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Bring Rapidly Degradable Hydroxyethyl Starch to the United States

Kozek-Langenecker, Sibylle M.D.

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In Reply:—

I appreciate Drs. Tang, Pittet, and Ganter’s interest in my article on the effects of hydroxyethyl starch (HES) solutions on hemostasis1 and their interesting comments. I agree completely with these authors that the availability of HES solutions varies considerably among the continents. In the United States, slowly degradable HES preparations are currently approved for perioperative intravascular volume expansion, whereas in Europe, a variety of new-generation rapidly degradable HESs are approved and widely popular. The reason for the different approaches, however, remains unclear to me.
My article was by no means intended to frustrate American readers of Anesthesiology. My aim was to elaborate on the effects of HES preparations on cellular and humoral coagulation and to derive some practical recommendations. In contrast to Dr. Tang et al., I am convinced that these logical conclusions are useful and advisable. The urgent call for rapidly degradable HES as a suitable volume expander with adequate volume efficacy and low risk of hemostatic side effects from overseas colleagues is easy to understand. How to implement supply and availability on the market, however, is beyond the scope of my article. These issues have to be tackled by the national anesthesiologic societies and the respective authorities. Until now, rapidly degradable HES solutions have already been used for scientific purposes in the United States.2 I strongly believe that such large-scale overseas studies using rapidly degradable HES in connection with our European experience will pave the way to Food and Drug Administration approval.
Sibylle Kozek-Langenecker, M.D.
Medical University of Vienna, Vienna, Austria.
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1. Kozek-Langenecker SA: Effects of hydroxyethyl starch solutions on hemostasis. Anesthesiology 2005; 103:654–60

2. Gandhi S, Warltier D, Weiskopf R, Bepperling F, Baus D, Jungheinrich C: Volume substitution therapy with HES 130/0.4 (Voluven®) versus HES 450/0.7 (hetastarch) during major orthopedic surgery. Critical Care 2005; 9:P206

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