Methodological Considerations for the Implementation of A European Mandated Retrospective Drug Utilisation Study (Dus) to Investigate the Use of Dexmedetomidine (Dexdor®) in Clinical Practice

Stein, Daniel C.; Weatherall, M.; Garratt, Chris; Aantaa, Riku; Conti, Giorgio; Ma, Liying; Moore, Nicholas; Gutthann, Susanne Pérez

doi:10.1016/j.jval.2015.09.2746

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“…Peter Hughes (Peter Hughes Associates) assisted with the first version of the manuscript on behalf of Orion Pharma . The results presented in this article were previously presented at the ISPOR 18th Annual European Congress , at the 31st International Conference on Pharmacoepidemiology and Therapeutic Risk Management , and at the 28th ESICM (European Society of Intensive Care Medicine) Lives Congress, Berlin, October 2015 .…”

Section: Competing Interestsmentioning

confidence: 99%

A multinational, drug utilization study to investigate the use of dexmedetomidine (Dexdor®) in clinical practice in the EU

Weatherall

Aantaa

Conti

et al. 2017

Brit J Clinical Pharma

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Aims Dexmedetomidine (dexdor®) is approved in the European Union (EU) for sedation of adults in the intensive care unit (ICU). The present observational, retrospective study was requested by the European Medicines Agency to investigate dexmedetomidine use in clinical practice, with a particular focus on off‐label use, including the paediatric population. Methods Study countries and sites were chosen from those with highest dexmedetomidine use, based on sales. Site selection (blind) was conducted by a multispecialist, independent group. Anonymized data on demographics, treatment indication, dexmedetomidine dosing, concomitant medications and treatment effectiveness were collected retrospectively from records of all dexmedetomidine‐treated patients at the site during the enrolment period. Informed consent was waived, to avoid influencing the prescribing of dexmedetomidine. Recruitment was completed within 18 months of first site initiation. Results Data from 2000 patients were collected from 16 hospitals in four EU countries (Finland 750, Poland 505, Germany 470, Austria 275). The median age was 62 years, with more males (70.2%) than females. Dexmedetomidine was primarily used in the adult ICU (86.0%) for ICU sedation (78.6%) and mostly dosed according the product label. The intended sedative effect was obtained in 84.9% of administrations. Paediatric use (5.9% of patients, mostly in Austria and Finland) occurred mainly in the adult or paediatric ICU (75.6%) for sedation (67.2%). Conclusions Overall, most patients were treated with dexmedetomidine according to the product labelling. Use in children was limited but significant and similar in scope to that in adults. Administrations not fully according to the product labelling usually occurred in an ICU environment and reflected extensively investigated clinical uses of dexmedetomidine.

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Section: Competing Interestsmentioning

confidence: 99%