Healthcare Industry News:  labetalol 

Biopharmaceuticals Cardiology Neurology

 News Release - January 11, 2010

Interim Study Data Indicate Improved Blood Pressure Management With Cardene(R) I.V. Compared to Labetalol in Patients with Acute Stoke

BEDMINSTER, N.J.--(HSMN NewsFeed)--EKR Therapeutics, Inc., a specialty pharmaceutical company commercializing acute-care hospital products, today said that interim study data1 demonstrate that Cardene(R) I.V. (nicardipine hydrochloride) is significantly more effective than intravenous labetalol for the management of blood pressure (BP) in stroke patients.

“Acute hypertension is generally associated with poor outcomes in the treatment of stroke patients,” said Howard Weisman, EKR’s CEO & President. “Thus, it is critically important to provide clinicians with evidence-based guidance regarding the safe and effective lowering of BP into a predefined target range, particularly with the large number of patients treated annually for acute hypertensive crisis.”

The interim data from a prospective randomized study evaluating Cardene I.V. and intravenous labetalol, a market leading antihypertensive, were presented January 10th at the 2010 Annual Congress of the Society of Critical Care Medicine. The data, obtained in a study of BP management in stroke patients, demonstrated that a pre-determined blood pressure goal can be achieved and maintained more effectively with Cardene I.V. than labetalol with no apparent difference in the occurrence of adverse effects.

This study is being conducted at Detroit Receiving Hospital, Detroit, MI. A total of 47 patients (Cardene=25: labetalol=22) were included in the interim analysis, 53% with a diagnosis of intracerebral hemorrhage. Baseline clinical characteristics, including BP and heart rate, were comparable in both treatment groups. Cardene I.V. was started at 5 mg/hr and gradually titrated by 2.5 mg/hr every 15 minutes to a maximum rate of 15 mg/hr. labetalol was given as a slow IV push of 20 mg over 1-2 minutes, and repeat doses of 20 mg to 40 mg were given at the clinician’s discretion to a maximum cumulative dose of 300 mg/day. Study results included:
  • All patients receiving Cardene I.V. achieved target BP by 24 hours, as compared to only 15 (68%) who received labetalol (p<0.001), with a significantly greater proportion of patients on Cardene I.V. achieving their target BP within one hour of starting treatment than those treated with labetalol (88% vs. 32%: p<0.001).
  • During the 24-hour study, patients receiving Cardene I.V. were within the target BP range for 82.5% (±19.6) of the time compared to 48.5% (±30.0) of the time for labetalol patients.
  • Additional antihypertensive agents were required by 0% of the Cardene I.V. patients and by 73% of the labetalol patients.
  • There was no significant difference between treatments in the incidence of bradycardia, tachycardia, or hypotension.
EKR also noted that two additional studies comparing labetalol and Cardene I.V. in the emergency department are ongoing. The first, CLUE (Cardene and labetalol Use in the Emergency Department), is a prospective, randomized study evaluating the short-term antihypertensive effects of the two agents in patients presenting with severe uncontrolled hypertension (BP=180 mm Hg) at 14 U.S. centers. The second, a 3-center study coordinated by the University of Cincinnati is a case-controlled study of prospectively enrolled patients comparing the safety and effectiveness of labetalol, Cardene I.V., and sodium nitroprusside in controlling acute elevation of BP in patients with ischemic stroke, subarachnoid hemorrhage, and intracerebral hemorrhage. The results of both these studies are anticipated early in 2010.

About Acute Stroke2

A stroke occurs when the blood supply to part of the brain is suddenly interrupted or when a blood vessel in the brain bursts, spilling blood into the spaces surrounding brain cells. Brain cells die when they no longer receive oxygen and nutrients from the blood or there is sudden bleeding into or around the brain. The symptoms of a stroke include sudden numbness or weakness, especially on one side of the body; sudden confusion or trouble speaking or understanding speech; sudden trouble seeing in one or both eyes; sudden trouble with walking, dizziness, or loss of balance or coordination; or sudden severe headache with no known cause. There are two forms of stroke: ischemic - blockage of a blood vessel supplying the brain, and hemorrhagic - bleeding into or around the brain.

About Ready-to-Use Cardene(R) I.V.

Cardene(R) I.V. (nicardipine hydrochloride) is a calcium ion influx inhibitor indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. Formerly supplied only in ampules, Cardene I.V. is now available in patented Ready-to-Use (RTU) preparations consisting of single (0.1 mg/mL) and double (0.2 mg/mL) concentrations of nicardipine in either dextrose or saline premixed in 200 ml intravenous bags.

Ready-to-Use Cardene I.V. Premixed Injection provides significant practical advantages for hospitals, including the convenience of point-of-use access in patient care areas, storage in automated dispensing cabinets, and extended product stability. In addition to supporting The Joint Commission3 standards and American Society of Health-System Pharmacists4 guideline for dispensing medication in the most ready to administer form, RTU Cardene I.V. facilitates rapid intervention in emergency settings, eliminates point-of-care medication admixture errors, and is well suited to meet a hospital’s after-pharmacy-hours medication needs5.

Close monitoring of the blood pressure is required during therapy. Cardene I.V. is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Reduction of diastolic pressure and reduced afterload may worsen rather than improve myocardial oxygen balance. Caution is advised when administering Cardene I.V. to patients with impaired renal or hepatic function, in combination with a beta-blocker in patients with congestive heart failure, or portal hypertension. Observe caution in patients with significant left ventricular dysfunction due to possible negative inotropic effect. Cardene I.V. gives no protection against the dangers of abrupt beta-blocker withdrawal; beta-blocker dosage should be gradually reduced. Levels of cyclosporine should be closely monitored during therapy. The most common side effects of Cardene I.V. are headache (14.6%), hypotension (5.6%), nausea/vomiting (4.9%), and tachycardia (3.5%). Less frequent adverse effects, in each case occurring at 1.4%, include ECG abnormalities, postural hypotension, ventricular extrasystoles, injection-site reaction, dizziness, sweating and polyuria.

Full prescribing, safety, and additional information on Cardene I.V. is available at www.cardeneiv.com

About EKR Therapeutics

EKR Therapeutics is a specialty pharmaceutical company focused on acquiring, developing and maximizing the potential utility of critical-care hospital products offering broader therapeutic options and greater control to improve in-patient care, speed recovery, and achieve optimal outcomes. Backed by the strength of its award winning management team, the dedication of its field force of product specialists and its commitment to excellence in customer service and medical education, EKR has been organized to be a class leader in commercializing products to address unmet and under-satisfied medical needs or to otherwise enhance the therapeutic value of acute-care products. For additional information about EKR visit the Company’s website at www.ekrtx.com.

References:

1. Liu-DeRyke X, Parker D, Atkinson BE, et al. A Prospective Evaluation of labetalol vs. Nicardipine for Blood Pressure Management in Patients with Acute Stroke. Crit Care Med. 2009;37(12):A161. Abstract 342.

2. National Institute of Neurological Disorders and Stroke (NINDS); Stroke Information Page. http://www.ninds.nih.gov/disorders/stroke/stroke.htm Accessed January 10, 2010

3. Rich DS. New JCAHO medication management standards for 2004. Am J Health-Syst Pharm. 2004; 61(13):1349-1458.

4. American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health-Syst Pharm. 1995; 52:2711–7.

5. 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.


Source: EKR Therapeutics

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