Gut and liver · 2026
A Phase III, Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan for the Prevention of Peptic Ulcer in Patients on Continuous Long-Term Treatment with Nonsteroidal Anti-Inflammatory Drugs.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеКлиническое исследование III фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kim Sang Gyun, Kim Tae-Oh, Jung Sung Woo, Min Byung-Hoon, Oh Jung-Hwan, Kim Hyun-Soo, Lee Gil Ho, Song Ji Hyun, Sung In Kyung, Cho Young Sin, Choi Suck Chei, Lim Yun Jeong, Kim Byung-Wook, Shin Cheol Min, Huh Cheal Wung, Kim Ji Won, Kim Kyung-Oh, Cho Yu Kyung, Lee Oh Young, Moon Jeong Seop, Lee Hyun Woo, Jung Hwoon-Yong, Shin Woon Geon, Kim Jae-Gyu, Lee Ju Yup, Han Su Jung, Kim Sang-Wook, Cho Joon Hyun, Lim Hyun, Kim Tae Ho, Park Moo In, Baik Gwang Ho, Cha Ra Ri, Lee Sang Kil, Kim Jae J
Аннотация
BACKGROUND/AIMS: Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of peptic ulcers. Tegoprazan, a novel potassium-competitive acid blocker, provides rapid and potent inhibition of acid production. This study evaluated whether tegoprazan 25 mg is non-inferior to lansoprazole 15 mg in preventing NSAID-induced peptic ulcer.
METHODS: In this double-blind, randomized, active-controlled, multicenter phase III trial, patients requiring NSAIDs for up to 24 weeks were randomized (1:1) to the tegoprazan or the lansoprazole group. The primary endpoint was the incidence of peptic ulcer at week 24 in the per-protocol population. Secondary endpoints were NSAID-induced gastrointestinal symptom-free rates. Safety outcomes included adverse drug reactions (ADRs) and serious adverse events (SAEs).
RESULTS: A total of 392 patients were randomized, and 269 patients were analyzed in the perprotocol set. Tegoprazan was non-inferior to lansoprazole for the prevention of gastroduodenal ulcers (p=0.0004). The heartburn-free rate at week 12 was higher in the tegoprazan group (p=0.0421), while other symptom-free rates did not differ significantly. In terms of safety, ADR and SAE rates were comparable and not significantly different.
CONCLUSIONS: Tegoprazan was non-inferior to lansoprazole in preventing NSAID-induced peptic ulcers with excellent tolerance. Tegoprazan represents a clinically effective alternative gastroprotective therapy (ClinicalTrials.gov identifier NCT04840550).
METHODS: In this double-blind, randomized, active-controlled, multicenter phase III trial, patients requiring NSAIDs for up to 24 weeks were randomized (1:1) to the tegoprazan or the lansoprazole group. The primary endpoint was the incidence of peptic ulcer at week 24 in the per-protocol population. Secondary endpoints were NSAID-induced gastrointestinal symptom-free rates. Safety outcomes included adverse drug reactions (ADRs) and serious adverse events (SAEs).
RESULTS: A total of 392 patients were randomized, and 269 patients were analyzed in the perprotocol set. Tegoprazan was non-inferior to lansoprazole for the prevention of gastroduodenal ulcers (p=0.0004). The heartburn-free rate at week 12 was higher in the tegoprazan group (p=0.0421), while other symptom-free rates did not differ significantly. In terms of safety, ADR and SAE rates were comparable and not significantly different.
CONCLUSIONS: Tegoprazan was non-inferior to lansoprazole in preventing NSAID-induced peptic ulcers with excellent tolerance. Tegoprazan represents a clinically effective alternative gastroprotective therapy (ClinicalTrials.gov identifier NCT04840550).