dose (n = 247), and 60.7% for the 20 mg dose (n = 235).
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Laine L, et al. Vonoprazan for the treatment of heartburn in nonerosive reflux disease: A randomized trial. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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