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Polaprezinc Combined with Triple Therapy for Helicobacter Pylori Associated Gastritis: A Prospective, Multicenter, Randomized Clinical Trial
Sa1196
POLAPREZINC COMBINED WITH TRIPLE THERAPY FOR HELICOBACTER PYLORI ASSOCIATED GASTRITIS: A PROSPECTIVE, MULTICENTER, RANDOMIZED CLINICAL TRIAL Bei Tan, Hanqing Luo, Hong Xu, Nonghua Lu, Ruihua Shi, Hesheng Luo, Jiansheng Li, Jian-Lin Ren, Yiyou Zou, Yanqing Li, Feng Ji, Jing-Yuan Fang, Jiaming QIan
COMPARISON OF AOC AND AOM TRIPLE, SEQUENTIAL, AND CONCOMITANT THERAPY AS THE FIRST LINE ERADICATION THERAPY FOR HELICOBACTER PYLORI Jin Il Kim Background/Aim: The eradication rates of the AOC standard triple therapy have continuously decreased, because of the widespread development of clarithromycin resistance. We compared the efficacy and adverse events of standard triple, sequential, and concomitant therapy for H. pylori eradication. Method: This was a prospective, multicenter, randomized controlled study involving 1,000 patients diagnosed with H. pylori infection between January 2014 and July 2016 in the five Catholic University Hospitals in affiliation. Diagnosis was made by histological evidence of H. pylori via Warthin-Starry silver staining. We compared 4 treatment regimens and 250 patients were enrolled in each group: the AOC therapy was treated with clarithromycin based triple therapy for 7 days; the AOM therapy was treated with metronidazole based triple therapy for 7 days; the sequential therapy consisted of rabeprazole and amoxicillin for the initial 5 days, followed by rabeprazole, clarithromycin, and metronidazole for the subsequent 5 days; the concomitant therapy consisted of rabeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days. Six weeks following completion of therapy, successful H. pylori eradication was defined by a negative 13C-urea breath test result. Adverse events and drug compliance were evaluated by physicians via direct questioning. Results: A total of 896 patients (224, 223, 218, and 231 patients in the concomitant, sequential, AOM Triple, and AOC standard triple groups, respectively) were analyzed. The mean age of the patients was 55.7 years. There were 464 male and 432 female patients. The eradication rate was significantly higher in the concomitant group (89.7%, 204/224) than in the AOC standard group (78.3%, 181/231), the AOM group (82.6%, 180/218) and the sequential group (85.7%, 191/223) (p=0.006). Drug compliance and adverse events were not statistically different among the three groups. Conclusions: Concomitant therapy appears to be more effective for H. pylori eradication compared to AOC, AOM triple therapy and sequential therapy. There were no statistically different adverse events among the three groups.
Background: Helicobacter pylori is one of the most prevalent global pathogens and treatment failure is increasing due to rising antibiotic resistance. Polaprezinc is a gastric mucosal protective agent complex of zinc and L-carnosine, shown to improve efficacy when combined with triple therapy in Japan. Aim: To compare the clinical efficacy and safety of the polaprezinc combined to triple therapy versus standard triple therapy in the eradication of H. pylori. Methods: This is a randomized, parallel-group controlled, prospective multicenter study in 11 cities of China. Treatment-naïve patients with H. pylori-associated gastritis were randomly assigned to the following groups: Arm A which consists of triple-therapy (omeprazole 20mg, amoxicillin 1g, and clarithromycin 500mg twice daily) plus polaprezinc 75mg twice daily, Arm B which consists of the same triple-therapy plus polaprezinc 150mg twice daily, or Arm C which is the standard triple-therapy for 14 days. Eradication was considered successful if C13 or C14 urea breath test was negative 4 weeks after completion of therapy as the primary outcome. Digestive symptoms improvement 7, 14, 28 days after completion of intervention and rates of adverse effects were the secondary outcomes. Results: 332 enrolled, and 303 patients completed the study, with 106, 96, and 101 patients in Arm A, Arm B, and Arm C. In the intention-to-treat (ITT) analysis, the rate of H. pylori eradication was significantly higher for Arm A (77.0%) and Arm B (75.9%) vs Arm C (58.6%) (p<0.01), whereas there was no difference between Arm A and Arm B (P=0.90) (Table 1, Figure 1). In the per-protocol (PP) analysis, the rate of H. pylori eradication was significantly higher for Arm A (81.1%) and Arm B (83.3%) vs Arm C (61.4%) (P<0.01), while there was no difference between Arm A and Arm B (P=0.62) (Table 1, Figure 1). In all three groups, there were significant symptomatic improvement including abdominal pain, acid reflux, belching, heartburn, bloating, nausea, and vomiting at 7 days, 14 days and 28 days after treatment compared to baseline (P<0.0001). The adverse event rate of Arm B was higher than Arm A (P=0.04) and Arm C (P=0.02), including mild leukopenia, elevated liver enzymes, elevated serum uric acid, and high blood pressure, but there were no serious adverse events. Conclusions: Standard dose polaprezinc combined with standard triple therapy can significantly improve H. pylori eradication rate without an increase in adverse event and is well-tolerated. H. pylori eradication rate in the ITT and PP populations
Sa1197 THE EFFICACY OF PCR-BASED TAILORED ERADICATION THERAPY FOR IN-PATIENTS WITH HELICOBACTER PYLORI INFECTION Young Sin Cho, Su Jung Han, Il-Kwun Chung, Yunho Jung, Tae Hoon Lee, Sang-Heum Park, Sun-Joo Kim Background/Aims: Helicobacter pylori (HP) is the causative pathogen of gastrointestinal diseases such as peptic ulcers and gastric malignancy. The eradication rates of HP infection are decreasing because of increasing resistance to clarithromycin. A previous study showed that a polymerase chain reaction (PCR)-based assay can detect HP and clarithromycin resistance. The aim of this work was to compare the efficacy of PCR-based tailored therapy with that of conventional triple therapy. Methods: From April 2015 to August 2016, 285 consecutive HP-infected patients received PCR-based tailored therapy or standard triple therapy (proton pump inhibitor, clarithromycin, amoxicillin) for 10 days. In the PCR-based tailored therapy group, patients received standard triple therapy or quadruple therapy (proton pump inhibitor, bismuth, metronidazole, tetracycline) according to clarithromycin resistance confirmed by the PCR-based clarithromycin resistance test, which detects most of the prevalent point mutations (A2143G and A2142G) in HP 23S rRNA. Eradication was assessed using the 13C-urea breath test 6-8 weeks after treatment. Eradication rates and adverse drug effects were compared between groups. Results: The mean age of the patients was 55.5 years. Standard triple therapy was administered to 191 patients and PCR-based tailored therapy to 94 patients. The eradication rates of standard triple therapy and PCR-based tailored therapy were 64.3% (126/191) and 84% (79/94) by intention to treat analysis, respectively (P = 0.005), and 72.4% (126/174) and 88.8% (79/89) by per protocol analysis, respectively (P = 0.002). The complication rates of the PCR-based tailored therapy and standard triple therapy groups were similar (11.1% vs. 12.4%, p=0.629). Conclusions: In HP-infected patients, PCR-based tailored therapy is more effective than conventional triple therapy and can substitute as the first-line HP eradication regimen in regions with high rates of clarithromycin resistance.
ITT, Intention-to-treat; PP, per-protocol; Arm A, polaprezinc 150mg/d combined omeprazole, amoxicillin, clarithromycin for 14 days; Arm B, polaprezinc 300mg/d combined omeprazole, amoxicillin, clarithromycin for 14 days; Arm C, omeprazole, amoxicillin and clarithromycin for 14 days.
Sa1198 EFFICACY AND SAFETY OF VONOPRAZAN-BASED TRIPLE ERADICATION THERAPY FOR HELICOBACTER PYLORI INFECTION IN 890 PATIENTS Taro Akashi, Daisuke Fukuda, Yutaka Fukuda, Yuko Akazawa, Kazuhiko Nakao Background and aim: Helicobacter pylori infection is the most common infectious disease worldwide, and is a cause of gastric cancer. The first line therapy for H. pylori infection has comprised co-administration of a proton-pump inhibitor (PPI) with two antibiotics, typically, amoxicillin and clarithromycin in Japan. However, with conventional PPIs, 3-5 days are required for lowering intragastric pH to the optimal levels for H.pylori eradication. Vonoprazan, a potassium-competitive acid blocker which rapidly and efficiently inhibits acid secretion, was approved in Japan in 2015. Information regarding Vonoprazan-based H.pylori eradication is still limited. In this study, we investigated the efficacy and tolerability of vonoprazanbased triple eradication therapy for H. pylori infection. Methods: This study included 890 patients (938 cases) who received vonoprazan-based triple eradication therapy for H. pylori infection in a single center. Eight hundred twenty five patients received first line therapy for H. pylori infection with vonoprazan, clarithromycin, and amoxicillin for seven days. One hundred thirteen patients, who had failed first line therapy at our center or other institutions, received second line therapy with vonoprazan, metronidazole and amoxicillin for seven days. Eradication of H. pylori was confirmed by urea breath test in all patients at least a month after the treatment. Eradication rate and side effects were then analyzed. Results: The patients consisted of 510 male (mean age: 58.5±11.3) and 380 female (mean age: 60±11.2). Among the 825 patients who received the first line therapy, H. pylori eradication was achieved in 759 patients (92.0%). Among 113 patients who received the second line
Figure 1 H. pylori eradication rate in the ITT and PP populations ITT, Intention-totreat; PP, per-protocol; Arm A, polaprezinc 150mg/d combined omeprazole, amoxicillin, clarithromycin for 14 days; Arm B, polaprezinc 300mg/d combined omeprazole, amoxicillin, clarithromycin for 14 days; Arm C, omeprazole, amoxicillin and clarithromycin for 14 days.* p<0.01
S-249
AGA Abstracts
AGA Abstracts
Sa1195
POLAPREZINC COMBINED WITH TRIPLE THERAPY FOR HELICOBACTER PYLORI ASSOCIATED GASTRITIS: A PROSPECTIVE, MULTICENTER, RANDOMIZED CLINICAL TRIAL Bei Tan, Hanqing Luo, Hong Xu, Nonghua Lu, Ruihua Shi, Hesheng Luo, Jiansheng Li, Jian-Lin Ren, Yiyou Zou, Yanqing Li, Feng Ji, Jing-Yuan Fang, Jiaming QIan
COMPARISON OF AOC AND AOM TRIPLE, SEQUENTIAL, AND CONCOMITANT THERAPY AS THE FIRST LINE ERADICATION THERAPY FOR HELICOBACTER PYLORI Jin Il Kim Background/Aim: The eradication rates of the AOC standard triple therapy have continuously decreased, because of the widespread development of clarithromycin resistance. We compared the efficacy and adverse events of standard triple, sequential, and concomitant therapy for H. pylori eradication. Method: This was a prospective, multicenter, randomized controlled study involving 1,000 patients diagnosed with H. pylori infection between January 2014 and July 2016 in the five Catholic University Hospitals in affiliation. Diagnosis was made by histological evidence of H. pylori via Warthin-Starry silver staining. We compared 4 treatment regimens and 250 patients were enrolled in each group: the AOC therapy was treated with clarithromycin based triple therapy for 7 days; the AOM therapy was treated with metronidazole based triple therapy for 7 days; the sequential therapy consisted of rabeprazole and amoxicillin for the initial 5 days, followed by rabeprazole, clarithromycin, and metronidazole for the subsequent 5 days; the concomitant therapy consisted of rabeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days. Six weeks following completion of therapy, successful H. pylori eradication was defined by a negative 13C-urea breath test result. Adverse events and drug compliance were evaluated by physicians via direct questioning. Results: A total of 896 patients (224, 223, 218, and 231 patients in the concomitant, sequential, AOM Triple, and AOC standard triple groups, respectively) were analyzed. The mean age of the patients was 55.7 years. There were 464 male and 432 female patients. The eradication rate was significantly higher in the concomitant group (89.7%, 204/224) than in the AOC standard group (78.3%, 181/231), the AOM group (82.6%, 180/218) and the sequential group (85.7%, 191/223) (p=0.006). Drug compliance and adverse events were not statistically different among the three groups. Conclusions: Concomitant therapy appears to be more effective for H. pylori eradication compared to AOC, AOM triple therapy and sequential therapy. There were no statistically different adverse events among the three groups.
Background: Helicobacter pylori is one of the most prevalent global pathogens and treatment failure is increasing due to rising antibiotic resistance. Polaprezinc is a gastric mucosal protective agent complex of zinc and L-carnosine, shown to improve efficacy when combined with triple therapy in Japan. Aim: To compare the clinical efficacy and safety of the polaprezinc combined to triple therapy versus standard triple therapy in the eradication of H. pylori. Methods: This is a randomized, parallel-group controlled, prospective multicenter study in 11 cities of China. Treatment-naïve patients with H. pylori-associated gastritis were randomly assigned to the following groups: Arm A which consists of triple-therapy (omeprazole 20mg, amoxicillin 1g, and clarithromycin 500mg twice daily) plus polaprezinc 75mg twice daily, Arm B which consists of the same triple-therapy plus polaprezinc 150mg twice daily, or Arm C which is the standard triple-therapy for 14 days. Eradication was considered successful if C13 or C14 urea breath test was negative 4 weeks after completion of therapy as the primary outcome. Digestive symptoms improvement 7, 14, 28 days after completion of intervention and rates of adverse effects were the secondary outcomes. Results: 332 enrolled, and 303 patients completed the study, with 106, 96, and 101 patients in Arm A, Arm B, and Arm C. In the intention-to-treat (ITT) analysis, the rate of H. pylori eradication was significantly higher for Arm A (77.0%) and Arm B (75.9%) vs Arm C (58.6%) (p<0.01), whereas there was no difference between Arm A and Arm B (P=0.90) (Table 1, Figure 1). In the per-protocol (PP) analysis, the rate of H. pylori eradication was significantly higher for Arm A (81.1%) and Arm B (83.3%) vs Arm C (61.4%) (P<0.01), while there was no difference between Arm A and Arm B (P=0.62) (Table 1, Figure 1). In all three groups, there were significant symptomatic improvement including abdominal pain, acid reflux, belching, heartburn, bloating, nausea, and vomiting at 7 days, 14 days and 28 days after treatment compared to baseline (P<0.0001). The adverse event rate of Arm B was higher than Arm A (P=0.04) and Arm C (P=0.02), including mild leukopenia, elevated liver enzymes, elevated serum uric acid, and high blood pressure, but there were no serious adverse events. Conclusions: Standard dose polaprezinc combined with standard triple therapy can significantly improve H. pylori eradication rate without an increase in adverse event and is well-tolerated. H. pylori eradication rate in the ITT and PP populations
Sa1197 THE EFFICACY OF PCR-BASED TAILORED ERADICATION THERAPY FOR IN-PATIENTS WITH HELICOBACTER PYLORI INFECTION Young Sin Cho, Su Jung Han, Il-Kwun Chung, Yunho Jung, Tae Hoon Lee, Sang-Heum Park, Sun-Joo Kim Background/Aims: Helicobacter pylori (HP) is the causative pathogen of gastrointestinal diseases such as peptic ulcers and gastric malignancy. The eradication rates of HP infection are decreasing because of increasing resistance to clarithromycin. A previous study showed that a polymerase chain reaction (PCR)-based assay can detect HP and clarithromycin resistance. The aim of this work was to compare the efficacy of PCR-based tailored therapy with that of conventional triple therapy. Methods: From April 2015 to August 2016, 285 consecutive HP-infected patients received PCR-based tailored therapy or standard triple therapy (proton pump inhibitor, clarithromycin, amoxicillin) for 10 days. In the PCR-based tailored therapy group, patients received standard triple therapy or quadruple therapy (proton pump inhibitor, bismuth, metronidazole, tetracycline) according to clarithromycin resistance confirmed by the PCR-based clarithromycin resistance test, which detects most of the prevalent point mutations (A2143G and A2142G) in HP 23S rRNA. Eradication was assessed using the 13C-urea breath test 6-8 weeks after treatment. Eradication rates and adverse drug effects were compared between groups. Results: The mean age of the patients was 55.5 years. Standard triple therapy was administered to 191 patients and PCR-based tailored therapy to 94 patients. The eradication rates of standard triple therapy and PCR-based tailored therapy were 64.3% (126/191) and 84% (79/94) by intention to treat analysis, respectively (P = 0.005), and 72.4% (126/174) and 88.8% (79/89) by per protocol analysis, respectively (P = 0.002). The complication rates of the PCR-based tailored therapy and standard triple therapy groups were similar (11.1% vs. 12.4%, p=0.629). Conclusions: In HP-infected patients, PCR-based tailored therapy is more effective than conventional triple therapy and can substitute as the first-line HP eradication regimen in regions with high rates of clarithromycin resistance.
ITT, Intention-to-treat; PP, per-protocol; Arm A, polaprezinc 150mg/d combined omeprazole, amoxicillin, clarithromycin for 14 days; Arm B, polaprezinc 300mg/d combined omeprazole, amoxicillin, clarithromycin for 14 days; Arm C, omeprazole, amoxicillin and clarithromycin for 14 days.
Sa1198 EFFICACY AND SAFETY OF VONOPRAZAN-BASED TRIPLE ERADICATION THERAPY FOR HELICOBACTER PYLORI INFECTION IN 890 PATIENTS Taro Akashi, Daisuke Fukuda, Yutaka Fukuda, Yuko Akazawa, Kazuhiko Nakao Background and aim: Helicobacter pylori infection is the most common infectious disease worldwide, and is a cause of gastric cancer. The first line therapy for H. pylori infection has comprised co-administration of a proton-pump inhibitor (PPI) with two antibiotics, typically, amoxicillin and clarithromycin in Japan. However, with conventional PPIs, 3-5 days are required for lowering intragastric pH to the optimal levels for H.pylori eradication. Vonoprazan, a potassium-competitive acid blocker which rapidly and efficiently inhibits acid secretion, was approved in Japan in 2015. Information regarding Vonoprazan-based H.pylori eradication is still limited. In this study, we investigated the efficacy and tolerability of vonoprazanbased triple eradication therapy for H. pylori infection. Methods: This study included 890 patients (938 cases) who received vonoprazan-based triple eradication therapy for H. pylori infection in a single center. Eight hundred twenty five patients received first line therapy for H. pylori infection with vonoprazan, clarithromycin, and amoxicillin for seven days. One hundred thirteen patients, who had failed first line therapy at our center or other institutions, received second line therapy with vonoprazan, metronidazole and amoxicillin for seven days. Eradication of H. pylori was confirmed by urea breath test in all patients at least a month after the treatment. Eradication rate and side effects were then analyzed. Results: The patients consisted of 510 male (mean age: 58.5±11.3) and 380 female (mean age: 60±11.2). Among the 825 patients who received the first line therapy, H. pylori eradication was achieved in 759 patients (92.0%). Among 113 patients who received the second line
Figure 1 H. pylori eradication rate in the ITT and PP populations ITT, Intention-totreat; PP, per-protocol; Arm A, polaprezinc 150mg/d combined omeprazole, amoxicillin, clarithromycin for 14 days; Arm B, polaprezinc 300mg/d combined omeprazole, amoxicillin, clarithromycin for 14 days; Arm C, omeprazole, amoxicillin and clarithromycin for 14 days.* p<0.01
S-249
AGA Abstracts
AGA Abstracts
Sa1195