NovoSeven shows promise for hemorrhagic stroke
Drug given within four hours after onset
New research is showing that recombinant factor VIIa [rFVIIa] (NovoSeven) shows promise in the treatment of intracerebral hemorrhage (ICH). The Phase IIb study demonstrated that the use of the hemophilia drug in ICH patients led to a significant reduction in hematoma growth when given within four hours of onset.
ICH is the most deadly and least treatable form of stroke. Researchers say these are the first positive results seen in any ICH trial.
"There is no question that NovoSeven is a major advance in the field of ICH research," said Stephan Mayer, MD, associate professor of neurology and neurosurgery at Columbia University in New York City. Mayer, who presented the findings in June at the 5th World Stroke Congress in Vancouver, Canada, also is director of the Neurological Intensive Care Unit at the Columbia-Presbyterian Campus of New York Presbyterian Hospital. "These trial data, which suggest the historical lack of recognized treatment for ICH may soon be at an end, will be welcomed worldwide. This could benefit many thousands of lives a year."
The international ICH trial began in August 2002 and involved 400 patients in a multicenter, randomized, double-blind, placebo-controlled trial. Patients were divided into four groups of 100 patients, comparing three doses of rFVIIa (40, 80, and 160 µg/kg) with placebo. Patients all had spontaneous ICH confirmed by computed tomography (CT) scan within three hours of onset, and were treated within one hour of the admission CT scan. The outcome measures were change in ICH volume between admission and 24-hour CT scans, the proportion of patients who were dead or severely disabled at 90 days, and overall adverse effects over the study period.
Researchers say that rFVIIa travels to the ICH site through the circulatory system and accelerates the coagulation process from within. By doing this, rFVIIa can limit the hematoma size, which predicts the outcome for ICH patients. In the study, the patients treated with rFVIIa had significantly improved neurological and functional outcome after treatment. The treatment was associated with a minor, nonsignificant increase in thromboembolic events, but researchers say this is outweighed by highly significant clinical benefits across the trial.