ACC Comment on FDA Approval of New Cholesterol-Lowering Drug

Contact: Katie Glenn, kglenn@acc.org, 202-375-6472

WASHINGTON (Jul 24, 2015) -

American College of Cardiology President Kim Allan Williams Sr., M.D., FACC, made the following statement regarding today's announcement from the U.S. Food and Drug Administration approving the first in a new class of medications for lowering LDL or "bad" cholesterol:

"The approval of this first in a new class of drugs, known as PCSK9 inhibitors, which have been shown to dramatically reduce levels of LDL cholesterol in the blood and potentially prevent or improve coronary heart disease, is an exciting development in cardiology," said American College of Cardiology President Kim Allan Williams Sr., M.D., FACC.

"Because more robust outcomes data, which could show whether these drugs reduce incidence of death and heart attacks, will not be available until 2017, the FDA has approved it for limited groups of patients at very high risk. The ACC eagerly awaits the results of the clinical trials that are in progress. In the meantime, we continue to recommend physicians limit prescribing to the very high risk, hard-to-treat groups approved by the FDA and otherwise follow the current guidelines, which recommend lifestyle change and, if needed, statins for most patients with or at-risk of heart disease. Improving diet and optimizing exercise are the cornerstones of heart disease management and prevention. Statins are available as low-cost generics, are well tolerated in most patients, and their effectiveness is supported by strong evidence."

The American College of Cardiology is a 49,000-member medical society that is the professional home for the entire cardiovascular team. The mission of the College is to transform cardiovascular care and to improve heart health. The ACC leads in the formation of health policy, standards and guidelines. The College operates national registries to measure and improve care, provides professional medical education, disseminates cardiovascular research, and bestows credentials upon cardiovascular specialists who meet stringent qualifications. For more information, visit www.acc.org.

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