Interim Study Data Indicate Improved Blood Pressure Management With Cardene® I.V. Compared to Labetalol in Patients with Acute Stroke EDIT Bedminster, N.J., January 11, 2010 – EKR Therapeutics, Inc., a specialty pharmaceutical company commercializing acute-care hospital products, today said that interim study data1 demonstrate that Cardene® 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 About Ready-to-Use Cardene® I.V. 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. Full prescribing, safety, and additional information on Cardene I.V. is available at www.cardeneiv.com About EKR Therapeutics 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.
Contact for EKR Therapeutics January 11, 2010 |
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