scholarly journals Single Capsule Bismuth Quadruple Therapy for Eradication of H. pylori Infection: A Real-Life Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Antonietta G. Gravina ◽  
Kateryna Priadko ◽  
Lucia Granata ◽  
Angela Facchiano ◽  
Giuseppe Scidà ◽  
...  
Keyword(s):  
Side Effects ◽  
Real Life ◽  
Treatment Compliance ◽  
Quadruple Therapy ◽  
Stool Antigen Test ◽  
Life Study ◽  
Intention To Treat ◽  
High Prevalence ◽  
Real Life Study ◽  
H Pylori

Background and aim: Bismuth quadruple therapy (BQT) or non-bismuth quadruple therapy (i.e., concomitant therapy) (CT) is the first-line regimens to eradicate H. pylori infection in areas with high prevalence of clarithromycin (CLA) resistance. Guidelines suggest that in areas of high prevalence of H. pylori strains with double resistance (i.e., CLA + metronidazole), BQT should be preferred to CT. The aim of this study was to evaluate the efficacy and safety of BQT administered through the three-in-one pill (Pylera) formulation in a large series of H. pylori–infected patients, naive to treatment in a region with high CLA and dual resistance.Patients and methods: We treated 250 patients (148 F and 102 M, mean age 48.6 years) with H. pylori infection naïve to treatment. Patients received esomeprazole 40 mg bid and Pylera 3 tablets qid for 10 days. Diagnosis of H. pylori infection was through 13C urea breath test (13C UBT), or stool antigen test or histology, as appropriate. The evaluation of eradication was through 13C UBT at least 45 days after the end of therapy. Incidence of treatment-related adverse events (TRAEs) was assessed through a questionnaire at the end of treatment. Compliance was considered good if at least 90% of medication had been taken. Statistical analysis was per intention-to-treat e per protocol (PP). 95% confidence intervals (CIs) were calculated.Results: 1) 13 patients (5.2%) discontinued therapy due to side effects; 2) eradication rates in ITT and PP were 227/250 (90.8%; 95% CI 86.3–93.7%) and 226/237 (95.3%; 95% CI 91–99%), respectively; 3) the prevalence of TRAEs was 26.8%; and 4) adherence to treatment was good with compliance greater than 90%.Conclusion: In this real-life study, we demonstrate that in an area with a high prevalence of H. pylori strains with CLA or CLA + metronidazole resistance, BQT using Pylera is an effective therapeutic strategy with ITT eradication rates higher than 90%; this therapy is associated with good compliance and low incidence of side effects.

scholarly journals Efficacy of a “Rescue” Ciprofloxacin-Based Regimen for Eradication ofHelicobacter pyloriInfection after Treatment Failures

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Maria Pina Dore ◽  
Vincenza Tadeu ◽  
Bianca Are ◽  
Ida Mura ◽  
Giuseppe Fanciulli ◽  
...  
Keyword(s):  
Side Effects ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Single Center Study ◽  
Urease Test ◽  
High Prevalence ◽  
Ciprofloxacin Resistance ◽  
Polymerase Chain ◽  
H Pylori ◽  
Post Therapy

The aim of our study was to evaluate the efficacy and tolerability of a ciprofloxacin-based regimen forH. pylorieradication failures as an alternative to bismuth based quadruple therapy.Methods.Design:prospective single-center study. Patients in whom a first eradication trial with omeprazole/esomeprazole, clarithromycin plus amoxicillin or tinidazole/metronidazole had failed were included.H. pylori status:established by histology, rapide urease test and polymerase chain reaction.Intervention:esomeprazole 20 mg, ciprofloxacin 500 mg, and metronidazole 500 mg, administered together before breakfast and dinner for 10 days. Susceptibility testing was performed by the Epsilometer test. Ciprofloxacin resistance was defined as a MIC of ≥1 μg/mL. Eradication was established by a negative 13C-UBT and 4–6 weeks post-therapy. Efficacy and side effects were determined.Results. 34 patients were enrolled, 32 completed the study. Compliance was excellent (100%). Side effects were mild. Ciprofloxacin-based therapy cured 65% (22/34) of patients by intention to treat and 69% (22/32) per protocol analysis. The prevalence of ciprofloxacin resistance was 8%.Conclusions. The effectiveness of ciprofloxacin-based therapy was greatly reduced despite the high prevalence of ciprofloxacin sensitiveH. pyloristrains. Bismuth based quadruple therapy still remain the best choice as a “rescue” regimen in our region.

Mandibular advancement device: Effectiveness and dental side effects. A real-life study

CRANIO® ◽  
2020 ◽  
pp. 1-10 ◽  
Author(s):  
Aoben Chen ◽  
Maud S. Burger ◽  
Margriet A.W.J. Rietdijk-Smulders ◽  
Frank W.J.M. Smeenk
Keyword(s):  
Side Effects ◽  
Real Life ◽  
Mandibular Advancement Device ◽  
Mandibular Advancement ◽  
Life Study ◽  
Real Life Study

scholarly journals A real life study of Helicobacter pylori eradication with bismuth quadruple therapy in naïve and previously treated patients

2017 ◽  
Vol 109 ◽  
Author(s):  
Blas José Gómez Rodríguez ◽  
Luisa Castro Laria ◽  
Federico Argüelles Arias ◽  
Cristina Castro Márquez ◽  
Ángel Caunedo Álvarez ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Real Life ◽  
Helicobacter Pylori Eradication ◽  
Quadruple Therapy ◽  
Life Study ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Real Life Study

EFFICACY OF 10 - DAY LEVOFLOXACIN CONTAINING SEQUENTIAL THERAPY IN PATIENTS WITH HELICOBACTER PYLORI–ASSOCIATED CHRONIC GASTRITIS

2017 ◽  
pp. 14-21
Author(s):  
Phan Hong Ngoc Nguyen ◽  
Van Huy Tran
Keyword(s):  
Side Effects ◽  
Clinical Symptoms ◽  
Sequential Therapy ◽  
First Line ◽  
Intention To Treat ◽  
Clarithromycin Resistance ◽  
Central Vietnam ◽  
Urease Test ◽  
High Prevalence ◽  
H Pylori

Background: The increasing of antibiotic resistance in H. pylori has become a main cause for treatment failure. A 10-day levofloxacin containing sequential therapy is efficient and safe in eradication H. pylori infection in an area with high prevalence of clarithromycin resistance. Aims: To evaluate the efficacy of 10day levofloxacin containing sequential therapy as first-line treatment for H. pylori eradication, side effects, symptoms and endoscopic responses and improvement of histological features in Centre Vietnam. Patients and methods: 120 Naïve H. pylori positive patients were received levofloxacin containing sequential therapy (rabeprazole 20mg twice daily, amoxicillin 1g twice daily for 5 days followed by rabeprazole 20mg, levofloxacin 500mg, and tinidazole 500mg, twice daily for 5 more days). These patients tested positive for H. pylori by urease test and gastric mucosal biopsy presented mononuclear cell infiltrating in lamina propria. Results: Intention to treat (ITT) eradication rates of RA-RLT was 73.5%. Per protocol (PP) eradication rates were 81.5%. Overall, 33.7% experienced mild to moderate adverse events. No patient stopped the treatment because of side effects. 6 months after H. pylori eradication clinical symptoms and only edema undergoing endoscopy significantly improved. Grade of activity inflammation and stage of gastritis significantly decreased at 6 months. Intestinal metaplasia and dysplasia did not change significantly at 6 months. Conclusion: 10day levofloxacin containing sequential therapy may be considered as one of the first choices in H. pylori eradication in Central Vietnam. H. pylori eradication may improve clinical symptoms, inflammative activity and stage of gastritis in histology. Key words: H. pylori, gastritis, levofloxacin

Effectiveness and Safety of Pylera® in Patients Infected by Helicobacter Pylori: A Multicenter, Retrospective, Real Life Study

2018 ◽  
Vol 36 (4) ◽  
pp. 264-268 ◽  
Author(s):  
Antonio Tursi ◽  
Marilisa Franceschi ◽  
Leonardo Allegretta ◽  
Edoardo Savarino ◽  
Rudi De Bastiani ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Eradication Rate ◽  
Rescue Therapy ◽  
Large Population ◽  
Real Life ◽  
Life Effectiveness ◽  
Life Study ◽  
Intention To Treat ◽  
Previously Treated Patients ◽  
H Pylori

Background: Our aims were to assess the real life effectiveness and safety of the new bismuth-containing quadruple therapy in a large population of patients infected by Helicobacter pylori. Methods: Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients were treated with Pylera® 3 capsules 4 times/daily plus omeprazole 20 mg or esomeprazole 40 mg 2 times/daily for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of the treatment). Efficacy and safety were assessed. Results: A total of 349 patients were treated. H. pylori eradication was achieved in 316 (90.5%, 95% CIs 80.8–1.0) patients in the intention-to-treat population, and in 93.5% (95% CIs 83.5–1.0) in the per-protocol population. No difference in the eradication rate was found between naïve and previously treated patients (91.3 vs. 90.0%, p = 0.901). Adverse events occurred in 55 patients (15.8%, 95% CIs 11.9–20.1). Five patients discontinued treatment: 2 patients suffered from severe abdominal pain, one patient from headache, one patient from diarrhea, and one patient from diffuse urticarial rush. Conclusions: Pylera® achieved a remarkable eradication rate in real life both as first treatment and as a rescue therapy, with a good safety profile.

scholarly journals Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marie-Caroline Rotty ◽  
Carey M. Suehs ◽  
Jean-Pierre Mallet ◽  
Christian Martinez ◽  
Jean-Christian Borel ◽  
...  
Keyword(s):  
Side Effects ◽  
Demographic Data ◽  
Real Life ◽  
Cross Sectional Study ◽  
Apnea Hypopnea Index ◽  
Cross Sectional ◽  
Life Study ◽  
Patient Reported ◽  
Real Life Study

Abstract Background For some patients, Continuous Positive Airway Pressure (CPAP) remains an uncomfortable therapy despite the constant development of technological innovations. To date, no real life study has investigated the relationship between mask related side-effects (MRSEs) and CPAP-non-adherence (defined as < 4 h/day) or residual-excessive-sleepiness (RES, Epworth-Sleepiness-Scale (ESS) score ≥ 11) in the long-term. Methods The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks). MRSEs were evaluated using visual-analogue-scales, CPAP-data using CPAP-software, sleepiness using ESS. Results 1484 patients were included in the analysis (72.2% male, median age 67 years (IQ25–75: 60–74), initial Apnea–Hypopnea-Index (AHI) of 39 (31–56)/h, residual AHIflow was 1.9 (0.9–4) events/h), CPAP-treatment lasted 4.4 (2.0–9.7) years, CPAP-usage was 6.8 (5.5–7.8) h/day, the prevalence of CPAP-non-adherence was 8.6%, and the prevalence of RES was 16.17%. Leak-related side-effects were the most prevalent side-effects (patient-reported leaks concerned 75.4% of responders and had no correlation with CPAP-reported-leaks). Multivariable logistic regression analyses evaluating explanatory-variable (demographic data, device/mask data and MRSEs) effects on variables-of-interest (CPAP-non-adherence and RES), indicated for patient-MRSEs significant associations between: (i) CPAP-non-adherence and dry-mouth (p = 0.004); (ii) RES and patient-reported leaks (p = 0.007), noisy mask (p < 0.001), dry nose (p < 0.001) and harness pain (p = 0.043). Conclusion In long-term CPAP-treated patients, leak-related side-effects remain the most prevalent side-effects, but patient-reported leaks cannot be predicted by CPAP-reported-leaks. Patient-MRSEs can be independently associated with CPAP-non-adherence and RES, thus implying a complementary role for MRSE questionnaires alongside CPAP-device-reported-data for patient monitoring. Trial registration InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).

scholarly journals A Real-Life Study of New Antiviral Therapies in a High Prevalence Geographical Area for Hepatitis C Virus Infection

2018 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Alessandro Federico ◽  
Marcello Dallio ◽  
Giuseppe Gerardo Caprio ◽  
Ilario de Sio ◽  
Gaetano Cotticelli ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Virus Infection ◽  
Geographical Area ◽  
Real Life ◽  
Hepatitis C Virus Infection ◽  
Life Study ◽  
Antiviral Therapies ◽  
High Prevalence ◽  
Real Life Study

scholarly journals Bismuth-based Quadruple Therapy Following H. pylori Eradication Failures: a Multicenter Study in Clinical Practice

2017 ◽  
Vol 26 (3) ◽  
pp. 225-229 ◽  
Author(s):  
Angelo Zullo ◽  
Vincenzo De Francesco ◽  
Annamaria Bellesia ◽  
Roberto Vassallo ◽  
Audenzio D’Angelo ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Side Effects ◽  
Multicenter Study ◽  
Breath Test ◽  
Rescue Therapy ◽  
Urea Breath Test ◽  
Open Label ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
H Pylori

Background & Aims: Helicobacter pylori (H. pylori) eradication in patients who failed one or more therapeutic attempts remains challenging. This study aimed to assess the efficacy of three-in-one capsules bismuth-based quadruple therapy (Pylera®) in these patients managed in clinical practice. Methods: This was a prospective, open-label, multicenter study enrolling consecutive, adult patients with persistent H. pylori infection following at least one standard therapy. All patients received a rescue quadruple therapy with Pylera (3 capsules four times daily) and esomeprazole 20 mg (1 tablet twice daily) for 10 days. H. pylori eradication was assessed by using Urea Breath Test 4-6 weeks following therapy ending. H. pylori eradication rates, compliance, and side-effects were calculated. Results: A total of 208 patients in the 9 participating centres were enrolled. Overall, 180 patients were successfully cured from the infection, accounting for 86.5% (95% CI 81.9-91.2) and 92.3% (95% CI 88.6-96.1) eradication rates at intention-to-treat analysis and at per protocol analysis, respectively. Cure rates were similar across patients who failed one to three previous therapy attempts, but the success rate fell to 67% after 4 or more therapy failures. Compliance to therapy was good in 198 (95.2%) patients, whilst in 7 (5.3%) cases the therapy was interrupted within 5 days due to side effects. A total of 97 (46.6%) patients complained of at least one side effect; nausea, diarrhea and vomiting were the most frequently reported. Conclusions: Our study found that this bismuth-based quadruple therapy is highly effective as second-line and rescue therapy for H. pylori eradication in clinical practice. Abbreviations: CI: confidence intervals; ITT: intention-to-treat; PP: per protocol; UBT: urea breath test.

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