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Drug used in heart bypass surgery significantly increases risk of kidney failure - NEJM.

A drug prescribed annually to about 250,000 patients undergoing heart by-pass surgery doubles the risk of kidney failure, and also significantly increases the risk of heart failure, heart attack, and stroke, according to a study in the New England Journal of Medicine (NEJM).

The drug, aprotinin, sold under the brand name Trasylol, is widely used to prevent or reduce blood loss during the surgery. It is manufactured and marketed by Bayer Healthcare, Leverkusen, Germany.

The report was based on a massive trial consisting of 4,374 patients having bypass surgery in Canada, Columbia, Europe, Israel, Mexico, Thailand and the US. To limit blood loss aprotinin was given to 1,295 patients, and 1,705 received two alternative generic drugs - aminocaproic acid or tranexamic acid - that are as effective as but far less expensive than aprotinin. A control group of 1,374 patients received no drugs to prevent bleeding.

The study was led by Dennis Mangano, PhD, of the Ischemia Research and Education Foundation in San Bruno, CA, with colleagues in the Multi-center Study of Perioperative Ischemia Research Group. They found that compared to other patients, those treated with aprotinin had twice the rate of kidney failure, 5%, as the other drugs. They also experienced increases in heart attacks, heart failure, strokes, and encephalopathy.

The researchers estimated stopping the use of aprotinin globally, and replacing it with the generic drugs would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion annually in dialysis costs, as well as nearly $250 million spent on the drug itself. "It would be nearly impossible for me to recommend using the drug in this patient population," Mangano said.

The US Food and Drug Administration (FDA) issued a statement calling the study a "complicated analysis based on a large observational base." FDA spokesperson Susan Cruzan said the agency is examining the data "and will make recommendations for the best use as soon as possible," the New York Times reported.

In a statement on the NEJM study Bayer said the conclusions were "not consistent with the more than 15 years of clinical trial data and experience [the company] has amassed on Trasylol."

"Bayer has studied aprotinin in a series of prospective, randomized, double-blind, placebo-controlled clinical trials encompassing almost 6,500 open heart surgery patients worldwide (aprotinin N=3817, placebo N=2682)," the company said. "This study population is larger than the patient population in the study by Mangano et al." Bayer also said in a comparison of the two studies the company "did not see the increases in renal failure, myocardial infarction, congestive heart failure and stroke or encephalopathy associated with the use of aprotinin in patients undergoing coronary-artery surgery that were reported in the Mangano et. al., observational study."

In an editorial accompanying the study, Gus Vlahakes, MD, chief of the division of cardiac surgery at Massachusetts General Hospital, said "the study shows the drug has risks. You shouldn't give it to everybody having heart surgery."

Vlahakes called on the FDA to improve the safety of testing of drugs after they have been approved, charging that "too many pharmacologic agents have entered into clinical practice for which considerable and potentially life-threatening outcomes were recognized only after a large number of patients had been treated."

However, Vlahakes did say aprotinin should still be used for patients with unusual bleeding problems because it works better at stopping bleeding than the generic drugs.

Last year, sales of Trasylol totaled $200 million but this year Bayer has projected the drug's sales will be much higher, $600 million, The Times reported. The company is also studying Trasylol in hope of having it approved to prevent blood loss from hip replacement and spinal surgery.

Bayer said 150,000 patients in the US used the drug in 2005.
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Title Annotation:New England Journal of Medicine
Publication:Transplant News
Geographic Code:4EUUK
Date:Feb 13, 2006
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