Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization

Oriana Simonetti,1,* Giulio Rizzetto,1,* Elisa Molinelli,1 Oscar Cirioni,2 Annamaria Offidani1 1Clinic of Dermatology, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy; 2Clinic of Infectious Diseases, Department of Biomedical Sciences and Public Health,...

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Autores principales:	Simonetti O, Rizzetto G, Molinelli E, Cirioni O, Offidani A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	dalbavancin adverse events safety skin infections absssi Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/ce1a843304f24890add6b3d7d6345f8c
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spelling	oai:doaj.org-article:ce1a843304f24890add6b3d7d6345f8c2021-12-02T17:06:26ZReview: A Safety Profile of Dalbavancin for On- and Off-Label Utilization1178-203Xhttps://doaj.org/article/ce1a843304f24890add6b3d7d6345f8c2021-03-01T00:00:00Zhttps://www.dovepress.com/review-a-safety-profile-of-dalbavancin-for-on--and-off-label-utilizati-peer-reviewed-article-TCRMhttps://doaj.org/toc/1178-203XOriana Simonetti,1,* Giulio Rizzetto,1,* Elisa Molinelli,1 Oscar Cirioni,2 Annamaria Offidani1 1Clinic of Dermatology, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy; 2Clinic of Infectious Diseases, Department of Biomedical Sciences and Public Health, Polytechnic University of Marche, Ancona, Italy*These authors contributed equally to this workCorrespondence: Oriana SimonettiDermatological Unit, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Via Conca 71, Ancona, 60126, ItalyEmail o.simonetti@staff.univpm.itIntroduction: Dalbavancin is a bactericidal lipoglycopeptide active against gram-positives. Its use has been approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI).Methods: We conducted a narrative review of the literature on the safety profile of dalbavancin. The bibliographic research was carried out on the PubMed database on 6 November 2020 by seeking combinations of the following keywords: dalbavancin, adverse effects, safety, drug interactions, and skin infections.Results: Five double-blind Phase 3 randomized clinical trials, 2 open-label randomized trials, and 4 retrospective studies were identified. No statistically significant differences were found between dalbavancin and comparators in the incidence of adverse events. Retrospective studies confirm the low incidence of adverse events.Conclusion: Dalbavancin is a therapeutic option that has demonstrated an excellent safety profile, also in relation to the other MRSA therapies available. Its use represents a cost-effective solution for the treatment of those patients with ABSSSI who would need hospitalization. One limitation of this study is that most of the available data are from Phase III clinical trials. Further real-life studies with a larger sample size are therefore needed to better assess the safety profile of the dalbavancin, especially to investigate the true incidence of rare adverse events.Keywords: dalbavancin, adverse events, safety, skin infections, ABSSSISimonetti ORizzetto GMolinelli ECirioni OOffidani ADove Medical Pressarticledalbavancinadverse eventssafetyskin infectionsabsssiTherapeutics. PharmacologyRM1-950ENTherapeutics and Clinical Risk Management, Vol Volume 17, Pp 223-232 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	dalbavancin adverse events safety skin infections absssi Therapeutics. Pharmacology RM1-950
spellingShingle	dalbavancin adverse events safety skin infections absssi Therapeutics. Pharmacology RM1-950 Simonetti O Rizzetto G Molinelli E Cirioni O Offidani A Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization
description	Oriana Simonetti,1,* Giulio Rizzetto,1,* Elisa Molinelli,1 Oscar Cirioni,2 Annamaria Offidani1 1Clinic of Dermatology, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy; 2Clinic of Infectious Diseases, Department of Biomedical Sciences and Public Health, Polytechnic University of Marche, Ancona, Italy*These authors contributed equally to this workCorrespondence: Oriana SimonettiDermatological Unit, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Via Conca 71, Ancona, 60126, ItalyEmail o.simonetti@staff.univpm.itIntroduction: Dalbavancin is a bactericidal lipoglycopeptide active against gram-positives. Its use has been approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI).Methods: We conducted a narrative review of the literature on the safety profile of dalbavancin. The bibliographic research was carried out on the PubMed database on 6 November 2020 by seeking combinations of the following keywords: dalbavancin, adverse effects, safety, drug interactions, and skin infections.Results: Five double-blind Phase 3 randomized clinical trials, 2 open-label randomized trials, and 4 retrospective studies were identified. No statistically significant differences were found between dalbavancin and comparators in the incidence of adverse events. Retrospective studies confirm the low incidence of adverse events.Conclusion: Dalbavancin is a therapeutic option that has demonstrated an excellent safety profile, also in relation to the other MRSA therapies available. Its use represents a cost-effective solution for the treatment of those patients with ABSSSI who would need hospitalization. One limitation of this study is that most of the available data are from Phase III clinical trials. Further real-life studies with a larger sample size are therefore needed to better assess the safety profile of the dalbavancin, especially to investigate the true incidence of rare adverse events.Keywords: dalbavancin, adverse events, safety, skin infections, ABSSSI
format	article
author	Simonetti O Rizzetto G Molinelli E Cirioni O Offidani A
author_facet	Simonetti O Rizzetto G Molinelli E Cirioni O Offidani A
author_sort	Simonetti O
title	Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization
title_short	Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization
title_full	Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization
title_fullStr	Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization
title_full_unstemmed	Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization
title_sort	review: a safety profile of dalbavancin for on- and off-label utilization
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/ce1a843304f24890add6b3d7d6345f8c
work_keys_str_mv	AT simonettio reviewasafetyprofileofdalbavancinforonandofflabelutilization AT rizzettog reviewasafetyprofileofdalbavancinforonandofflabelutilization AT molinellie reviewasafetyprofileofdalbavancinforonandofflabelutilization AT cirionio reviewasafetyprofileofdalbavancinforonandofflabelutilization AT offidania reviewasafetyprofileofdalbavancinforonandofflabelutilization
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Review: A Safety Profile of Dalbavancin for On- and Off-Label Utilization

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