Hemophilia Medication Might Benefit Patients With Intracerebral Hemorrhages, Study Finds
A medication approved for treating hemophilia reduced mortality in people with intracerebral hemorrhages by 38% and reduced additional bleeding by 50%, compared with those taking a placebo, according to results of a Phase II clinical trial published in Thursday's New England Journal of Medicine, the Wall Street Journal reports. For the trial, researchers led by Columbia University neurologist Stephan Mayer gave Novo Nordisk's Factor VIIa to stroke patients at 73 hospitals in 20 countries.
Of 399 patients with intracerebral hemorrhages, in which bleeding occurs after a small artery in the brain ruptures, 96 received a placebo, and the remainder were divided into three groups that received different doses of Factor VIIa, marketed under the brand-name NovoSeven. After 90 days, 29% of patients taking the placebo died, compared with 18% in the NovoSeven groups.
In addition, 69% of patients in the placebo group died or became severely disabled, compared with 55%, 49% and 54% in the NovoSeven groups. For patients taking NovoSeven, the volume of bleeding and blood clots decreased by 50%, meaning less pressure and damage to a patient's brain tissue and a better chance for the patient to resume a normal life.
Only about 20% of patients with intracerebral hemorrhages generally are able to completely recover, the Journal reports. Serious blood clots increased from 2% in placebo patients to 7% for patients taking NovoSeven, though researchers say the treatment's potential benefits outweigh that risk. Researchers found that NovoSeven "within four hours after the onset of the intracerebral hemorrhage limits the growth of the hematoma, reduces mortality and improves functional outcomes at 90 days."
FDA officials declined to comment on whether NovoSeven would be put on the fast-track approval process. According to the Journal, FDA generally "insists on two confirmatory studies before approving a drug" (Burton, Wall Street Journal, 2/24).
Mayer said it would be at least two years before the company seeks FDA approval, and a 580-patient Phase III trial is scheduled to begin this summer.
Mayer said he was "fairly amazed" about "how well this drug worked" (Chang, AP/Las Vegas Sun, 2/24).
Owen Samuels, director of neuroscience critical care at Emory University, called the study results potentially "the greatest advance in treating intracranial hemorrhage, ever."
But Gregory Albers, director of Stanford University's stroke center, said that while the results are "very impressive for phase II study data," there have been many promising stroke treatments that later failed (Wall Street Journal, 2/24).
The study is available online.