TOPLINE

Among non-Asian adults with Los Angeles (LA) grade B-D erosive esophagitis, tegoprazan 50 mg once daily did not significantly improve endoscopic healing at 4 weeks compared with pantoprazole 40 mg once daily. However, it provided faster symptom relief, with significantly more participants experiencing at least 50% symptom improvement during the first week.

METHODOLOGY

• Tegoprazan, a potassium-competitive acid blocker, has shown noninferior or superior mucosal healing compared with conventional proton pump inhibitors (PPIs) in Asian populations, but data about non-Asian adults with erosive esophagitis remain limited.
• Researchers conducted a clinical trial at two centers in Mexico, enrolling 70 adults with endoscopically confirmed LA grade B-D erosive esophagitis to test whether tegoprazan is superior to pantoprazole, a standard PPI.
• Participants were randomly assigned to receive tegoprazan 50 mg once daily (n = 36; mean age, 50.4 years; 44.4% women) or pantoprazole 40 mg once daily (n = 34; mean age, 50.8 years; 55.9% women) for 4 weeks. The 64 participants who completed the study (32 per group) formed the per-protocol population.
• Participants recorded heartburn and regurgitation severity daily in an electronic diary, starting 1 week before treatment and continuing through the first week of treatment. They also completed the gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL) at baseline and at weeks 1 and 4, and were seen weekly.
• The primary outcome was endoscopic healing at 4 weeks, meaning the esophagitis had improved from LA grade B-D to grade A or showed no visible erosions. 

TAKEAWAY

• Among the 70 patients with erosive esophagitis, endoscopic healing at 4 weeks occurred in 88.9% of participants receiving tegoprazan vs 79.4% of those receiving pantoprazole, but the difference did not reach statistical significance (P = .33).
• In the per-protocol population, healing rates were 100% with tegoprazan vs 84.4% with pantoprazole (P = .053). In an exploratory subgroup analysis of participants with LA grade C or D esophagitis, the healing rate was significantly higher with tegoprazan than with pantoprazole (100% vs 68.8%; P = .04).
• During the first 7 days of the treatment, 84.4% of participants in the tegoprazan group achieved at least 50% symptom improvement vs 31.3% of those in the pantoprazole group (P < .001). Quality-of-life scores on the GERD-HRQL improved in both groups, with no significant difference between them.
• At least one adverse event occurred in 2.9% of participants receiving tegoprazan and 6.3% of those receiving pantoprazole. The researchers judged all events to be mild, to resolve on their own, and to be unrelated to the drugs; nausea was the most commonly reported event.

IN PRACTICE

"These findings extend the clinical evidence for tegoprazan beyond Asian populations and provide the first randomized controlled data in Latin American participants with objectively confirmed erosive GORD [gastro-oesophageal reflux disease]," the authors wrote.

SOURCE

The study was led by José M. Remes-Troche, MD, of Universidad Veracruzana in Veracruz, Mexico. It was published online in Alimentary Pharmacology & Therapeutics.

LIMITATIONS

The small sample and recruitment at only two centers in Mexico may have limited the extent to which the findings could be applied to other Latin American or Western populations. The erosive cohort was underpowered for definitive superiority conclusions and subgroup analyses. The 4-week treatment period did not allow assessment of the durability of healing, relapse prevention, maintenance therapy, rebound symptoms, or long-term safety.

DISCLOSURES

The study was supported by Carnot Laboratorios México. Some authors reported serving as speakers, advisory board members, or consultants for multiple companies, whereas some reported working in medical affairs and research, including at the organization that funded the study.

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