Two papers on the findings of our Rivaroxaban Observational Safety Evaluation (ROSE) study have just been published. ROSE is is a prime example of our SCEM (Specialist Cohort Event Monitoring) methodology developed for post-authorisation safety studies (PASS) undertaken on drugs for which prescribing is initiated in secondary or specialist care. Read our recent article for more information on SCEM and ROSE or click here to find out more our the SCEM method.
Rivaroxaban is a direct oral anticoagulant (DOAC) recommended for stroke prevention in patients with non-valvular atrial fibrillation, based on Phase III data. The ROSE study was conducted to collect further information on the safety and utilisation of rivaroxaban in a broader range of patient groups in routine clinical practice.
The first paper details the incidence of bleeding in patients with atrial fibrillation who were prescribed rivaroxaban for stroke prevention:
Evans A, Davies M, Osborne V, Roy D, Shakir S (2020) Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study. PLoS ONE 15(10): e0240489. https://doi.org/10.1371/journal.pone.0240489
The second paper evaluates the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: Evans A, Davies M, Osborne V, et al. Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study. BMJ Open 2020;10:e038102. doi: 10.1136/bmjopen-2020-038102