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Post-hoc Analysis of the ATHOS-3 Clinical Trial

Patients on RRT at Baseline in the ATHOS-3 Trial Experienced Improved Outcomes1

Click here for the ATHOS-3 clinical trial design

ATHOS-3 Clinical Trial Design

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*There were statistically significant differences at baseline between the placebo group and the GIAPREZA group; including but not limited to significantly higher baseline MELD scores and higher baseline NED doses in the placebo group patients.

†Achievement of target MAP of at least 75 mmHg or increase of at least 10 mmHg from baseline without an increase in background vasopressor therapy. SoC in the ATHOS-3 trial was defined as > 0.2 mcg of norepinephrine per kilogram of body weight per minute or the equivalent dose of another vasopressor. aChi-square test from logistic regression model including Ang II treatment compared to placebo, and adjusted by baseline MAP, baseline APACHE II score, vasopressin use 6 hours prior to randomization, and average vasopressor norepinephrine equivalent dose over the 6 hours prior to randomization.

Important Safety Information See more

Warnings and Precautions The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled ATHOS-3 study. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo treated patients in the ATHOS-3 study [13% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.

IndicationGIAPREZA™ (angiotensin II) increases blood pressure in adults with septic or other distributive shock.

Important Safety Information

Indication GIAPREZA™ (angiotensin II) increases blood pressure in adults with septic or other distributive shock.

Contraindications None.

Warnings and Precautions The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled ATHOS-3 study. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo treated patients in the ATHOS-3 study [13% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.

Adverse Reactions The most common adverse reactions reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events. Adverse reactions occurring in ≥4% of patients treated with GIAPREZA and ≥1.5% more often than placebo-treated patients in the ATHOS-3 study were thromboembolic events (including deep vein thrombosis), thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia, and peripheral ischemia.

Drug Interactions Angiotensin converting enzyme inhibitors may increase response to GIAPREZA.

Angiotensin II receptor blockers may reduce response to GIAPREZA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional Important Safety Information, please see the full Prescribing Information.

Reference: 1. Tumlin JA et al. Crit Care Med.2018; 46(6): 949-9572.

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