Cleviprex Results Reported From Study In Patients With Intracerebral Hemorrhage

Main Category: Blood / Hematology
Also Included In: Hypertension
Article Date: 15 Nov 2009 - 0:00 PST

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First reported interim data from the Evaluation of patients with acute hypertension and intracerebral hemorrhage with intravenous clevidipine treatment (ACCELERATE) trial were presented today at the Neurocritical Care Society (NCS) 2009 Annual Meeting, showing that Cleviprex (clevidipine butyrate) effectively and safely reduces blood pressure in patients with acute, non-traumatic intracerebral hemorrhage (ICH).

According to Dr. Carmelo Graffagnino M.D., FRCPC, Associate Professor of Medicine/ Neurology, Director, Duke Neurosciences Critical Care Unit, and the Principal Investigator of the study, "Cleviprex has proven to be safe and effective in this critical patient population requiring fast, precise blood pressure control within a target range. It is an important tool for physicians managing blood pressures in a variety of patients including those with acute, non-traumatic intracerebral hemorrhage."

The ACCELERATE trial evaluated the safety and efficacy of Cleviprex for the management of blood pressure in patients with acute, non-traumatic ICH in an open-label, single-arm, trial conducted in 16 centers in the United States and in Germany. Acute ICH patients with elevated blood pressure were treated with Cleviprex to lower systolic blood pressure to a target range of 140-160 mmHg; the primary endpoint was the time to reach the target range. Interim analyses of data from the first 30 patients were presented by Dr. Graffagnino; enrollment of approximately 10 additional patients is planned.

In ACCELERATE:

-- Reduction to target blood pressure was achieved in 100% of patients within 30 minutes;
-- 97% of patients reached target with Cleviprex monotherapy;
-- Median time to target blood pressure was 6.5 minutes;
-- There were no instances of hypotension and no need for supplemental therapy to raise blood pressure in the initial 30-minute period of Cleviprex therapy.

"These data in ICH patients are very exciting for clinicians managing stroke; they further emphasize the efficacy and safety of Cleviprex in managing blood pressure across a wide spectrum of critically ill patients," said James Ferguson, M.D., Vice President of Global Medical at The Medicines Company.

About Intracerebral Hemorrhage

Intracerebral hemorrhage (ICH) is bleeding directly into the brain, thought to be caused by leakage from small blood vessels damaged by chronic hypertension. ICH occurs in about 80,000 U.S. patients per year, and is responsible for 10% of all strokes. Outcomes following ICH are poor -- 30-day mortality is 32-52%, with approximately 50% of all deaths occurring within the first 48 hours. Only 20% of survivors are living independently at 6 months following an ICH. There are relatively few therapeutic options; acute blood pressure control is thought to be important in these patients to limit the expansion of blood in the brain, but safely reducing blood pressure in such unstable patients has been a problem in the past.

About Cleviprex

Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex was based on six Phase III trials, including the three ECLIPSE studies, and involved 1,406 medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints. Cleviprex may produce systemic hypotension and reflex tachycardia. The most common adverse reactions (greater than 2%) seen with Cleviprex are headache, nausea and vomiting. Cleviprex is contraindicated in patients with allergy to soy or eggs, defective lipid metabolism or severe aortic stenosis. Please see full prescribing information available at http://www.cleviprex.com.

Source
The Medicines Company