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Published on 11/16/2005 in the Prospect News Biotech Daily.

Kos' Niaspan/statin combination causes regression of atherosclerosis, study says

By Angela McDaniels

Seattle, Nov. 16 - Kos Pharmaceuticals Inc. said a new study has shown that reversal of atherosclerosis can be achieved with a combination of Niaspan (prolonged-release nicotinic acid) and a statin.

Results of the open-label phase of the study show that patients treated with Niaspan and a statin achieved significant regression of carotid atherosclerosis, compared to a continued progression in patients treated with statin alone, the company said.

The study was conducted in 148 patients who were typical of at-risk patients seen in daily practice with an average low-density lipoprotein cholesterol level of 82 mg/dL and average high-density lipoprotein cholesterol level of 40 mg/dL. They received 1,000 milligrams of Niaspan daily in addition to statin, usually 40 milligrams of simvastatin.

The data was presented at the Scientific Sessions of the American Heart Association in Dallas.

Additionally, patients treated for an additional 12 months after the study ended had a 24% reduction in high-density lipoprotein cholesterol, which further reduced atherosclerosis, the company said.

"This is an exciting advance in our knowledge of the benefits of raising high-density lipoprotein cholesterol, which previous studies suggest should be translated into reduced risk of fatal and non-fatal events," lead investigator Allen Taylor of the Walter Reed Army Medical Center in Washington, D.C., said in a company press release.

That hypothesis will be tested in a U.S. National Institutes of Health study that begins recruiting patients this month and will compare clinical endpoints of coronary death, non-fatal events and stroke in 3,300 patients with established heart disease treated either with the combination of Niaspan and simvastatin or simvastatin alone, the company said.

Atherosclerosis is a primary cause of stroke and heart attacks.

Niaspan was developed by Cranbury, N.J.-based Kos Pharmaceuticals and is marketed in Europe by Merck, a pharmaceutical and chemical company based in Whitehouse Station, N.J., under a license agreement with Kos.


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