Comparing dexmedetomidine prescribing patterns and safety in the naturalistic setting versus published data

BACKGROUND: In clinical practice, new drugs may be used differently than the product labeling recommends. Furthermore, it often takes several years of use before adverse drug reactions (ADRs) are reported. OBJECTIVE: To compare prescribing patterns and safety of the newly released drug dexmedetomidine as observed in clinical practice with published data on the drug. METHODS: Information from a convenience sample of adults receiving dexmedetomidine as part of routine patient care at 10 institutions was retrospectively collected from June 27, 2001, to May 31, 2002. Investigators reviewed medical records daily and entered dosing information, patient demographics, and predefined categories of ADR severity and probability anonymously via the Internet on a secure server. RESULTS: Only 33% of the total sample (n = 136) of patients received a loading infusion of dexmedetomidine; however, maintenance dosing was usually within product labeling guidelines. Of note, 27.2% of patients received dexmedetomidine above the maximum dose and 33.8% received the drug beyond 24 hours. Some patients (15.4%) were never mechanically ventilated, while 59.5% received dexmedetomidine following extubation for an average of 11.3 hours. ADRs were reported in 30% of patients: 20% of the reactions required treatment or increased length of stay. Hypotension was the most common ADR, occurring in 22.7% of patients. Bradycardia was reported in 4.4% of patients. The rate and type of ADRs were similar in patients receiving dexmedetomidine >24 hours compared with the total population. CONCLUSIONS: Dexmedetomidine is prescribed within product labeling guidelines except for low use of a loading dose, some patients received the drug at doses above the maximum, and others received it for longer than 24 hours. Since ADR rates are similar to those of other published reports, dexmedetomidine maintained its expected safety profile in our patients.