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TOPLINE:

Vonoprazan, a potassium-competitive acid blocker, provides rapid relief from heartburn in patients with nonerosive reflux disease (NERD), with sustained improvements lasting up to 20 weeks.

 METHODOLOGY:

• Vonoprazan is an emerging treatment option for patients with NERD that could serve as a potential alternative to proton pump inhibitors, which are commonly prescribed for gastroesophageal reflux disease but are not always effective against NERD.
• Researchers assessed the efficacy of vonoprazan in adult patients from the United States diagnosed with NERD.
• Patients were randomly assigned to receive vonoprazan 10 mg or 20 mg or placebo for 4 weeks, after which they either continued receiving the same dose of vonoprazan or switched from placebo to vonoprazan 10 mg or 20 mg for 20 weeks.
• The primary outcome was the percentage of days without diurnal or nocturnal heartburn (24-hour heartburn-free days) over 4 weeks. The secondary outcome was the percentage of days without the use of a rescue antacid over the treatment period.

TAKEAWAY:

• Overall, 739 patients were randomized and completed the 4-week placebo-controlled phase, and 728 were randomized into the 20-week extension phase.
• Vonoprazan 10 mg and 20 mg demonstrated a significantly higher percentage of 24-hour heartburn-free days vs placebo (44.8% and 44.4% vs 27.7%; P < .0001 for all), with approximately 10% more patients achieving a heartburn-free day with vonoprazan than with placebo as early as the first day of therapy.
• Compared with placebo, both doses of vonoprazan reduced the percentage of days without the use of a rescue antacid (least squares mean difference, 15.8% for vonoprazan 10 mg and 13.7% for vonoprazan 20 mg; P < .0001 for both).
• The efficacy of vonoprazan persisted through the 20-week extension period, with the mean percentage of 24-hour heartburn-free days being more than 60%.
• The overall incidence of adverse events was higher with both doses of vonoprazan than with placebo. Treatment discontinuation was reported in 2.0%, 1.2%, and 2.3% of patients receiving placebo, vonoprazan 10 mg, and vonoprazan 20 mg, respectively.

IN PRACTICE:

"Vonoprazan was efficacious in reducing heartburn symptoms in patients with NERD, with the benefit appearing to begin as early as the first day of therapy. This treatment effect persisted after the initial 4-week placebo-controlled period throughout the 20-week extension period," the authors wrote.

SOURCE:

The study, led by Loren Laine, MD, from Yale School of Medicine, New Haven, Connecticut, and VA Connecticut Healthcare System, West Haven, Connecticut, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Inclusion of individuals with acid reflux not being a cause of their symptoms could have introduced bias.

DISCLOSURES:

The study was supported by Phathom Pharmaceuticals. Several of the authors reported being consultants, advisory board members, advisors, or speakers for various pharmaceutical and medical device companies. Four authors declared being employees and possessing stock or stock options with Phathom Pharmaceuticals.