Reassuring data of generic rivaroxaban from new real-world evidence

The recently published GUARDIAN non-interventional study evaluated clinical outcomes and treatment satisfaction with generic rivaroxaban in 1,092 patients with atrial fibrillation (AF) treated in routine clinical practice.

Over one year of follow-up, the study assessed clinically relevant outcomes, including thromboembolic events, major bleeding, treatment persistence, and patient and physician satisfaction.

Data were collected at baseline and at follow-up visits after 3, 6 and 12 months. All enrolled patients were prescribed generic rivaroxaban 20 mg once daily, or 15 mg once daily in patients with creatinine clearance (CrCL) <50mL/min.

During the one-year follow-up, symptomatic thromboembolic events occurred in 0.6% of patients and major bleeding in 0.2%. No intracranial or fatal major bleeding events were reported. At 12 months, 93% of patients remained on generic rivaroxaban therapy.

Treatment satisfaction remained consistently high throughout the study. At 12 months, 99% of patients were satisfied or very satisfied with treatment, while physicians also reported high levels of satisfaction throughout follow-up. Among patients previously treated with another oral anticoagulant, most reported greater satisfaction after switching to generic rivaroxaban.

According to the authors, the results provide “reassuring observations regarding the use of generic rivaroxaban in patients with AF in clinical practice” and demonstrate “persistently high patients’ and physicians’ satisfaction” over one year of follow-up.

The GUARDIAN study adds prospective real-world evidence on the use of generic rivaroxaban in patients with AF, showing low observed rates of thromboembolic and major bleeding events, high treatment persistence, and consistently high patient and physician satisfaction.

Publications

EMA RWD Catalogues: Rivaroxaban real world effectiveness in patients with atrial fibrillation (GUARDIAN). In: RWD Catalogues [database on internet]. Strasbourg: EMA; 2025. p. 1-11. Available from: https://catalogues.ema.europa.eu/node/4773/administrative-details

Potpara T, Pojskic B, Otasevic P, et al. Clinical Event rates and patient satisfaction with generic rivaroxaban in atrial fibrillation: The prospective Guardian study. TH Open 2026; 10: a29498821. https://doi.org/10.1055/a-2949-8821

Markovic BG, Mihajlovic M, Kocijancic A, et al. Patient self‐reported global satisfaction with rivaroxaban in patients with atrial fibrillation: A comparison between oral anticoagulation‐naïve versus oral anticoagulation‐experienced patients. Clinical Cardiology 2026; 49: e70461. https://doi.org/10.1002/clc.70461