Saturday, July 16, 2011

The ATRIA Risk Prediction Score - A New Tool to Predict Bleeding Risk from Warfarin in Kidney Patients and Others.

A new 5-variable score, developed by Margaret Fang, MD, MPH, of the University of California San Francisco, and colleagues, outperformed six other published and validated risk scores in predicting the risk of warfarin-associated hemorrhage in patients with atrial fibrillation.

Five independent variables were included in the final model and weighted by regression coefficients: anemia (3 points), severe renal disease (e.g., glomerular filtration rate <30 ml/min or dialysis-dependent, 3 points), age 75 years (2 points), prior bleeding (1 point), and hypertension (1 point). Major hemorrhage rates ranged from 0.4% (0 points) to 17.3% per year (10 points). Collapsed into a 3-category risk score, major hemorrhage rates were 0.8% for low risk (0 to 3 points), 2.6% for intermediate risk (4 points), and 5.8% for high risk (5 to 10 points). The c-index for the continuous risk score was 0.74 and 0.69 for the 3-category score, higher than in the other risk schemes. There was net reclassification improvement versus all 6 comparators (from 27% to 56%).

Ref: Fang M, et al "A new risk scheme to predict warfarin-associated hemorrhage: The ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) study" J Am Coll Cardiol 2011; 58: 395-401.

Tuesday, June 28, 2011

FDA approves a novel anti-rejection medication for kidney transplant recipients.

The US Food and Drug Administration (FDA) approved Belatacept (Nulojix, Bristol-Myers Squibb Company) on June 15th, 2011, for the prevention of acute rejection in adult patients who have had a kidney transplant.

This novel biologic agent is a fusion protein composed of the Fc fragment of a human IgG1 immunoglobulin linked to the extracellular domain of CTLA-4. It is an antagonist of the B7 ligands, B7-1 (CD80) and B7-2 (CD86), present on antigen-presenting cells. The CD80 and CD86 are essential precursors to the initiation of "signal 2" in the three-signal transplant model of T-cell activation, This antagonistic effect results in the inability to produce effector cytokines, such as interleukin (IL)-2, and results in inhibition of T-cell activation.It is given in 30-minute intravenous infusions.

Belatacept is approved for use with corticosteroids and the immunosuppressant agents basiliximab and mycophenolate mofetil.

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