What You Need to Know:
Treatment with synthetic human angiotensin II (LJPC-501) was more effective in increasing blood pressure in patients with vasodilatory shock not responsive to high dose vasopressors compared to placebo.
Trial Design:
- Randomized, double-blinded, placebo-controlled study evaluated the efficacy of angiotensin II in patients with vasodilatory shock not responding to therapy with 0.2 mg norepinephrine/kg/min or equivalent vasopressor
- 344 patients randomized to placebo or angiotensin II infusion over 48 hours
- Primary endpoint: mean arterial pressure of ³75 mm Hg or an increase of ³10 mm Hg from baseline 3 hours after infusion initiation without vasopressor dose increases
- Secondary endpoints: changes in the score of the cardiovascular Sequential Organ Failure Assessment (SOFA), the total SOFA score at baseline and after 48 hours
Key Outcomes:
- 69.9% of angiotensin II patients (114/163) attained the primary endpoint compared to 23.4% of placebo patients (37/158) (OR: 7.95; 95% CI: 4.76, 13.3; P<0.001)
- Greater improvement in the cardiovascular SOFA score seen in angiotensin II patients (-1.75) compared to placebo patients (-1.28) (P=0.01)
- 60.7% of angiotensin II patients reported serious adverse events compared to 67.1% of placebo patients
- By day 28 of the study, death occurred in 46% of angiotensin II patients (75/163) compared to 54% of placebo patients (85/158) (HR: 0.78; 95% CI: 0.57, 1.07; P=0.12)
