New Publication Shows Cleviprex™ Is Effective For Rapid Treatment Of Acute Hypertension After Cardiac Surgery

Main Category: Hypertension
Also Included In: Cardiovascular / Cardiology
Article Date: 15 Jul 2008 - 2:00 PDT

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The Medicines Company (NASDAQ: -MDCO) announced that the results of ESCAPE -2, a pivotal Phase 3 efficacy trial of its investigational agent Cleviprex™ (clevidipine butyrate) injectable emulsion, were published in the July issue of the journal Anesthesia and Analgesia. The clinical trial demonstrated that Cleviprex is effective and safe in the rapid treatment of acute hypertension after cardiac surgery.

ESCAPE-2, a randomized, double-blind, placebo-controlled trial, examined the efficacy and safety of Cleviprex in treating patients with acutely elevated blood pressure after cardiac surgery. A total of 110 patients with a systolic blood pressure (SBP) greater than 140 mm Hg following cardiac surgery were randomized to a 30 to 60 minute infusion of Cleviprex or placebo. The primary end point was the incidence of treatment failure, defined as the inability to decrease SBP by 15% or more from baseline, or the discontinuation of study treatment for any reason within the 30 minute period after study drug initiation. The study demonstrated:

- Treatment success (absence of treatment failure) was achieved in significantly more Cleviprex-treated patients than placebo-treated patients (91.8% vs. 20.4%, P <0.0001).

- Median time to achieving target systolic blood pressure with Cleviprex was 5.3 minutes (95% confidence interval, 4-7 min).

- No clinically significant increase in heart rate from baseline was observed, and adverse event rates were similar for both treatment groups.

"These additional data build upon the findings of the ESCAPE-1 trial, which indicated that Cleviprex was effective and safe in study patients with acute elevations of blood pressure prior to cardiac surgery," said lead investigator Neil Singla, MD, Department of Anesthesia, Huntington Memorial Hospital, Pasadena, California. "Together, both ESCAPE trials suggest that Cleviprex could be a promising drug for acute hypertension patients undergoing cardiac surgery."

"These data are an important piece of a large body of clinical information reinforcing our commitment to advancing the understanding and importance of acute blood pressure management in the critical care setting," said James Ferguson M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company.

About Cleviprex

Cleviprex is a novel investigational IV antihypertensive for acute blood pressure management in the critical care setting, when the use of oral therapy is not feasible or desirable. Cleviprex has a rapid onset and offset of action and can be titrated for predictable blood pressure control. Unlike current antihypertensive treatments which are metabolized by the kidney or liver, Cleviprex is metabolized in the blood and does not accumulate in the body.

Six Phase 3 trials of Cleviprex met all of their primary endpoints. The most common adverse reactions seen with Cleviprex use were headache, sinus tachycardia, hypotension, nausea, polyuria, flushing, dizziness and vomiting.

About The Medicines Company

The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Company also has two products in late-stage development, CleviprexTM (clevidipine butyrate) injectable emulsion and cangrelor.

The Medicines Company