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Helicobacter Pylori Eradication in Obese Patients Undergoing Bariatric Surgery
treated with a PPI or vonoprazan, clarithromycin 200 mg or 400 mg bid and amoxicillin 750 mg b.i.d. or 500 mg t.i.d. for 1 week. At 1-2 months after the end of each of eradication regimen, patients underwent the urea breath test to determine whether eradiation was successful. Results: Eradication rates for the amoxicillin 750 mg b.i.d. with PPI (P2) regimen, amoxicillin 500 mg t.i.d. with PPI (P3) regimen, amoxicillin 750 mg b.i.d. with vonoprazan (V2) regimen, and amoxicillin 500 mg t.i.d. with vonoprazan (V3) regimen were 71.8% (176/245: 95% CI = 65.8-77.4%), 81.4% (271/332: 95% CI = 76.8-85.4%), 87.2% (129/ 148: 95% CI = 80.7-92.1%) and 92.0% (446/484: 95% CI = 89.2-94.2%), respectively. Eradication rate of the P3 regimen was significantly higher than that of the P2 regimen. There was no significant difference in eradication rates between the V2 and V3 regimens. Conclusion: The dosing scheme of amoxicillin significantly influenced the eradication rates of triple therapy that included a PPI, whereas the eradication rates of the regimens that included vonoprazan were not affected by the dosing scheme of amoxicillin. Vonoprazan is an optimal inhibitor of gastric acid secretion that results in stability and increased bioavailability of amoxicillin in the stomach, even when amoxicillin is administered twice daily.
Sa1188 A LARGE-SCALE STUDY TO COMPARE SUCCESS RATES AMONG H. PYLORI ERADICATION THERAPIES USING SECOND-GENERATION PROTON PUMP INHIBITORS AND ANOTHER TO EVALUATE THE EFFICACY OF POTASSIUM-COMPETITIVE ACID BLOCKER-BASED ERADICATION THERAPY Satoshi Harada, Toshihisa Takeuchi, Hiroki Sakamoto, Yuichi Kojima, Shinpei Kawaguchi, Yoshiaki Takahashi, Kazuhiro Ota, Haruhiko Ozaki, Kazuhide Higuchi Introduction Helicobacter pylori (H.pylori) has been associated with gastrointestinal diseases and H. pylori eradication therapy is effective in the treatment and prevention of these diseases. second generation PPIs are considered to be less affected by CYP2C19. We had been investigating the efficacy of second generation PPIs for H.pylori eradication therapy. On the other hand, vonoprazan, novel oral anti-acid secretory potassium-competitive acid blocker (PCAB), has been demonstrated to achieve high eradication rates in well-controlled randomized controlled trials. Thus, we evaluated the efficacy of vonoprazan based on eradication rates. Method First study: In total, 147 patients who were confirmed to have H. pylori infection were randomly assigned to receive either EPZ-based eradication therapy (EPZ group) or RPZ-based eradication therapy (RPZ group). The eradication effect was assessed by a urea breath test performed at least 4 weeks after the end of therapy. Second study: In total, consecutive 2,042 patients who were confirmed to have H. pylori infection were enrolled in this study. Of these, 1,688 underwent primary eradication with 7-day triple therapy involving 40 mg vonoprazan + 400 or 800 mg CAM + 1500 mg AMX. Eradication was assessed by a urea breath test performed at least 4 weeks after the end of triple therapy. Patients who failed primary eradication underwent secondary eradication with triple therapy involving 40 mg vonoprazan + 500 mg MTZ + 1500 mg AMX. Eradication was assessed by a urea breath test, as in case of primary eradication. Reslut First study: Eradication rate was 77.5% in the EPZ group and 68.4% in the RPZ group; no significant difference was observed between the two groups. Second study: The successful primary eradication rate was 90.8%, and the successful secondary eradication rate was 86.3%. Conclusion The present clinical study has demonstrated the efficacy of vonoprazan in H. pylori eradication therapy. It is suggested that vonoprazan is very likely to become the first option for future eradication therapy
Sa1186 PROTON PUMP INHIBITOR-BISMUTH-TETRACYCLINE-LEVOFLOXACIN QUADRUPLE THERAPY ACHIEVES A HIGHER ERADICATION RATE THAN STANDARD LEVOFLOXACIN-CONTAINING TRIPLE THERAPY IN THE SECOND-LINE TREATMENT OF HELICOBACTER PYLORI INFECTION AND A RANDOMIZED CONTROLLED TRIAL Sung-Shuo Kao, Deng-Chyang Wu, Feng-Woei Tsay Tsay, Kuo-Wang Tsai, Ping-I Hsu ABSTRACT Background: Proton pump inhibitor-amoxicilline-levofloxacin triple therapy is recommended in the Maastricht V/Florence Consensus Report as a standard second-line treatment of Helicobacter pylori (H pylori) infection. The rescue therapy is markedly less effective when facing levofloxacin-resistant H pylori strains. Objectives: To compare the efficacy of esomeprazole-bismuth-tetracycline-levofloxacin quadruple therapy and esomeprazole-amoxicillin-levofloxacin triple therapy in the rescue treatment for H pylori infection. Methods: Consecutive H pylori-infected subjects following failure of first-line therapies were randomly allocated to receive either an EBTL (esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., levofloxacin 500 mg o.d.) or EAL therapy (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. H pylori status was assessed 6 weeks after treatment. Results: The study was stopped after an interim analysis. Of 50 patients in the EBTL group, 49 (98.0%) had successful eradication of H pylori infection. Cure of H pylori infection was achieved in 36 of 52 patients (69.2%) receiving EAL therapy. Intention-to-treat analysis demonstrated that EBTL therapy achieved a higher eradication rate than EAL therapy (Difference: 29.8%; 95% confidence interval: 16.7% 42.0%; P < 0.001). Per-protocol analysis yielded similar result (97.8% vs 68.6%; P < 0.001). The two treatment groups exhibited comparable frequencies of overall adverse events (22.0% vs 11.5%) and drug compliance (90.0% vs 98.1%). Subgroup analysis showed that EBTL therapy was superior to EAL therapy in patients with either failure of standard triple therapy (100% vs 75.0%; P = 0.010) or failure of non-bismuth quadruple therapy (95.0% vs 52.6%; P = 0.003). Both therapies yielded high cure rate against H pylori strains with failure by bismuth quadruple therapy (100% vs 100%). The eradication rates of EBTL and EAL therapies for levofloxacin-resistant strains were 100% and 66.7%, respectively. Conclusions: 10-day proton pump inhibitor-bismuth-tetracycline-levofloxacin quadruple therapy is significantly more effective for rescue treatment of H pylori infection than proton pump inhibitor-amoxicillin-levofloxacin triple therapy. The novel quadruple therapy is potential to become a standard second-line eradication regimen.
Sa1189 HELICOBACTER PYLORI ERADICATION IN OBESE PATIENTS UNDERGOING BARIATRIC SURGERY Oscar Laudanno, Gabriel Ahumaran, Pablo Gollo, Marcelo Thome, Patricia Gonzalez, Ricardo Lasagna Many bariatric surgeons recommend routine Helicobacter pylori (HP) screening as a part of the workup for bariatric surgery. HP eradication failure could delay the access to bariatric surgery of obese patients. Some studies suggested that obese patients showed a significantly lower HP eradication rate and the Body Mass Index (BMI) could be an independent risk factor for this failure. Some explanations for this lower eradication rate included a higher distribution volume of the drugs with a lower gastric mucosa level. On the other hand, the Toronto Consensus on Helicobacter pylori infection in adults recommends a 14-day regimen in order to improve the eradication rate. OBJETIVES: The aim of this study was to evaluate the HP eradication of a 14 days Quadruple Concomitant therapy in obese patients undergoing bariatric surgery. MATERIAL AND METHODS: Prospective-control study included 76 obese patients undergoing bariatric surgery and 75 controls patients with a normal BMI and dyspepsia. Upper endoscopy and HP assessment by histology was performed at baseline and the post-treatment status was assessed by C13 Urea Breath Test 6-8 weeks after the end of therapy. The study adopted a 14 days Quadruple Concomitant HP eradication with proton pump inhibitor BID, clarithromycin 500 mgr BID, amoxicillin 1000 mgr BID and metronidazole 500 mgr BID. RESULTS: In the obese group, H pylori was eradicated in 53/ 76 (69%), 95% CI: 59-79 ; whereas in the control group the eradication rate was 66/75, (88%), 95% CI 78-93 , p< 0.001 , with odds ratio (OR) 3.18 (95% CI 1.35-7.45).The distribution of age, gender , smoking and diabetes did not differ significantly between the two groups. CONCLUSIONS: Obese patients showed a significantly lower eradication of HP infection than controls to a two weeks Quadruple Concomitant therapy. Obesity seems to be independent risk factor for eradication failure. New eradication regimens or a tailored eradication regimen based on body weight are necessary.
Sa1187 EFFECTS OF DOSING STRATEGY OF AMOXICILLIN ON ERADICATION RATES OF HELICOBACTER PYLORI WITH AMOXICILLIN-BASED TRIPLE THERAPY Naohito Shirai, Masafumi Nishino, Kosuke Takagaki, Naoya Matsushita, Yasuo Takeuchi, Satoru Takahashi, Takahisa Furuta, Masayoshi Kajimura Backgrounds and Aims: Drugs used in standard regimens for eradication of Helicobacter pylori (H. pylori) are usually given twice daily. Because the plasma half-lives of clarithromycin and metronidazole are relatively long and their bactericidal effects depend on Cmax/MIC and AUC/MIC, twice daily dosing is appropriate for these agents. However, the bactericidal effect of amoxicillin depends on the proportion of time above MIC, not Cmax/MIC or AUC/ MIC. Given that the plasma half-life of amoxicillin is short, twice daily dosing of amoxicillin appears theoretically inappropriate; rather, three or four daily dosings is thought to be a reasonable dosing scheme. Vonoprazan is a novel oral potassium-competitive acid blocker which produces more potent and sustained acid-inhibitory effects than lansoprazole. Vonoprazan has been shown to be non-inferior to lansoprazole as a component of H. pylori eradication therapy with amoxicillin and clarithromycin. In this study, we retrospectively investigated whether the different dosing schemes of amoxicillin and a regimen including proton pump inhibitors (PPIs) or vonoprazan influenced the eradication rates of H. pylori. Methods: From July 2014 to October 2016, a total of 1211 patients who underwent the urea breath test after H. pylori eradication therapy were enrolled in this study. Patients were
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AGA Abstracts
AGA Abstracts
(CAM), and amoxicillin (AMPC)) was applied to health insurance treatment in 2015, and now became one of a major eradication method. However, because of newly medicine, few reports with regard to the safety and the factor concerning about success rate have been published. Therefore, we retrospectively investigated the efficacy and the safety of eradication with VPZ by comparing PPI. Subjects and Methods. Analysis included 1,337 patients who received PPI-based triple therapy (Lansoprazole or Rabeprazole or Esomeprazole twice daily, CAM, and APMC) between 2005 and 2014 (the former period) and 255 patients received VPZ or PPI-based triple therapy between March 2015 and October 2016 (the latter period) for HP eradication in Nagoya city university hospital. The eradication success rate was assessed in the former periods. Next, we divided all subjects in the latter periods into VPZbased therapy (group V) or PPI-based therapy (group P). Subsequently, we evaluated the success rate of first and second-line therapy and investigated the factor concerning success rate (sex, age, dosage of CAM, period of eradication judgement, evaluation methods, prescribed by gastroenterologist or the others, presence of liver or kidney disorder, acid blocker; VPZ or PPI) and assessed adverse event between two groups. Results. The first and second-line eradication success rate in the former period was 73.2 and 83.5%, respectively. In latter period, group V and group P included 157 and 64 subjects respectively in the first-line therapy. Per protocol set (PPS) analysis demonstrated that success rate of group V was significantly higher than that of group P (91.7% vs 67.2%; P<0.01). In the second-line therapy, analysis showed no differences between eradication rates of the 2 groups (84.8% vs 80.0% P=0.78). Both groups exhibited similar frequencies of adverse events (1.2% vs 1.6% P=0.12). Multivariate analysis disclosed that the acid blocker was the only independent factors predictive of eradication success rate with an odds ratio of 0.2 (95% confidence interval: 0.08-0.54). Conclusion. As previously reported, VPZ-based eradication in the firstline therapy achieved higher eradication success rate than that of PPI and probed to be the only independent factors predictive of eradication success among various factors. Moreover, VPZ-based therapy performed as safe as conventional PPI method. According to these result, VPZ-based eradication would be the main HP eradication method.
Sa1188 A LARGE-SCALE STUDY TO COMPARE SUCCESS RATES AMONG H. PYLORI ERADICATION THERAPIES USING SECOND-GENERATION PROTON PUMP INHIBITORS AND ANOTHER TO EVALUATE THE EFFICACY OF POTASSIUM-COMPETITIVE ACID BLOCKER-BASED ERADICATION THERAPY Satoshi Harada, Toshihisa Takeuchi, Hiroki Sakamoto, Yuichi Kojima, Shinpei Kawaguchi, Yoshiaki Takahashi, Kazuhiro Ota, Haruhiko Ozaki, Kazuhide Higuchi Introduction Helicobacter pylori (H.pylori) has been associated with gastrointestinal diseases and H. pylori eradication therapy is effective in the treatment and prevention of these diseases. second generation PPIs are considered to be less affected by CYP2C19. We had been investigating the efficacy of second generation PPIs for H.pylori eradication therapy. On the other hand, vonoprazan, novel oral anti-acid secretory potassium-competitive acid blocker (PCAB), has been demonstrated to achieve high eradication rates in well-controlled randomized controlled trials. Thus, we evaluated the efficacy of vonoprazan based on eradication rates. Method First study: In total, 147 patients who were confirmed to have H. pylori infection were randomly assigned to receive either EPZ-based eradication therapy (EPZ group) or RPZ-based eradication therapy (RPZ group). The eradication effect was assessed by a urea breath test performed at least 4 weeks after the end of therapy. Second study: In total, consecutive 2,042 patients who were confirmed to have H. pylori infection were enrolled in this study. Of these, 1,688 underwent primary eradication with 7-day triple therapy involving 40 mg vonoprazan + 400 or 800 mg CAM + 1500 mg AMX. Eradication was assessed by a urea breath test performed at least 4 weeks after the end of triple therapy. Patients who failed primary eradication underwent secondary eradication with triple therapy involving 40 mg vonoprazan + 500 mg MTZ + 1500 mg AMX. Eradication was assessed by a urea breath test, as in case of primary eradication. Reslut First study: Eradication rate was 77.5% in the EPZ group and 68.4% in the RPZ group; no significant difference was observed between the two groups. Second study: The successful primary eradication rate was 90.8%, and the successful secondary eradication rate was 86.3%. Conclusion The present clinical study has demonstrated the efficacy of vonoprazan in H. pylori eradication therapy. It is suggested that vonoprazan is very likely to become the first option for future eradication therapy
Sa1186 PROTON PUMP INHIBITOR-BISMUTH-TETRACYCLINE-LEVOFLOXACIN QUADRUPLE THERAPY ACHIEVES A HIGHER ERADICATION RATE THAN STANDARD LEVOFLOXACIN-CONTAINING TRIPLE THERAPY IN THE SECOND-LINE TREATMENT OF HELICOBACTER PYLORI INFECTION AND A RANDOMIZED CONTROLLED TRIAL Sung-Shuo Kao, Deng-Chyang Wu, Feng-Woei Tsay Tsay, Kuo-Wang Tsai, Ping-I Hsu ABSTRACT Background: Proton pump inhibitor-amoxicilline-levofloxacin triple therapy is recommended in the Maastricht V/Florence Consensus Report as a standard second-line treatment of Helicobacter pylori (H pylori) infection. The rescue therapy is markedly less effective when facing levofloxacin-resistant H pylori strains. Objectives: To compare the efficacy of esomeprazole-bismuth-tetracycline-levofloxacin quadruple therapy and esomeprazole-amoxicillin-levofloxacin triple therapy in the rescue treatment for H pylori infection. Methods: Consecutive H pylori-infected subjects following failure of first-line therapies were randomly allocated to receive either an EBTL (esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., levofloxacin 500 mg o.d.) or EAL therapy (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) for 10 days. H pylori status was assessed 6 weeks after treatment. Results: The study was stopped after an interim analysis. Of 50 patients in the EBTL group, 49 (98.0%) had successful eradication of H pylori infection. Cure of H pylori infection was achieved in 36 of 52 patients (69.2%) receiving EAL therapy. Intention-to-treat analysis demonstrated that EBTL therapy achieved a higher eradication rate than EAL therapy (Difference: 29.8%; 95% confidence interval: 16.7% 42.0%; P < 0.001). Per-protocol analysis yielded similar result (97.8% vs 68.6%; P < 0.001). The two treatment groups exhibited comparable frequencies of overall adverse events (22.0% vs 11.5%) and drug compliance (90.0% vs 98.1%). Subgroup analysis showed that EBTL therapy was superior to EAL therapy in patients with either failure of standard triple therapy (100% vs 75.0%; P = 0.010) or failure of non-bismuth quadruple therapy (95.0% vs 52.6%; P = 0.003). Both therapies yielded high cure rate against H pylori strains with failure by bismuth quadruple therapy (100% vs 100%). The eradication rates of EBTL and EAL therapies for levofloxacin-resistant strains were 100% and 66.7%, respectively. Conclusions: 10-day proton pump inhibitor-bismuth-tetracycline-levofloxacin quadruple therapy is significantly more effective for rescue treatment of H pylori infection than proton pump inhibitor-amoxicillin-levofloxacin triple therapy. The novel quadruple therapy is potential to become a standard second-line eradication regimen.
Sa1189 HELICOBACTER PYLORI ERADICATION IN OBESE PATIENTS UNDERGOING BARIATRIC SURGERY Oscar Laudanno, Gabriel Ahumaran, Pablo Gollo, Marcelo Thome, Patricia Gonzalez, Ricardo Lasagna Many bariatric surgeons recommend routine Helicobacter pylori (HP) screening as a part of the workup for bariatric surgery. HP eradication failure could delay the access to bariatric surgery of obese patients. Some studies suggested that obese patients showed a significantly lower HP eradication rate and the Body Mass Index (BMI) could be an independent risk factor for this failure. Some explanations for this lower eradication rate included a higher distribution volume of the drugs with a lower gastric mucosa level. On the other hand, the Toronto Consensus on Helicobacter pylori infection in adults recommends a 14-day regimen in order to improve the eradication rate. OBJETIVES: The aim of this study was to evaluate the HP eradication of a 14 days Quadruple Concomitant therapy in obese patients undergoing bariatric surgery. MATERIAL AND METHODS: Prospective-control study included 76 obese patients undergoing bariatric surgery and 75 controls patients with a normal BMI and dyspepsia. Upper endoscopy and HP assessment by histology was performed at baseline and the post-treatment status was assessed by C13 Urea Breath Test 6-8 weeks after the end of therapy. The study adopted a 14 days Quadruple Concomitant HP eradication with proton pump inhibitor BID, clarithromycin 500 mgr BID, amoxicillin 1000 mgr BID and metronidazole 500 mgr BID. RESULTS: In the obese group, H pylori was eradicated in 53/ 76 (69%), 95% CI: 59-79 ; whereas in the control group the eradication rate was 66/75, (88%), 95% CI 78-93 , p< 0.001 , with odds ratio (OR) 3.18 (95% CI 1.35-7.45).The distribution of age, gender , smoking and diabetes did not differ significantly between the two groups. CONCLUSIONS: Obese patients showed a significantly lower eradication of HP infection than controls to a two weeks Quadruple Concomitant therapy. Obesity seems to be independent risk factor for eradication failure. New eradication regimens or a tailored eradication regimen based on body weight are necessary.
Sa1187 EFFECTS OF DOSING STRATEGY OF AMOXICILLIN ON ERADICATION RATES OF HELICOBACTER PYLORI WITH AMOXICILLIN-BASED TRIPLE THERAPY Naohito Shirai, Masafumi Nishino, Kosuke Takagaki, Naoya Matsushita, Yasuo Takeuchi, Satoru Takahashi, Takahisa Furuta, Masayoshi Kajimura Backgrounds and Aims: Drugs used in standard regimens for eradication of Helicobacter pylori (H. pylori) are usually given twice daily. Because the plasma half-lives of clarithromycin and metronidazole are relatively long and their bactericidal effects depend on Cmax/MIC and AUC/MIC, twice daily dosing is appropriate for these agents. However, the bactericidal effect of amoxicillin depends on the proportion of time above MIC, not Cmax/MIC or AUC/ MIC. Given that the plasma half-life of amoxicillin is short, twice daily dosing of amoxicillin appears theoretically inappropriate; rather, three or four daily dosings is thought to be a reasonable dosing scheme. Vonoprazan is a novel oral potassium-competitive acid blocker which produces more potent and sustained acid-inhibitory effects than lansoprazole. Vonoprazan has been shown to be non-inferior to lansoprazole as a component of H. pylori eradication therapy with amoxicillin and clarithromycin. In this study, we retrospectively investigated whether the different dosing schemes of amoxicillin and a regimen including proton pump inhibitors (PPIs) or vonoprazan influenced the eradication rates of H. pylori. Methods: From July 2014 to October 2016, a total of 1211 patients who underwent the urea breath test after H. pylori eradication therapy were enrolled in this study. Patients were
S-247
AGA Abstracts
AGA Abstracts
(CAM), and amoxicillin (AMPC)) was applied to health insurance treatment in 2015, and now became one of a major eradication method. However, because of newly medicine, few reports with regard to the safety and the factor concerning about success rate have been published. Therefore, we retrospectively investigated the efficacy and the safety of eradication with VPZ by comparing PPI. Subjects and Methods. Analysis included 1,337 patients who received PPI-based triple therapy (Lansoprazole or Rabeprazole or Esomeprazole twice daily, CAM, and APMC) between 2005 and 2014 (the former period) and 255 patients received VPZ or PPI-based triple therapy between March 2015 and October 2016 (the latter period) for HP eradication in Nagoya city university hospital. The eradication success rate was assessed in the former periods. Next, we divided all subjects in the latter periods into VPZbased therapy (group V) or PPI-based therapy (group P). Subsequently, we evaluated the success rate of first and second-line therapy and investigated the factor concerning success rate (sex, age, dosage of CAM, period of eradication judgement, evaluation methods, prescribed by gastroenterologist or the others, presence of liver or kidney disorder, acid blocker; VPZ or PPI) and assessed adverse event between two groups. Results. The first and second-line eradication success rate in the former period was 73.2 and 83.5%, respectively. In latter period, group V and group P included 157 and 64 subjects respectively in the first-line therapy. Per protocol set (PPS) analysis demonstrated that success rate of group V was significantly higher than that of group P (91.7% vs 67.2%; P<0.01). In the second-line therapy, analysis showed no differences between eradication rates of the 2 groups (84.8% vs 80.0% P=0.78). Both groups exhibited similar frequencies of adverse events (1.2% vs 1.6% P=0.12). Multivariate analysis disclosed that the acid blocker was the only independent factors predictive of eradication success rate with an odds ratio of 0.2 (95% confidence interval: 0.08-0.54). Conclusion. As previously reported, VPZ-based eradication in the firstline therapy achieved higher eradication success rate than that of PPI and probed to be the only independent factors predictive of eradication success among various factors. Moreover, VPZ-based therapy performed as safe as conventional PPI method. According to these result, VPZ-based eradication would be the main HP eradication method.