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news.Cleviprex reduces blood pressure in patients with acute, non-traumatic ICH
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The Medicines Company reported interim data from the evaluation of patients with acute hypertension and intracerebral hemorrhage with intravenous clevidipine treatment (ACCELERATE) trial. The study was presented at the Neurocritical Care Society (NCS) 2009 Annual Meeting. The result shows that Cleviprex (clevidipine butyrate) is effective and safe in reducing blood pressure in patients with acute, non-traumatic intracerebral hemorrhage (ICH).
Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The ACCELERATE trial was conducted in 16 centers in the US and in Germany. Acute ICH patients with elevated blood pressure were treated with Cleviprex to lower systolic blood pressure to a target range of 140-160mmHg. The company plans enrollment of approximately 10 additional patients.
In ACCELERATE trail, it was observed that reduction to target blood pressure was achieved in 100% of patients within 30 minutes and 97% of patients reached target with Cleviprex monotherapy. It is also observed that 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.
James Ferguson, vice president of global medical at The Medicines Company, said: “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.”
Carmelo Graffagnino, associate professor of medicine/ neurology, director, duke neurosciences critical care unit and the principal investigator of the study, said: “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.”