Thromboembolic events a risk in off-label use of rFVIIa
- PDF / 142,226 Bytes
- 1 Pages / 595.245 x 841.846 pts (A4) Page_size
- 26 Downloads / 171 Views
1
Thromboembolic events a risk in off-label use of rFVIIa Patients who receive recombinant activated factor VII (rFVIIa) on an off-label basis are at significant risk of experiencing arterial thromboembolic events, according to a study conducted by researchers from The Netherlands and the US, and published in the NEJM.1 The researchers analysed data from 35 randomised, placebo-controlled trials to assess the frequency of thromboembolic events occurring among patients who received rFVIIa off-label to treat life-threatening bleeding, or among healthy volunteers involved in evaluating the efficacy of rFVIIa in reversing drugs that alter the clotting mechanism. Pooled analysis showed that thromboembolic events occurred in 498 of 4468 subjects (11.1%). Rates of arterial thromboembolic events were higher among rFVIIa recipients than placebo recipients (5.5% vs 3.2%; p = 0.003), although rates of venous events were similar (5.3% vs 5.7%). The rate of coronary arterial thromboembolic events was 2.9% among rFVIIa recipients, compared with 1.1% among placebo recipients (p = 0.002). Elderly rFVIIa patients exhibited particularly high rates of arterial thromboembolic events versus placebo, at 9.0% vs 3.8% for those aged ≥ 65 years and 10.8% vs 4.1% for those aged > 75 years.
"Informative and unusual" In a commentary published alongside the study, Dr Louis M Aledort from Mount Sinai School of Medicine, New York, declares this analysis to be "both informative and unusual", in that it uses data from all published studies from off-label, prospective trials.2 Dr Aledort says that the thrombotic sequelae reported here "are not inconsequential", particularly among older patients. As such, he contends that this study "should serve as a template for pharmaceutical companies to report all studies involving the use of a given drug, on-label and off-label", in order for physicians to "fully appreciate the benefit and risks when making therapeutic decisions". 1. Levi M, et al. Safety of recombinant activated factor VII in randomized clinical trials. New England Journal of Medicine 363: 1791-800, No. 19, 4 Nov 2010. Available from: URL: http://dx.doi.org/10.1056/nejmoa1006221. 2. Aledort LM. Off-label use of recombinant activated factor VII--safe or not safe? New England Journal of Medicine 363: 1853-4, No. 19, 4 Nov 2010. Available from: URL: http://dx.doi.org/10.1056/nejme1008857. 801108806
0114-9954/10/1327-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved
Reactions 13 Nov 2010 No. 1327
Data Loading...
