FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock

American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions
Fortunato SenatoreNorman Stockbridge

Abstract

Distributive shock is a subset of shock marked by decreased systemic vascular resistance, organ hypoperfusion and altered oxygen extraction. Despite the use of intravenous fluids and either higher dose of catecholamines or other additional exogenous vasopressors to maintain blood pressure in the target range, the rate of mortality remains higher in patients with septic shock. Therefore, there is clearly an unmet need for additional safe and effective treatments. The use of angiotensin II to raise the mean arterial pressure (MAP) could provide additional therapy and the opportunity to evaluate a catecholamine-sparing effect by decreasing the dose of concomitant catecholamines while maintaining a target MAP. ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock phase 3; ClinicalTrials.gov number, NCT02338843) was an adequate and well-controlled trial. The primary endpoint was the rate of MAP response at hour 3 of treatment with study drug, defined as either a 10-mmHg increase from baseline in MAP or a MAP of at least 75 mmHg. The secondary endpoints were changes from baseline in Sequential Organ Failure Assessment (SOFA) scores (total and cardiovascular). Mortality was an exploratory endpoint. The trial provided substant...Continue Reading

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Citations

Aug 24, 2019·Nature Reviews. Nephrology·Beatriz Desanti De OliveiraPrasad Devarajan
Apr 22, 2020·PloS One·Gwendolyn VliegenIngrid De Meester
Aug 21, 2020·Seminars in Respiratory and Critical Care Medicine·James A RussellNiranjan Kissoon
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Aug 29, 2021·Journal of Cardiothoracic and Vascular Anesthesia·Amit AlamJennifer L Mooney

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