Search

Your search keyword '"Opri, Sibilla"' showing total 20 results
Start Over Author "Opri, Sibilla"
20 results on '"Opri, Sibilla"'

3. Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study

Author

Stoppa, Giovanna, D’Amore, Carmen, Conforti, Anita, Traversa, Giuseppe, Venegoni, Mauro, Taglialatela, Maurizio, Leone, Roberto, Messa, Michele Giuseppe, Petrolino, Alessandro, Cavallini, Lucia, Fiorini, Fulvio, Guarda, Laura, Lidestri, Vincenzo, Toffoletto, Pierpaolo, Rebeschini, Mirca, Cantaro, Salvatore, Paciolla, Adriana, Spinello, Michela, Tarroni, Giovanni, Bertoli, Massimo, Lentini, Paolo, Gatti, Pier Luigi, Garibotto, Giacomo, Brigante, Maurizio, Bolasco, Piergiorgio, Opri, Sibilla, Zocca, Margherita, Michielan, Silvia, Bisso, Ilaria, Russo, Claudio, Ambrosino, Paolo, Businco, Fabrizio, Stoppa, G, D'Amore, C, Conforti, A, Traversa, G, Venegoni, M, Taglialatela, M, Leone, R, and ESAVIEW Study, Group

Subjects
Male, medicine.medical_specialty, Anemia, Erythropoiesis-stimulating agents (ESAs), medicine.medical_treatment, 030232 urology & nephrology, Peritoneal dialysis, 03 medical and health sciences, 0302 clinical medicine, Renal Dialysis, chronic renal failure, Internal medicine, medicine, Humans, Pharmacology (medical), Original Research Article, Prospective Studies, 030212 general & internal medicine, Renal Insufficiency, Chronic, Prospective cohort study, Biosimilar Pharmaceuticals, Dialysis, Aged, Pharmacology, Biotechnology, Pharmacology, Pharmacology (medical), business.industry, prospective study, anemia , chronic renal failure, Erythropoiesis-stimulating agents (ESAs), Epoetin alfa, Biosimilar, General Medicine, Middle Aged, medicine.disease, anemia, Epoetin Alfa, Transplantation, Treatment Outcome, Female, Hemodialysis, business, medicine.drug, prospective study, Biotechnology
Abstract

Background Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007. Aim This study aimed to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting. Methods A prospective study was conducted in four Italian regions between 1 October 2013 and 30 June 2015. The study population included patients aged ≥ 18 years undergoing hemodialysis and treated with epoetins as per the clinical practice of the participating centers. The two comparison cohorts included patients treated with either an originator or a biosimilar epoetin alfa. Each patient was followed up until occurrence of any safety outcome of interest (grouped into three major categories), switch to a different ESA product, transplant or peritoneal dialysis, death, or end of the study period, whichever came first. Results Overall, 867 subjects were included in the study (originator: N = 423; biosimilar: N = 444). Biosimilar users were older than originator users (median age of 76 vs 64 years, respectively), more frequently affected by arrhythmia (29.3 vs 22.5%), and less frequently candidates for transplantation (3.8 vs 18.2%). Cox-regression analysis showed no increase in risk of safety outcomes in biosimilar users, even after adjusting for confounding factors: 1.0 (95% confidence interval [CI] 0.7–1.3) for any outcomes; 1.1 (95% CI 0.7–1.8) for problems related to dialysis device; 0.9 (95% CI 0.6–1.5) for cardio- and cerebro-vascular conditions; 0.9 (95% CI 0.6–1.5) for infections. Conclusion This study confirms the comparable safety profiles of originator and biosimilar epoetin alfa drugs when used in patients receiving dialysis. Electronic supplementary material The online version of this article (10.1007/s40259-018-0293-2) contains supplementary material, which is available to authorized users.

Published
2018

5. Farmacosorveglianza

Author

Leone, Roberto, Arzenton, Elena, and Opri, Sibilla

Subjects
Reazioni avverse da farmaci, epidemiologia, segnalazione spontanea
Published
2014

19. α-Adrenergic receptor antagonists and gynecomastia. A case series from the Italian spontaneous reporting system and VigiBase.

Author

Viola, Ermelinda, Opri, Sibilla, Moretti, Ugo, Leone, Roberto, Casini, Maria, Ruggieri, Sara, Minore, Claudia, and Conforti, Anita

Abstract

Purpose: The aim of this study was to analyze the cases of gynecomastia associated with α-adrenergic receptor antagonists (α-ARAs) in the Italian spontaneous reporting system database (Rete Nazionale di Farmacovigilanza or RNF) and in the World Health Organization ICSRs database (VigiBase), focusing on tamsulosin use. Methods: We analyzed the spontaneous reports of gynecomastia related to the use of α-ARAs and collected from the RNF and from VigiBase up to December 2012. Cases of gynecomastia have been defined as reports associated with gynecomastia according with Medical Dictionary for Regulatory Activities (MedDRA). Reporting odds ratio (ROR) and Information Component (IC) were calculated as measures of disproportionality in RNF and VigiBase, respectively. Results: Up to December 2012, about 186,000 reports were recorded in the RNF. Among these, 902 reports of adverse drug reaction (ADR) have been associated with the use of at least one α-ARAs. Of these, in 15 cases, gynecomastia was a listed ADR: in 10, the suspected drug was tamsulosin (in eight, it was the sole suspect); in two, doxazosin and alfuzosin, respectively; and in one, terazosin. ROR for tamsulosin was 5.3 (95 % CI 1.8, 15.7). In VigiBase, 84 reports of gynecomastia indicated tamsulosin as suspected drug. Tamsulosin-associated gynecomastia showed the highest IC value within this class of drugs (IC 95 % 2.43). Conclusion: In this study, we highlight a possible association between gynecomastia and tamsulosin use. To our knowledge, this association has not been described before and could represent a potential signal. [ABSTRACT FROM AUTHOR]

Published
2008
Full Text
View/download PDF

20. [Venus study: a research and education project on nurses and drug surveillance].

Author

Opri S, D'Incau P, Meglioranzi M, Pignata C, Brasola S, Conforti A, and Leone R

Subjects
Adolescent, Adult, Aged, Child, Child, Preschool, Education, Nursing, Continuing, Female, Humans, Infant, Male, Middle Aged, Young Adult, Adverse Drug Reaction Reporting Systems statistics & numerical data, Nurse's Role
Abstract

Introduction: Adverse events (AE) are a relevant problem with major health consequences for both patients and health system in different countries., Aims: To estimate and describe the AE and Adverse Drug Reactions (ADRs) detected by nurses in hospital during an observation time of six months., Methods: The observational study involved 174 nurses and 36 head nurses. Nurses recorded for each patient: health condition, unexpected AE, administered drugs, and suspected ADR. Nurses were also requested to send ADR reports to the Italian Pharmacovigilance System., Results: Data were collected from 4608 patients. Nurses identified AE in 2458 patients and observed 6647 different events, mostly psychiatric (800 cases). Female, elderly, and 0-1 years old patients, number of administered drugs, and poor health conditions were all risk factors for adverse events (p < 0.01). Nurses identified 160 patients with ADRs (3.5% of observed patients)., Conclusions: Nurses have shown a good observational skill for AE, but low ability to detect ADRs probably due to lack of knowledge on drugs and ADR. For this reason a continuing education is essential.

Published
2011

Catalog

Books, media, physical & digital resources
See catalog results