ABBOTT PARK, Ill., April 6 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has approved Abbott's new coated Niaspan(R) (niacin extended-release tablets). Niaspan is the leading medication for boosting HDL cholesterol -- the "good" cholesterol.
Heart disease is the leading cause of death in both men and women in the United States, and studies have shown that every 1 percent increase in HDL cholesterol is associated with a 2 percent decrease in heart disease risk.
"Niaspan has the proven ability to elevate good cholesterol, a known risk factor in cardiovascular disease," said Eugene Sun, M.D., vice president of Global Pharmaceutical Clinical Development, Abbott. "With the FDA approval of a new Niaspan coated tablet, our next step is to expand upon two published studies to determine the effect on flushing intensity. We'll do that by initiating larger clinical studies."
Niaspan is the only FDA-approved, once-daily extended-release prescription niacin formulation for the treatment of lipid disorders with an ability to significantly raise HDL cholesterol. Collective results from three major clinical studies show an average 22 percent increase of HDL for patients receiving 2000 mg of Niaspan at bedtime. Niacin is also indicated for the secondary prevention of heart attacks, and in combination with a bile acid binding resin, niacin is indicated to promote regression of coronary atherosclerosis in patients with history of coronary artery disease.
"More and more, physicians and their patients understand that good cholesterol management means trying to bring all lipid parameters to optimal levels," said Richard Karas, M.D., Ph.D., professor of medicine, Tufts-New England Medical Center, Boston, MA. "Introducing a new coated tablet that may enhance patient convenience is an important factor in improving our ability to provide good cholesterol management for our patients," he added.
About Niaspan
Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels.
Indications
Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, to reduce elevated total cholesterol, LDL- C, Apo B, and triglyceride levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction or in patients with coronary artery disease and hypercholesterolemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Important Safety Information
Niaspan is contraindicated in patients with allergies to any of its ingredients, active peptic ulcer disease, significant or unexplained persistent liver dysfunction, or arterial bleeding. Niaspan should not be substituted for equivalent doses of immediate-release niacin. Niaspan should be prescribed with caution in patients who consume substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with Niaspan. Use of Niaspan with other lipid-altering medications called statins may increase the risk of rhabdomyolysis, a rare condition that causes muscles to breakdown. The most common side effect with Niaspan is flushing of the skin. Patients with diabetes should carefully monitor their blood sugar and report changes to their doctor. Other commonly reported side effects include indigestion, headache, pain, abdominal pain, nausea, itching, diarrhea, runny nose, vomiting and rash.
More information about Niaspan, including full prescribing information, is available on the Web site www.rxabbott.com/pdf/niaspan.pdf or by calling Abbott Medical Information at 1-800-633-9110.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
AbbottCONTACT: DeAnna DuBose, +1-847-938-9002, or Laureen Cassidy,+1-847-938-7743, Financial: Lawrence J. Peepo, +1-847-935-6722, all ofAbbott
