TRASYLOL DOUBLES RISK OF KIDNEY FAILURE, SAYS STUDY
Bayer Pharmaceutical's blood-loss treatment Trasylol doubles a patient's risk of kidney failure and increases risks of heart attack, heart failure and stroke, says a study published recently in The New England Journal of Medicine (NEJM).
Trasylol (aprotinin), which has been on the market for 13 years, has been given to an estimated one million surgery patients to limit bleeding, according to the Ischemia Research and Education Foundation (IREF), whose study in association with the McSPI Research Group was the basis of the NEJM article, "The Risk of Aprotinin in Cardiac Surgery."
"Our study provides compelling evidence of aprotinin's serious risks, and strongly suggests discontinuation of use and replacement with either of the two alternative generic and far less costly medications proven safe in this study," said Dennis Mangano, founder and principal scientist of IREF and McSPI.
According to the study, replacing aprotinin with one of two safe generic drugs would annually prevent as many as 11,050 dialysis complications, save at least $1 billion in dialysis costs and reduce drug costs by at least $250 million. Trasylol's 2006 sales are projected to exceed $600 million, according to IREF.
The study also found that among primary surgery patients, aprotinin use increased risk of myocardial infarction by 48 percent, heart failure by 109 percent and stroke by 181 percent. Neither of aprotinin's generic competitors was associated with increased renal, cardiac or cerebral events, IREF said.
The study was based on observations at 69 leading cardiac centers and institutions in North and South America, Europe, the Middle East and Asia. Roughly 7,500 data fields were collected from 4,374 patients by independent McSPI investigators.
Responding to the findings, Bayer said it had just become aware of the observational study, and had not yet received or reviewed the data from which the authors derived their conclusions. "Therefore we cannot address their assertions in comprehensive detail," the company said recently.
"We can, however, clearly state that the results they have reported in terms of increases in renal failure, myocardial infarction, congestive heart failure and stroke or encephalopathy associated with use of aprotinin in patients undergoing coronary-artery surgery are not consistent with the more than 15 years of clinical data and experience Bayer has amassed on this drug," Bayer said.
Upcoming Events
-
23May
-
30May
-
13Jun
-
20Jun
-
21Oct