Vonoprazan vs Esomeprazole for Treating Symptomatic Gastroesophageal Reflux Disease

Vonoprazan was as efficacious and safe as esomeprazole for reducing symptoms of gastroesophageal reflux disease (GERD), suggesting vonoprazan may be an effective alternative for patients who exhibit only a partial response to proton pump inhibitors (PPIs). Researchers published their findings in Neurogastroenterology and Motility.

“Evidence suggests that most patients exhibit partial response to PPIs, suggesting the need for novel therapies that can provide an improved and sustained increase in gastric pH,” said Jan Tack, MD, PhD, department of gastroenterology, University Hospitals Leuven, Belgium, and coauthors.

Vonoprazan is an oral, potassium-competitive acid blocker. Dr Tack and coinvestigators compared vonoprazan to esomeprazole in European patients with symptomatic GERD who previously had a partial response to esomeprazole.

The randomized, double-blind, phase 2 trial was conducted between 2016 and 2018 and included 256 patients. Patients were treated with vonoprazan 20 mg once daily (n=85), vonoprazan 40 mg once daily (n=85), or esomeprazole 40 mg once daily (n=86).

Throughout 4 weeks of treatment, the percentages of heartburn-free days were similar across groups, at 36.7% (SD 33.4%) for those receiving the lower dose of vonoprazan; 36.5% (SD 35.6%) for those in the vonoprazan 40 mg group; and 38.4% (SD 34.8%) for the esomeprazole group.

Most adverse events were mild, and no patients died during the study.

“No statistically significant difference in efficacy and safety was observed among treatment groups, and vonoprazan was well tolerated,” Dr Tack and coauthors concluded.

Vonoprazan was approved in Japan in 2015 for treating several acid-related diseases, including erosive esophagitis and GERD. Two vonoprazan-based treatments are approved by the US Food and Drug Administration for Helicobacter pylori infections, but the acid blocker has not yet received any indications for GERD in the United States.

Reference:
Tack J, Vladimirov B, Horny I, et al. Randomized clinical trial: A double-blind, proof-of-concept, phase 2 study evaluating the efficacy and safety of vonoprazan 20 or 40 mg versus esomeprazole 40 mg in patients with symptomatic gastro-esophageal reflux disease and partial response to a healing dose of a proton-pump inhibitor. Neurogastroenterol Motil. Published online September 30, 2022. doi:10.1111/nmo.14468