Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis.
Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis.
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DOI：
10.1111/apt.13331
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发表时间：
2015-09
影响因子：
7.6
通讯作者：
Chiba T
中科院分区：
文献类型：
--
作者：
Ashida K;Sakurai Y;Nishimura A;Kudou K;Hiramatsu N;Umegaki E;Iwakiri K;Chiba T
钾竞争性酸阻滞剂沃诺拉赞（VPZ）具有强效酸抑制作用，可能比酸相关疾病的常规治疗具有临床优势。目的：探讨VPZ治疗糜烂性食管炎（EO）的有效性和安全性。在这项多中心、随机化、双盲、平行组、剂量范围探索研究中，年龄≥20岁且经内镜检查证实为EO [洛杉矶（LA）A-D级]的患者接受VPZ 5、10、20或40 mg或兰索拉唑（LPZ）30 mg每日一次治疗，持续8周。主要终点是第4周内镜检查显示的EO受试者愈合比例。共有732例受试者接受了VPZ或LPZ。VPZ 5、10、20和40 mg组和LPZ 30 mg组第4周时EO治愈受试者比例分别为92.3%、92.5%、94.4%、97.0%和93.2%。根据基线LA分级A/B和C/D调整后，所有VPZ剂量均非劣效于LPZ。在LA分级为C/D的受试者中，VPZ 5、10、20和40 mg组和LPZ 30 mg组的EO受试者愈合比例分别为87.3%、86.4%、100%、96.0%和87.0%。各组不良事件的发生率相似。沃诺拉赞在EO愈合方面有效且不劣于LPZ。VPZ 20 mg或更高剂量对重度EO（LA等级C/D）高度有效。在这项为期8周的研究中，VPZ与安全性问题无关，而血清胃泌素呈剂量依赖性增加。每日一次VPZ 20 mg是治疗EO的推荐临床剂量。
The potassium‐competitive acid blocker vonoprazan (VPZ) has potent acid‐inhibitory effects and may offer clinical advantages over conventional therapy for acid‐related disorders. To investigate the efficacy and safety of VPZ in patients with erosive oesophagitis (EO). In this multicentre, randomised, double‐blind, parallel‐group, dose‐ranging study, patients ≥20 years with endoscopically confirmed EO [Los Angeles (LA) grades A−D] received VPZ 5, 10, 20 or 40 mg, or lansoprazole (LPZ) 30 mg once daily for 8 weeks. The primary endpoint was the proportion of healed EO subjects as shown by endoscopy at week 4. A total of 732 subjects received VPZ or LPZ. The proportion of healed EO subjects at week 4 was 92.3%, 92.5%, 94.4%, 97.0% and 93.2%, respectively, with VPZ 5, 10, 20 and 40 mg and LPZ 30 mg. All VPZ doses were non‐inferior to LPZ when adjusted for baseline LA grades A/B and C/D. Among those with LA grades C/D, the proportions of healed EO subjects were 87.3%, 86.4%, 100%, 96.0% and 87.0%, respectively, with VPZ 5, 10, 20 and 40 mg and LPZ 30 mg. The incidence of adverse events was similar across the groups. Vonoprazan was effective and non‐inferior to LPZ in healing EO. VPZ 20 mg or higher was highly efficacious for severe EO (LA grades C/D). VPZ was associated with no safety concern during this 8‐week study, while there was a dose‐dependent increase in serum gastrin. Once‐daily VPZ 20 mg is the recommended clinical dose for treating EO.
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影响因子：
1.9
作者：
Agreus, Lars;Storskrubb, Tom;Sipponen, Pentti
通讯作者：
Sipponen, Pentti
影响因子：
2.1
作者：
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作者：
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通讯作者：
Hunt, Richard
影响因子：
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作者：
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通讯作者：
Sostek, M
影响因子：
5.8
作者：
Matsukawa, Jun;Hori, Yasunobu;Inatomi, Nobuhiro
通讯作者：
Inatomi, Nobuhiro