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 Biofilm discovery suggests new way to prevent dangerous infections
23.05.2017 | University of Texas at Austin

nachricht Another reason to exercise: Burning bone fat -- a key to better bone health
19.05.2017 | University of North Carolina Health Care

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: Can the immune system be boosted against Staphylococcus aureus by delivery of messenger RNA?

Staphylococcus aureus is a feared pathogen (MRSA, multi-resistant S. aureus) due to frequent resistances against many antibiotics, especially in hospital infections. Researchers at the Paul-Ehrlich-Institut have identified immunological processes that prevent a successful immune response directed against the pathogenic agent. The delivery of bacterial proteins with RNA adjuvant or messenger RNA (mRNA) into immune cells allows the re-direction of the immune response towards an active defense against S. aureus. This could be of significant importance for the development of an effective vaccine. PLOS Pathogens has published these research results online on 25 May 2017.

Staphylococcus aureus (S. aureus) is a bacterium that colonizes by far more than half of the skin and the mucosa of adults, usually without causing infections....

Im Focus: A quantum walk of photons

Physicists from the University of Würzburg are capable of generating identical looking single light particles at the push of a button. Two new studies now demonstrate the potential this method holds.

The quantum computer has fuelled the imagination of scientists for decades: It is based on fundamentally different phenomena than a conventional computer....

Im Focus: Turmoil in sluggish electrons’ existence

An international team of physicists has monitored the scattering behaviour of electrons in a non-conducting material in real-time. Their insights could be beneficial for radiotherapy.

We can refer to electrons in non-conducting materials as ‘sluggish’. Typically, they remain fixed in a location, deep inside an atomic composite. It is hence...

Im Focus: Wafer-thin Magnetic Materials Developed for Future Quantum Technologies

Two-dimensional magnetic structures are regarded as a promising material for new types of data storage, since the magnetic properties of individual molecular building blocks can be investigated and modified. For the first time, researchers have now produced a wafer-thin ferrimagnet, in which molecules with different magnetic centers arrange themselves on a gold surface to form a checkerboard pattern. Scientists at the Swiss Nanoscience Institute at the University of Basel and the Paul Scherrer Institute published their findings in the journal Nature Communications.

Ferrimagnets are composed of two centers which are magnetized at different strengths and point in opposing directions. Two-dimensional, quasi-flat ferrimagnets...

Im Focus: World's thinnest hologram paves path to new 3-D world

Nano-hologram paves way for integration of 3-D holography into everyday electronics

An Australian-Chinese research team has created the world's thinnest hologram, paving the way towards the integration of 3D holography into everyday...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Marine Conservation: IASS Contributes to UN Ocean Conference in New York on 5-9 June

24.05.2017 | Event News

AWK Aachen Machine Tool Colloquium 2017: Internet of Production for Agile Enterprises

23.05.2017 | Event News

Dortmund MST Conference presents Individualized Healthcare Solutions with micro and nanotechnology

22.05.2017 | Event News

 
Latest News

How herpesviruses win the footrace against the immune system

26.05.2017 | Life Sciences

Water forms 'spine of hydration' around DNA, group finds

26.05.2017 | Life Sciences

First Juno science results supported by University of Leicester's Jupiter 'forecast'

26.05.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>