Background: Dexmedetomidine (Dex) is a sedative drug approved as dexdor® for ICU sedation in adults in the European Union in 2011. This observational, retrospective drug utilisation study was requested by the Committee for Human Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to investigate Dex use in clinical practice.
Objectives: The objective of the study was to evaluate how Dex is used in the EU, with particular focus on off-label use including the paediatric population.
Methods: Study countries and sites were chosen from those with highest dexdor use, based on sales. Site selection (blind) was conducted by a multinational, multi-specialist, independent group. All patients treated with Dex at the study sites during the enrolment period were to be included. Anonymised data on demographics, treatment indication, Dex dosing, concomitant medications and treatment effectiveness were collected retrospectively from the patient records. Informed consent was waived to avoid influence of the study on the prescribing of Dex. Recruitment was limited to 750 patients per country or 300 patients per study site and was completed within 18 months of the first site initiation.
Results: Data from 2000 patients were collected from 16 hospitals in 4 EU countries (Finland 750, Poland 505, Germany 470, Austria 275) between 13th June 2013 and 4th December 2014. The median age was 62 years, with more males (70.2%) than females. The overall proportion of paediatric patients was 5.2% with the highest incidence in Austria and Finland. Dex was primarily used in adult ICU (86.0%) for ICU sedation (78.6%) and mostly dosed according the product label. Overall in 84.9% of administrations the intended sedative effect were obtained.
Conclusions: This drug utilisation study indicates that dexmedetomidine (dexdor®) is mostly used according to the terms of its product licence in the EU, although a variable degree of use was also seen in other settings and populations.
