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FDA Approves New Cholesterol-Cutting Combination Drug — Physician’s First Watch

Medical News |
May 6, 2013

FDA Approves New Cholesterol-Cutting Combination Drug

By Kristin J. Kelley

The FDA has approved a new ezetimibe-atorvastatin tablet (brand name, Liptruzet) for lowering cholesterol in patients with primary or mixed hyperlipidemia, and in those with homozygous familial hypercholesterolemia.

In a trial of some 620 patients, the once-daily tablet reduced LDL cholesterol by 53% at the lowest dose (10/10 mg) and 61% at the highest dose (10/80 mg). Common side effects include changes in liver function tests, muscle pain, memory loss, and tendon problems.

The combination treatment has not been shown to improve cardiovascular outcomes better than atorvastatin, which has some cardiologists questioning the FDA's decision. Steven Nissen, chairman of cardiology at the Cleveland Clinic, says in Forbes that the agency seems to be "tone deaf" to concerns "about approving drugs with surrogate endpoints like cholesterol without evidence of a benefit for the disease [cardiologists] are truly trying to treat — cardiovascular disease."

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