Rivaroxaban Safety and Persistence in Patients With Nonvalvular Atrial Fibrillation: Prospective, Observational,...

Area of Science:

• Pharmacology
• Cardiology
• Real-world evidence

Background:

• Nonvalvular atrial fibrillation (NVAF) increases stroke risk, necessitating anticoagulation.
• Rivaroxaban is a widely used direct oral anticoagulant for NVAF.
• Real-world data are crucial for understanding long-term safety and adherence in routine clinical practice.

Purpose of the Study:

• To evaluate the real-world safety and adherence of rivaroxaban in patients with NVAF.
• To assess bleeding events and other adverse drug reactions associated with rivaroxaban use.
• To determine therapy adherence levels using the Morisky Medication Adherence Scale-8 (MMAS-8).

Main Methods:

• Prospective, observational, cohort, postmarketing study over six months.
• Inclusion of 1184 patients with NVAF.
• Assessment of bleeding events (major, non-major, fecal occult blood positivity) and adverse reactions.
• Measurement of therapy adherence using the MMAS-8.

Main Results:

• Cumulative incidence of major bleeding was 0.9%, non-major bleeding 13.3%, and fecal occult blood positivity 3.4%.
• Adverse drug reactions were infrequent and mild (e.g., headache, fatigue); no significant laboratory parameter deterioration.
• Mean MMAS-8 score indicated good adherence (1.0), with one-third showing full adherence and one-fifth poor adherence.

Conclusions:

• Rivaroxaban demonstrates a favorable safety profile in real-world NVAF patient populations.
• Generally good patient adherence to rivaroxaban was observed, supporting its clinical utility.
• Continued monitoring for bleeding risk and enhanced patient education on adherence are recommended for optimal outcomes.