Bayer's Trasylol seen unlikely to be sold again
By Gene Emery
BOSTON (Reuters) - Trasylol, which Bayer (BAYG.DE: Quote, Profile, Research) withdrew from the market when evidence showed it raised the risk of death, is not likely to be sold again to reduce bleeding in high-risk heart surgery, according to a long-awaited study and commentary published on Wednesday.
The Canadian study, released online by the New England Journal of Medicine, showed patients given Trasylol had a more than 50 percent higher death rate than patients who got other, cheaper drugs.
"Thus, in all likelihood, this is the end of the aprotinin story," Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University in Tennessee wrote in the commentary.
The expensive drug, also known by its generic name aprotinin, has been widely used since the 1990s during heart bypass surgery. Bayer pulled the drug in November, saying it would reevaluate its options once details from the new study, known as BART, were released.
In the comparison with two other cheaper drugs, tranexamic acid, sold by Pfizer (PFE.N: Quote, Profile, Research) under the brand name Cyklokapron, and aminocaproic acid, sold by Xanodyne as Amicar, the death rate among Trasylol patients was 53 percent higher at the 30-day mark, even though Trasylol seemed to do a slightly better job of controlling bleeding.
"Of the 108 patients who died, the proportion who were believed to have died of cardiogenic shock, right ventricular failure, congestive heart failure or myocardial infarction (heart attack) was higher in the aprotinin group than in the other two groups," Dean Fergusson of the Ottawa Health Research Institute and colleagues wrote.
There was even a suggestion from the data that healthier patients -- those under 65 and without a coexisting illness -- also faced a higher risk of death, they reported.
Aprotinin treatment cost $1,200 to $1,500, compared to $150 for the other two drugs, a major savings when there are more than a million heart procedures worldwide each year. Continued...
© Thomson Reuters 2008. All rights reserved. | Learn more about Thomson Reuters

