Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Department of Gastroenterology, Hainan General Hospital, Affiliated Hainan Hospital of Hainan Medical University, Haikou, China.
Curr Med Res Opin. 2024 Nov;40(11):1855-1862. doi: 10.1080/03007995.2024.2414090. Epub 2024 Oct 21.
Tegoprazan represents a newly developed potassium-competitive acid blocker utilized for the treatment of acid-related disorders. The present study aimed to explore the therapeutic effectiveness of tegoprazan in Chinese individuals with duodenal ulcers (DU).
In the current multicenter, randomized, double-blind, double-dummy, parallel-group, non-inferiority, phase III clinical trial, individuals with DU underwent randomization 1:1 to be administered tegoprazan 50 mg or lansoprazole 30 mg once daily. The primary efficacy endpoint was the 6-week cumulative endoscopic ulcer healing rate. Secondary endpoints included 4-week endoscopic ulcer healing rate and relief of DU-related gastrointestinal symptoms at weeks 2, 4, and 6. Safety analysis encompassed adverse events (AEs) and laboratory indexes.
The 6-week cumulative endoscopic ulcer healing rates were 96.9% (188/194) and 99.0% (189/191) in the tegoprazan and lansoprazole groups, respectively, indicating a difference of -2.0% (95% confidence interval (CI) = -4.9 to 0.8) in the full analysis set (FAS). The corresponding healing rates were 98.4% (185/188) and 99.5% (183/184) in the per-protocol set, respectively, indicating a difference of -1.1% (95% CI = -3.1 to 1.0). The 4-week healing rates in the tegoprazan and lansoprazole groups were 89.2% (173/194) and 88.5% (169/191) in the FAS, respectively, with a difference of 0.7% (95% CI = -5.6 to 7.0). Treatment-related AEs, all mild-to-moderate, were reported in 38.2% (78/204) and 48.2% (94/195) of participants in the tegoprazan and lansoprazole groups, respectively.
Tegoprazan 50 mg once daily is effective and non-inferior to lansoprazole 30 mg once daily in Chinese patients with DU, showing a promising safety and tolerability profile.
CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT05010954.
替戈拉赞是一种新开发的钾竞争性酸阻滞剂，用于治疗与酸相关的疾病。本研究旨在探讨替戈拉赞在中国十二指肠溃疡（DU）患者中的治疗效果。
在这项多中心、随机、双盲、双模拟、平行分组、非劣效性、III 期临床试验中，DU 患者按 1:1 随机分组，分别接受替戈拉赞 50mg 或兰索拉唑 30mg 每日 1 次治疗。主要疗效终点为 6 周累积内镜溃疡愈合率。次要终点包括 4 周内镜溃疡愈合率和治疗 2、4、6 周时 DU 相关胃肠道症状的缓解率。安全性分析包括不良事件（AE）和实验室指标。
替戈拉赞组和兰索拉唑组的 6 周累积内镜溃疡愈合率分别为 96.9%（188/194）和 99.0%（189/191），全分析集（FAS）差异为-2.0%（95%置信区间（CI）=-4.9 至 0.8）。在符合方案集（per-protocol set，PPS）中，相应的愈合率分别为 98.4%（185/188）和 99.5%（183/184），差异为-1.1%（95%CI=-3.1 至 1.0）。替戈拉赞组和兰索拉唑组在 FAS 中的 4 周愈合率分别为 89.2%（173/194）和 88.5%（169/191），差异为 0.7%（95%CI=-5.6 至 7.0）。替戈拉赞组和兰索拉唑组分别有 38.2%（78/204）和 48.2%（94/195）的患者报告与治疗相关的 AEs，均为轻至中度。
替戈拉赞 50mg 每日 1 次治疗中国 DU 患者有效且非劣效于兰索拉唑 30mg 每日 1 次，具有良好的安全性和耐受性。
NCT05010954。
