Key result
Potential off-label use of dabigatran etexilate had an estimated prevalence ranging from 5.7% to 34.0% (broad definition) and 17.4% to 44.1% (restrictive definition) across European databases.
Cross-Sectional (n=36,573)
Yes
Estimates of potential off-label use of dabigatran from electronic health records vary widely depending on the database and definition used, suggesting caution in interpretation due to limited clinical information.
Wide variation in off-label dabigatran estimates across databases cautions EHR interpretation; leaves open true prevalence.
PURPOSE: To report and discuss estimated prevalence of potential off-label use and associated methodological challenges using a case study of dabigatran. METHODS: Observational, cross-sectional study using 3 databases with different types of clinical information available: Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD), France (cardiologist panel, n = 1706; general practitioner panel, n = 2813; primary care data); National Health Databases, Denmark (n = 28 619; hospital episodes and dispensed ambulatory medications); and Clinical Practice Research Datalink (CPRD), UK (linkable to Hospital Episode Statistics [HES], n = 2150; not linkable, n = 1285; primary care data plus hospital data for HES-linkable patients). STUDY PERIOD: August 2011 to August 2015. Two definitions were used to estimate potential off-label use: a broad definition of on-label prescribing using codes for disease indication (eg, atrial fibrillation [AF]), and a restrictive definition excluding patients with conditions for which dabigatran is not indicated (eg, valvular AF). RESULTS: Prevalence estimates under the broad definition ranged from 5.7% (CPRD-HES) to 34.0% (CSD-LPD) and, under the restrictive definition, from 17.4% (CPRD-HES) to 44.1% (CSD-LPD). For the majority of potential off-label users, no diagnosis potentially related to anticoagulant use was identified. Key methodological challenges were the limited availability of detailed clinical information, likely leading to overestimation of off-label use, and differences in the information available, which may explain the disparate prevalence estimates across data sources. CONCLUSIONS: Estimates of potential off-label use should be interpreted cautiously due to limitations in available information. In this context, CPRD HES-linkable estimates are likely to be the most accurate.
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Cainzos‐Achirica et al. (2018) conducted a cross-sectional in Off-label prescribing (n=36,573). Dabigatran etexilate was evaluated on Prevalence of potential off-label use. Potential off-label use of dabigatran etexilate had an estimated prevalence ranging from 5.7% to 34.0% (broad definition) and 17.4% to 44.1% (restrictive definition) across European databases.
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