Background:Owing to the high prevalence of antibiotic resistance in Helicobacter pylori(H.pylori)in China,bismuth-containing quadruple therapies have been recommended for H.pylori eradication.This study compared the e...Background:Owing to the high prevalence of antibiotic resistance in Helicobacter pylori(H.pylori)in China,bismuth-containing quadruple therapies have been recommended for H.pylori eradication.This study compared the efficacy and safety of quadruple regimens containing vonoprazan vs.esomeprazole for H.pylori eradication in a patient population in China.Methods:This was a phase 3,multicenter,randomized,double-blind study.Patients with confirmed H.pylori infection were randomized 1:1 to receive quadruple therapy for 14 days:amoxicillin 1000 mg and clarithromycin 500 mg after meals,bismuth potassium citrate 600 mg before meals,plus either vonoprazan 20 mg or esomeprazole 20 mg before meals,all twice daily.The primary outcome was the eradication rate of H.pylori,evaluated using a ^(13)C urea breath test at 4 weeks after treatment.The non-inferiority margin was at 10%.Results:The study included 510 patients,506 of whom completed the follow-up assessment.The primary analysis revealed eradication rates of 86.8%(210/242)and 86.7%(208/240)for vonoprazan and esomeprazole therapy,respectively(treatment difference:0.1%;95%confidence interval[CI]:-5.95,6.17;non-inferiority P=0.0009).Per-protocol analysis showed eradication rates of 87.4%for vonoprazan and 86.3%for esomeprazole(treatment difference:1.2%;95%CI:-5.03,7.36;non-inferiority P=0.0004).Vonoprazan and esomeprazole were well tolerated,with similar safety profiles.Conclusion:Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H.pylori in patients from China.展开更多
Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus.Proton pump inhibitors are widely used as maintenance therapy for EE,but many patients still rela...Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus.Proton pump inhibitors are widely used as maintenance therapy for EE,but many patients still relapse.In this trial,we evaluated the noninferiority of vonoprazan vs.lansoprazole as maintenance therapy in patients with healed EE.Methods: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 2019.Patients 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 weeks.The 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 recorded.Results: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 weeks.Evidence of superiority(upper bound of 95%CI<0%)was also observed.At 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,respectively.TEAEs 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,respectively.The 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 group.Conclusion:Vonoprazan maintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence in Asian patients with healed EE.Trial Registration:https://clinicaltrials.gov;NCT02388737.展开更多
文摘Background:Owing to the high prevalence of antibiotic resistance in Helicobacter pylori(H.pylori)in China,bismuth-containing quadruple therapies have been recommended for H.pylori eradication.This study compared the efficacy and safety of quadruple regimens containing vonoprazan vs.esomeprazole for H.pylori eradication in a patient population in China.Methods:This was a phase 3,multicenter,randomized,double-blind study.Patients with confirmed H.pylori infection were randomized 1:1 to receive quadruple therapy for 14 days:amoxicillin 1000 mg and clarithromycin 500 mg after meals,bismuth potassium citrate 600 mg before meals,plus either vonoprazan 20 mg or esomeprazole 20 mg before meals,all twice daily.The primary outcome was the eradication rate of H.pylori,evaluated using a ^(13)C urea breath test at 4 weeks after treatment.The non-inferiority margin was at 10%.Results:The study included 510 patients,506 of whom completed the follow-up assessment.The primary analysis revealed eradication rates of 86.8%(210/242)and 86.7%(208/240)for vonoprazan and esomeprazole therapy,respectively(treatment difference:0.1%;95%confidence interval[CI]:-5.95,6.17;non-inferiority P=0.0009).Per-protocol analysis showed eradication rates of 87.4%for vonoprazan and 86.3%for esomeprazole(treatment difference:1.2%;95%CI:-5.03,7.36;non-inferiority P=0.0004).Vonoprazan and esomeprazole were well tolerated,with similar safety profiles.Conclusion:Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H.pylori in patients from China.
文摘Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus.Proton pump inhibitors are widely used as maintenance therapy for EE,but many patients still relapse.In this trial,we evaluated the noninferiority of vonoprazan vs.lansoprazole as maintenance therapy in patients with healed EE.Methods: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 2019.Patients 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 weeks.The 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 recorded.Results: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 weeks.Evidence of superiority(upper bound of 95%CI<0%)was also observed.At 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,respectively.TEAEs 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,respectively.The 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 group.Conclusion:Vonoprazan maintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence in Asian patients with healed EE.Trial Registration:https://clinicaltrials.gov;NCT02388737.
