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

Denosumab is a human monoclonal antibody that neutralizes RANKL, a cytokine able to interact with the RANK receptor on preosteoclasts and osteoclasts, decreasing their recruitment and differentiation, leading to a decreased bone resorption. The aim of this observational real-life study was to analyze adherence to denosumab therapy and assess its efficacy in increasing bone mineral density (BMD) and modulating biochemical skeletal markers following previous treatments with bisphosphonates in a group of post-menopausal women with osteoporosis. Women were recruited in the specialized center from March 2012 to September 2019. Biochemical markers were recorded at baseline and every six months prior to subsequent drug injection. Dual X-ray absorptiometry was requested at baseline and after 18/24 months. Comparing BMD at baseline and after denosumab therapy in naive patients and in those previously treated with bisphosphonates, a positive therapeutic effect was observed in both groups. The results of our real-life study demonstrate, as expected, that BMD values significantly increased upon denosumab treatment. Interestingly, denosumab showed an increased efficacy in patients previously treated with bisphosphonates. Moreover, biochemical markers data indicate that osteoporotic patients, without other concomitant unstable health conditions, could be evaluated once a year, decreasing the number of specialistic center access.

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P.06.14 EFFECTIVENESS AND SAFETY OF PYLERA ® IN PATIENTS INFECTED BY HELICOBACTER PYLORI: A LARGE, PROSPECTIVE, REAL LIFE STUDY

Digestive and Liver Disease ◽

10.1016/s1590-8658(18)30534-6 ◽

2018 ◽

Vol 50 (2) ◽

pp. e184-e185

Author(s):

A. Tursi ◽

M. Franceschi ◽

L. Allegretta ◽

E. Savarino ◽

R. De Bastiani ◽

...

Keyword(s):

Helicobacter Pylori ◽

Real Life ◽

Life Study ◽

Real Life Study

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

Digestive Diseases ◽

10.1159/000487391 ◽

2018 ◽

Vol 36 (4) ◽

pp. 264-268 ◽

Cited By ~ 11

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.

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Tu1311 - Effectiveness and Safety of Pylera ® in Patients Infected by Helicobacter Pylori : A Large, Prospective, Real Life Study

Gastroenterology ◽

10.1016/s0016-5085(18)33137-8 ◽

2018 ◽

Vol 154 (6) ◽

pp. S-930

Author(s):

Antonio Tursi ◽

Marilisa Franceschi ◽

Leonardo Allegretta ◽

Edoardo V. Savarino ◽

Rudi De Bastiani ◽

...

Keyword(s):

Helicobacter Pylori ◽

Real Life ◽

Life Study ◽

Real Life Study

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Effectiveness of Denosumab Therapy after Treatment with Bisphosphonates in Women Affected by Osteoporosis: A Real-Life Study

10.20944/preprints202012.0498.v1 ◽

2020 ◽

Author(s):

Chiara Marocco ◽

Giovanna Zimatore ◽

Edoardo Mocini ◽

Rachele Fornari ◽

Giovanni Iolascon ◽

...

Keyword(s):

Biochemical Markers ◽

Human Monoclonal Antibody ◽

Real Life ◽

Mineral Density ◽

Life Study ◽

Positive Therapeutic Effect ◽

Specialized Center ◽

Previously Treated ◽

Real Life Study ◽

Post Menopausal

Denosumab is a human monoclonal antibody that neutralizes RANKL, a cytokine able to interact with the RANK receptor on preosteoclasts and osteoclasts, decreasing their recruitment and differentiation, leading to a decreased bone resorption. The aim of this observational real-life study was to analyze adherence to denosumab therapy, its effectiveness in increasing bone mineral density (BMD) and in modulating biochemical skeletal markers upon previous treatments with bisphosphonates in a group of post-menopausal women affected by osteoporosis. Women were recruited in the specialized center from March 2012 to September 2019. Biochemical markers were recorded at baseline and every six months prior to subsequent drug injection. Dual X-ray Absorptiometry was requested at baseline and after 18/24 months. Comparing BMD at baseline and after denosumab therapy in naive patients and in those previously treated with bisphosphonates, a positive therapeutic effect was observed in both groups. The results of our real-life study demonstrate, as expected, that BMD values significantly increased upon denosumab treatment. Interestingly, denosumab showed an increased effectiveness in patients previously treated with bisphosphonates. Moreover, biochemical markers data indicate that osteoporotic patients, without other concomitant unstable health conditions, could be evaluated once a year, decreasing the number of specialistic center access.

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

Frontiers in Pharmacology ◽

10.3389/fphar.2021.667584 ◽

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.

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