Key result
Intravenous clevidipine safely and effectively managed severe hypertension in patients with renal dysfunction, with almost 90% reaching their target blood pressure range within 30 minutes.
Why the study?
Does clevidipine reduce blood pressure to target range in patients with severe hypertension and renal dysfunction?
Does clevidipine reduce blood pressure to target range in patients with severe hypertension and renal dysfunction?
Clevidipine safely and effectively achieves rapid blood pressure control in patients with severe hypertension and renal dysfunction.
Supports clevidipine in renal dysfunction; hypothesis-generating and should not yet change practice.
INTRODUCTION: Acute and severe hypertension is common, especially in patients with renal dysfunction (RD). Clevidipine is a rapidly acting (t½∼1 min) intravenous (IV) dihydropyridine calcium-channel blocker metabolized by blood and tissue esterases and may be useful in patients with RD. The purpose of this analysis was to assess the safety and efficacy of clevidipine in patients with RD. METHODS: VELOCITY, a multicenter open-label study of severe hypertension, enrolled 126 patients with persistent systolic blood pressure (SBP) >180 mmHg. Investigators pre-specified a SBP initial target range (ITR) for each patient to be achieved within 30 min. Blood pressure monitoring was by cuff. Clevidipine was infused via peripheral IV at 2 mg/h for at least 3 min, then doubled every 3 min as needed to a maximum of 32 mg/h (non-weight-based treat-to-target protocol). Per protocol, clevidipine was continued for at least 18 h (96 h maximum). RD was diagnosed and reported as an end-organ injury by the investigator and was defined as requiring dialysis or an initial creatinine >2.0 mg/dl. Primary endpoints were the percentage of patients within the ITR by 30 min and the percentage below the ITR after 3 min of clevidipine infusion. RESULTS: Of the 24 patients with moderate to severe RD, most (13/24) were dialysis dependent. Forty-six percent were male, with mean age 51 ± 14 years; 63% were black and 96% had a hypertension history. Median time to achieve the ITR was 8.5 min. Almost 90% of patients reached the ITR in 30 min without evidence of overshoot and were maintained on clevidipine through 18 h. Most patients (88%) transitioned to oral antihypertensive therapy within 6 h of clevidipine termination. CONCLUSIONS: This report is the first demonstrating that clevidipine is safe and effective in RD complicated by severe hypertension. Prolonged infusion maintained blood pressure within a target range and allowed successful transition to oral therapy.
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Peacock et al. (2010) studied Severe hypertension with renal dysfunction (n=24). Clevidipine was evaluated on Percentage of patients within the initial target range (ITR) by 30 min and percentage below the ITR after 3 min of infusion. Intravenous clevidipine safely and effectively managed severe hypertension in patients with renal dysfunction, with almost 90% reaching their target blood pressure range within 30 minutes.
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