Abstract Number: PB1086
Meeting: ISTH 2022 Congress
Background: During the last few years, several generic versions of rivaroxaban were approved to be used interchangeably with their branded equivalent Xarelto®. However, there were no previous studies in the literature that directly compared the anticoagulant effects of branded and generic preparations of rivaroxaban on different coagulation assays.
Aims: The main aim of this in vitro study was to compare the anticoagulant effects of Xarelto® with two generic versions (Rivaroxaban Sandoz® and Rivarolto®) on a panel of coagulation assays.
Methods: The study was performed by first pooling normal plasma and spiking with different concentrations of the branded type and the two generic versions of rivaroxaban (concentration range 50 -1000 ng/ml). Several coagulation assays were performed: Prothrombin time (PT), activated Partial Thromboplastin time (aPTT), Thrombin time (TT), Clauss Fibrinogen, Diluted Russell’s Viper Venom Test (dRVVT), Factor VII one-stage assay, Factor VIII assays (one-stage & chromogenic), Factor IX assays (one-stage & chromogenic). The Pearson’s correlation test was utilized to check for correlation between the concentrations of the three different preparations of rivaroxaban and the selected assays. The One-Way ANOVA test was utilized to identify any variabilities in their action on the selected assays.
Results: There was a positive correlation between the concentrations of the three preparations of rivaroxaban and PT, aPTT and dRVVT (Pearson’s r > 0.93, p < 0.05 for all). There was a negative correlation between the concentrations of the three preparations and the one-stage and chromogenic factor assays (Pearson's r < - 0.83, p < 0.05 for all). TT did not correlate with any of the preparations (Table). No significant difference was identified in the anticoagulant effect of the three rivaroxaban formulations (p > 0.05 for all).
Conclusion(s): This study showed that the generic versions of rivaroxaban do not exert any different in vitro anticoagulant effect from Xarelto® on several coagulation assays.
To cite this abstract in AMA style:Mangion K, Vella K, Gatt A, Borg Aquilina D, Riva N. A comparative in vitro study of the coagulation effects of branded versus generic preparations of rivaroxaban [abstract]. https://abstracts.isth.org/abstract/a-comparative-in-vitro-study-of-the-coagulation-effects-of-branded-versus-generic-preparations-of-rivaroxaban/. Accessed December 6, 2023.
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