{"id":403,"date":"2010-11-01T00:00:01","date_gmt":"2010-11-01T00:00:01","guid":{"rendered":"https:\/\/awge.doctime.es\/?p=403"},"modified":"2016-05-24T08:21:07","modified_gmt":"2016-05-24T06:21:07","slug":"awge-57","status":"publish","type":"post","link":"https:\/\/awge.doctime.es\/index.php\/2010\/11\/01\/awge-57\/","title":{"rendered":"Safety of Recombinant Activated Factor VII in Randomized Clinical Trials"},"content":{"rendered":"

N Engl J Med
\nMarcel Levi, M.D., Jerrold H. Levy, M.D., Henning Friis Andersen, M.Sc., and David Truloff, D.V.M.
\nAcceso al enlace publicador<\/a><\/p>\n

Background
\nThe use of recombinant activated factor VII (rFVIIa) on an off-label basis to treat life-threatening bleeding has been associated with a perceived increased risk of thromboembolic complications. However, data from placebo-controlled trials are needed to properly assess the thromboembolic risk. To address this issue, we evaluated the rate of thromboembolic events in all published randomized, placebo-controlled trials of rFVIIa used on an off-label basis.
\nMethods
\nWe analyzed data from 35 randomized clinical trials (26 studies involving patients and 9 studies involving healthy volunteers) to determine the frequency of thromboembolic
\nevents. The data were pooled with the use of random-effects models to calculate the odds ratios and 95% confidence intervals.
\nResults
\nAmong 4468 subjects (4119 patients and 349 healthy volunteers), 498 had thromboembolic events (11.1%). Rates of arterial thromboembolic events among all 4468
\nsubjects were higher among those who received rFVIIa than among those who received placebo (5.5% vs. 3.2%, P = 0.003). Rates of venous thromboembolic events
\nwere similar among subjects who received rFVIIa and those who received placebo (5.3% vs. 5.7%). Among subjects who received rFVIIa, 2.9% had coronary arterial
\nthromboembolic events, as compared with 1.1% of those who received placebo(P = 0.002). Rates of arterial thromboembolic events were higher among subjects
\nwho received rFVIIa than among subjects who received placebo, particularly among those who were 65 years of age or older (9.0% vs. 3.8%, P = 0.003); the rates were
\nespecially high among subjects 75 years of age or older (10.8% vs. 4.1%, P = 0.02).
\nConclusions
\nIn a large and comprehensive cohort of persons in placebo-controlled trials of rFVIIa,treatment with high doses of rFVIIa on an off-label basis significantly increased the
\nrisk of arterial but not venous thromboembolic events, especially among the elderly.
\n(Funded by Novo Nordisk.)<\/p>\n","protected":false},"excerpt":{"rendered":"