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| |  Niaspan (Niacin Extended Release) Superior To Gemfibrozil in Raising "Good" Cholesterol MIAMI, FL -- May 15, 2000 -- Kos Pharmaceuticals, Inc. announced the recent publication, in two peer-reviewed medical journals of two clinical trials highlighting Niaspan's broad, potent efficacy and reliable safety profile. The results of a comparative study of the Company's Niaspan(R) (niacin extended release tablets) product with gemfibrozil were published in the April 24 issue of the Archives of Internal Medicine, and the results of a study describing the safety and efficacy of Niaspan at escalating doses were published in the May 1 issue of the American Journal of Cardiology. Both studies confirm Niaspan's superior efficacy in raising HDL, or "good," cholesterol and in sharply improving other lipid components, while showing a consistent safety profile. The study published in the Archives of Internal Medicine compared Niaspan with gemfibrozil in a multicenter, randomized, double-blind trial in patients with low levels of HDL cholesterol. (Gemfibrozil belongs to a class of drugs known as fibrates, which are commonly prescribed for lowering triglycerides and raising HDL cholesterol.) After 19 weeks of therapy, Niaspan increased HDL levels, on average, up to 26 percent compared with 13 percent for gemfibrozil. Additionally, Niaspan reduced lipoprotein (a) levels 20 percent, compared with no change for gemfibrozil, while reducing triglyceride levels 29 percent, compared with 40 percent with gemfibrozil. The dose escalation study, published in the American Journal of Cardiology, evaluated the safety and efficacy of Niaspan at increasing doses from 500 to 3000 mg per day. The study showed that Niaspan, at the maximum approved dose of 2000 mg, increased HDL cholesterol levels an average of 26 percent, decreased LDL levels by 17 percent and decreased triglycerides by 35 percent. Equally important, at all doses, Niaspan did not show a significant difference from placebo in liver enzyme elevations greater than three times the upper limit of normal. Liver enzyme elevation is a common concern with non-prescription forms of niacin at therapeutic doses. Niaspan is the only once-daily, sustained-release formulation of niacin approved by the U.S. Food and Drug Administration (FDA) for the treatment of mixed-lipid disorders, and maintains the well-established HDL efficacy of immediate-release niacin while minimizing side effects and virtually eliminating liver toxicity. Gemfibrozil was the drug used in the U.S. Veterans Administration HDL Intervention Trial (VA-HIT), the results of which were published in 1999. "The VA-HIT results confirmed the importance of treating HDL as an independent risk factor in coronary heart disease, and these recently published results reaffirm that Niaspan is the most potent once-daily agent available for raising HDL," said Daniel M. Bell, President and Chief Executive Officer of Kos. "The publication of these articles, along with numerous others recently published, reflects a heightened and growing level of interest in HDL cholesterol within the medical community." Kos Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical company engaged in developing and commercializing proprietary prescription pharmaceutical products, primarily for the treatment of chronic cardiovascular and respiratory diseases. Kos has drug-delivery capabilities in both solid- dose and aerosolized formulation technologies.
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