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

Autor:	Joon Seong Lee, Hyun Wook Park, Bong Tae Kim, Hoon Jai Chun, Eunji Kim, Dongho Lee, Kwang Hyun Ko, Sang Woo Lee, Joong Goo Kwon, Ah Rong Kim, Sang Gyun Kim, Hwoon-Yong Jung, Soo Heon Park, Kwang Bum Cho, Suck Chei Choi, Geun Seog Song, Yong Chan Lee, Hyojin Park, Sam Ryong Jee, Seun Ja Park, Seung Han Kim, Hyun Soo Kim, Jiwon Kim
Rok vydání:	2021
Předmět:	medicine.medical_specialty Hepatology business.industry Nerd Tegoprazan in Non‐erosive Reflux Disease Gastroenterology Reflux Heartburn Randomised Clinical Trial Placebo Clinical trial Tolerability Internal medicine medicine Clinical endpoint Pharmacology (medical) medicine.symptom business Adverse effect
Zdroj:	Alimentary Pharmacology & Therapeutics
ISSN:	1365-2036 0269-2813
Popis:	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 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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9b6b2a1b1a7389f058a14437c3368c57 https://doi.org/10.1111/apt.16477 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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