Clevidipine, an Intravenous Dihydropyridine Calcium Channel Blocker, Is Safe and Effective for the Treatment of Patients With Acute Severe Hypertension
Presented as a poster at the American College of Emergency Physicians 2007 Scientific Assembly, October 2007, Seattle, WA.
Received 11 January 2008; received in revised form 5 March 2008 and 11 March 2008; accepted 7 April 2008. published online 06 June 2008.
Study objective
We assess the safety and efficacy of intravenous clevidipine for treating patients with acute severe increase in blood pressure by using prespecified, non–weight-based titration dosing, with continuous maintenance infusion for 18 hours or longer.
Methods
Prospective, open-label, single-arm evaluation of patients aged 18 years or older and presenting in the emergency department or ICU with severe hypertension (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >115 mm Hg) and treated with clevidipine to achieve a predetermined, patient-specific systolic blood pressure target range. Clevidipine was initiated at 2 mg per hour and titrated as needed in doubling increments every 3 minutes to a maximum of 32 mg per hour, during 30 minutes, and then continued for a total duration of 18 to 96 hours.
Results
Study patients commonly presented with both acute hypertension and end-organ injury; 81% (102/126) had demonstrable end-organ injury at baseline. Within 30 minutes of starting clevidipine, 88.9% (104/117) of patients achieved target range. Median time to target range was 10.9 minutes. No concomitant intravenous antihypertensives were needed in 92.3% (108/117) of patients receiving 18 hours or more of clevidipine infusion. Clevidipine was well tolerated with successful transition to oral antihypertensive therapy after infusion to a defined blood pressure target in 91.3% (115/126) of patients.
Conclusion
Clevidipine, dosed in a non–weight-based manner, was safe and effective in a cohort of patients with severe hypertension at a starting dose of 2 mg per hour, followed by simple titration during 18 hours or more of continuous infusion. Patients were effectively managed via simple blood pressure cuff monitoring throughout.
aDepartment of Emergency Medicine, Pennsylvania Hospital, University of Pennsylvania, Philadelphia, PA
bThe University of Texas Health Science Center at Houston, The University of Texas Medical Branch at Galveston, St. Luke's Episcopal Hospital/Texas Heart Institute, Houston, TX
dUniversity of California Los Angeles and VA Greater Los Angeles Healthcare Center, Los Angeles, CA
eLouisiana State University Health Science Center, New Orleans, LA
fThe Cleveland Clinic, Department of Emergency Medicine, Cleveland, OH
Address for correspondence: Charles V. Pollack, MA, MD, Department of Emergency Medicine, Pennsylvania Hospital, 800 Spruce Street, 2 Pine East, Philadelphia, PA 19107; 215-829-7549, fax 610-687-0137
Supervising editor: Rita K. Cydulka, MD, MS
Author contributions: All authors contributed to the development of the study protocol, enrolled patients, and participated in data analysis and drafting of the article. CP and FP take responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. Funding for this study was provided by The Medicines Company, Parsippany, NJ. Drs. Pollack, Varon, and Peacock have served as consultants for The Medicines Company.
ABSTRACT
Clevidipine, an Intravenous Dihydropyridine Calcium Channel Blocker, Is Safe and Effective for the Treatment of Patients With Acute Severe Hypertension