“We’ve never seen a drug have that kind of impact on stroke mortality,” said Yale neurologist Kevin Sheth, co-principal investigator of the randomized, double-blinded, placebo-control trial conducted at 18 sites nationally.
About 10% to 15% of the 800,000 Americans who suffer strokes annually suffer from large, ischemic strokes, in which blood clots develop dangerous levels of swelling in the brain. About half of these patients end up dying.
The trial assessed impact of a reformulated version of the drug glyburide, which has been used to treat diabetes for decades. The intravenous drug Cirara™ is delivered in a three-stage dosing regimen designed to target swelling following a central nervous system injury.
Brain swelling was reduced by 50% in patients who took the study drug, based on the most commonly accepted measure of swelling following a stroke. The frequency of emergency decompressive craniectomies — surgical procedures in which part of the skull is removed to reduce internal pressure from swelling common to large, ischemic strokes — was not reduced among those given Cirara. However, mortality was reduced in subjects receiving the drug whether they underwent the procedure or not.
Remedy Pharmaceuticals, which makes Cirara, sponsored the trial.
Sheth has no financial ties to Remedy.