A Randomized, Comparative Trial of a Potassium-Competitive Acid Blocker (X842) and Lansoprazole for the Treatment of Patients With Erosive Esophagitis
Siying Zhu, Muzhou Han, Ye Zong, Fandong Meng, Qi Liu, Biguang Tuo, Zhenyu Zhang, Qizhi Wang, Xiaowei Liu, Song He, Yanbo Zhen, Dong Shao, Shenglan Wang, Baohong Xu, Xing Li, Haitao Tang, Yangde Miu, Chengxia Liu, Jiuye Hu, Pingsheng Hu, Jin Xiu, Ming Lu, Yongdong Wu, Shutian ZhangINTRODUCTION:
X842 is a new type of gastric acid-suppressing agent with a rapid onset of action and a long duration of effect. We aim to investigate the efficacy and safety of different doses of X842 vs lansoprazole in the treatment of patients with erosive esophagitis (EE).
METHODS:
This phase 2 study included 90 patients with EE (Los Angeles grades A–D) who were randomized (1:1:1) to receive oral low-dose X842 (50 mg/d, n = 31), high-dose X842 (100 mg/d, n = 31), or lansoprazole (30 mg/d, n = 30) for 4 weeks. The main efficacy end point was the EE healing rate, which was the proportion of patients who achieved endoscopic healing after 4 weeks of treatment.
RESULTS:
For intention-to-treat analysis, the EE healing rates at 4 weeks were 93.6% (29/31), 79.3% (23/29), and 80.0% (24/30) for the X842 50 mg, the X842 100 mg, and the lansoprazole 30 mg groups. For per-protocol analysis, the EE healing rates at 4 weeks were 93.6% (29/31), 80.8% (21/26), and 82.1% (23/28) in the 3 groups, respectively. The EE healing rate did not significantly differ among the 3 groups in either the intention-to-treat (
DISCUSSION:
Our findings confirmed that X842 had efficacy and a favorable safety profile similar to those of lansoprazole. Therefore, X842, a novel potassium-competitive acid blocker, is expected to become a promising therapeutic agent for EE.