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Title: ACC: Niaspan (Niacin Extended-Release) Raises HDL Twice As Much as Gemfibrozil
URL: http://www.pslgroup.com/dg/18F65E.htm
Doctor's Guide
March 14, 2000


ANAHEIM, CA -- March 14, 2000 -- Data presented at the American College of Cardiology 49th Annual Session indicate that only one of two commonly prescribed cholesterol-lowering agents positively influences LP-AI, the critical cardioprotective subfraction of HDL cholesterol, known as the "good" cholesterol.

Niaspan(R) (niacin extended-release tablets) significantly increased HDL cholesterol up to twice as much as gemfibrozil, 26 percent versus 13 percent (p<0.001). Moreover, only Niaspan significantly elevated the HDL subfraction LP-AI concentration in patients with isolated low HDL state. Administered at one- and two-gram doses, Niaspan significantly increased LP-AI levels by 8.7 percent +/- 3.9 percent (p=0.033) and 24.0 percent +/- 4.43 percent (p<0.001), respectively.

"These findings show that Niaspan is considerably more effective than gemfibrozil at raising HDL cholesterol levels and, in particular, the LP-AI component of HDL," said Moti L. Kashyap, MD, Director, Cholesterol Research Center, VA Long Beach HealthCare System, and Professor of Medicine, University of California, Irvine, and lead investigator for the analysis. "According to the High Density Lipoprotein Intervention Trial (HIT) sponsored by the Veterans Administration, raising HDL levels significantly reduces the incidence of coronary events. Further studies show that LP-AI is the component of HDL most closely linked to coronary heart disease."

These data, from a randomized, double-blind, multi-center trial, included 139 patients who received increasing doses of Niaspan up to 2 grams once per night or gemfibrozil (600 mg, twice daily) for up to 19 weeks. A separate in-vitro analysis also was conducted to demonstrate how Niaspan works. Results indicated that Niaspan increases LP-AI levels in patients with an isolated low HDL state by inhibiting the removal of the HDL particle. "These findings suggest that Niaspan recycles the HDL particle LP-AI so that it stays in the system and is not removed by the liver, thus increasing levels of this cardioprotective component of HDL cholesterol," said Dr. Kashyap.

"Based on Dr. Kashyap's analysis, it is clear that Niaspan provides important clinical benefits beyond its potency in raising HDL," said Mark McGovern, MD, Vice President of Medical Affairs, Kos Pharmaceuticals, the company that researched and developed Niaspan. "By adding Niaspan to a patient's treatment regimen, the clinician not only increases the patient's good cholesterol levels, but he also specifically improves the most cardioprotective component of HDL cholesterol." Niaspan, the niacin formulation used in the study, is the only extended release niacin product that has undergone U.S. Food and Drug Administration (FDA) review and received approval based on submission of a New Drug Application, establishing both the safety and efficacy of this formulation.

The VA Long Beach Healthcare System (VALBHS) is one of the most diversified tertiary health care providers in the VA. The facility provides a comprehensive array of inpatient, outpatient and extended care programs. The Medical Center consists of 448 operating beds. These beds are located in the following program areas: medicine, surgery, psychiatry, neurology, physical medicine and rehabilitation, spinal cord injury, and the Nursing Home Care Unit. In fiscal year 1999, approximately 36,000 unique patients utilized the facility, with 6,000 inpatients treated, 400,000 outpatient clinic visits, and 800,000 clinic stops.

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