Sang Gyun Kim, Tae Oh Kim, Sung Woo Jung, Byung‐Hoon Min, Jung Hwan Oh, Hyun‐Soo Kim, Gil Ho Lee, Ji Hyun Song, In‐Kyung Sung, Young Sin Cho, Suck Chei Choi, Yun Jeong Lim, Byung‐Wook Kim, Cheol Min Shin, Cheal Wung Huh, Ji Won Kim, Kyoung Oh Kim, Yu Kyung Cho, Oh Young Lee, Jeong Seop Moon, Hyun Woo Lee, Hwoon‐Yong Jung, Woon Geon Shin, Jae Gyu Kim, Ju Yup Lee, Su Jung Han, Sang Wook Kim, Joon Hyun Cho, Hyun Lim, Tae Ho Kim, Moo In Park, Gwang Ho Baik, Ra Ri Cha, Sang Kil Lee, Jae J. Kim
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).