Patient Deaths End Anti-Bleeding Studies
Marley Seaman, AP
Cubist Pharmaceuticals, Inc. says it has stopped enrolling patients in trials of a drug intended to reduce bleeding during heart surgery because of deaths among patients that took it.
Cubist said a data monitoring board wants to assess the difference between patients on the drug, and those who were on an alternative treatment. Overall, the rate of deaths in the studies was consistent with expected outcomes, and the causes of death were typical for a group of patients that was at a high risk for bleeding during cardiac surgery, the company stated.
The monitors suggested Cubist suspend enrollment in a study that compared the experimental drug to Cyklokapron, a drug that is approved in Europe to control bleeding. Cubist decided to stop enrolling patients in that study, and in a second study that compared its drug to a placebo.