PARSIPPANY, NJ--(Marketwire - November 02, 2012) - The Medicines Company (NASDAQ: MDCO) announced today that new data on the use of the intravenous antihypertensive agent Cleviprex® (clevidipine) Injectable Emulsion in acute heart failure patients will be presented at the American Heart Association Scientific Sessions 2012 in Los Angeles, California on Monday, November 5, 2012.
In 2010, the American Heart Association published a scientific statement(1) highlighting the issue that acute heart failure, "... is viewed as a single disease entity rather than as a multifaceted disorder." That statement went on to say, "Despite the heterogeneous clinical profiles ... the majority of patients with AHFS are treated with homogeneous therapy, namely intravenous diuretics. A next logical step would be to determine whether select subsets of patients, classified via reliable objective measures after initial evaluation, would benefit from targeted therapy aimed at their risk profile, HF etiology, and reason for decompensation."
To address the need for therapy aimed at hypertensive acute heart failure patients, W. Frank Peacock IV, MD, FACEP led the clinical trial PRONTO, which enrolled the subset of hypertensive acute heart failure patients with dyspnea presenting to the emergency department. The purpose of PRONTO was to evaluate the safety and efficacy of clevidipine, a short-acting arteriospecific calcium antagonist vs. the current standard of care for these patients.
Dr. Peacock, Emergency Medicine Research Director at Baylor College of Medicine (former Vice-Chair, Emergency Services Institute at The Cleveland Clinic) and Chief Medical Officer of the Society of Cardiovascular Patient Care, is a leading authority on heart failure and acute coronary syndromes and served as the Principal Investigator for PRONTO. He commented on significant findings from PRONTO regarding dyspnea: "Patients hospitalized for acute heart failure often suffer dyspnea, which causes them incredible discomfort. It also complicates our options for heart failure treatment. As an emergency medical physician, I want to address dyspnea early and quickly. With that in mind, I'm excited to present the PRONTO data and discuss the possibilities that may emerge from these findings."
Robert M. Califf, MD, FACC, Donald F. Fortin, MD, Professor of Cardiology, and Vice Chancellor for Clinical Research and Director of the Duke Translational Medicine Institute (DTMI), also expressed interest in the PRONTO study. "Any treatment options other than the current standard of care for acute heart failure and dyspnea stir up controversy, but alternatives must be explored. The mortality rate and the excessive costs -- for patients and hospitals -- that stem from long lengths of stay and the high number of readmissions demand it. It will be interesting to see if this multi-center trial in hypertensive acute heart failure patients offers further insight," stated Dr. Califf.
Hospitals around the nation share Dr. Califf's concerns about the costs of heart failure for both hospitals and patients. Recent figures estimate the cost of heart failure to be "approximately $40 billion in the United States alone."(2) Heart failure patients also often endure repeat visits to the emergency department, readmissions and high mortality.(3-6) Authorized by the 2010 Federal health care law, penalties for readmissions are now part of an "effort by Medicare to use its financial muscle to force improvements in hospital quality," and more than 2,000 hospitals could be penalized.(7)
PRONTO and Data Presentation Details
The Medicines Company, sponsor of the randomized, open-label, multi-center, pilot study (n=104 patients) entitled "PRONTO (A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure)," manufactures and markets clevidipine under the brand name Cleviprex®.
The oral presentation is scheduled as part of the session titled, "AOS.504.01 Who Needs the Animal Laboratory? Insights into CHF from the Human Experience." Other important details about the presentation are as follows:
- Presentation Title: Clevidipine Improves Dyspnea in Emergency Department Acute Heart Failure: A Randomized, Open Label Study
- Abstract Number: 15606
- Presentation Time: 2:15 p.m. - 2:30 p.m. (15-minute presentation and 5-minute Q & A)
- Place: Room 407
- Presenter: W. Frank Peacock IV, MD, FACEP
- Moderators: Mark H. Drazner, MD, MSc, FACC and John R. Teerlink, FACC, FAHA, FESC
About Cleviprex® (clevidipine) Injectable Emulsion
Cleviprex is an intravenous dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. In June 2011, the U.S. Food and Drug Administration (FDA) approved the current formulation, which triples the maximum allowable infusion time per vial, commonly referred to in hospitals as "hang time," to 12 hours compared to the original 4-hour hang time vial approved by the FDA in 2008.
Important Safety Information About Cleviprex
Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs or egg products; defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if it is accompanied by hyperlipidemia; and severe aortic stenosis.
Cleviprex is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. If either occurs, decrease the dose of Cleviprex. There is limited experience with short-duration therapy with beta-blockers as a treatment for Cleviprex-induced tachycardia.
Cleviprex contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.
Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.
Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.
There is no information to guide use of Cleviprex in treating hypertension associated with pheochromocytoma.
Most common adverse reactions are ( > 2%) headache, nausea, and vomiting.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company 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, including the Company's preliminary revenue results, 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 the extent of the commercial success of Angiomax, the Company's ability to develop its global operations and penetrate foreign markets, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, 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 Quarterly Report on Form 10-Q filed on August 9, 2012, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
1. Weintraub NL, Collins SP, Pang PS, et al. Acute heart failure syndromes: emergency department presentation, treatment, and disposition: current approaches and future aims: a scientific statement from the American Heart Association. Circulation. 2010;122(19):1975-1996.
2. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012;125(1):e2-e220.
3. O'Connor CM, Abraham WT, Albert NM, et al. Predictors of mortality after discharge in patients hospitalized with heart failure: an analysis from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2008;156(4):662-673.
4. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360(14):1418-1428.
5. Lee DS, Austin PC, Stukel TA, et al. "Dose-dependent" impact of recurrent cardiac events on mortality in patients with heart failure. Am J Med. 2009;122(2):162-169
6. Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007;154(2):260-266
7. Rau Jordan. Medicare to penalize 2,217 hospitals for excess readmissions. Kaiser Health News website. http://www.kaiserhealthnews.org/Stories/2012/August/13/medicare-hospitals-readmissions-penalties.aspx
Accessed October 26, 2012.