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.
The only advantage of the Davis pipette is that patients can take their own sample without the need to attend a clinic or to see a doctor; it might therefore be possible to reach a larger proportion of the population at risk. However, the low rate of detection would necessitate repeated screenings of each patient at fairly short time-intervals, and although the initial response might be good, it could prove difficult to persuade women to take repeated samples, especially in view of the complaints from the clinics participating in this survey. Like Macgregor and her colleagues, we think that the cytopipette is not an appropriate instrument for urban-community-screening programmes.
ConclusionsOur results leave us in no doubt that when a cervical cytology specimen is taken by a doctor the Ayre smear is a more effective method than the Davis cytopipette in the detection of malignancy. The Davis method has been extensively used in Denmark (Bredahl et al., 1965) al., 1962, 1963) and subsequently both have been found useful in patients with rheumatoid arthritis (Coodley, 1963;Young, 1963
An open, single centre study was carried out to evaluate the accuracy of the Spuncrit (Micro Diagnostics, Bethlehem, PA, USA) infra-red analyser which can be used for near-patient testing to measure haematocrit and estimate haemoglobin concentration. The primary comparison was with the Sysmex NE1500 (Tao Medical) analyser situated in the main hospital laboratory. Secondary comparison was with the Ciba Corning 288 (Ciba Corning Diagnostics Ltd, Halstead, UK) blood gas analyser currently used for near-patient testing in the Northern General Hospital. A total of 217 samples from 50 patients was analysed. The Pearson's correlation coefficients for haematocrit and haemoglobin concentration between the Spuncrit and Sysmex NE1500 and between the Spuncrit and Ciba Corning 288 were all close, between 0.85 and 0.92. The method of Bland and Altman was used to assess agreement between the results of the Spuncrit and the Sysmex NE1500. The agreement for haematocrit was good with 2 SD of the Spuncrit results being between -5.66 and +4.42% of the measurement from the Sysmex NE1500. In conclusion, the Spuncrit haematocrit measurement agreed well with results from the central laboratory, but the estimated haemoglobin concentrations agreed less well and three reasons are discussed.
The average indexed bypass pump flow was significantly lower with Mini-CPB. When combined with haemoglobin concentration, the average oxygen delivery was the same between groups. Patients in the C-CPB group had a greater duration and severity of cerebral desaturation to a level <20% below baseline values, but none reached the depth and duration of the cerebral desaturation associated with poor outcome. Cerebral oxygen desaturation with C-CPB was significantly associated with low flows during bypass, whereas desaturation with Mini-CPB was associated with low perioperative haemoglobin concentration.
A723targeted in this analysis. ConClusions: Prospective inclusion of health-economic endpoints in clinical trials for PAD is important to support future decision-making by payers and providers. The OPTIMIZE study collects targeted information on quality of life and resource utilization to facilitate future health-economic analyses.
PRM232 Methodological consideRations foR the iMPleMentation of a euRoPean Mandated RetRosPective dRug utilisation study (dus)to investigate the use of dexMedetoMidine (dexdoR®) in clinical PRactice
SummaryEleven patients with osteoarthritis and mild hypertension completed an 8-week, double-blind crossover study in which 200 mg tiaprofenic acid 3-times daily or placebo were substituted for their normal non-steroidal anti-inflammatory therapy. Systolic blood pressure was significantly higher on tiaprofenic acid therapy than on placebo and plasma renin activity was significantly lower on active treatment. No significant changes were seen in biochemical parameters, though the weight of the patient was also higher on tiaprofenic acid than on placebo. Duration of morning stiffness was also lower on tiaprofenic acid than on placebo. Blood pressure on tiaprofenic acid was not different from baseline readings on other non-steroidal antiinflammatory drug therapy. This study suggests that tiaprofenic acid, like other nonsteroidal anti-inflammatory agents, may interfere with blood pressure control in treated hypertensive patients.
Key words: Tiaprofenic acid -analgesics, anti-inflammatory -antihypertensivesosteoarthritis -h y p e r t e n s i o n
I n t r o d u c t i o nTiaprofenic acid is a new non-steroidal anti-inflammatory drug which has significant anti-inflammatory and analgesic effects in animal models of inflammation.
5Pharmacokinetic studies demonstrate rapid absorption from the gastro-intestinal tract with a relatively short plasma elimination half-life of about 2 hours.
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