To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AHA: Niaspan (Niacin Extended Release Tablets) Safe And Effective For Diabetics URL: http://www.pslgroup.com/dg/1EA936.htm Doctor's Guide November 14, 2000
MIAMI, FL -- November 14, 2000 -- Kos Pharmaceuticals, Inc. reported the summary findings from a 16-week study of Niaspan (niacin extended release tablets) in treating lipid abnormalities in adult-onset diabetic patients. The findings were presented at a clinical investigators' meeting November 11 in New Orleans, where the American Heart Association is currently in session. With nearly 150 patients in the study, it was one of the largest cholesterol studies ever to focus exclusively on diabetic patients. The study concluded that Niaspan significantly improved the critical lipoprotein abnormalities in these diabetic patients without adversely affecting their blood sugar levels. The study, which is expected to be published early next year, was a double-blind, placebo-controlled trial. Patients entered the study with normal levels of LDL cholesterol (known as the bad cholesterol), low levels of HDL cholesterol (known as the good cholesterol) and high levels of triglycerides. All patients in the study were on an oral antihyperglycemic medication and/or insulin, and adjustment to such medication was permitted during the study; patients also were allowed to enter the study while taking statins. Patients received either 1,000 mg or 1,500 mg of Niaspan, or placebo. Results from the trial indicated that Niaspan therapy increased HDL up to 24 percent and decreased triglycerides as much as 30 percent. Niaspan therapy also proved to be extremely safe and well tolerated. There were no clinically significant increases in hemoglobin A1C levels, a primary marker for measuring glucose control; fewer than 15 percent of patients at the highest dose required any changes in their antihyperglycemic medication; and only three patients withdrew from the study because of flushing. Among other important indicators of cardiovascular well-being, levels of C-Reactive Protein and Lp(a) also improved. "These compelling new data establish that Niaspan, either alone or in combination with a statin, is effective in treating the dyslipidemia associated with diabetes," said Daniel Rader, M.D., Director, Preventive Cardiology, University of Pennsylvania, Philadelphia, PA. "The findings are particularly important, and timely, in light of the aggressive new treatment approaches being recommended for diabetic patients, most of whom have low HDL, and who are at very high risk for developing coronary heart disease and other vascular disease." The results of this Niaspan study compared favorably with the findings of another recent study published in the September 18 issue of the Journal of the American Heart Association. The study, entitled Arterial Disease Multiple Intervention Trial ("ADMIT"), concluded that therapeutic doses of niacin can be used by diabetics for the control of cholesterol disorders safely and effectively and may be considered as an alternative to existing therapies used to manage high triglycerides or low HDL cholesterol. ADMIT was a placebo-controlled, double-blind trial that reported on the effects of immediate-release niacin in 125 diabetic participants with diagnosed peripheral arterial disease. Although both Niaspan and immediate-release niacin have been shown to be effective in treating dyslipidemia in diabetic patients, previous research comparing the two formulations found Niaspan therapy to be safer and more tolerable than immediate-release niacin. "We expect the growing body of evidence about the safety and efficacy of Niaspan in diabetic patients to greatly expand its usage by specialist physicians who treat diabetic patients with cholesterol abnormalities," said Daniel M. Bell, President and Chief Executive Officer of Kos. "There are about 16 million diabetics in the U.S., and we believe that Niaspan can be highly beneficial to a significant number of these patients, 80 percent of whom succumb to coronary heart disease." --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.