Cardene IV::CLUE

CLUE trial provides data from the comparison of
Ready-to-Use CARDENE I.V. and IV labetalol for
treatment of acute severe hypertension in the ED

The Evaluation of IV CARDENE and Labetalol Use in the Emergency Department (CLUE) trial was a phase IV multicenter, prospective, open-label, randomized trial evaluating the efficacy of IV nicardipine vs IV labetalol for emergency department management of acute severe hypertension.¹

Study participants (N=226) were patients older than 18 years of age who had 2 systolic blood pressure (SBP) readings ≥ 180 mm Hg, taken 10 minutes apart. Of these patients, 63% had signs and symptoms suggestive of end-organ damage. Before randomization, the physician specified a target SBP ± 20 mm Hg, the target range. The primary endpoint was the percent of patients meeting target SBP range during the initial 30 minutes of treatment.

Proven Performance: Ready-to-Use CARDENE I.V.
reduces BP rapidly

More Ready-to-Use CARDENE I.V. patients with acute severe hypertension than IV labetalol patients reached target SBP range within 30 minutes¹
– The mean time to target SBP range was approximately 11 minutes²
– Ready-to-Use CARDENE I.V. patients were 2.7 times more likely to be in target SBP
range within 30 minutes (odds ratio, 2.73; 95% confidence interval [CI], 1.1- 6.7)¹

Abbreviation: SBP, systolic blood pressure.

Percent of patients (N=223 evaluable patients) achieving target SBP range within 30 minutes. Target range was defined as individually prespecified SBP ± 20 mm Hg.

Most common adverse reactions, according to the Ready-to-Use CARDENE I.V. package insert, are headache (15%), hypotension (6%), nausea/vomiting (5%), and tachycardia (4%).

Proven Performance: Ready-to-Use CARDENE I.V.
reduces BP predictably

Ready-to-Use CARDENE I.V. produced relevant BP reductions over time, with the mean percent change in SBP reaching target range within 15 minutes¹

Abbreviations: CI, confidence interval; SBP, systolic blood pressure.

Mean percent change and 95% CI, evaluated by Student t test, relative to presenting SBP, during the initial 30 minutes, with the median upper level of target range and median target range indicated by horizontal dotted lines.

In administering nicardipine, close monitoring of blood pressure and heart rate is required.

Premixed: Ready-to-Use CARDENE I.V. benefits

Ready-to-Use CARDENE I.V. is the only available premixed formulation of nicardipine hydrochloride.

Immediately available for rapid intervention

Can be stored at the point of care

Eliminates admixture errors

Saves time and labor^3,4

For more information about Ready-to-Use CARDENE I.V.,
visit www.cardeneiv.com

Indication

CARDENE^® I.V. (nicardipine hydrochloride) Premixed Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits.⁵

Important Safety Information

CARDENE I.V. Premixed Injection is contraindicated in patients with advanced aortic stenosis because part of the effect of CARDENE I.V. is secondary to reduced afterload

In administering nicardipine, close monitoring of blood pressure and heart rate is required. Nicardipine may occasionally produce symptomatic hypotension or tachycardia. Avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage

Increases in frequency, duration, or severity of angina have been seen in chronic therapy with oral nicardipine. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with CARDENE I.V. The mechanism of this effect has not been established

Titrate slowly when using CARDENE I.V., particularly in combination with a beta-blocker, in patients with heart failure or significant left ventricular dysfunction because of possible negative inotropic effects

Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor responses in patients with impaired liver function or reduced hepatic blood flow

When nicardipine was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) was observed. These results are consistent with those seen after oral administration of nicardipine. Titrate gradually in patients with renal impairment

To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the occurrence of vascular impairment, administer drug through large peripheral veins or central veins rather than arteries or small peripheral veins, such as those on the dorsum of the hand or wrist. To minimize the risk of peripheral venous irritation, change the site of the drug infusion every 12 hours

Most common adverse reactions are headache (15%), hypotension (6%), nausea/vomiting (5%), and tachycardia (4%)

Please see full prescribing information.

References: 1. Peacock WF, Varon J, Baumann BM, et al. CLUE: a randomized comparative effectiveness
trial of IV nicardipine versus labetalol use in the emergency department. Crit Care. 2011;15(3):R157. http://ccforum.com/content/15/3/R157. Accessed August 12, 2011. 2. Data on file, EKR Therapeutics, Inc.; 2010. 3. Fanikos J, Erickson A, Munz KE, et al. Observations on the use of ready-to-use and point-of-care activated parenteral products in automated dispensing cabinets in U.S. hospitals. Am J Health-Syst Pharm. 2007;64(19):2037-2043. 4. van der Linden P, Douchamps J, Schmitt C, Forget D. Ready-to-use injection preparations versus conventional reconstituted admixtures: economic evaluation in a real-life setting. Pharmacoeconomics. 2002;20(8):529-536. 5. CARDENE I.V. [package insert]. Bedminster, NJ: EKR Therapeutics, Inc; 2011.