Jan 12 2010
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>
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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).
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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.
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Additional antihypertensive agents were required by 0% of the Cardene
I.V. patients and by 73% of the labetalol patients.
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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.