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Vonoprazan 10 mg or 20 mg *** 15 mg as maintenance therapy in Asian patients with healed erosive esophagitis:A randomized controlled trial

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Chinese Medical Journal 2024年第8期137卷 962-971页

作者： Yinglian Xiao Jiaming Qian Shutian Zhang Ning Dai Hoon Jai Chun Chengtang Chiu Chui Fung Chong nobuo funao Yuuichi Sakurai Jessica D.Eisner Li Xie Minhu Chen Department of Gastroenterology The First Affiliated HospitalSun Yat-sen UniversityGuangzhouGuangdong 510062China Department of Gastroenterology Peking Union Medical College HospitalPeking Union Medical CollegeChinese Academy of Medical SciencesBeijing 100006China Department of Gastroenterology Beijing Friendship HospitalCapital Medical UniversityBeijing 100050China Department of Gastroenterology Sir Run Run Shaw HospitalSchool of Medicine Zhejiang UniversityHangzhouZhejiang 310020China Department of Internal Medicine Korea University Anam HospitalKorea University College of Medicine73 Goryeodae-roSeongbuk-guSeoul 02841Republic of Korea Department of Gastroenterology&Hepatology Linkou Medical CenterChang Gung Memorial HospitalTaoyuanTaiwan 33353China College of Medicine Chang Gung UniversityTaoyuanTaiwan 33353China Takeda Development Center Asia Singapore 018981Singapore Takeda Pharmaceutical Company Chuo-kuOsaka 540-8645Japan Takeda Pharmaceuticals International Company CambridgeMA02142 USA China Medical Team Takeda ChinaBeijing 100027China Hoffmann-La Roche Basel4070 Switzerland Abbott Laboratories Lake ForestIL 60045USA

Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the *** pump inhibitors are widely used as maintenance therapy for EE,but many patients still *** this trial,we evaluated the noninferiority of vonoprazan *** as maintenance therapy in patients with healed ***:We performed a double-blind,double-dummy,multicenter,phase 3 clinical trial among non-Japanese Asian adults with endoscopically confirmed healed EE from April 2015 to February *** from China,South Korea,and Malaysia were randomized to vonoprazan 10 mg or 20 mg once daily or lansoprazole 15 mg once daily for 24 *** primary endpoint was endoscopically confirmed EE recurrence rate over 24 weeks with a noninferiority margin of 10%using a two-sided 95%confidence interval(CI).Treatment-emergent adverse events(TEAEs)were ***:Among 703 patients,EE recurrence was observed in 24/181(13.3%)and 21/171(12.3%)patients receiving vonoprazan 10 mg or 20 mg,respectively,and 47/184(25.5%)patients receiving lansoprazole(differences:-12.3%[95%CI,-20.3%to-4.3%]and-13.3%[95%CI,-21.3%to-5.3%],respectively),meeting the primary endpoint of noninferiority to lansoprazole in preventing EE recurrence at 24 *** of superiority(upper bound of 95%CI<0%)was also *** 12 weeks,endoscopically confirmed EE recurrence was observed in 5/18,2/20,and 7/20 of patients receiving vonoprazan 10 mg,vonoprazan 20 mg,and lansoprazole,*** were experienced by 66.8%(157/235),69.0%(156/226),and 65.3%(158/242)of patients receiving vonoprazan 10 mg,vonoprazan 20 mg,and lansoprazole,*** most common TEAE was upper respiratory tract infection in 12.8%(30/235)and 12.8%(29/226)patients in vonoprazan 10 mg and 20 mg groups,respectively and 8.7%(21/242)patients in lansoprazole ***:Vonoprazan maintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence i

关键词： Erosive esophagitis Lansoprazole Maintenance therapy Potassium-competitive acid blockers Vonoprazan

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