scholarly journals Empiric “Three-in-One” Bismuth Quadruple Therapy for Second-Line Helicobacter pylori Eradication: An Intervention Study in Southern Italy

Antibiotics ◽  
2022 ◽  
Vol 11 (1) ◽  
pp. 78
Author(s):  
Giuseppe Losurdo ◽  
Ilaria Lacavalla ◽  
Francesco Russo ◽  
Giuseppe Riezzo ◽  
Irene Vita Brescia ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Events ◽  
Eradication Rate ◽  
Sequential Therapy ◽  
Second Line ◽  
Capsule Formulation ◽  
Second Line Therapy ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Line Therapy

The eradication of Helicobacter pylori (H. pylori) may be difficult due to antibiotic resistance. Indeed, after one failure, a second-line therapy is needed and a bismuth containing quadruple therapy (BQT) with a three-in-one capsule formulation is becoming very popular. Therefore, we aimed to evaluate effectiveness and safety of BQT as a second-line therapy. We recruited consecutive patients with one therapy failure. For ten days patients received the three-in-one BQT Pylera® therapy, in combination with a proton-pump inhibitor (PPI), decided at the choice of the investigator, at full dose bid. The eradication rate was calculated by intention-to-treat (ITT) and per-protocol (PP)analyses and 95% confidence intervals (CI) were calculated. Seventy-three patients were recruited, 41 females and 32 males (mean age 53.0±13.1 years). Fifty-five patients failed triple therapy with amoxicillin and clarithromycin and the remaining 18 received sequential therapy. Seventy-two patients consumed at least 90% of the capsules, while only one did not complete the therapy due to adverse events (nausea and diarrhea). By ITT analysis, BQT was successful in 62 subjects (eradication rate 84.9%, 95%CI 76.7–93.1%). By PP analysis, the eradication rate was 86.1% (95%CI 78.1–94.1%).Adverse events were observed in 14 subjects (20.5%).In conclusion, our report confirmed that BQT is effective as an empiric second-line regimen.

scholarly journals Second-Line Bismuth-Containing Quadruple Therapy for Helicobacterpylori Infection: A 12-Year Study of Annual Eradication Rates

2021 ◽  
Vol 10 (15) ◽  
pp. 3273
Author(s):  
Kiwon Shin ◽  
Min-Jae Cho ◽  
Jung-Hwan Oh ◽  
Chul-Hyun Lim
Keyword(s):  
Adverse Events ◽  
Gastrointestinal Symptoms ◽  
Long Term Results ◽  
Second Line ◽  
Second Line Therapy ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Line Therapy ◽  
Standard Triple Therapy ◽  
H Pylori

Background: Bismuth-containing quadruple therapy (BQT) consisting of a proton-pump inhibitor (PPI), bismuth, metronidazole and tetracycline is recommended as a second-line treatment for Helicobacter pylori (H. pylori) infection when PPI-based standard triple therapy (STT) consisting of a PPI, amoxicillin and clarithromycin is unsuccessful. The purpose of this study was to analyze the long-term results of BQT as a second-line therapy to determine its effectiveness. Methods: This study included 643 subjects who failed first-line STT and received 7 or 10–14 days of BQT as a second-line therapy. We retrospectively analyzed the annual H. pylori eradication rates, demographic factors and adverse events. Results: The overall eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses were 80.7% (519/643) and 93.3% (519/556), respectively. By PP analysis, the eradication rates for 2008–2011, 2012–2015, and 2016–2019 were 93.3%, 91.0%, and 96.4%, respectively (p = 0.145). There were no significant differences between the 7-day group and the 10–14-day group in both the ITT (79.7% vs. 86.0%, p = 0.148) and the PP analyses (92.7% vs. 96.6%, p = 0.187). A multivariate analysis showed that current smoking was associated with eradication failure. Eighty-nine subjects (16.0%) suffered adverse events, mainly gastrointestinal symptoms, but only six cases were severe. Conclusions: BQT as a second-line therapy is an effective treatment for H. pylori. Treatment for 10–14 days showed a higher eradication rate compared with a 7-day regimen, but not significantly.

scholarly journals Fourteen-Day Sequential Therapy Containing Rabeprazole Versus 10 And 14-Day Concomitant Therapy in The First Line Treatment of Helicobacter Pylori Infection: A Randomized, Open-Label Clinical Trial

2021 ◽  
Author(s):  
Hassan Seddik ◽  
Hanae Boutallaka ◽  
Sanaa Berrag ◽  
Samir Mrabti ◽  
Khaoula Loubaris ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Effects ◽  
Eradication Rate ◽  
Cost Effective ◽  
Sequential Therapy ◽  
Open Label ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
13C Urea Breath Test ◽  
Treat Analysis

Abstract Aims:To compare an optimized sequential therapy to 10 and 14-day non-Bismuth quadruple therapies currently recommended, in terms of efficacy, incidence of adverse effects and cost.Patients and methods:This open-label prospective study randomized patients with confirmed Helicobacter pylori (H.Pylori) infection to 3 groups (1:1:1): The first group received quadruple therapy of twice-daily (bid) Omeprazole 20mg, Amoxicillin 1g, Clarithromycin 500mg and Metronidazole 500mg for 10days (QT-10), the second group received a 14 day quadruple therapy following the same regimen (QT-14), and the third received an optimized sequential therapy consisting on a bid Rabeprazole 20 mg plus amoxicillin 1g for 7 days, followed by bid Rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500mg for the next 7 days (OST-14). Adverse events (AEs) were recorded throughout the study, and the H.Pylori eradication rate was determined 4 to 6 weeks after treatment using the 13C urea breath test.Results:In intention to treat analysis, eradication rate was 85,5%, 91,8% and 95,4% respectively in QT-10, QT-14 and OST-14 groups (p=0,03). In the per protocol analysis, the eradication rate was significantly higher in the OST- 14 group compared to the QT-14 and QT-10 groups (98,1%, 94,4% and 89,5% respectively, p=0,02).The overall incidence of AEs was significantly lower in the OST-14 group (p=0,01). Furthermore, the OST-14 was the most cost-effective among the three groups.Conclusion:14-day optimized sequential therapy is a safe and effective alternative that allows a higher eradication rate compared to 10 and 14-days quadruple therapies while causing less adverse effects and allowing a gain in term of cost.

Helicobacter pylori eradication rates in Slovenia in the period from 2017 to 2019 – data from the European Registry on Helicobacter pylori Management (Hp-EuReg)

2020 ◽  
Author(s):  
Bojan Tepes ◽  
Natasa Brglez Jurecic ◽  
Katja Tepes ◽  
Marta Espada Sanchez ◽  
Olga Perez Nyssen ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Triple Therapy ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Intention To Treat ◽  
Line Therapy ◽  
Medical Institutions ◽  
H Pylori ◽  
European Registry

Abstract Background. Helicobacter pylori (H pylori) is the most common chronic bacterial infection in the world, affecting over 50% of the world’s population. H pylori is a grade I carcinogen, responsible for the development of 89% of non-cardia gastric cancers. In the present study, we analyzed the data for H pylori eradication treatments in Slovenia after the 3rd National recommendations were implemented. Patients and methods. Slovenia is part of the European Registry on H pylori Management (Hp-EuReg) since the study was launched in 2013. Data were collected at AEG-REDCap e-CRF from September 2017 to December 2019. H pylori eradication treatment was assessed by modified intention-to-treat (mITT) and per-protocol (PP) analyses. Results. Overall, 823 patients from 3 medical institutions were included. Effectiveness with first line 14-day triple therapy with a proton-pomp-inhibitor (PPI), clarithromycin 500 mg, amoxicillin 1000 mg, all BID, was 93% by mITT (714 patients). In patients allergic to penicillin, first line 14-day triple therapy with PPI-clarithromycin-metronidazole achieved 83% effectiveness by mITT (35 patients). Second-line 14-day triple therapy with a PPI-amoxicillin-levofloxacin achieved 89% mITT eradication rate (51 patients). Second-line therapy with the 10-day three-in-one single capsule containing bismuth-tetracycline- metronidazole achieved optimal effectiveness (100% mITT) in 10 patients ( p=0.02). Conclusions. Slovenia is a country with < 15% H pylori resistance to clarithromycin. Triple therapy with a PPI plus two antibiotics during 14 days reported optimal effectiveness (over 90%). Ten-day quadruple bismuth second-line therapy had better results than 14-day triple therapy with levofloxacin).

scholarly journals Comparison of Second-Line Quadruple Therapies with or without Bismuth forHelicobacter pyloriInfection

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Guang-Hong Jheng ◽  
I-Chen Wu ◽  
Hsiang-Yao Shih ◽  
Meng-Chieh Wu ◽  
Fu-Chen Kuo ◽  
...  
Keyword(s):  
Eradication Rate ◽  
Rescue Therapy ◽  
Controlled Trial ◽  
Second Line ◽  
Second Line Therapy ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Acceptable Side ◽  
Treat Analysis

The bismuth-based quadruple regimen has been applied inHelicobacter pylorirescue therapy worldwide. The non-bismuth-based quadruple therapy or “concomitant therapy” is an alternative option in first-line eradication but has not been used in second-line therapy. Discovering a valid regimen for rescue therapy in bismuth-unavailable countries is important. We conducted a randomized controlled trial to compare the efficacies of the standard quadruple therapy and a modified concomitant regimen. One hundred and twenty-four patients were randomly assigned into two groups: RBTM (rabeprozole 20 mg bid., bismuth subcitrate 120 mg qid, tetracycline 500 mg qid, and metronidazole 250 mg qid) and RATM (rabeprozole 20 mg bid., amoxicillin 1 g bid., tetracycline 500 mg qid, and metronidazole 250 mg qid) for 10 days. The eradication rate of the RBTM and RATM regimen was 92.1% and 90.2%, respectively, in intention-to-treat analysis. Patients in both groups had good compliance (~96%). The overall incidence of adverse events was higher in the RATM group (42.6% versus 22.2%,P=0.02), but only seven patients (11.5%) experienced grades 2-3 events. In conclusion, both regimens had good efficacy, compliance, and acceptable side effects. The 10-day RATM treatment could be an alternative rescue therapy in bismuth-unavailable countries.

EFFICACY OF MODIFIED BISMUTH QUADRUPLE THERAPY (RBMA) AS FIRST-LINE THERAPY FOR ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH CHRONIC GASTRITIS

2019 ◽  
pp. 28-32
Author(s):  
Van Huy Tran
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Effects ◽  
Chronic Gastritis ◽  
Eradication Rate ◽  
High Rate ◽  
First Line ◽  
Helicobacter Pylori Eradication ◽  
Quadruple Therapy ◽  
First Line Therapy ◽  
Line Therapy

Background and aims: Efficacy with substitution of tetracycline with amoxicillin, an antibiotics having a very low resistance rate and a high tolerability, in bismuth quadruple therapy (BQT) have not been studied in Vietnam. Our study aimed to evaluate the efficacy and tolerability of modified BQT vs. standard BQT for first-line Helicobacter pylori eradication. Patients and methods: This is a randomized, prospective study. 120 patients with H.pylori positive-chronic gastritis were randomly divided into two groups. The RBMA group containing rabeprazole 20 mg, bismuth subsalicylic 524mg, metronidazole 500mg, amoxicillin 1000mg, all 2 times a day, for 14 days. The RBMT group received rabeprazole, bismuth subsalicylic, metronidazole and tetracycline. Evaluation for compliance and drug-related side effects were evaluated at the end of two weeks. 4-6 weeks after the end of treatment, the H.pylori eradication rate was determined by the C13urease breath test. Results: Eradication rate was not statistically significative different between the RBMA and the RBMT: 91.2%; 95% confidence interval, 78.2% - 96.7%) vs. 90%; 95% CI, 81.6% - 96.3%) by per-protocol analysis (p = 0.42) and 86.7% (95%CI, 75.84% - 93.09%) vs. 75% (95%CI, 62.1% - 85.3%) by intention-to-treat analysis (ITT, p = 0.06). Adverse effects were significant higher in the RBMT group than in the RBMA group (48.3% vs. 26.7%; p = 0.071) and rate of good compliance was significantly higher in RBMA group than in RBMT group (p < 0.05). Conclusion: The modified BQT including rabeprazole, bismuth, metronidazole and amoxicillin achieved a fairly high rate of H.pylori infection eradication with a higher compliance and lower rate of adverse effects compared to the BQT in patients with chronic gastritis. Further studies need to conduct to confirm this new regimens as a first-line therapy in our country. Key words: Modified bismuth quadruple therapy, BQT, Helicobacter pylori eradication

Nivolumab and ipilimumab for second-line therapy in elderly patients with advanced esophageal squamous cell cancer: Safety interim analysis of the RAMONA trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4029-4029
Author(s):  
Nicolai Hartel ◽  
Nadja M Meindl-Beinker ◽  
Martin Maenz ◽  
Wolfgang Hiegl ◽  
Johannes Betge ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Interim Analysis ◽  
Treatment Duration ◽  
Safety Assessment ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy

4029 Background: Advanced esophageal squamous cell cancer (ESCC) is frequently diagnosed in elderly patients (pts) with additional comorbidities. Limited treatment options are available. We report the safety interim analysis of a phase II clinical trial evaluating nivolumab and ipilimumab as second-line therapy for advanced ESCC in elderly pts. Methods: RAMONA is a multicenter open-label phase II trial assessing nivolumab/ipilimumab combination therapy in elderly pts (≥65 years). The geriatric status of the pts was assessed using the G8 screening tool and the Deficit Accumulation Frailty Index (DAFI). After a run-in phase of 3 cycles nivolumab (240mg Q2W), cohort assignment was based on a safety assessment. Pts with toxicities grade ≤2 were considered eligible for escalation to nivolumab (240mg Q2W)/ipilimumab (1mg/kg Q6W) combination therapy (cohort B). Other pts remained on nivolumab monotherapy (cohort A). Primary endpoint is overall survival (OS). Key secondary endpoint is time to Quality of Life deterioration defined as a loss of ≥ 10 points in the EORTC QLQ-C30 compared to baseline. Adverse events were assessed according to NCI-CTCAE version 4.03. Results: From February 2018 until February 2020, 69 pts entered the study. 61 pts were eligible for safety interim analysis. Median age of the pts was 71.9 yrs (± 5.4), median KPS score was 80% (50-100%). In 73.8% of the pts, metastases were detected at the time of study inclusion. Most pts received the IO therapy in ≥ 2nd line (91.8%). The mean G8-score at screening was 11.9 points (46 pts ≤ 14 points, 75.4%) (mean DAFI: 0.19). Based on safety assessment, 42 pts were escalated to nivolumab/ipilimumab, while 9 pts remained on nivolumab monotherapy. 10 pts were not allocated at the time of analysis. Median numbers of cumulative doses were 3.0 [1.0 - 3.0] for the run-in phase (nivolumab), 6.0 [1.0 – 48.0] for nivolumab therapy (cohort A/B) and 2.5 [1.0 – 16.0] for ipilimumab (cohort B). Median treatment duration was 144.5 days (56-781 days) in cohort A and 231 days (85-484 days) in cohort B. Frailty indices remained stable after 3 cycles of nivolumab with limited toxicity at the time of the safety assessment. Drug-related treatment emergent adverse events (AEs) were observed in 42 pts (68.9%); 29/42 in cohort A, 8/9 in cohort B, and 5/10 pts not allocated at the time of analysis. Grade ≥3 AEs were detected in 9 pts of 42 in cohort A and 4 of 9 pts in cohort B. Drug-related treatment emergent serious adverse events (SAEs) were detected in 12 pts (19.7%); 8/42 in cohort A, 2/9 pts in cohort B, and 2/10 pts not yet allocated. Conclusions: Combined nivolumab/ipilimumab is a safe and feasible second-line therapy for elderly pts with advanced ESCC. Most pts could be escalated to nivolumab/ipilimumab. Treatment duration was exceptional long for a subset of pts. Clinical trial information: NCT03416244.

scholarly journals Helicobacter pylori Eradication Therapy: Current Availabilities

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
M. Gasparetto ◽  
M. Pescarin ◽  
G. Guariso
Keyword(s):  
Helicobacter Pylori ◽  
Eradication Rate ◽  
Antimicrobial Agents ◽  
Eradication Therapy ◽  
Sequential Therapy ◽  
Industrialized Countries ◽  
Quadruple Therapy ◽  
Medline Search ◽  
Meta Analyses ◽  
Resistance Rates

Background. Though Helicobacter pylori (HP) infections have progressively declined throughout most of the industrialized countries, a gradual increase in failure of HP eradication treatments is observed. Aim. To critically review evidence on the efficacy of the therapeutic availabilities for HP eradication, as yet. Methods. A selection of Clinical Trials, Systematic Reviews and Meta-analyses within the time period 2010–2012, was performed through a Medline search. Previous references were included when basically supporting the first selection. Results. An increasing rise in HP resistance rates for antimicrobial agents is currently observed. Further causes of HP treatment failure include polymorphisms of the CYP 2C19, an increased body mass index (BMI), smoking, poor compliance and re-infections. Alternative recent approaches to standard triple therapy have been attempted to increase the eradication rate, including bismuth-containing quadruple therapy, non-bismuth containing quadruple therapy, sequential therapy and levofloxacin-containing regimens. Conclusions. The main current aims should be the maintenance of a high eradication rate (>85%) of HP and the prevention of any increase in antimicrobial resistance. In the next future, the perspective of a tailored therapy could optimize eradication regimens within the different countries.

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