PulmCCM - December 22, 2017
"The FDA approved angiotensin-II (Giapreza) as a new intravenous vasopressor for septic shock and other forms of distributive shock. The first new FDA-approved vasopressor in decades, angiotensin-II could significantly change the management of severe septic shock.
FDA based its expedited approval (under priority review) on the ATHOS-3 trial enrolling 321 patients with shock refractory to catecholamines like norepinephrine or epinephrine. At 3 hours, almost 70% of patients with angiotensin II added reached the target blood pressure, compared to 23% receiving placebo and usual vasopressors. The study was not designed to detect a mortality benefit from angiotensin II.
Patients receiving angiotensin II also required lower doses of other vasopressors. The general strategy in the study was to wean off vasopressin first, then catecholamines, while titrating up angiotensin-II.
Angiotensin II patients experienced more thromboses, and FDA advised “Giapreza can cause dangerous blood clots with serious consequences (clots in arteries and veins, including deep venous thrombosis); prophylactic treatment for blood clots should be used.” Similar language will be on the product's label..."