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

Fortunato Senatore; Gowraganahalli Jagadeesh; Martin Rose; Venkateswaran C. Pillai; Sudharshan Hariharan; Ququan Liu; McDowell Tzu-Yun; Mohan K. Sapru; Mary Ross Southworth; Norman Stockbridge


Am J Cardiovasc Drugs. 2019;19(1):11-20. 

In This Article


The ATHOS-3 trial provided substantial evidence demonstrating that angiotensin II increased MAP in patients with distributive shock receiving a variety of other vasopressors. Results for mortality favored angiotensin II, but the advantage was not statistically significant. Adverse events occurring at a higher rate in the angiotensin II arm than in the placebo arm included thrombotic events, peripheral ischemia, lactic acidosis and delirium. None of these are rare in ICU patients with distributive shock treated with other pressor agents. Overall, the data suggested that the hemodynamic benefits of angiotensin II in patients with distributive shock outweighed its risks. The results of ATHOS-3 supported approval of this drug by the FDA for marketing in the USA. Full prescribing information for angiotensin II in the treatment of distributive shock is available at https://www.accessdata.fda.gov/drugsatfdadocs/label/2017/209360s000lbl.pdf.