TOPLINE:

Patients with nonerosive reflux disease treated with vonoprazan experienced a rapid reduction in nocturnal symptoms and an increase in heartburn-free nights.

METHODOLOGY:

• Nocturnal symptoms of gastroesophageal reflux disease (GERD) are common but often underrecognized. Researchers evaluated whether treatment with the potassium-competitive acid blocker vonoprazan, previously shown to be effective for both erosive esophagitis and nonerosive reflux disease (NERD), reduced nocturnal symptoms.
• The researchers analyzed data from a prospective, double-blind phase 3 study conducted at 91 US centers. Adults who experienced heartburn on 4 days or more during any consecutive 7-day screening period without esophagitis or Barrett esophagus on endoscopy were included.
• Patients were randomly assigned to receive once-daily placebo or vonoprazan (10 mg or 20 mg) for 4 weeks. In a 20-week extension, patients taking placebo were randomly assigned to receive one of the two doses of vonoprazan and those already taking vonoprazan continued their assigned doses.
• Patients recorded the presence and severity of daytime and nighttime heartburn in electronic diaries, and these records were used to calculate the number of heartburn-free nights.
• Patients completed the 20-item Nocturnal GERD Questionnaire (N-GSSIQ) — which measures nighttime symptom severity, morning impact of the symptoms, and patients’ concerns about nocturnal GERD — at baseline and weeks 4, 12, and 24. An improvement of 0.5 points in the total N-GSSIQ score was considered a minimal important difference.

TAKEAWAY:

• A total of 772 patients (mean age, 50.4-51.5 years; 64.6%-70.8% women) received placebo or vonoprazan for 4 weeks. In the 20-week extension, 241 placebo recipients were switched to 10 mg or 20 mg vonoprazan, whereas most of the initial vonoprazan recipients continued their assigned doses.
• At week 4, the mean percentage of heartburn-free nights was 43.3% for placebo vs 59.9% for 10 mg vonoprazan (least squares [LS] mean difference, 16.5%; P < .0001) and 56.4% for 20 mg vonoprazan (LS mean difference, 13.1%; P < .0001). Differences between the placebo and vonoprazan groups were evident after the first dose.
• Both doses of vonoprazan improved the N-GSSIQ total score more than placebo at week 4 (LS mean differences, -2.9 for 10 mg and -1.8 for 20 mg; P < .005 for both). Scores on the N-GSSIQ subscales for severity of nocturnal symptoms and patients’ concerns about their symptoms also improved significantly (P < .001 for both doses).
• Rates of heartburn-free nights were similar between patients who switched from placebo to vonoprazan and patients initially assigned to vonoprazan. Improvements in N-GSSIQ scores were sustained through the 20-week extension period.

IN PRACTICE:

“[The study] findings provide important data for the management of NERD patients with nocturnal symptoms and suggest a role for vonoprazan in the armamentarium of therapies for patients with nighttime symptoms,” the authors wrote.

SOURCE:

This study was led by Catiele Antunes, MD, Yale School of Medicine, New Haven, Connecticut, and Gaurav Ghosh, MD, Weill Cornell Medicine, New York City. It was published online in The American Journal of Gastroenterology. 

LIMITATIONS:

Positive pH testing was not used to confirm whether acid reflux was the true cause of symptoms. The influence of prior use of proton pump inhibitors may need cautious analysis.

DISCLOSURES:

This study received funding from Phathom Pharmaceuticals, which manufactures vonoprazan. Three authors reported being employees of and five authors reported serving as consultants for Phathom Pharmaceuticals. Two authors reported having relationships with other healthcare companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.