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. (November 2018)

• Record Type: Journal Article
• Authors: Ramacciotti, Eduardo; Ferreira, Ubirajara; Costa, Agenor José Vasconcelos; Raymundo, Selma Regina O.; Correa, João Antônio; Neto, Salvador Gullo; Osvaldt, Alessandro Bersch; Agati, Leandro; Aguiar, Valéria Cristina Resende; Davila, Ronaldo; Caltabiano, Tania Benevenuto; Magella, Flávia Magalhães; Volpiani, Giuliano Giova; Castelli, Valter; Caffaro, Roberto Augusto; DalAcqua, Lucas Zeponi; Matheus, Wagner Eduardo; Sato, Debora Yuri; Russeff, Gleison Juliano da Silva; de Souza, Daniela Garcia; Pazetto, Lucas Eduardo; de Lima, Tiago Aparecido Maschio; Colnago, Eloá Maria da Silva; Fugii, Eliane Yumii; Mussalem, Juliana Sekeres; Assao, Vanessa Therumi; Toffoletto, Odaly; Rodrigues, Debora Garcia; Afiune, Jorge Barros; Araujo, Gilson Roberto
• Is Part Of: Clinical and applied thrombosis/hemostasis. Volume 24:Number 8(2018)
• Page Start: 1208
• Page End: 1215
• Publication Date: 2018-11
• Subjects: enoxaparin -- biosimilar low molecular weight heparins -- randomized controlled trial -- abdominal surgery -- prophylaxis -- venous thromboembolism; Hemostasis -- Periodicals; Thrombosis -- Periodicals; 616.13
• DOI: 10.1177/1076029618786583
• Languages: English
• ISSNs: 1076-0296

Abstract

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.