Rapid fluctuations in factor VII during warfarin anticoagulation change the international normalised ratio (INR) but contribute little to the antithrombotic effect. We aimed to assess non-inferiority ...of anticoagulation stabilisation with a warfarin monitoring method affected only by factors II and X (Fiix-prothrombin time Fiix-PT) compared with standard PT-INR monitoring that includes factor VII measurement as well.
The Fiix trial was a single centre, double-blind, prospective, non-inferiority, randomised controlled clinical trial. Ambulatory adults on warfarin with an INR target of 2-3 managed by an anticoagulation dosing service using software-assisted dosing at the National University Hospital of Iceland, Reykjavik, Iceland, were eligible for inclusion in this study. We excluded patients undergoing electroconversion and nursing home residents. Patients were randomly assigned (1:1) to either the Fiix-PT monitoring group or the PT monitoring group by block randomisation. A blinded research INR (R-INR) based on results of the respective test was reported to the dosing staff. Participants were contacted by a study nurse at 4-week intervals to elicit information about thromboembolism or bleeding otherwise unknown to the anticoagulation management centre. The primary efficacy outcome was a composite of objectively diagnosed non-fatal and fatal arterial or venous thromboembolism, including myocardial infarction and transient ischaemic attacks, assessed in all eligible patients who were randomised (intention-to-monitor population). The safety endpoint was major bleeding or other clinically relevant bleeding, assessed in the per-protocol population. We assumed a 3% annual thromboembolism incidence and a non-inferiority margin of 2·5%. This trial is registered with ClinicalTrials.gov, number NCT01565239.
Between March 1, 2012, and Feb 28, 2014, we enrolled 1156 patients. 573 patients were assigned to Fiix-PT and 575 to PT-INR monitoring after exclusion of four patients from each group for various reasons. Median follow-up was 1·7 years (IQR 1·1-1·9). During days 1-720, ten (1·2% per patient year) thromboembolic events occurred in the Fiix-PT group versus 19 (2·3% per patient year) in the PT group (relative risk RR 0·52, 95% CI 0·25-1·13; pnon-inferiority<0·0001). Major bleeding occurred in 17 of 571 patients in the Fiix group (2·2% per patient year) versus 20 of 573 patients in the PT group (2·5% per patient year; RR 0·85, 0·45-1·61; pnon-inferiority=0·0034). Anticoagulation stability was improved with Fiix-PT monitoring as manifested by fewer tests, fewer dose adjustments, increased time in range and less INR variability than reported with standard PT monitoring.
Monitoring of warfarin with Fiix-PT improved anticoagulation and dosing stability and was clinically non-inferior to PT monitoring. Results from this trial suggest that during vitamin K antagonist treatment INR monitoring could be replaced by Fiix-PT and that this would lead to at least a non-inferior clinical outcome compared with monitoring with PT-INR.
Innovation Center Iceland, University of Iceland Science Fund, Landspitali Science Fund and Actavis.
Growth references for Norwegian children Júlíusson, Pétur B; Roelants, Mathieu; Eide, Geir Egil ...
Tidsskrift for den Norske Lægeforening,
2009-Feb-12, 20090212, Volume:
129, Issue:
4
Journal Article
Peer reviewed
The growth charts currently used in Norway, are based on measurements from the 1970s and 80s. New data are available from the Bergen Growth Study collected in 2003 - 6. In 2006, WHO published ...international charts for 0-5 year-old children.
New growth charts based on data from the Bergen Growth Study and the Medical Birth Registry of Norway are presented for children aged 0-19 years. These were compared with existing references and with the WHO curves.
Norwegian children aged 0-4 years have length, height and weight measurements that are only marginally different from those in the Norwegian growth charts in current use. In older children there has been an increase in the 50-percentile for height up to 3.4 cm in boys and 2.5 cm in girls. For children older than four years, weight for height has increased, especially for the upper percentiles. The percentile lines in the new Norwegian reference are generally positioned above the WHO standard for weight at birth, and for length/height, weight and head circumference in the age group 6 months to 5 years.
The secular trends in growth mirror the need for new charts. The fact that Norwegian children differ from the WHO standards may reflect population differences relating to environment or growth potential between the populations.
Aims: To examine differences between children with obesity and normal weight children (aged 7–13 years) in terms of physical activity, screen time, food intake and blood parameters indicative of ...cardio‐metabolic risk. Further, to explore the relationship between physical activity, screen time and food intake with cardio‐metabolic parameters.
Methods: Forty‐three children with obesity were compared with 43 normal weight peers. Physical activity was monitored by accelerometers and screen time and food intake by diaries. Blood parameters indicative of cardio‐metabolic risk were analysed.
Results: The group of children with obesity had significantly less vigorous activity (p = 0.013), more daily screen time (p = 0.004) and consumed more fat (p = 0.04) than the group of normal weight children. The former group also demonstrated higher values of triglycerides (p = 0.001), HbA1c (p = 0.009), C‐peptide (p = 0.001), had a higher HOMA‐R score (p = 0.001), and lower levels of HDL (p = 0.001). After controlling for weight category, regression analyses revealed that screen time was significantly and positively related to the HOMA‐R score and C‐peptide levels independent of physical activity and intake of fat and sugar.
Conclusions: The results indicate that screen time is an important behavioural factor related to obesity and cardio‐metabolic risk indicators in children.
Full text
Available for:
BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
Load filters
No result was selected!
Please select the results that you wish to export.
The search was successfully saved.
Editing
The search could not be saved.
Saved searches can be viewed in the list My searches.
The changes made to the saved search were saved successfully.
Save search
Shelf entry
No result was selected!
Adding material to shelf was successful.
Adding material to shelf was partly successful.
Adding material to shelf failed completely.
It was not necessary to add the material to the shelf.
Please select the results that you want to put on shelf!
On shelf the following records have been successfully added:
On shelf the following records have been successfully added:
PDF
