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GIAPREZA (ANGIOTENSIN II) INJECTION

In December 2017, GIAPREZA (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA mimics the body's endogenous angiotensin II peptide. This peptide is central to the

renin-angiotensin-aldosterone system (RAAS), which regulates blood pressure.

 
 

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PIVOTAL CLINICAL STUDY

Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) was a multinational, randomized, double-blind study in which 321 adults with septic or other distributive shock who remained hypotensive despite fluid and vasopressor therapy received either GIAPREZA or placebo, both in addition to background standard-of-care vasopressors (Khanna et al, New England Journal of Medicine 2017; 377:419-430). The primary endpoint was mean arterial pressure (MAP) response, defined as a MAP of 75 mm Hg or higher or an increase in MAP from baseline of at least 10 mm Hg without an increase in the dose of background vasopressors at Hour 3.