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

Abstract

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.

Hypnotics with novel modes of action

“…The same can be said for α 2 adrenoceptor modulators e.g. dexmedetomidine and medetomidine; the former is principally used as a sedative in adult intensive care unit patients, the latter in animal health. Also, the cannabinoid system has been targeted, e.g.…”

Off-label use of dexmedetomidine in paediatric anaesthesiology: an international survey of 791 (paediatric) anaesthesiologists

“…Studies describing the pharmacokinetics of dexmedetomidine indicate that children would require a higher dosage per kilogram bodyweight compared to adults to achieve comparable exposure, due to a larger volume of distribution in children [ 25 ]. A previous study described the off-label use of dexmedetomidine in paediatric care within the European Union (EU), indicated for ICU sedation, anaesthesia and procedural sedation [ 7 ]. In the EU, a maximum infusion rate of 1.4 μg kg −1 h −1 is approved for adult sedation; however, a recently published study in Europe showed that infusion rates exceeding 1.4 μg kg −1 h −1 were used in 11% of children [ 7 ].…”

“…Despite the lack of evidence and off-label use of dexmedetomidine for anaesthesia in patients younger than 18 years of age, the worldwide use of dexmedetomidine for paediatric anaesthesia is still increasing [ 7 , 8 ]. Experimental research has shown that dexmedetomidine may have a neuroprotective effect when co-administered with other anaesthetic medications [ 9 , 10 ].…”

Dexmedetomidine: What’s New for Pediatrics? A Narrative Review

“…Despite a paucity of large studies examining DEX utilization in the pediatric intensive care unit (PICU) setting, it has become an increasing commonplace adjunct worldwide. A 2017 multinational European study (16 hospitals, four EU countries) reported that up to 6% of children in the PICU receive DEX [ 125 ]. DEX has been shown to have particular benefits when used as the primary sedative for less critically ill PICU children, allowing rapid achievement of targeted sedation levels and still maintaining ability for clinical assessments.…”