Randomised clinical trial: comparison of tegoprazan and placebo in non‐erosive reflux disease

Citations Over TimeTop 10% of 2021 papers

Abstract

Summary Background Tegoprazan is a novel, fast‐ and long‐acting potassium‐competitive acid blocker that suppresses gastric acid secretion, which could benefit patients with non‐erosive reflux disease (NERD), a type of gastroesophageal reflux disease. Aim To evaluate the efficacy and safety profiles of tegoprazan compared with those of a placebo in Korean patients with NERD. Methods In this phase 3, double‐blind, placebo‐controlled, multicentre study, 324 Korean patients with NERD were randomised into three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and placebo. These drugs were provided once daily for 4 weeks. The primary endpoint was the proportion of patients with complete resolution of major symptoms (both heartburn and regurgitation) for the last 7 days of the 4‐week treatment period. Other outcomes related to efficacy, safety and tolerability were also evaluated. Results Among all, 42.5% (45/106), 48.5% (48/99) and 24.2% (24/99) of patients showed complete resolution of major symptoms at week 4 after receiving tegoprazan 50 mg, tegoprazan 100 mg, and placebo, respectively. Both doses of tegoprazan showed superior efficacy than the placebo ( P = 0.0058 and P = 0.0004, respectively). The complete resolution rates of heartburn and proportions of heartburn‐free days (as other efficacy outcomes) were significantly higher in both tegoprazan groups than in the placebo group ( P < 0.05 for all). No significant difference in the incidence of treatment‐emergent adverse events were noted. Conclusions Tegoprazan 50 and 100 mg showed superior therapeutic efficacy compared with the placebo, as well as a favourable safety profile in patients with NERD. Registration number: ClinicalTrials.gov identifier NCT02556021.

Related Papers

• → Mechanisms of heartburn(2008)66 cited
• Role of non-acid reflux in patients with non-erosive reflux disease.(2013)
• → Tu1837 Stronger Upper GI Symptoms in Patients With Nonerosive Reflux Disease (NERD) Than in Those With Erosive Gastroesophageal Reflux Disease (Egerd) During Proton Pump Inhibitor (PPI) Maintenance Therapy(2013)
• → Rabeprazole Versus Esomeprazole in Non-Erosive Gastro-Oesophageal Reflux (NERD) Disease: A Randomized, Double Blind Study in Urban Asia(2005)
• → Clinical classification and characteristics of consecutive patients with frequent heartburn(2011)