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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 (EValuation 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 evaluated 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

  • Efficacy: percentage of patients in whom SBP fell within the SBP initial target range (ITR) within 30 minutes of initiating infusion
  • Safety: percentage of patients whose SBP fell below the lower limit of the SBP ITR within 3 minutes of initiating infusion
     

Secondary End Points

  • Efficacy: time to achieve the 30-minute SBP ITR
  • 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

  • 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
     
     
J Figure

ITR=initial target range; SBP=systolic blood pressure.

  • 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
  • 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
  • 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
  • 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)
       

IMPORTANT SAFETY INFORMATION

Cleviprex is intended for intravenous use. Titrate drug depending on the response of the individual patient to achieve the desired blood pressure reduction. Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable. Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.

Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis.

Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal.

Most common adverse reactions (> 2%) are headache, nausea, and vomiting.

Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Maintain aseptic technique while handling Cleviprex. Cleviprex contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use and discard within 4 hours.

Please see full Prescribing Information.

Reference

  1. Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF IV. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2008; Jun 6. [Epub ahead of print].