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UK Part of Nationwide Study to Explore Promising New Drug for Stroke

by Jeff Worley

Stroke, the third leading cause of death in the United States, claims over half a million new victims each year and kills one third of these. Often the survivors are left paralyzed or unable to talk. They can no longer return to work or take care of themselves.

Now, however, a new treatment for stroke may help to reverse these statistics. In a recent nationwide study, a promising new medicine called citicoline was found to protect the brain from catastrophic damage after a stroke. Citicoline is made by the body and is a building block of cell membranes. A drug version was made for the study by Interneuron Pharmaceuticals in Lexington, Massachusetts.

The University of Kentucky Medical Center was one of 21 centers that participated in this study of 259 stroke patients. The patients were split up into four groups: three dosage groups (500, 1,000, and 2,000 milligrams of citicoline) and one group that was given a placebo. The drugs were administered for six weeks.

"The results of this study are very exciting, very promising," says Creed Pettigrew, a UK professor of neurology and head of the UK study. "In this study citicoline appeared to limit the size of a stroke, speed up recovery and improve victims' mental functioning."

Pettigrew explains that each of the centers that participated had a trained examiner assess a stroke patient exactly one week after admission to the hospital, then again at three, six and 12 weeks. Twenty-five different cognitive functions were measured, including tests of a patient's intellectual abilities -- concentration, memory and attention span. The citicoline patients scored 20 percent to 30 percent higher than the placebo group.

"We were pleased with what we saw," Pettigrew says. "Five of the 25 cognitive measures were dramatically helped by citicoline. As long as people took the drug, their cognitive performance got better in these five categories; once they stopped taking the drug, their performance scores dropped."

Of major importance in the study, he says, is the finding that citicoline appears to help injured membranes repair themselves, which limits cell death and paves the way for the brain to repair damaged circuits or create new ones to restore functions lost in the stroke. Brain tissue repair was measured at UK noninvasively, through use of magnetic resonance equipment.

"We can measure the volume of injured brain tissue this way," Pettigrew says. "And shrinkage of this volume correlates positively with people getting better faster. They can get back to work more quickly and stand a much better chance of taking care of themselves."

In addition to obvious health benefits, there is also the consideration of cost. Stroke often results in long hospital stays. "If a drug such as citicoline turns out to be as effective as we think it will, this could save billions of dollars annually in hospital and insurance costs," Pettigrew says.

Interneuron Pharmaceuticals has asked the U.S. Food and Drug Administration to approve citicoline as a drug that may be prescribed for stroke patients. "We hope the FDA will approve citicoline, though that approval, for now, is on hold," Pettigrew says.