Low Blood Pressure (Hypotension)

June 5, 2017

La Jolla Pharmaceutical reported results of a phase III study of LJPC-501 (angiotensin II) for the treatment of catecholamine resistant hypotension (CRH), which is a severe form of vasodilatory shock. The ATHOS-3 study was a multicenter, randomized, double-blind, placebo-controlled clinical study. A total of 344 patients were randomized across nine countries, 321 of whom received study treatment and are included in the primary analysis. Patients were randomized 1:1 to receive either LJPC-501 or placebo on a background of standard-of-care vasopressors selected by the investigators. Randomized patients received their assigned treatment via continuous intravenous infusion. The analysis of the primary efficacy endpoint of ATHOS-3, defined as the percentage of patients achieving a mean arterial pressure (MAP) = 75mmHg or a 10mmHg increase from baseline MAP at 3 hours following the initiation of study treatment without an increase in standard-of-care vasopressors, was statistically significant: 23.4% of the 158 placebo-treated patients achieved the pre-specified blood pressure response, compared to 69.9% of the 163 angiotensin II-treated patients (p<0.001). In addition, a trend toward longer survival was observed for angiotensin II-treated patients (22% reduction in mortality risk through day 28; hazard ratio=0.78 [CI: 0.57, 1.07; p=0.12]). In this critically ill patient population, 91.8% of placebo-treated patients experienced at least one adverse event, compared to 87.1% of angiotensin II-treated patients, and 21.5% of placebo-treated patients discontinued treatment due to an adverse event, compared to 14.1% of angiotensin II-treated patients. The study was conducted under a Special Protocol Assessment (SPA) agreed to with the FDA in 2015.