er the curve; NIC=nicardipine; NTG=nitroglycerin; SBP=systolic blood pressure;
SNP=sodium nitroprusside.
In general, the incidence of adverse events (AEs) and serious AEs, including the most commonly occurring AEs of atrial fibrillation and acute renal failure, were similar between Cleviprex and the comparator agents No clinically significant differences in clinical laboratory data were seen between Cleviprex and the comparators, including no change in triglyceride levels from baseline
VELOCITY Trial
In Severe Hypertensive Patients Requiring Rapid Reduction of BP, Rapid Control in a Range of Patients
Cleviprex is effective and well tolerated for controlling BP in patients with severe hypertension requiring urgent treatment, as demonstrated by the VELOCITY (eva luation of the Effect of ULtra-ShOrt-Acting Clevidipine In the Treatment of Patients With Severe HYpertension) trial.1
The VELOCITY trial was a phase 3, open-label, single-arm, multicenter study that eva luated the safety and efficacy of Cleviprex in 126 patients who presented to the emergency department or the intensive care unit with severe hypertension.1
Primary End Points
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Efficacy: percentage of patients in whom SBP fell within the SBP initial target range (ITR) within 30 minutes of initiating infusion
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Safety: percentage of patients whose SBP fell below the lower limit of the SBP ITR within 3 minutes of initiating infusion
Secondary End Points
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Efficacy: time to achieve the 30-minute SBP ITR
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Safety: proportion of patients successfully transitioned to oral antihypertensive therapy (defined as SBP within the last specified target range at 6 hours after discontinuation of Cleviprex infusion); safety of prolonged continuous infusion of Cleviprex (>=18 hours)
Cleviprex Rapidly Lowered BP to Target in ~90% of Patients in 30 Minutes
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The probability of achieving the prespecified SBP target range by 30 minutes (N=117; modified intent-to-treat patients) was 91.4%, according to Kaplan-Meier analysis
ITR=initial target range; SBP=systolic blood pressure.
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Cleviprex was initiated at 2 mg/h and titrated as needed in doubling increments every 3 minutes up to 32 mg/h over a 30-minute period
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Titratable BP control reduces the risk of overshoot and reduces the need for a rescue agent
- 2 patients (1.6%) fell below the lower SBP ITR limit within the first 3 minutes of drug infusion
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99% of patients (125 of 126) were safely and effectively managed with BP cuff monitoring throughout the infusion and did not require an arterial line
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Median time to achieve target BP was 10.9 minutes (95% confidence interval: 9.0, 15.0)
- Median time to achieve a 15% reduction in SBP was 9.5 minutes (post-hoc analysis)
Titratable Control Maintains Performance
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Patients achieving target BP within 30 minutes continued infusion up to 32 mg/h for a protocol-specified duration of at least 18 hours and up to 96 hours, with dosing adjustments as needed to maintain desired blood pressure
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More than 90% of patients maintained BP control on Cleviprex monotherapy, eliminating the need for additional intravenous antihypertensive therapy
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Headache (6.3%; 8 of 126), nausea (4.8%; 6 of 126), chest discomfort (3.2%; 4 of 126), and vomiting (3.2%; 4 of 126) were the most common AEs
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Cleviprex did not raise serum triglyceride levels
- Median percentage change in concentration of s |
