FDAnews
www.fdanews.com/articles/74935-protamine-safer-than-new-blood-thinning-drug

PROTAMINE SAFER THAN NEW BLOOD-THINNING DRUG

August 2, 2005

The results of an international clinical trial led by Duke University Medical Center researchers has shown that a new drug is not a suitable replacement for protamine, a drug that has been used for more than 40 years after coronary artery bypass surgery to return thinned blood to its normal state.

While protamine is effective in reversing the blood-thinning properties of heparin, recent studies have shown that its use can cause changes in blood pressure, which have been linked to increased mortality in some patients. In addition to its negative effects on blood pressure, protamine can also depress heart function, activate certain immune responses, and lead to pulmonary hypertension, the researchers said. However, they emphasized, the drawbacks of protamine do not compromise the overall success of heart bypass surgery, and patients should not be overly concerned by those drawbacks.

The latest candidate alternative to protamine is heparinase I, a compound naturally produced by Flavobacterium heparinum, a bacterium commonly found in soil and water. The bacterial enzyme from which heparinase I is derived deactivates heparin through a mechanism different than protamine.