Phase III study of LJPC 501 (angiotensin II) published online by The New England Journal of Medicine- La Jolla Pharma
La Jolla Pharmaceutical Company announced that results of the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase III study of LJPC 501 (angiotensin II) have been published online by The New England Journal of Medicine (NEJM). The article, entitled �Angiotensin II for the Treatment of Vasodilatory Shock,� also will be published in the May 25, 2017 print issue of NEJM. The analysis of the primary efficacy endpoint of ATHOS-3, defined as the percentage of patients achieving a mean arterial pressure (MAP) more than 75 mmHg or a 10 mmHg 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.
In addition, a trend toward longer survival was observed for angiotensin II-treated patients (22% reduction in mortality risk through day 28). 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.
See: "Angiotensin II for the Treatment of Vasodilatory Shock" Ashish Khanna et al. NEJM May 21, 2017 DOI: 10.1056/NEJMoa1704154
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