PURPOSE: Severe hypertension is common and requires rapid, predictable and safe reduction of blood pressure (BP). Clevidipine (CLV) is a novel arterial-selective calcium antagonist with an ultra-short half life (t½ ∼ 1 min). The purpose of this predefined analysis from the VELOCITY trial was to assess the safety and efficacy of a prolonged infusion of CLV in severe hypertension (HTN).
METHODS: An open-label, single-arm trial was performed at 11 centers across the US. Patients presenting in the emergency department with persistent systolic BP (SBP) >180 or diastolic BP >115 mmHg were eligible. SBP target ranges to be achieved within the first 30 min were selected and patients received CLV infusion via a peripheral line using a non-weight based titration algorithm. Patients were monitored with a BP cuff. The infusion rate was maintained or further titrated after 30 min to the desired long-term (≥18 h) SBP target.
RESULTS: Of the 126 patients in the safety population, 117 (mITT population) were included in the efficacy analysis. The mean age was 53 yrs, 51% were female and 77% were black. Almost all patients (97%) had a history of HTN. Mean baseline SBP was 203 mmHg. After initiating CLV the mean SBP rapidly decreased during the titration period: -12 mmHg (-6%) at 3 min, -34 mmHg (-16.5%) at 15 min and -45 mmHg (-21%) at 30 min. Median time to patients achieving a 15% reduction in SBP was 9.5 min. At 18 h the BP reduction was -55 mmHg (-27%) from baseline. Throughout 18 h, target SBP was maintained at a steady CLV infusion rate. A modest 9 bpm increase in HR was seen at 30 min. After 30 min and up to 18 h HR trended back to baseline. AEs were reported in 10% of patients. No hypotensive events were reported.
CONCLUSION: CLV was safe and effective after prolonged infusion in patients with acute severe HTN.
CLINICAL IMPLICATIONS: CLV offers rapid, predictable and safe BP control in patients with acute severe HTN.
DISCLOSURE: J Varon, Consultant fee, speaker bureau, advisory committee, etc. Consultant and Advisor: The Medicines Company; Other Investigator: The Medicines Company; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Clevidipine for acute, severe hypertension