Cincinnati (July 1, 2015) – An expert panel that advises the Food and Drug Administration recently recommended the agency approve two new drugs that significantly lower levels of cholesterol and are expected to have a major impact on atherosclerotic cardiovascular disease, the leading cause of death and disability worldwide. If approved, Praluent (alirocumab) and Repatha (evolocumab) would be the first members in a new class of medicines that protect against heart attacks and strokes.
The Lindner Center for Research and Education at The Christ Hospital, a leading cardiovascular research facility, is currently participating in clinical trials for Praulent, a Sanofi and Regeneron Pharmaceuticals drug, and Repatha, created by Amgen. The Lindner Center has been studying both drugs since 2011.
“This represents the major breakthrough in cardiovascular disease therapy of the past decade,” said Dean Kereiakes, MD, medical director of both The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education at The Christ Hospital.
Patients involved in the Praulent and Repatha clinical trials at The Lindner Center have seen their LDL cholesterol, often referred to as the bad cholesterol, drop by 60-80%. The drugs work by inhibiting a naturally occurring enzyme, PCSK9, which degrades LDL-C receptors in the liver and thus diminishes the liver’s ability to take LDL-C out of the blood. Inhibiting PCSK9 increases LDL-C receptors and allows the liver to remove LDL-C from the bloodstream thereby lowering the cholesterol level.
“These are the most effective and best tolerated medicines we have used,” said Dr. Kereiakes. “The only problem I can see will be in cost and insurance coverage.
“Pharmaceutical companies can spend close to a billion dollars bringing this type of drug to market in a stringent U.S. regulatory system,” Kereiakes said. “It should come as no surprise that such new, leading edge medicines will be expensive, unfortunately.”
The F.D.A. usually follows the advice of its expert committees. Once a drug is approved doctors can prescribe it to patients outside of a clinical trial.
The Lindner Center for Research and Education at The Christ Hospital will complete its clinical trials on Praluent and Repatha in 2017.
To learn more about The Lindner Center for Research and Education at The Christ Hospital, call 513-585-1777 or visit LindnerResearch.com. To learn more about cardiovascular care at The Christ Hospital, call 513-206-1170 or visit TheChristHospital.com/Heart.
About The Christ Hospital Health Network: The Christ Hospital Health Network is a regional care system comprised of The Christ Hospital and more than 100 outpatient/physician locations in the Greater Cincinnati area. Our mission is to improve the health of our community and to create patient value by providing exceptional outcomes, affordable care and the finest experiences. Led by the region’s Most Preferred hospital (National Research Corporation), the network is dedicated to transforming care by delivering integrated, individualized healthcare and wellness services through its comprehensive physician network and advanced specialty service. For more than 125 years, The Christ Hospital has provided compassionate care to all those we serve.
About The Lindner Research Center: For the past 25 years, The Carl and Edyth Lindner Center for Research and Education (Lindner Research Center) has provided leading-edge medicines and medical technology research covering a broad spectrum of conditions from obesity, diabetes, coronary disease, hypertension and hyperlipidemia to new vascular interventional devices, adult stem cell therapies, structural heart disease, cardiovascular surgery, heart failure and electrophysiology. Physicians at the Lindner Research Center have conducted more than 1,200 clinical trials including multiple first-in-man and first-in-the-U.S procedures, which have contributed to best practice standards for the care of patients. For information on current trials, please call 513-585-1777.