Higher Risk of Brain Hemorrhage In Acute Ischemic Stroke Patients Treated With ReoPro
On October 28, 2005 Eli Lilly & Co. and Johnson & Johnson's Centocor unit announced that they had permanently stopped a late-stage trial of ReoPro, a blood-clot drug being investigated for the treatment of acute ischemic stroke patients. The reason given by the drug companies was that an independent safety committee had found a higher-than-expected rate of brain hemorrhaging among the 808 patients enrolled in the trial.
The history of this emerging safety issue started in May 2005, when ReoPro treatment was stopped for a small arm of this ReoPro Phase III clinical trial because of a higher risk of brain hemorrhage. At that time, the independent safety committee recommended continuing enrollment for this ReoPro trial, but with a wider group of stroke patients. Next, on October 4, 2005 Eli Lilly & Co. ("Lilly") and Johnson & Johnson ("J&J") said that they had temporarily suspended enrollment for this ReoPro clinical trial. Then, in late October, after reviewing more data from the ReoPro trial, the safety committee recommended stopping enrollment permanently.
Lilly and J&J both said in late October 2005 that they agreed with the safety committee's recommendation to permanently discontinue enrollment in this ReoPro stroke trial.
As background, it is estimated that about 85 percent of all strokes are "ischemic", meaning that the stroke was caused by a blood clot or plaque that blocks a blood vessel in the brain. At present, there are drug therapies used to treat patients within three hours of suffering an ischemic stroke, but most patients fail to make it to the hospital within the three-hour window. Lilly and J&J said that the purpose of their ReoPro stroke trial was to study whether ReoPro could be use to treat patients who suffered their acute ischemic stroke at least four-and-a-half hours earlier, i.e., outside the three-hour window period.
Because the information about which stroke patients took ReoPro and not the placebo in this drug trial will not be revealed until March 2006, it is unknown at present how many of the stroke patients taking ReoPro suffered hemorrhaging.
ReoPro was approved by the FDA in 1994 for use when patients are undergoing heart procedures to clear clogged arteries. As part of their announcement in late October 2005 about the ReoPro stroke trial being halted, Lilly and J&J said they are not aware of any new data to question ReoPro's safety in the context of this approved use.
(Posted by: Tom Lamb)