Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Antibody injection lowers LDL, adding to effectiveness of statin therapy

27.03.2012
New research shows SAR236553/REGN727 reduces LDL by up to 72 percent in patients

A novel monoclonal antibody identified in a new study dramatically lowered circulating LDL cholesterol by 40 percent to 72 percent, a development with potential to provide a new option for patients who are resistant to cholesterol-lowering drugs such as statins or to the current standard of care, according to research presented today at the American College of Cardiology's 61st Annual Scientific Session.

The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.

The traditional statin therapy used by millions of Americans lowers LDL cholesterol – the "bad" cholesterol that leads to plaque build-up in the arteries and subsequently heart disease – by inhibiting the production of cholesterol in liver cells, causing an increase in the number of LDL receptors on the cell surface. These receptors grab LDL circulating in the blood and deliver it into the liver, where it is subsequently processed and flushed out of the body. About one in five people with high low-density lipoprotein (LDL) are resistant to cholesterol-lowering drugs such as statins, and for many others the current standard of care does not lower cholesterol enough.

A recent discovery showed that statin therapy stimulates the production of PCSK9, an enzyme that leads to the destruction of LDL receptors. The present study tested SAR236553/REGN727, a monoclonal antibody that binds to PCSK9, blocking its effects and preventing the degradation of LDL receptors. More LDL receptors mean more LDL is brought out of the blood into the liver, and circulating levels of LDL cholesterol decrease.

"We've known for 30 years that lowering LDL cholesterol with statins lowers the risk of heart disease and that the more you can lower LDL cholesterol, the greater reduction in that risk," said James McKenney, PharmD, chief executive officer of National Clinical Research, and the study's lead investigator. "However, we know in some cases that even the best statin can't get LDL cholesterol as low as it should be."

This multi-center, randomized trial looked at 183 patients who had an LDL cholesterol reading of 100 mg/dL or higher. The patients had already been treated with atorvastatin for more than six weeks at stable doses of 10, 20 or 40 mg. The participants were divided into six groups: a placebo control; three groups who received a subcutaneous injection of SAR236553/REGN727 every two weeks (Q2W) at doses of either 50, 100, or 150 mg; and two groups who received an injection of SAR236553/REGN727 at 200 or 300 mg every 4 weeks (Q4W), alternating with placebo shots at two weeks. The study's primary endpoint was the percentage LDL cholesterol reduction from baseline to after 12 weeks.

Dr. McKenney reported a remarkable dose-response to SAR236553/REGN727 injections. Circulating LDL cholesterol was lowered by 40 percent, 64 percent, and 72 percent in patients assigned to 50, 100, or 150 mg Q2W doses, respectively. LDL cholesterol was reduced by 43 percent and 48 percent for patients who received 200 or 300 mg Q4W injections. The placebo group reported a 5 percent reduction of circulating LDL cholesterol.

"Our LDL cholesterol treatment goals were less than 100 or 70 mg/dL," Dr. McKenney said. "All of the participants receiving one of our doses met those goals."

Dr. McKenney said the results surprised him, "Statins are good medicines and getting a 70 percent reduction on top of them is remarkable."

The SAR236553/REGN727 antibody was discovered two years ago, and these are the first Phase II results for an anti-PCSK9 antibody to be presented. Dr. McKenney said a longer study is needed to establish the long-term safety of the antibody, but the results from this trial were promising, with only one adverse reaction reported.

"This is a very hopeful step in the treatment of heart disease in this country," said Dr. McKenney.

This study was funded by Sanofi US, Bridgewater, N.J., and Regeneron Pharmaceuticals, Tarrytown, N.Y. Dr. McKenney reports that he is an employee of a research company that has received research funding from Regeneron and Sanofi.

The study will be simultaneously published in the Journal of the American College of Cardiology and will be published online at the time of presentation.

Dr. McKenney will be available to the media on Monday, March 26 at 12:15 p.m. in Media Room 1, McCormick Place N, Level 1, Hall C1.

Dr. McKenney will present the study "A Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease, REGN727/SAR236553, in Patients with Primary Hypercholesterolemia" on Monday, March 26 at 10:30 a.m. in McCormick Place North: Main Tent.

About the American College of Cardiology

The American College of Cardiology (www.cardiosource.org) is a 40,000-member nonprofit medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers. The College transforms cardiovascular care and improves heart health as it supports and advocates for quality improvement, patient-centered care, payment innovation and professionalism. The ACC bestows credentials upon cardiovascular specialists who meet its stringent qualifications and leads the formulation of health policy, standards and guidelines. It provides professional education, supports and disseminates cardiovascular research, and operates national registries to measure and promote quality.

The ACC's Annual Scientific Session brings together cardiologists and cardiovascular specialists from around the world each year to share the newest discoveries in treatment and prevention.

Beth Casteel | EurekAlert!
Further information:
http://www.acc.org

Further reports about: Cardiology LDL Sanofi heart disease monoclonal antibody statin therapy

More articles from Health and Medicine:

nachricht Cystic fibrosis alters the structure of mucus in airways
29.06.2017 | University of Iowa Health Care

nachricht Mice provide insight into genetics of autism spectrum disorders
28.06.2017 | University of California - Davis

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: Making Waves

Computer scientists use wave packet theory to develop realistic, detailed water wave simulations in real time. Their results will be presented at this year’s SIGGRAPH conference.

Think about the last time you were at a lake, river, or the ocean. Remember the ripples of the water, the waves crashing against the rocks, the wake following...

Im Focus: Can we see monkeys from space? Emerging technologies to map biodiversity

An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.

Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...

Im Focus: Climate satellite: Tracking methane with robust laser technology

Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.

Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...

Im Focus: How protons move through a fuel cell

Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.

As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...

Im Focus: A unique data centre for cosmological simulations

Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.

With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Plants are networkers

19.06.2017 | Event News

Digital Survival Training for Executives

13.06.2017 | Event News

Global Learning Council Summit 2017

13.06.2017 | Event News

 
Latest News

Nanostructures taste the rainbow

29.06.2017 | Physics and Astronomy

New technique unveils 'matrix' inside tissues and tumors

29.06.2017 | Life Sciences

Cystic fibrosis alters the structure of mucus in airways

29.06.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>