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(Stroke. 2005;36:2527.)
© 2005 American Heart Association, Inc.

Editorials

From Trials to "Real Life"

Necessity of Efficacy

Charlotte Cordonnier, MD

From the Department of Neurology and Stroke Unit, Lille University Hospital, France.

Correspondence to Dr Charlotte Cordonnier, Department of Neurology and Stroke Unit, Hôpital Roger Salengro. Lille University Hospital, 59037 Lille Cedex, France. E-mail charlotte.cordonnier2@wanadoo.fr

Key Words: intracerebral hemorrhage

An extract of the first 250 words of the full text is provided, because this article has no abstract.

See related article, pages 2660–2664

Primary intracerebral hemorrhage (ICH) is a devastating disease with a very poor outcome: 40% of patients will die within the first month, and two thirds of survivors will never regain independency.¹ To date, there is no specific treatment beyond supportive medical care. Recently, recombinant factor VIIa (rFVIIa) was tested in phase 2 trials in ICH patients:^2,3 the results of the largest phase II trial are encouraging in terms of safety issues and open a new area for the management of ICH because this trial provides some efficacy data.²

In this issue of Stroke, Flaherty et al⁴ discuss the potential applicability of rFVIIa in a population-based registry of ICH and suggest that 13.1% to 17.5% of patients with primary ICH may be eligible for this treatment. Taking into account epidemiological data⁵ and Flaherty’s results,⁴ 5 to 6 patients might be eligible each year in a Western population of 100 000 inhabitants. This study is of major importance because the successful translation of new treatments from trials into "real life" is of crucial importance.

However, we should bear in mind that the trial suggesting efficacy of rFVIIa only enrolled 399 patients and was designed to evaluate safety and not efficacy of the drug.

By projecting the results on a population-based registry, the authors underline the burden of the disease and how far we are in the management of primary ICH. If rFVIIa is proven effective in a large randomized trial, we will have to rethink . . . [Full Text of this Article]

Related Article:

Potential Applicability of Recombinant Factor VIIa for Intracerebral Hemorrhage

Matthew L. Flaherty, Daniel Woo, Mary Haverbusch, Charles J. Moomaw, Padmini Sekar, Laura Sauerbeck, Brett Kissela, Dawn Kleindorfer, and Joseph P. Broderick
Stroke 2005 36: 2660-2664. [Abstract] [Full Text] [PDF]