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Factors That Determine the Sensitivity of Rapid Urease Tests for the Detection of Helicobacter pylori Infection
of H. pylori infection of whom 152 (15.4%) had a positive RUT. 9 patients had a false positive RUT. The specificity of the RUT was therefore 98.8% and sensitivity 70% compared to histology. Of the 65 patients with a false negative RUT, 56 had positive H. pylori serology (7 negative, 2 not done). 20 (30.1%) of the patients with a false negative RUT showed H. pylori infection in the gastric corpus only compared to only 2.6% of those patients who had a true positive RUT (χ2 p<0.0001). A false negative RUT was also associated with concurrent PPI use (50.8% of patients with a false negative RUT were taking PPIs compared to 23% of those with a true positive RUT (χ2 p<0.0001)). CagA negative H. pylori serology was detected in 78.4% of the patients with a false negative RUT compared to 53.9% of those with a true positive RUT (χ2 p<0.001). The presence of preneoplastic gastric pathology did not appear to affect the sensitivity of the RUT in this cohort of patients. Conclusions: This study confirms that concomitant PPI use, corpus predominant H. pylori infection and less virulent (cagA negative) strains of H. pylori are more likely to lead to false negative RUT results. The RUT should therefore be used with caution as the sole determinant of H. pylori infection in these settings, especially in areas of the world in which H. pylori prevalence is low.
Levofloxacin/Amoxicillin-Based Regimens Versus Quadruple Therapy for Helicobacter pylori Eradication in Second-Line: A Meta-Analysis Simona Di Caro, Lucia Fini, Yayha Daoud, Luigi Laghi, Antonio Gasbarrini, Sara McCartney, Stuart L. Bloom Background: Antibiotic resistance is the main reason for decreasing cure rate of anti-Helicobacter pylori (H. pylori). The recommended anti-Helicobacter pylori (H. pylori) second-line therapy is a quadruple, complex scheme that achieves eradication rates of 65-80% with a significant incidence of side effects and low compliance. Levofloxacin-based second-line schemes are the most promising alternative but duration and dosage of levofloxacin and choice of combination drug have not been optimized. Aims: To compare eradication rates and tolerability (SE) of second-line anti-H. pylori levofloxacin/amoxicillin-based triple schemes (LAO) versus standard quadruple therapy (Q) in European and Asian studies. Methods: Extensive English language medical literature searches were performed up to end of October 2010. A Meta analysis was performed including only randomized clinical trials published in English or available as abstract comparing 7- or 10-days LAO combination versus 7-days Q therapy. A sub-analysis was conducted to evaluate differences between European and Asian population studies. Overall, 8 articles and 3 abstracts were identified. Tolerability data were available in 6 articles. Results: The overall eradication rate (pooled data) with levofloxacin was 71.7% (95%,CI:64.3-79.1). When only the 7-day schemes were included, the cure rate was 66.6 % (95% CI:58.5-74.7), whereas for the 10-day combination cure the rate was significantly higher (79.9%; 95% CI:68.4-91.5;p<0.05). Main eradication rate for Q therapy was 58.8% (95% CI: 49.7-67.9). The overall analysis showed a trend indicating superiority of both the 7- and 10-day LAO schemes to Q therapy (OR: 0.6; 95% CI: 0.3-1.0; p=0.07, I2 =77 %). The 7-day LAO and Q therapies showed comparable efficacy (OR: 0.78; 95% CI:0.45-1.38; p= 0.40), whereas the 10-day regimen was significantly more effective (OR: 0.54, 95% CI: 0.32-0.92; p=0.02; I2 =75%). No differences were reported in Q eradication rates between Asian and European studies whereas the LAO regimen was more effective in the European population (79.3% versus 59.6%; p=0.001). Mean incidence of SE was higher in Q therapy (17.8% versus 28.5%; p=0.05), but not differences were reported between geographic areas. Conclusions: Data support the use of 10-day levofloxacin (500 mg once daily)/amoxicillin scheme as a simple (5 pills/day) second-line treatment for H. pylori eradication with an excellent eradication rate and tolerability. The optimal secondline alternative scheme might differ between areas, countries and races mostly related to quinolone resistance.
Tu2049 Clinical Usefulness of Sitafloxacin-Based Triple Therapy as a Third Line Regimen for Helicobacter pylori Eradication in Japan Yoshihiro Hirata, Tomoya Ohmae, Ayako Yanai, Kosuke Sakitani, Yoku Hayakawa, Shuntaro Yoshida, Takafumi Sugimoto, Shin Maeda, Kazuhiko Koike Background; Eradication of Helicobacter pylori (H. pylori) is an effective therapy for ulcer diseases, MALToma, as well as idiopathic thrombocytopenia. Clarithromycin (CAM) and metronidazole (MNZ) -based triple therapy are used as first and second line regimen for H. pylori eradication in Japan, and these regimen show almost 80% and 90% efficacy, respectively. However the third line regimen was not established. Method; To evaluate effectiveness of sitafloxacin (STFX) against H. pylori In Vitro, one hundred consecutive isolates obtained from gastric mucosa by endoscopy at our institute were examined for the susceptibilities to antibiotics including STFX by agar dilution method. gyrA mutation in quinolone resistancedetermining region was assessed by direct sequencing in some strains. To evaluate clinical usefulness of STFX-based triple therapy, patients in whom eradication with CAM and MNZbased triple therapy failed, were treated with STFX-based triple therapy consists of rabeprazole (10mg b.i.d.), amoxicillin (750mg b.i.d.), and STFX (100mg b.i.d.) for 7 days in a multicenter prospective study (UMIN: 1902). Result; Among 100 clinical strains, only two strains (2%) showed resistance to STFX (MIC ≧ 1.0 μg/ml). The range of MICs and MIC50 of STFX were < 0.03 - 1.0 μg/ml and < 0.03 μg/ml. Two resistant strains had gyrA mutation (Asn87Ile, Asn87Lys + Asp91Gly). The resistance to STFX was significantly rare than that to CAM (MIC ≧ 1 μg/ml; 42%, MIC50 0.06 μg/ml), MNZ (MIC ≧ 8 μg/ml; 9%, MIC50 2 μg/ml), and levofloxacin (MIC ≧ 1 μg/ml; 48%, MIC50 0.5 μg/ml). Twenty eight patients (mean age; 59.4, male/female; 22/6) were enrolled to STFX-based eradication study. Eradication rate was 75% by intension-to-treat analysis and 80% by per-protocol analysis. Adverse events were observed in 5 patients (19%), and none of them required specific treatment for the events. One patient discontinued the therapy after 4 days due to tinnitus. Conclusion; STFX resistant H. pylori strains are rare and STFX-based triple therapy is an effective and relatively safe regimen as a third line eradication therapy in Japan.
Tu2047 Efficacy of 10-Day and 5-Day Concomitant Therapy for Helicobacter pylori Eradication in Thai Patients With Non Ulcer Dyspepsia Chutima Kongchayanun, Varocha Mahachai, Bubpha Pornthisarn, Surachai Amornsawadwattana, Ratha-korn Vilaichone Background and aim: Antimicrobial resistance has decreased eradication rates of H. pylori worldwide including Thailand. Newer regimen is required to achieve better outcome. The study was designed to determine the eradication rate of 10-day and 5-day concomitant therapy for H. pylori infection in Thai patients with non-ulcer dyspepsia. METHODS: Between September 2009-November 2010, patients who underwent gastroscopic examination at the Thammasat University Hospital, for dyspeptic symptoms were recruited. Two biopsy samples from gastric antrum were obtained, one for rapid urease test and another for culture. Patients were randomized to receive 10 days or 5 days concomitant therapy which consisted of Rabeprazole(20 mg) twice daily, amoxicillin 1 g twice daily, metronidazole 500 mg three time a day and clarithromycin MR 1g once daily. UBT was performed to assess eradication therapy. RESULTS: Total 100 patients were enrolled in this study including 40 males and 60 females with mean age 57.5 years. All patients completed 5-day and 10-day concomitant therapy without significant side effects. There was no significant different in eradication rate in 5-day concomitant regimen and 10-day concomitant regimen (90% vs 96%; P-value >0.05). Minor side effects were reported including bitter taste and nausea (8%) and palpitation after taking clarithromycin (4%) CONCLUSIONS: The 5-day concomitant regimen provides a high eradication rate similar to 10-day concomitant treatment. This 5-day concomitant regimen is well tolerated, highly effective with only minor side effects and should be used as first line H. pylori eradication in Thailand.
Tu2050 Rescue Treatment With Quadruple Therapy (3-in-1 Capsule of Bismuth, Metronidazole and Tetracycline With Omeprazole) for H Pylori in Patients With Multi-Drug Resistance to Clarithromycin, Fluoroquinolones and Metronidazole: Preliminary Data Nelly Muller, Jean-Charles Delchier Background: The standard for H pylori eradication in Europe is omeprazole, amoxicillin and clarithromycin given for 7 days, although increasing resistance has necessitated substitution with fluoroquinolones and/or metronidazole. Bismuth-containing quadruple therapy may be an alternative. Pylera® (3-in-1 capsule of bismuth subcitrate potassium, metronidazole and tetracycline; BMT) has been available in the US since 2007 for H pylori eradication when administered with omeprazole (OBMT) and is currently under regulatory review in Europe. Aim: Evaluate eradication of H pylori infections after treatment with OBMT in patients with resistance to clarithromycin (CLA-R), fluoroquinolones (FLQ-R) and metronidazole (MTZ-R) who have failed at least 3 prior triple eradication therapies and/or reported allergies to antibiotics. Methods: Patients with confirmed H pylori by C13 urea breath test (UBT) or biopsy (with positive PCR ± culture) and CLA-R, MTZ-R and FLQ-R by culture and sensitivity testing (within 6 months of enrollment) were treated with 3 single Pylera® capsules (3-in-1 capsule containing bismuth subcitrate potassium 140mg, metronidazole 125mg and tetracycline 125mg) QID + omeprazole 20mg BID for 10 days in a special dispensation protocol in France (Authorization for Temporary Utilization [ATU]). Eradication was confirmed by UBT at least 28 days after end of treatment. Results: Preliminary data (prospectively included from June-August 2010) were available from 19 adult patients; patients had active or inactive peptic ulcer disease (4), first-degree relatives with gastric cancer (3), gastric MALT lymphoma (2), preneoplastic lesions (severe atrophy ± intestinal metaplasia; 1), nonulcer dyspepsia with chronic active gastritis (9). No patients withdrew/ discontinued treatment. Sixteen of 19 patients (84%) reported eradication after treatment with OBMT. No serious adverse events (AEs) were reported; 13 patients reported at least 1 AE. Most common AEs were gastrointestinal including nausea/vomiting (5), dark stools (4), diarrhea (3) and epigastralgia (4). Other common AEs included asthenia (7), headache (7) and dizziness (3). Conclusions: Preliminary data from a French ATU program showed that bismuth-containing quadruple therapy (with a 3-in-1 capsule of bismuth subcitrate potassium, metronidazole and tetracycline given with omeprazole) is remarkably efficacious for H pylori eradication in patients with CLA-R, FLQ-R and MTZ-R who have failed previous antibiotic combinations.
Tu2048 Factors That Determine the Sensitivity of Rapid Urease Tests for the Detection of Helicobacter pylori Infection Senthil V. Murugesan, Islay Steele, László Tiszlavicz, Tracey Farragher, Andrew R. Moore, Andrea Varro, David M. Pritchard Introduction: Rapid urease tests (RUT) are routinely utilised to diagnose H. pylori infection, although histological examination of gastric biopsies remains the gold standard diagnostic test. As H. pylori prevalence is decreasing in Western countries, we have evaluated whether the RUT is still useful in current clinical practice and have investigated the roles of various host, drug and bacterial factors which may affect the accuracy of RUT for detecting H. pylori infection. Methods: Patients undergoing diagnostic gastroscopy for investigation of dyspepsia were prospectively recruited with informed consent and ethical approval. Clinical and demographic characteristics including current drug use were recorded. RUT was performed using the commercially available PRONTO DRY® test as per protocol, using two biopsies from the antrum in patients who were not using acid suppressing drugs and one antral and one corpus biopsy if patients were taking a proton pump inhibitor (PPI). Gastric antral and corpus biopsies were analysed for the presence of H. pylori and any preneoplastic changes (atrophic gastritis, intestinal metaplasia or dysplasia) by an experienced GI pathologist. H. pylori and cagA serology were determined by enzyme linked immunoassay. Results: 986 patients (56.9% female; mean age 56.9 years) were recruited, of whom 469 were taking PPI at the time of enrolment and 221 showed evidence of gastric preneoplastic pathology. All patients had RUT and histology performed. 217 (22%) patients showed histological evidence
S-879
AGA Abstracts
AGA Abstracts
Tu2046
Levofloxacin/Amoxicillin-Based Regimens Versus Quadruple Therapy for Helicobacter pylori Eradication in Second-Line: A Meta-Analysis Simona Di Caro, Lucia Fini, Yayha Daoud, Luigi Laghi, Antonio Gasbarrini, Sara McCartney, Stuart L. Bloom Background: Antibiotic resistance is the main reason for decreasing cure rate of anti-Helicobacter pylori (H. pylori). The recommended anti-Helicobacter pylori (H. pylori) second-line therapy is a quadruple, complex scheme that achieves eradication rates of 65-80% with a significant incidence of side effects and low compliance. Levofloxacin-based second-line schemes are the most promising alternative but duration and dosage of levofloxacin and choice of combination drug have not been optimized. Aims: To compare eradication rates and tolerability (SE) of second-line anti-H. pylori levofloxacin/amoxicillin-based triple schemes (LAO) versus standard quadruple therapy (Q) in European and Asian studies. Methods: Extensive English language medical literature searches were performed up to end of October 2010. A Meta analysis was performed including only randomized clinical trials published in English or available as abstract comparing 7- or 10-days LAO combination versus 7-days Q therapy. A sub-analysis was conducted to evaluate differences between European and Asian population studies. Overall, 8 articles and 3 abstracts were identified. Tolerability data were available in 6 articles. Results: The overall eradication rate (pooled data) with levofloxacin was 71.7% (95%,CI:64.3-79.1). When only the 7-day schemes were included, the cure rate was 66.6 % (95% CI:58.5-74.7), whereas for the 10-day combination cure the rate was significantly higher (79.9%; 95% CI:68.4-91.5;p<0.05). Main eradication rate for Q therapy was 58.8% (95% CI: 49.7-67.9). The overall analysis showed a trend indicating superiority of both the 7- and 10-day LAO schemes to Q therapy (OR: 0.6; 95% CI: 0.3-1.0; p=0.07, I2 =77 %). The 7-day LAO and Q therapies showed comparable efficacy (OR: 0.78; 95% CI:0.45-1.38; p= 0.40), whereas the 10-day regimen was significantly more effective (OR: 0.54, 95% CI: 0.32-0.92; p=0.02; I2 =75%). No differences were reported in Q eradication rates between Asian and European studies whereas the LAO regimen was more effective in the European population (79.3% versus 59.6%; p=0.001). Mean incidence of SE was higher in Q therapy (17.8% versus 28.5%; p=0.05), but not differences were reported between geographic areas. Conclusions: Data support the use of 10-day levofloxacin (500 mg once daily)/amoxicillin scheme as a simple (5 pills/day) second-line treatment for H. pylori eradication with an excellent eradication rate and tolerability. The optimal secondline alternative scheme might differ between areas, countries and races mostly related to quinolone resistance.
Tu2049 Clinical Usefulness of Sitafloxacin-Based Triple Therapy as a Third Line Regimen for Helicobacter pylori Eradication in Japan Yoshihiro Hirata, Tomoya Ohmae, Ayako Yanai, Kosuke Sakitani, Yoku Hayakawa, Shuntaro Yoshida, Takafumi Sugimoto, Shin Maeda, Kazuhiko Koike Background; Eradication of Helicobacter pylori (H. pylori) is an effective therapy for ulcer diseases, MALToma, as well as idiopathic thrombocytopenia. Clarithromycin (CAM) and metronidazole (MNZ) -based triple therapy are used as first and second line regimen for H. pylori eradication in Japan, and these regimen show almost 80% and 90% efficacy, respectively. However the third line regimen was not established. Method; To evaluate effectiveness of sitafloxacin (STFX) against H. pylori In Vitro, one hundred consecutive isolates obtained from gastric mucosa by endoscopy at our institute were examined for the susceptibilities to antibiotics including STFX by agar dilution method. gyrA mutation in quinolone resistancedetermining region was assessed by direct sequencing in some strains. To evaluate clinical usefulness of STFX-based triple therapy, patients in whom eradication with CAM and MNZbased triple therapy failed, were treated with STFX-based triple therapy consists of rabeprazole (10mg b.i.d.), amoxicillin (750mg b.i.d.), and STFX (100mg b.i.d.) for 7 days in a multicenter prospective study (UMIN: 1902). Result; Among 100 clinical strains, only two strains (2%) showed resistance to STFX (MIC ≧ 1.0 μg/ml). The range of MICs and MIC50 of STFX were < 0.03 - 1.0 μg/ml and < 0.03 μg/ml. Two resistant strains had gyrA mutation (Asn87Ile, Asn87Lys + Asp91Gly). The resistance to STFX was significantly rare than that to CAM (MIC ≧ 1 μg/ml; 42%, MIC50 0.06 μg/ml), MNZ (MIC ≧ 8 μg/ml; 9%, MIC50 2 μg/ml), and levofloxacin (MIC ≧ 1 μg/ml; 48%, MIC50 0.5 μg/ml). Twenty eight patients (mean age; 59.4, male/female; 22/6) were enrolled to STFX-based eradication study. Eradication rate was 75% by intension-to-treat analysis and 80% by per-protocol analysis. Adverse events were observed in 5 patients (19%), and none of them required specific treatment for the events. One patient discontinued the therapy after 4 days due to tinnitus. Conclusion; STFX resistant H. pylori strains are rare and STFX-based triple therapy is an effective and relatively safe regimen as a third line eradication therapy in Japan.
Tu2047 Efficacy of 10-Day and 5-Day Concomitant Therapy for Helicobacter pylori Eradication in Thai Patients With Non Ulcer Dyspepsia Chutima Kongchayanun, Varocha Mahachai, Bubpha Pornthisarn, Surachai Amornsawadwattana, Ratha-korn Vilaichone Background and aim: Antimicrobial resistance has decreased eradication rates of H. pylori worldwide including Thailand. Newer regimen is required to achieve better outcome. The study was designed to determine the eradication rate of 10-day and 5-day concomitant therapy for H. pylori infection in Thai patients with non-ulcer dyspepsia. METHODS: Between September 2009-November 2010, patients who underwent gastroscopic examination at the Thammasat University Hospital, for dyspeptic symptoms were recruited. Two biopsy samples from gastric antrum were obtained, one for rapid urease test and another for culture. Patients were randomized to receive 10 days or 5 days concomitant therapy which consisted of Rabeprazole(20 mg) twice daily, amoxicillin 1 g twice daily, metronidazole 500 mg three time a day and clarithromycin MR 1g once daily. UBT was performed to assess eradication therapy. RESULTS: Total 100 patients were enrolled in this study including 40 males and 60 females with mean age 57.5 years. All patients completed 5-day and 10-day concomitant therapy without significant side effects. There was no significant different in eradication rate in 5-day concomitant regimen and 10-day concomitant regimen (90% vs 96%; P-value >0.05). Minor side effects were reported including bitter taste and nausea (8%) and palpitation after taking clarithromycin (4%) CONCLUSIONS: The 5-day concomitant regimen provides a high eradication rate similar to 10-day concomitant treatment. This 5-day concomitant regimen is well tolerated, highly effective with only minor side effects and should be used as first line H. pylori eradication in Thailand.
Tu2050 Rescue Treatment With Quadruple Therapy (3-in-1 Capsule of Bismuth, Metronidazole and Tetracycline With Omeprazole) for H Pylori in Patients With Multi-Drug Resistance to Clarithromycin, Fluoroquinolones and Metronidazole: Preliminary Data Nelly Muller, Jean-Charles Delchier Background: The standard for H pylori eradication in Europe is omeprazole, amoxicillin and clarithromycin given for 7 days, although increasing resistance has necessitated substitution with fluoroquinolones and/or metronidazole. Bismuth-containing quadruple therapy may be an alternative. Pylera® (3-in-1 capsule of bismuth subcitrate potassium, metronidazole and tetracycline; BMT) has been available in the US since 2007 for H pylori eradication when administered with omeprazole (OBMT) and is currently under regulatory review in Europe. Aim: Evaluate eradication of H pylori infections after treatment with OBMT in patients with resistance to clarithromycin (CLA-R), fluoroquinolones (FLQ-R) and metronidazole (MTZ-R) who have failed at least 3 prior triple eradication therapies and/or reported allergies to antibiotics. Methods: Patients with confirmed H pylori by C13 urea breath test (UBT) or biopsy (with positive PCR ± culture) and CLA-R, MTZ-R and FLQ-R by culture and sensitivity testing (within 6 months of enrollment) were treated with 3 single Pylera® capsules (3-in-1 capsule containing bismuth subcitrate potassium 140mg, metronidazole 125mg and tetracycline 125mg) QID + omeprazole 20mg BID for 10 days in a special dispensation protocol in France (Authorization for Temporary Utilization [ATU]). Eradication was confirmed by UBT at least 28 days after end of treatment. Results: Preliminary data (prospectively included from June-August 2010) were available from 19 adult patients; patients had active or inactive peptic ulcer disease (4), first-degree relatives with gastric cancer (3), gastric MALT lymphoma (2), preneoplastic lesions (severe atrophy ± intestinal metaplasia; 1), nonulcer dyspepsia with chronic active gastritis (9). No patients withdrew/ discontinued treatment. Sixteen of 19 patients (84%) reported eradication after treatment with OBMT. No serious adverse events (AEs) were reported; 13 patients reported at least 1 AE. Most common AEs were gastrointestinal including nausea/vomiting (5), dark stools (4), diarrhea (3) and epigastralgia (4). Other common AEs included asthenia (7), headache (7) and dizziness (3). Conclusions: Preliminary data from a French ATU program showed that bismuth-containing quadruple therapy (with a 3-in-1 capsule of bismuth subcitrate potassium, metronidazole and tetracycline given with omeprazole) is remarkably efficacious for H pylori eradication in patients with CLA-R, FLQ-R and MTZ-R who have failed previous antibiotic combinations.
Tu2048 Factors That Determine the Sensitivity of Rapid Urease Tests for the Detection of Helicobacter pylori Infection Senthil V. Murugesan, Islay Steele, László Tiszlavicz, Tracey Farragher, Andrew R. Moore, Andrea Varro, David M. Pritchard Introduction: Rapid urease tests (RUT) are routinely utilised to diagnose H. pylori infection, although histological examination of gastric biopsies remains the gold standard diagnostic test. As H. pylori prevalence is decreasing in Western countries, we have evaluated whether the RUT is still useful in current clinical practice and have investigated the roles of various host, drug and bacterial factors which may affect the accuracy of RUT for detecting H. pylori infection. Methods: Patients undergoing diagnostic gastroscopy for investigation of dyspepsia were prospectively recruited with informed consent and ethical approval. Clinical and demographic characteristics including current drug use were recorded. RUT was performed using the commercially available PRONTO DRY® test as per protocol, using two biopsies from the antrum in patients who were not using acid suppressing drugs and one antral and one corpus biopsy if patients were taking a proton pump inhibitor (PPI). Gastric antral and corpus biopsies were analysed for the presence of H. pylori and any preneoplastic changes (atrophic gastritis, intestinal metaplasia or dysplasia) by an experienced GI pathologist. H. pylori and cagA serology were determined by enzyme linked immunoassay. Results: 986 patients (56.9% female; mean age 56.9 years) were recruited, of whom 469 were taking PPI at the time of enrolment and 221 showed evidence of gastric preneoplastic pathology. All patients had RUT and histology performed. 217 (22%) patients showed histological evidence
S-879
AGA Abstracts
AGA Abstracts
Tu2046