Favorable findings of
the investigational drug Cleviprex(TM) (clevidipine) (The Medicines Company
[Nasdaq: MDCO]) compared to current intravenous antihypertensive agents in
controlling perioperative hypertension -- a potentially harmful elevation
in blood pressure just before, during and/or after surgery -- were
presented for the first time at a late-breaking session here at the 56th
Annual Scientific Session of the American College of Cardiology. The
findings were from ECLIPSE, the largest safety program to date comparing
intravenous antihypertensive therapies.
"This analysis from ECLIPSE showed tight perioperative blood pressure
control with Cleviprex," said lead author of the presentation, Solomon
Aronson, MD, Duke University Medical Center. "If approved, Cleviprex may
provide a potentially important new treatment option for acute
hypertension, a condition which affects nearly 3 million people in the U.S.
each year."
"We are extremely pleased with the favorable findings of Cleviprex in
the ECLIPSE program," said John Kelley, President and Chief Operating
Officer of The Medicines Company. "Given the trial successfully met all of
its primary endpoints, this marks the completion of our Phase III efforts
for Cleviprex. The Medicines Company remains committed and on track to
expeditiously move forward with an NDA submission before the end of June."
Study and Findings
The ECLIPSE program included a total of 1,964 cardiac surgery patients
each enrolled in one of three randomized, open-label trials comparing
Cleviprex to current intravenous antihypertensive agents: nitroglycerin,
sodium nitroprusside or nicardipine (ECLIPSE-NTG, ECLIPSE-SNP and
ECLIPSE-NIC trials, respectively). Beginning just before surgery,
investigators monitored patients' blood pressure (BP) and administered the
assigned antihypertensive agent, at their discretion, if BP became too
high. Based on each patient's BP response for 24 hours after initiating the
therapy, investigators determined "BP excursions" -- how much and how long
systolic BP went above or below predefined, acceptable perioperative BP
ranges.
The ECLIPSE analysis evaluated BP excursions from data pooled from all
three studies and from the individual studies. In the pooled analysis, for
the widest predefined acceptable perioperative BP range of 75-145 mm Hg
pre- and post-operatively and 65-135 mm Hg during surgery, Cleviprex
resulted in approximately half the BP excursion compared to the other
agents (3.8 vs. 7.8 mm Hg x min/h, p = 0.0004). Results for the narrowest
BP range of 105-145 mm Hg pre- and post-operatively and 95-135 mm Hg during
surgery also favored Cleviprex (87.7 vs. 111.5 mm Hg x min/h, p = 0.0002).
In the individual ECLIPSE-NTG and ECLIPSE-SNP studies, for the widest
BP range, Cleviprex resulted in approximately half the BP excursion
compared to nitroglycerin (4.14 vs. 8.87 mm Hg x min/h, p = 0.0006) and
sodium nitroprusside (4.37 vs. 10.50 mm Hg x min/h, p = 0.0027),
respectively. At this BP range, there was no significant difference in BP
excursions for Cleviprex vs. nicardipine (1.76 vs. 1.79 mm Hg x min/h, p =
0.8508), however that comparison was restricted to the post-operative
period only, since nicardipine is not generally used before or during
surgery due to its relatively slow onset and offset of action. Other
standard intravenous BP control agents were administered, as deemed
appropriate, just before or during surgery in the ECLIPSE-NIC trial.
For the narrowest BP range, Cleviprex also resulted in less BP
excursion compared to sodium nitroprusside (100.17 vs. 127.87 mm Hg x
min/h, p = 0.0068), nicardipine (76.5 vs. 101.59 mm Hg x min/h, p =
0.0231), and nitroglycerin (83.74 vs. 108.57 mm Hg x min/h, p = 0.0556).
The ECLIPSE-SNP trial also showed that the rate of death was
significantly lower with Cleviprex than with sodium nitroprusside (1.7% vs.
4.7%, p = 0.045). Other than this difference, the primary endpoints --
rates of death, stroke, heart attack and kidney dysfunction -- were similar
for Cleviprex compared to the other three agents.
About Perioperative Hypertension
Perioperative hypertension affects patients in the operating room,
post- anesthesia care unit and intensive care unit. It is thought to be
caused by the rapid shifts in blood volume and increased activity of the
sympathetic nervous system that accompany surgery, which in turn increase
vasoconstriction, vascular resistance, and both systolic and diastolic BP.
The increased pressure can damage blood vessels, resulting in inflammation
and leaking of fluid or blood into tissues, and complications such as
hemorrhagic stroke, ischemic stroke, encephalopathy, myocardial ischemia or
infarction, heart arrhythmia, congestive heart failure, and bleeding at the
surgical site.
Perioperative hypertension is treated using intravenous
antihypertensive agents, but current therapies have various shortcomings.
For example, nitroglycerin and sodium nitroprusside dilate both arteries
and veins, which can result in less predictable BP control. Nicardipine is
selective for arteries, but because it has a slower onset and longer
duration of action, and accumulates over time in the body, it is rarely
used to control BP during surgery, and is only used occasionally after
surgery.
About Cleviprex
Cleviprex is a novel, investigational drug rationally designed to meet
the needs of the acute care practitioner for an intravenous hypertensive
agent. It is the first third-generation dihydropyridine calcium channel
blocker that acts rapidly and reliably, is vascular- and
arterial-selective, and has an ultrashort half-life. Cleviprex recently
completed Phase III clinical trials.
MDCO-G
About The Medicines Company
The Medicines Company is committed to delivering innovative, cost-
effective acute care products in the worldwide hospital marketplace. The
Company markets AngiomaxR (bivalirudin) in the U.S. 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, Cleviprex(TM) (clevidipine) and
cangrelor. The Company's website is themedicinescompany.
Statements contained in this press release about The Medicines Company
and Cleviprex that are not purely historical, and all other statements that
are not purely historical, may be deemed to be forward-looking statements
for purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995. Without limiting the foregoing, the words
"believes," "anticipates" and "expects" and similar expressions are
intended to identify forward-looking statements. These forward-looking
statements involve known and unknown risks and uncertainties that may cause
the Company's actual results, levels of activity, performance or
achievements to be materially different from those expressed or implied by
these forward-looking statements. Important factors that may cause or
contribute to such differences include whether the Company's products will
advance in the clinical trials process on a timely basis or at all, whether
clinical trial results will warrant submission of applications for
regulatory approval, whether the Company will be able to obtain regulatory
approvals, whether physicians, patients and other key decision makers will
accept clinical trial results, and such other factors as are set forth in
the risk factors detailed from time to time in the Company's periodic
reports and registration statements filed with the Securities and Exchange
Commission including, without limitation, the risk factors detailed in the
Company's Annual Report on Form 10-K filed on March 1, 2007, which are
incorporated herein by reference. The Company specifically disclaims any
obligation to update these forward-looking statements.
The Medicines Company
themedicinescompany
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