• Eduardo Ramacciotti, Ubirajara Ferreira, Agenor José Vasconcelos Costa, Selma Regina O Raymundo, João Antônio Correa, Salvador Gullo Neto, Alessandro Bersch Osvaldt, Leandro Agati, Valéria Cristina Resende Aguiar, Ronaldo Davila, Tania Benevenuto Caltabiano, Flávia Magalhães Magella, Giuliano Giova Volpiani, Valter Castelli, Roberto Augusto Caffaro, Lucas Zeponi DalAcqua, Wagner Eduardo Matheus, Debora Yuri Sato, Gleison Juliano da Silva Russeff, Daniela Garcia de Souza, Lucas Eduardo Pazetto, Tiago Aparecido Maschio de Lima, Eloá Maria da Silva Colnago, Eliane Yumii Fugii, Juliana Sekeres Mussalem, Vanessa Therumi Assao, Odaly Toffoletto, Debora Garcia Rodrigues, Jorge Barros Afiune, and Gilson Roberto Araujo.
• 1 Vascular Surgery, Hospital e Maternidade Dr. Christóvão da Gama, Santo André, São Paulo, Brazil.
• Clin. Appl. Thromb. Hemost. 2018 Nov 1; 24 (8): 1208-1215.

AbstractSeveral 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.

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