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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.

Please see full GIAPREZA FDA prescribing information for additional safety information.

66% 16% 16% 2% Vasodilatation Distributive shock Loss of plasma or blood volume Hypovolemic shock Ventricular failure Cardiogenic shock Pericardial tamponade Obstruction Obstructive shock
Distributive Shock Is a Leading Cause of Death in Hospitalized Patients
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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 vasopressor therapy (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. 

Multinational, Randomized, Double-Blind, Placebo-Controlled 321 Randomized and Treated Primary Endpoint : MAP response of ≥75 mm Hg or an increase from baseline of ≥10 mm Hg at Hour 3, without an increase in the dose of background vasopressors Patients not adequately responding to standard of care Patients with distributive shock despite adequate volume resuscitation over the previous 24 hours and administration of high-dose vasopressors (>0.2 mcg/kg/min of norepinephrine-equivalent dose) and who had a MAP between 55 and 70 mm Hg GIAPREZA Placebo
Median MAP, mm Hg (IQR) Europe (%) Placebo (N=158) 120 (75.9%) 132 (83.5%) 29 (22-34) 66.3 (63.0-68.3) 24 (15.2%) 65 (53-75) 14 (8.9%) 0.34 (0.23-0.56) 111 (70.3%) All Patients (N=321) 236 (73.5%) 259 (80.7%) 28 (22-33) 66.3 (63.7-68.7) 52 (16.2%) 64 (52-75) 33 (10.3%) 0.34 (0.23-0.56) 224 (69.8%) GIAPREZA (N=163) 63 (52-75) 19 (11.7%) 0.33 (0.23-0.56) 66.3 (63.7-69.0) 28 (17.2%) 116 (71.2%) 127 (77.9%) 27 (22-33) 113 (69.3%) Geographic region Median APACHE II score (IQR) Australia or New Zealand (%) Median age, yr. (IQR) United States or Canada (%) Cause of shock, sepsis (%) Median vasopressor dose (NED), mcg/kg/min (IQR) Vasopressin use during 6 hours before randomization (%)
Ability to Rapidly Achieve and Adjust Therapeutic Response 5 MIN <1 MIN
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