Factor VIIa

Todd Fraser on 09-12-2010

Over the last few years a number of very useful interventions in ICU have gone from evidence based to obselete - Steroids in severe sepsis, Activated Protein C, tight glycaemic control to name a few. But its always been reassuring that we intensivists have retained the right to pull out the "magic bullets" that no-one else has. Until recently, Factor VIIa had been one of them. I can clearly recall several occasions where I've unleashed the Novomagic, with compelling results (Andectodal-Based Medicine). Data obtained from the factor VII registry appeared to support its use, but disappointing results in a number of clinical trials have recently appeared. Recently, a Canadian systematic review of Off Label use of Factor VIIa has shown trivial benefit. So what now? Tranexamic acid recently had a boost in the trauma setting (see the paper in our library), but larger trials await. Do you use Factor VIIa? In whom?

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Todd Fraser wrote 04-28-2011 12:01:07 pm
Novoseven continues to take the hits - two new papers (April 2011) have again underscored the lack of evidence for this agent.

The papers by Logan and Yank can be found in the Journal Club

alexander browne wrote 06-29-2011 10:35:10 pm
SAFETY OF RECOMBINANT ACTIVATED FACTOR VII IN RANDOMIZED CLINICAL TRIALS

Levi, M., et al, N Engl J Med 363(19):1791, November 4, 2010

BACKGROUND: Recombinant factor VIIa (rFVIIa, Novo Seven [Novo Nordisk]) has been approved for control of bleeding in patients with hemophilia but extensive off-label use has been reported. The risk of thromboembolic complications is a major safety concern in patients treated with this agent.

METHODS: These multinational authors, coordinated in the Netherlands and funded by Novo Nordisk, examined rates of thromboembolic events in 35 randomized, controlled trials involving 4,468 patients treated with off-label rFVIIa or placebo.

RESULTS: All but six of the trials were sponsored by Novo Nordisk. The overall rate of thromboembolic events was 10.2% in patients receiving rFVIIa and 8.7% in controls (odds ratio [OR] 1.17). Corresponding rates of arterial thromboembolic events were 5.5% vs. 3.2% (OR 1.68), and these events most often involved coronary thrombosis (OR 2.39). The risk of an arterial thromboembolic event was increased in patients aged 65 or older (9.0% vs. 3.8%, OR 2.43) and particularly in those aged 75 or older (OR 3.02). Additional risk factors for arterial thromboembolic events included administration of rFVIIa for the treatment of spontaneous CNS bleeding (8.6% vs. 5.4% in controls, OR 1.67). In the group treated for spontaneous CNS bleeding a dose-dependent effect of rFVIIa was observed, with arterial thromboembolic events occurr

Todd Fraser wrote 06-30-2011 11:52:49 am
Oh dear.

It's a bit hard to continue to justify its use outside the context of an RCT isn't?