Efficacy and Safety of a Biosimilar Versus Branded Enoxaparin in the Prevention of Venous Thromboembolism Following Major Abdominal Surgery: A Randomized, Prospective, Single-Blinded, Multicenter Clinical Trial.

Autor:	Ramacciotti E; 1 Vascular Surgery, Hospital e Maternidade Dr. Christóvão da Gama, Santo André, São Paulo, Brazil.; 2 Loyola University Medical Center, Maywood, IL, USA., Ferreira U; 3 Oncological Urology Group-FCM-UNICAMP-Universidade Estadual de Campinas, São Paulo, Brazil., Costa AJV; 4 Vascular Surgery Department, Hospital Estadual Mário Covas, Faculdade de Medicina do ABC, Santo André, São Paulo, Brazil., Raymundo SRO; 5 Fundação Faculdade Regional de Medicina de São José do Rio Preto, São Paulo, Brazil., Correa JA; 6 Vascular Surgery, Hospital de Ensino da Faculdade de Medicina do ABC, São Paulo, Brazil., Neto SG; 7 Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil., Osvaldt AB; 8 Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil., Agati L; 1 Vascular Surgery, Hospital e Maternidade Dr. Christóvão da Gama, Santo André, São Paulo, Brazil., Aguiar VCR; 1 Vascular Surgery, Hospital e Maternidade Dr. Christóvão da Gama, Santo André, São Paulo, Brazil., Davila R; 1 Vascular Surgery, Hospital e Maternidade Dr. Christóvão da Gama, Santo André, São Paulo, Brazil.; 9 Vascular Surgery, Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil., Caltabiano TB; 1 Vascular Surgery, Hospital e Maternidade Dr. Christóvão da Gama, Santo André, São Paulo, Brazil., Magella FM; 1 Vascular Surgery, Hospital e Maternidade Dr. Christóvão da Gama, Santo André, São Paulo, Brazil., Volpiani GG; 1 Vascular Surgery, Hospital e Maternidade Dr. Christóvão da Gama, Santo André, São Paulo, Brazil.; 9 Vascular Surgery, Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil., Castelli V Jr; 9 Vascular Surgery, Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil., Caffaro RA; 9 Vascular Surgery, Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil., DalAcqua LZ; 3 Oncological Urology Group-FCM-UNICAMP-Universidade Estadual de Campinas, São Paulo, Brazil., Matheus WE; 3 Oncological Urology Group-FCM-UNICAMP-Universidade Estadual de Campinas, São Paulo, Brazil., Sato DY; 5 Fundação Faculdade Regional de Medicina de São José do Rio Preto, São Paulo, Brazil., Russeff GJDS; 5 Fundação Faculdade Regional de Medicina de São José do Rio Preto, São Paulo, Brazil., de Souza DG; 5 Fundação Faculdade Regional de Medicina de São José do Rio Preto, São Paulo, Brazil., Pazetto LE; 5 Fundação Faculdade Regional de Medicina de São José do Rio Preto, São Paulo, Brazil., de Lima TAM; 5 Fundação Faculdade Regional de Medicina de São José do Rio Preto, São Paulo, Brazil., Colnago EMDS; 5 Fundação Faculdade Regional de Medicina de São José do Rio Preto, São Paulo, Brazil., Fugii EY; 6 Vascular Surgery, Hospital de Ensino da Faculdade de Medicina do ABC, São Paulo, Brazil., Mussalem JS; 10 Cristália Produtos Químicos Farmacêuticos LTDA, São Paulo, Brazil., Assao VT; 10 Cristália Produtos Químicos Farmacêuticos LTDA, São Paulo, Brazil., Toffoletto O; 10 Cristália Produtos Químicos Farmacêuticos LTDA, São Paulo, Brazil., Rodrigues DG; 10 Cristália Produtos Químicos Farmacêuticos LTDA, São Paulo, Brazil., Afiune JB; 10 Cristália Produtos Químicos Farmacêuticos LTDA, São Paulo, Brazil., Araujo GR; 11 Vascular Surgery, Hospital de Base de Brasília, DF, Brazil.
Jazyk:	angličtina
Zdroj:	Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis [Clin Appl Thromb Hemost] 2018 Nov; Vol. 24 (8), pp. 1208-1215. Date of Electronic Publication: 2018 Jul 18.
DOI:	10.1177/1076029618786583
Abstrakt:	Several biosimilar versions of enoxaparin are already approved and in use globally. Analytical characterization can establish good quality control in manufacturing, but they may not assure similarity in clinical outcomes between biosimilar and branded enoxaparin. This study evaluated the efficacy and safety of biosimilar Cristália versus branded Sanofi enoxaparin in venous thromboembolism (VTE) prevention in patients undergoing major abdominal surgery at risk for VTE. In this randomized, prospective single-blind study, we compared Cristália enoxaparin (Ce), a biosimilar version, versus branded Sanofi enoxaparin (Se; at a dose of 40 mg subcutaneously per day postoperatively from 7 to 10 days) in 243 patients submitted to major abdominal surgery at risk for VTE for VTE prevention. The primary efficacy outcome was occurrence of VTE or death related to VTE. The principal safety outcomes were a combination of major bleeding and clinically relevant non-major bleeding. Bilateral duplex scanning of the legs was performed from days 10 to 14, and follow-ups were performed up to 60 days after surgery. The incidence of VTE was 4.9% in the Cristália group and 1.1% in the Sanofi group (absolute risk difference = 3.80%, 95% confidence interval [CI]: -1.4%-9.0%) yielding noninferiority since the 95% CI does not reach the prespecified value Δ = 20%. Clinically significant bleeding occurred in 9.9% in the Cristália group and in 5.5% in the Sanofi group (n.s. ). In conclusion, this study suggests that 40 mg once daily of Ce, a biosimilar enoxaparin, is as effective and safe as the branded Sanofi enoxaparin in the prophylaxis of VTE in patients submitted to major abdominal surgery at risk for VTE.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu