Randomised clinical trial: comparison of tegoprazan and placebo in non‐erosive reflux disease. Issue 4 (6th July 2021)

• Record Type: Journal Article
• Authors: Kim, Seung Han; Cho, Kwang Bum; Chun, Hoon Jai; Lee, Sang Woo; Kwon, Joong Goo; Lee, Dong Ho; Kim, Sang Gyun; Jung, Hwoon‐Yong; Kim, Ji Won; Lee, Joon Seong; Park, Hyojin; Choi, Suck Chei; Jee, Sam Ryong; Kim, Hyun‐Soo; Ko, Kwang Hyun; Park, Seun Ja; Lee, Yong Chan; Park, Soo Heon; Kim, Ah Rong; Kim, Eun Ji; Park, Hyun Wook; Kim, Bong Tae; Song, Geun Seog
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 54:Issue 4(2021)
• Page Start: 402
• Page End: 411
• Publication Date: 2021-07-06
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.16477
• Languages: English
• ISSNs: 0269-2813

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. Abstract : Tegoprazan 50 and 100 mg showed superior therapeutic efficacy compared with the placebo, as well as a favourable safety profile in patients with non‐erosive reflux disease.