Background and Importance Dexmedetomidine is an alpha-2 agonist with sedative effects. It is used for the sedation of patients in the Intensive Care Unit (ICU) and sedation of surgical procedures. In June-2022, the Spanish Agency for Medicines and Medical Devices (AEMPS) published a safety letter reporting an increased risk of mortality in patients≤65 years of age compared to standard sedative agents1.
Aim and Objectives To analyse the use of dexmedetomidine in our hospital and to compare the heterogeneity of the effect on mortality according to age in real life.
Material and Methods Observational, descriptive and retrospective study. Patients treated with dexmedetomidine or propofol during the year 2021 were included. Variables collected: age, sex, number of days on treatment with dexmedetomidine/propofol, admission diagnosis to the ICU, surgical intervention during ICU stay and 90-day mortality from any cause. Variables were collected through the digital medical record and the hospital's electronic prescription program. Data were analysed using Excel.
Results 403 patients were included (169=dexmedetomidine vs 234=propofol). 75.7% were men (125=dexmedetomimidine vs 180=propofol). Baseline patient characteristics are shown in the following table. There were 74 deaths at 90-days in the control group vs 31 deaths at 90-days in the dexmedetomidine group, odds ratio (OR)=0,49 [95% CI: 0,30 – 0,78]. In the >65 years group there were 35 vs 13 deaths at 90 days (propofol vs dexmedetomidine, respectively), OR=0,39 [95% CI: 0,18 – 0,86]. Deaths at 90 days in the group aged ≤65 years were 39 vs 18 (propofol vs dexmedetomidine, respectively), OR=0,55 [95% CI: 0,30 – 1,02].
Conclusion and Relevance The data obtained do not reproduce those obtained in the study on which the alert received was based. This may be due to limitations of our study. Even so, the use of dexmedetomidine in young patients should be carried out with caution. The pharmacy service has communicated the alert to the hospital services.
References and/or Acknowledgements 1 https://sinaem.aemps.es/CartasFarmacovigilanciaDoc/2022/DHPC-dexmedetomidine.pdf
Conflict of Interest No conflict of interest
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.