Patients diagnosed with non-erosive reflux disease (NERD) who were treated with once-daily tegoprazan, a novel oral potassium-competitive acid blocker (P-CAB), experienced a significant decline in heartburn frequency, as demonstrated in a recent phase III trial.
In the study, participants were randomly assigned to receive either a placebo, tegoprazan 50 mg, or 100 mg. The mean percentage of heartburn-free days over a 24-hour period by week 4 was recorded as 17.3%, 26.2%, and 30.1% for placebo, tegoprazan 50 mg, and 100 mg, respectively. This translates to relative improvements of 51% (P=0.0006) and 74% (P<0.0001) for tegoprazan compared to placebo, as reported by Dr. Ronnie Fass from Case Western Reserve University School of Medicine in Cleveland.
The study also revealed significant enhancements in key secondary endpoints, including the percentage of days without daytime and nighttime heartburn, which were also markedly improved with tegoprazan. These findings were shared during the annual meeting of the American College of Gastroenterology held in Nashville, Tennessee.
In an exploratory analysis, tegoprazan demonstrated notable improvements in the rates of regurgitation-free days. Patients receiving 50 mg and 100 mg reported 31.9% and 33.8% regurgitation-free days, respectively, compared to 23.6% for those on placebo (P=0.0012 and P<0.0001).
After a 20-week extension of the study, the percentage of days free from heartburn remained impressive, at 47.8% for the 50 mg and 50.4% for the 100 mg groups.
Dr. Fass affirmed, “These findings strongly position tegoprazan as a viable therapeutic option for patients suffering from non-erosive reflux disease.” During a Q&A session following the presentation, Dr. Henry Parkman from the Lewis Katz School of Medicine at Temple University raised concerns regarding the improvements observed in the placebo group, questioning whether additional interventions, such as dietary management, might have contributed to the reduction in heartburn and regurgitation.
Dr. Fass acknowledged that various factors, including lifestyle modifications made during the study, might have influenced the placebo response. However, he emphasized that the significant difference between the treatment and placebo groups remained evident.
Study Background and Design
Dr. Fass explained that gastroesophageal reflux disease (GERD) affects about 20% of adults in the United States, with NERD being the most common type, impacting up to 70% of patients. Importantly, approximately 35% of GERD patients express dissatisfaction with existing proton pump inhibitors (PPIs).
He highlighted, “In the case of NERD, symptom relief achieved through standard-dose PPIs is reported to be about 50%.” Notably, while both P-CABs and PPIs inhibit the proton pump, they have distinct pharmacokinetic and pharmacodynamic profiles. Tegoprazan, in particular, exhibits unique binding properties that differentiate it from other P-CABs.
Additionally, Dr. Fass noted that tegoprazan is characterized by its rapid onset: it can elevate stomach pH above 4 within 45 minutes of administration, achieving a stable state within one day and maintaining gastrin levels within normal ranges throughout treatment.
The double-blind TRIUMpH-NERD trial involved 783 patients across 91 U.S. sites (mean age 51-53, with 65-74% women, 68-74% white, and 22-27% Black). At baseline, only 6.2% of patients reported heartburn-free days.
Inclusion criteria for the trial required patients to have experienced heartburn symptoms for at least 6 months prior to randomization, having undergone a normal endoscopy during the 1-week screening period while also presenting symptoms on at least 4 days of that period.
Data regarding secondary endpoints indicated significant outcomes for tegoprazan, specifically 36% and 38.4% of days without daytime heartburn for 50 mg and 100 mg doses, respectively, compared to 27.4% for placebo by day 28. The mean percentages of days without nighttime heartburn and combined heartburn and regurgitation were also favorable for tegoprazan.
When assessing the severity of GERD symptoms, both treatment groups showed notable enhancements compared to placebo in reducing heartburn and regurgitation severity.
Rates of serious treatment-emergent adverse events (TEAEs) were comparable across all three groups, with TEAEs leading to treatment discontinuation at 1.1% for placebo, 1.9% for 50 mg tegoprazan, and 1.5% for 100 mg.
A new drug application for tegoprazan to treat GERD was submitted to the FDA in January.
Disclaimer: This information is intended for educational purposes only and should not replace professional medical advice. Always consult a healthcare provider for diagnosis and treatment options.
Fuente: https://www.medpagetoday.com/meetingcoverage/acg/123436
Join the doctors who get the most relevant medical news, curated by specialty, every week — no spam, unsubscribe anytime.
