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Statin Alternative Looks Promising in Early Trials
Date:3/21/2012

which include liver damage or muscle pain -- and others don't achieve the recommended LDL blood levels of 70 milligrams (mg) per deciliter or lower for those at risk of heart disease.

Two randomized, single-dose studies of the antibody, known as REGN727, were administered either intravenously (in 40 participants) or by injection (in 32 participants) and compared with a group given an inactive placebo. These trials were followed by a randomized study of multiple doses in 51 adults with high cholesterol who were taking atorvastatin (brand name Lipitor) and whose baseline LDL levels were more than 100 mg per deciliter.

Higher doses of REGN727 lowered LDL cholesterol levels by up to 64 percent, and the effect was similar across the board whether or not participants were also taking a statin, which works by a different mechanism.

Commenting on the study, Christine Metz, head of the Laboratory of Medicinal Biochemistry at the Feinstein Institute for Medical Research in Manhasset, N.Y., said, "The next step would be to test a much larger group of people for a much longer time. But this is very promising, apparently safe under the conditions used, and worth very quickly going forward."

Garratt noted that the new drug, which could take at least several years to reach the market, would need to be injected, since antibodies typically can't be formulated into pills. Such a compound would likely be extremely expensive, especially when compared to statins, which are now available as generic drugs. Also, like statins, such a drug would probably need to be taken for life, he said.

Metz pointed out that the trials were very small and consisted heavily of men, making it hard to generalize results for a broader population.

However, "I thought the study was very beautifully conceived and well done," she added. "It did everything it set out to do."

More information

The U.S. National Library of Medicine has
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