Vonoprazan for PPI-Refractory Functional Dyspepsia among Asian Patients, Study Highlights

A recent study published in the December issue of the Journal of Gastroenterology and Hepatology highlights Vonoprazan's significant effectiveness in alleviating symptoms in patients with PPI-refractory functional dyspepsia (FD).

This prospective, single-center, double-blind, randomized controlled trial included 60 patients (36 females and 24 males) with an average age of 51 years and a BMI of 23.88 kg/m². All enrolled patients were diagnosed with FD, as defined by the ROME IV criteria, and were unresponsive to the standard dose of PPI for at least four weeks before enrollment.

Patients were randomized into two groups: Vonoprazan 10 mg and 20 mg. In both groups, Vonoprazan was administered once daily before breakfast. The primary outcome was to compare efficacy of 10mg and 20mg Vonoprazan using the Global Overall Symptoms Scale (GOSS). Secondary objectives included evaluating symptom relief (GOSS), quality of life using Nepean Dyspepsia Index, positive response rates i.e. >50% improvement in GOSS, and safety profiles.

The efficacy and safety were evaluated on days 14, 28, 42, and 56.

Key Highlights of the Study

Symptom Improvement (GOSS):

• After a 4-week treatment and an additional 4-week follow-up, the mean GOSS scores for the 10 mg and 20 mg Vonoprazan groups were 25.73 and 26.17 at baseline (week 0). By week 2, the scores improved to 14.33 and 15.50, further decreasing to 9.37 and 10.04 at week 4, 7.28 and 7.55 at week 6 and 9.79 and 9.33 at week 8, respectively.

Quality of Life:

• Quality of life improvements were reflected in the Nepean Dyspepsia Index scores, which decreased by −4.13 in the 10 mg group and −4.25 in the 20 mg group after 4 weeks of treatment.

Dyspepsia Response Rates:

• Post-treatment response rates for the 10 mg and 20 mg vonoprazan groups were 31.0% and 35.7% at week 2 (p = 0.937), 75.8% and 78.6% at week 4 (p = 1.00), 86.2% and 89.3% at week 6 and 72.4% and 75.9% at week 8 (p = 0.24), respectively.

Adverse Events:

• No serious adverse events were reported. The most common side effects were mild, including bloating (6.7%), nausea (5%), and constipation (3.3%).

Vonoprazan significantly improved the quality of life and alleviated symptoms of Functional Dyspepsia among Asian patients unresponsive to PPIs. Both the 10 mg and 20 mg doses showed comparable efficacy, with no statistically significant differences in outcomes.

*Rome IV Diagnostic Criteria for functional gastrointestinal (GI) disorders

Reference:

1) Bunchorntavakul C, Jaigla P. Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor-Refractory Functional Dyspepsia: A Double-Blinded, Randomized Study. JGH Open. 2024 Dec 20;8(12):e70082. doi: 10.1002/jgh3.70082. PMID: 39713745; PMCID: PMC11659636.