Cardene I.V. more effective than intravenous labetalol for BP management in acute stroke patients

EKR Therapeutics, Inc., a specialty pharmaceutical company commercializing acute-care hospital products, today said that interim study data 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”

“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>

• 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.