Bayer's Trasylol safe for some heart patients-study

By Michael Kahn

LONDON, Feb 8 (Reuters) - Bayer AG's BAYG.DE anti-bleeding drug Trasylol appears safe in certain heart procedures, according to a study suggesting the treatment linked to kidney damage -- and even death -- poses little risk for some people.

A British team wrote in the Lancet medical journal published on Friday the drug appeared safe for people undergoing on-pump bypass surgery where a machine keeps a person's heart beating during the operation.

But the risk of severe kidney damage remained for patients taking ACE inhibitors, a type of high-blood pressure drug, who undergo off-pump surgery in which doctors attach a device to the heart to keep it beating.

"With our trial we identified a smaller population where there is a risk," said Kai Zacharowski, an anaesthesiologist at the Bristol Royal Infirmary, who led the study. "We also showed in a large population there is no risk if it is used in the appropriate way."

The findings come after Germany's Bayer in November temporarily suspended global marketing of Trasylol after preliminary results from a Canadian study linked its use to higher risk of kidney damage and death.

The drug, approved in 1993 and known generically as aprotinin, is designed to prevent blood loss in patients with an increased risk for blood loss during heart bypass surgery.

In their study of nearly 10,000 patients who had heart surgery between 2000 and 2007, the British team looked at whether Trasylol was associated with kidney damage -- one of the main problems with the treatment.

KIDNEY LINK

They found no significant link between the drug and post-operative kidney problems in the more than 5,000 patients who had on-pump surgery, regardless of whether they were on ACE inhibitors.

But in the nearly 850 patients taking the widely used blood-pressure medication who had the other type of heart surgery, Trasylol was associated with a greater than two-fold increase in kidney damage risk.

The researchers do not know exactly why but ACE inhibitors have a known impact on kidney function and Trasylol could somehow be aggravating this effect, Zacharowski said.

The findings are important because the drug works but has been restricted in the United States and Europe following the the Canadian study, Derek Hausenloy, a researcher at the Hatter Cardiovascular Institute in London, wrote in a commentary.

But this means some patients at highest risk of bleeding may not be receiving the best possible treatment, and the new study offers evidence the drug may be safe for some people, he and his colleagues wrote in the Lancet.

"(The researchers) provide reassuring evidence that aprotinin use does not worsen postoperative (kidney) function in this group of patients," they wrote. (Reporting by Michael Kahn, Editing by Maggie Fox and Sue Thomas)