Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Data show drug being tested to reduce cardiovascular events increased risk of heart attack

19.11.2013
VISTA-16 trial was halted for futility and possible harm in 2012

Patients with acute coronary syndrome who were treated with the experimental drug varespladib were more likely to experience additional cardiovascular events – including sudden death, heart attack and stroke – than those treated with placebo, according to research from the Cleveland Clinic Coordinating Center for Clinical Research (C5Research).

The results of the VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome for 16 Weeks) trial, which was halted last year for futility and possible harm, were presented today at the American Heart Association Scientific Sessions 2013 in Dallas and published simultaneously in the Journal of the American Medical Association (JAMA).

Varespladib inhibits production of the compound secretory phospholipase A2 (sPLA2), which promotes the vascular inflammation implicated in the development of atherosclerosis, or the clogging and hardening of arteries.VISTA-16 was designed to test whether the use of varespladib to reduce sPLA2 would lower the risk of cardiovascular events in patients with acute coronary syndrome. Patients with acute coronary syndrome have had a heart attack or experienced unstable angina, which can lead to a heart attack.

Rather than reduce additional cardiovascular events, including sudden death, heart attack, stroke, and unstable angina, the study found that patients treated with varespladib were more likely than those treated with placebo to experience these events. Both groups of patients were also treated with statin therapy and standard-of-care protocols. The primary endpoint, a composite of sudden death, heart attack, stroke and unstable angina, occurred in 6.1 percent of patients on varespladib compared to 5.1 percent of those on placebo.

In addition, the study found that varespladib was associated with a significantly greater risk of heart attack, occurring in 3.4 percent of the study population on varespladib and 2.2 percent of those on placebo.

After reviewing this data, the trial's independent Data and Safety Monitoring Board called off the trial in March 2012.

"Despite prior experimental and observational data suggesting that varespladib would have beneficial cardiovascular effects, this trial proves the contrary, that it is actually detrimental to cardiovascular morbidity and mortality," said VISTA-16 executive committee chair Stephen J. Nicholls, M.D., Ph.D., senior consultant to Cleveland Clinic's C5Research and Professor of Cardiology and Deputy Director at the South Australian Health & Medical Research Institute (SAHMRI) in Adelaide, Australia.

"The drug cannot be used to prevent cardiovascular events in patients with acute coronary syndrome," he said.

The researchers do not know whether the outcome of the VISTA-16 trial is attributable to the varespladib molecule itself, or the across-the-board inhibition of sPLA2, which is known to have both protective and inflammatory affects on the cardiovascular system.

"We know that vascular inflammation plays a significant role in the development of coronary disease, and it's important for the scientific community to continue to pursue drugs that may ease the inflammatory process and reduce cardiovascular risk," said Steven Nissen, M.D., senior author on the JAMA paper and Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at Cleveland Clinic. "Unfortunately, the complexity of the inflammatory process continues to confound our efforts at taming it."

VISTA-16 was a double-blind, randomized, placebo-controlled trial designed to enroll more than 5,000 patients at 362 academic and community hospitals in Australia, Europe, India, New Zealand, and North America. It was an academically directed trial developed by an independent executive steering committee with input from the sponsor, Anthera Pharmaceuticals, and monitored by a Data and Safety Monitoring Board independent from both the executive committee and the sponsor.

About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. More than 3,000 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. The Cleveland Clinic health system includes a main campus near downtown Cleveland, more than 75 Northern Ohio outpatient locations, including 16 full-service Family Health Centers, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and, currently under construction, Cleveland Clinic Abu Dhabi. In 2012, there were 5.1 million outpatient visits throughout the Cleveland Clinic health system and 157,000 hospital admissions. Patients came for treatment from every state and from more than 130 countries. Visit us at http://www.clevelandclinic.org. Follow us at http://www.twitter.com/ClevelandClinic.
Contact:
Wyatt DuBois, 216.904.3344, duboisw@ccf.org
Tora Vinci, 216.339.4277, vinciv@ccf.org

Wyatt DuBois | EurekAlert!
Further information:
http://www.ccf.org

More articles from Health and Medicine:

nachricht TSRI researchers develop new method to 'fingerprint' HIV
29.03.2017 | Scripps Research Institute

nachricht Periodic ventilation keeps more pollen out than tilted-open windows
29.03.2017 | Technische Universität München

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: A Challenging European Research Project to Develop New Tiny Microscopes

The Institute of Semiconductor Technology and the Institute of Physical and Theoretical Chemistry, both members of the Laboratory for Emerging Nanometrology (LENA), at Technische Universität Braunschweig are partners in a new European research project entitled ChipScope, which aims to develop a completely new and extremely small optical microscope capable of observing the interior of living cells in real time. A consortium of 7 partners from 5 countries will tackle this issue with very ambitious objectives during a four-year research program.

To demonstrate the usefulness of this new scientific tool, at the end of the project the developed chip-sized microscope will be used to observe in real-time...

Im Focus: Giant Magnetic Fields in the Universe

Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.

The results will be published on March 22 in the journal „Astronomy & Astrophysics“.

Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...

Im Focus: Tracing down linear ubiquitination

Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.

Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...

Im Focus: Perovskite edges can be tuned for optoelectronic performance

Layered 2D material improves efficiency for solar cells and LEDs

In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...

Im Focus: Polymer-coated silicon nanosheets as alternative to graphene: A perfect team for nanoelectronics

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

International Land Use Symposium ILUS 2017: Call for Abstracts and Registration open

20.03.2017 | Event News

CONNECT 2017: International congress on connective tissue

14.03.2017 | Event News

ICTM Conference: Turbine Construction between Big Data and Additive Manufacturing

07.03.2017 | Event News

 
Latest News

Researchers shoot for success with simulations of laser pulse-material interactions

29.03.2017 | Materials Sciences

Igniting a solar flare in the corona with lower-atmosphere kindling

29.03.2017 | Physics and Astronomy

As sea level rises, much of Honolulu and Waikiki vulnerable to groundwater inundation

29.03.2017 | Earth Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>