Welcome!

News Feed Item

Emergency Hypertensive Acute Heart Failure Study PRONTO Demonstrates Clevidipine Superior to Standard of Care

Early Treatment of Patients in Hospital Emergency Setting Reduces High Blood Pressure and Relieves Shortness of Breath

LOS ANGELES, CA -- (Marketwire) -- 11/05/12 -- The Medicines Company (NASDAQ: MDCO) announced today the first presentation of PRONTO, a study of emergency patients with acute heart failure associated with high blood pressure enrolled within hours of their hospital arrival, making it the earliest examination of acute heart failure treatment ever performed in a clinical trial. More than 1 million acute heart failure patients each year present -- mainly to emergency departments -- at US hospitals. About half of these have high blood pressure.

The primary objective and the main secondary objective of the PRONTO clinical trial were met. Patients randomized to early treatment with Cleviprex® (clevidipine) Injectable Emulsion demonstrated more rapid and greater blood pressure reductions (p-value < 0.001). Patients reported that shortness of breath, their most distressing symptom, resolved more rapidly than with the current standard of care (SOC) (overall p-value 0.037). Safety measures were similar for both randomized treatments.

These findings were presented by W. Frank Peacock IV, MD, FACEP, Emergency Medicine Research Director at Baylor College of Medicine and Principal Investigator for PRONTO on behalf of a group of leading international acute heart failure investigators and discussed during the "Clevidipine Improves Dyspnea in Emergency Department Acute Heart Failure: A Randomized, Open Label Study" presentation (abstract 15606), presented today at the American Heart Association Scientific Sessions 2012 in Los Angeles, California.

PRONTO Purpose and Potential Implications
Dr. Peacock discussed why he is particularly excited about the data: "PRONTO was the first major heart failure trial in the last decade that displayed a significant improvement in dyspnea vs. SOC." Dr. Peacock added, "Dyspnea is the number one reason heart failure patients go to the hospital and stay there. An agent that can relieve dyspnea may have the potential to decrease associated length of stay and hospital costs as well as improve the quality of life for patients. The faster we can improve their breathing, the sooner they can go home." Of the more than 1 million patients admitted to hospitals for heart failure each year, the mean length of stay is nearly 5 days. The costs associated with these patients' hospitalizations is estimated at approximately $40 billion annually in the US.1

Gregg C. Fonarow, MD, FACC, Professor of Medicine, Ahmanson-UCLA Cardiomyopathy Center Director, UCLA Division of Cardiology Co-Chief and PRONTO Steering Committee member, noted potentially important clinical implications in the PRONTO data: "According to the findings, clevidipine treated dyspnea better than established standard of care therapies. This challenges previously held paradigms that calcium channel antagonists should be avoided in patients with acute heart failure. Further trials are needed to corroborate these findings, but clevidipine may provide an attractive treatment option to reduce blood pressure and improve breathing for acute heart failure patients who are hypertensive."

PRONTO Study Methods, Results and Limitations
A randomized open-label, multi-center trial, PRONTO (A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure -- A Pilot Study), enrolled 104 emergency department hypertensive acute heart failure patients who exhibited pulmonary congestion. After setting a 30-minute target systolic blood pressure (SBP) range, patients were randomly treated with clevidipine or SOC (predominantly nitroglycerin and nicardipine), each administered per approved labeling.

In this trial, clevidipine met the composite primary endpoint of median time and percent of patients to reach target SBP range and a 15% blood pressure reduction in the first 30 minutes of therapy. Approximately twice as many clevidipine-treated patients achieved this endpoint than SOC-treated patients (70.5 vs. 36.6%). The median time to achieve this endpoint for clevidipine-treated patients was 15 minutes. The median time for SOC treated patients could not be estimated because fewer than 50% of patients achieved the primary endpoint (p=0.0006). The SOC-treated patients that achieved this endpoint did so in a median of 18 minutes.

In addition, clevidipine met the main secondary endpoint: dyspnea reduction (improved breathing). Within 45 minutes, the dyspnea visual analogue scale (VAS) for shortness of breath decreased more from baseline with clevidipine (median -3.6 cm) than with SOC (-2.1 cm), p=0.012. This effect was maintained to 3 hours with overall effect (p=0.037).

The percentage of patients with at least one study drug related treatment-emergent adverse event was similar in the clevidipine (9.8%) and SOC (13.2%) groups. The most common of these events was headache.

Limitations of the trial included its relatively small sample size, powered for the primary but not for all secondary endpoints, and the open label design, which makes subjective dyspnea assessments challenging. The standard of care (SOC) treatment comparator -- while representative of real care -- may have provided an inconsistent control group, although subset analysis did not suggest such confounding.

About Cleviprex® (clevidipine) Injectable Emulsion
Cleviprex (clevidipine) 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 (clevidipine)
Cleviprex (clevidipine) 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. Beta-blocker use for this purpose is not recommended.

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 is not a beta-blocker, does not reduce heart rate and 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.

References
1. 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.

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
The Art of DevOps provides a fun overview to help teams understand DevOps. Written in the style of the famous 6th century Chinese manuscript “The Art of War,” this eBook describes DevOps in the form of a mission to continuously deliver assets to the operational battlegrounds safely, securely, and quickly. It’s a fun read with valuable insights.
The Quantified Economy represents the total global addressable market (TAM) for IoT that, according to a recent IDC report, will grow to an unprecedented $1.3 trillion by 2019. With this the third wave of the Internet-global proliferation of connected devices, appliances and sensors is poised to take off in 2016. In his session at @ThingsExpo, David McLauchlan, CEO and co-founder of Buddy Platform, will discuss how the ability to access and analyze the massive volume of streaming data from mil...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, will give users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion w...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
WebSocket is effectively a persistent and fat pipe that is compatible with a standard web infrastructure; a "TCP for the Web." If you think of WebSocket in this light, there are other more hugely interesting applications of WebSocket than just simply sending data to a browser. In his session at 18th Cloud Expo, Frank Greco, Director of Technology for Kaazing Corporation, will compare other modern web connectivity methods such as HTTP/2, HTTP Streaming, Server-Sent Events and new W3C event APIs ...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
SYS-CON Events announced today that (ISC)²® (“ISC-squared”) will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Two leading non-profits focused on cloud and information security, (ISC)² and Cloud Security Alliance (CSA), developed the Certified Cloud Security Professional (CCSP) certification to address the increased demand for cloud security expertise due to rapid growth in cloud. Recently named “The Next...
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...