Drug used in cardiac surgery increases death rate

February 21st, 2008 - 12:22 pm ICT by admin  

New York, Feb 21 (IANS) A controversial cardiac surgery drug increases death rates and damages kidney function, according to a study by Duke University Medical Centre researchers. Aprotinin, a drug used for inhibiting bleeding, was temporarily suspended in the US in November 2007 after similar reports surfaced elsewhere.

The Duke study, based on data collected between 1996 and 2005, is twice as exhaustive as another large study of Aprotinin, said Andrew Shaw of the medical centre.

Findings of the study appear in the latest issue of the New England Journal of Medicine.

Of the 10,275 patients studied in the new study, 1,343 (13.2 percent) received Aprotinin, 6,776 (66.8 percent) received Aminocaproic acid - another drug used to limit bleeding - and 2,029 (20.0 percent) received no therapy.

All patients underwent coronary-artery bypass surgery (CABG), and 1,181 of them also underwent valve surgery.

Patients who received either Aminocaproic acid or no therapy did not have high rates of death or poor kidney function seen in the Aprotinin group.

“Unlike randomised trials, our data represent everyday cardiac bypass surgery patient population. The data were collected at a time when Aprotinin was thought to be safe,” said Shaw.

The Duke University team started analysing its database after a 2006 study reported that Aprotinin use was likely to increase risk of heart attack, stroke and serious kidney injury.

“We found an increased incidence of death in patients who received Aprotinin. It seemed to persist even when we were able to control for the differences seen between the patient groups,” said Shaw.

Shaw and his colleagues also linked Aprotinin to impaired kidney function.

“Kidney function is measured by serum creatinine levels which indicate how well the blood is filtering waste products,” he said.

The study found Aprotinin use increased serum creatinine levels, but they did not report an increase in patients requiring dialysis.

After gaining approval of the US Food and Drug Administration (FDA) in 1993, Aprotinin was used routinely during cardiac surgery, particularly on high-risk patients, to reduce bleeding and the need for blood transfusion.

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