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      Efectividad y eficiencia de la dalbavancina en condiciones reales de uso Translated title: Effectiveness and efficiency of dalbavancin in real clinical practice use

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          Abstract

          Resumen Objetivos: El tratamiento de las infecciones por Gram positivos supone un reto asistencial, en un contexto en el que están aumentando las resistencias antibióticas. La dalbavancina, gracias a su alta vida media y alta actividad frente a Gram positivos, puede ser una buena opción terapéutica. Nuestros objetivos son conocer los usos, efectividad y eficiencia de la dalbavancina en pacientes del Hospital General Universitario de Valencia. Métodos: Se realiza un estudio descriptivo retrospectivo y un análisis de costes de los pacientes tratados con dalbavancina en el Hospital General Universitario de Valencia. Resultados: 15 pacientes (con 17 episodios de infección) fueron incluidos, con un Charlson medio de 3,7. Se trataron 4 infecciones de piel y partes blandas, 6 infecciones osteoarticulares y 7 infecciones intravasculares, aislándose en el 70,6% de los casos un Gram positivo. La tasa de curación fue del 59%, sin efectos adversos por la dalbavancina ni exitus en relación con la infección. Se evitaron 239 días de hospitalización, lo cual supone un ahorro de 6.556,02 € por paciente. Conclusiones: Series clínicas como la actual permiten analizar el papel de la dalbavancina en la práctica médica habitual y demuestran su importante función en el ahorro de recursos económicos.

          Translated abstract

          Abstract Objectives: The treatment of Gram-positive infections it's a medical challenge, in a context in which antibiotic resistances are increasing. Dalbavancin, due to its long half-life and high activity against Gram-positive bacteria, could be a good therapeutic option. Our objectives are to know the uses, effectiveness and efficiency of dalbavancin in patients of the General University Hospital of Valencia. Methods: A retrospective descriptive study and a cost analysis of patients treated with dalbavancin are carried out at the General University Hospital of Valencia. Results: 15 patients (with 17 episodes of infection) were included, with a mean Charlson index of 3.7. Were treated 4 skin and soft tissue infections, 6 osteoarticular infections and 7 intravascular infections. A Gram-positive bacteria was isolated in 70.6% of the patients. The cure rate was 59%, with no adverse effects due to dalbavancin or death in relation to infection. 239 days of hospitalization were saved with outpatient treatment, which means a saving of € 6,556.02 per patient. Conclusions: Clinical series like ours allow us to analyse the role of dalbavancin in routine medical practice and demonstrate its important function in saving economic resources.

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          Once-weekly dalbavancin versus daily conventional therapy for skin infection.

          Dalbavancin, a lipoglycopeptide antibiotic agent that is active against gram-positive pathogens, has a long plasma half-life, allowing for once-weekly dosing. DISCOVER 1 and DISCOVER 2 were identically designed noninferiority trials of dalbavancin for the treatment of acute bacterial skin and skin-structure infection.
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            Efficacy and safety of weekly dalbavancin therapy for catheter-related bloodstream infection caused by gram-positive pathogens.

            Catheter-related bloodstream infections (CR-BSIs) are associated with substantial mortality, prolongation of hospital stay, and increased cost of care. Dalbavancin, a new glycopeptide antibiotic with unique pharmacokinetic properties that have allowed clinical development of a weekly dosing regimen, possesses excellent activity against clinically important gram-positive bacteria, suggesting utility in the treatment of patients with CR-BSIs. A phase 2, open-label, randomized, controlled, multicenter study of 75 adult patients with CR-BSIs compared treatment with intravenous dalbavancin, administered as a single 1000-mg dose followed by a 500-mg dose 1 week later, with intravenous vancomycin, administered twice daily for 14 days. Gram-positive bacteria isolated in this study included coagulase-negative staphylococci (CoNS) and Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA). Infected patients who received weekly dalbavancin (n=33) had an overall success rate (87.0%; 95% confidence interval [CI], 73.2%-100.0%) that was significantly higher than that of those who received vancomycin (n=34) (50.0%; 95% CI, 31.5%-68.5%). Adverse events and laboratory abnormalities were generally mild and were comparable for the 2 drugs. Dalbavancin thus appears to be an effective and well-tolerated treatment option for adult patients with CR-BSIs caused by CoNS and S. aureus, including MRSA.
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              Randomized, double-blind comparison of once-weekly dalbavancin versus twice-daily linezolid therapy for the treatment of complicated skin and skin structure infections.

              Dalbavancin, a novel lipoglycopeptide with a pharmacokinetic profile that allows weekly dosing, is active against gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The efficacy of dalbavancin for treatment of skin and skin structure infections (SSSIs) was demonstrated in a phase 2 study. In a phase 3 noninferiority study, patients with complicated SSSIs, including infections known or suspected to involve MRSA, were randomized (ratio, 2 : 1) in a double-blind manner to receive dalbavancin (1000 mg given intravenously on day 1 and 500 mg given intravenously on day 8) or linezolid (600 mg given intravenously or intravenously/orally every 12 h for 14 days). Efficacy was assessed by determining clinical and microbiological responses at the end of therapy and at the test-of-cure visit. Relapses were identified by additional follow-up approximately 1 month later. MRSA was identified in 51% of patients from whom a pathogen was isolated at baseline. Dalbavancin and linezolid demonstrated comparable clinical efficacy in the clinically evaluable population at the test-of-cure visit (88.9% and 91.2% success, respectively). The rate of clinical success at the end of therapy was >90% in both arms. Less than 1.0% of patients in either treatment arm experienced relapse after the test-of-cure visit. Both treatments yielded successful microbiological response in excess of 85% among microbiologically evaluable patients at end of therapy and at the test-of-cure visit for all pathogens combined, for all S. aureus strains, and for MRSA. Gastrointestinal symptoms were among the most common adverse events in both arms. A higher proportion of patients in the linezolid arm reported adverse events that were judged by the investigator to be probably/possibly related to treatment (dalbavancin arm, 25.4% of subjects; linezolid arm, 32.2% of subjects). Two doses of dalbavancin (1000 mg given on day 1 followed by 500 mg given on day 8) were as well tolerated and as effective as linezolid given twice daily for 14 days for the treatment of patients with complicated SSSI, including those infected with MRSA.
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                Author and article information

                Journal
                ofil
                Revista de la OFIL
                Rev. OFIL·ILAPHAR
                Organización de Farmacéuticos Ibero-Latinoamericanos (Madrid, Madrid, Spain )
                1131-9429
                1699-714X
                June 2023
                : 33
                : 2
                : 149-153
                Affiliations
                [1] orgnameHospital General Universitario de Valencia España
                Article
                S1699-714X2023000200009 S1699-714X(23)03300200009
                10.4321/s1699-714x2023000200009
                8fb59814-f6a9-4278-8039-6b96ee143873

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 28 June 2021
                : 05 August 2021
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 20, Pages: 5
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                SciELO Spain

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                eficiencia,Dalbavancin,effectiveness,efficiency,Dalbavancina,efectividad

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