Sandeep Dhanda, Miranda Davies, Deborah Layton, Vicki Osborne and Saad AW Shakir
A UK PASS is being conducted as part of a risk management plan to monitor the safety and use of rivaroxaban (Riv) as prescribed for medical conditions requiring anticoagulation. Increasingly, patient (pt) prescribing is influenced by published guidelines. One study objective was to evaluate Riv prescribing in real-life clinical practice in primary care in England.
A planned interim analysis to describe cohort characteristics and determinants of prescribing.
An observational cohort study. Interim cohort was identified from dispensed prescriptions of Riv in England from Dec 2011 to Jul 2015 (datalock). Questionnaires requesting information on drug utilisation were sent to prescribing general practitioners (GPs) at ≥3, and ≥12 months after 1st Riv prescription issued for each pt. Summary descriptive statistics were calculated; % denominator where response given; pts with single indications reported were analysed within mutually exclusive groups.
Interim evaluable cohort = 8372 pts (median age 75 years (IQR 64-83)); 4223 (50.5%) female; indication of non-valvular atrial fibrillation (AF) reported for 4764 pts (56.9% cohort) and venous thromboembolism (VTE) for 2286 pts (27.3% cohort). More than half of pts (4862, 59.4%) were initiated on 20mg od. Riv was initiated more frequently in secondary vs. primary care setting (4467, 55.3% vs. 3530, 43.7%). Recommendation from a specialist was the most frequent reason for prescribing (4509, 56.3%), followed by clinical judgement (2029, 25.3%), lifestyle/anticoagulation monitoring needs (1695, 21.1%) and recommendation by guidelines (1073, 13.4%).
The interim analysis reveals that Riv is largely prescribed within the licensed indications of AF and VTE. In terms of GP prescribing determinants, recommendation from a specialist would appear to be most influential, however approximately one fifth of GPs cite pt lifestyle factors (anticoagulation monitoring needs) as critical to the decision to prescribe. These results will become obsolete when further evaluation and validation are complete for the final report.