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'Advent' Study Highlights Safety And Efficacy Of Niaspan (Niacin) In Diabetic Patients

Kos Pharmaceuticals Files sNDA for Niaspan to Treat Diabetic Dyslipidemia

MIAMI, FL -- July 22, 2002 -- According to a study published today in the Archives of Internal Medicine, NiaspanŽ (extended-release niacin), alone or in combination with a statin, significantly improved lipid profiles in patients with type 2 diabetes and had minimal impact on blood sugar control. The study, the largest of its kind ever conducted with niacin, highlights the therapeutic utility of Niaspan in managing lipid abnormalities in a patient population with a disproportionately high risk of cardiovascular disease.

Supported by these findings, Kos Pharmaceuticals, Inc. announced today that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Niaspan to expand the current label to include the treatment of dyslipidemia in patients with type 2 diabetes. Niaspan is the only FDA-approved once-daily extended-release formulation of niacin for the treatment of lipid disorders. It is also indicated for the secondary prevention of heart attacks and, in combination with a bile-acid binding resin, atherosclerotic disease regression.

The 148 patient study, Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial, (ADVENT), found that Niaspan increased levels of HDL ("good") cholesterol by as much as 24%, and reduced levels of triglycerides by as much as 36% versus placebo. Half of the patients in the study were also receiving treatment with a statin, principally atorvastatin. These substantial improvements were achieved without significant impact on patients' blood glucose levels as measured by fasting blood glucose and hemoglobin A1c (HbA1c), an important indicator of glycemic control. Specifically, at 16 weeks, patients receiving 1,000 mg/day or 1,500 mg/day of Niaspan showed no statistically significant increase in fasting blood glucose compared with placebo. Levels of HbA1c were unchanged compared with placebo in patients receiving 1,000 mg/day and increased marginally (by 0.03%) in patients receiving 1,500 mg/day, which barely reached statistical significance (p=0.048). Patients exhibited few clinical or laboratory adverse effects, and no statistically significant differences were found across treatment groups. No patient experienced elevated liver enzymes greater than three times the upper limit of the reference range. There were no reports of drug-induced myopathy, even among patients concomitantly taking a statin.

"Approximately 97% of people with diabetes have at least one lipid abnormality, therefore effective dyslipidemia treatment is an important consideration for diabetic patients, who are at great risk of heart disease," said Scott M. Grundy, M.D., Ph.D., professor of internal medicine, director, Center for Human Nutrition at the University of Texas Southwestern Medical Center at Dallas and principal investigator of the study. "The ADVENT study is significant for people with diabetic dyslipidemia, because we now know that low doses of niacin can effectively treat lipid abnormalities in these
patients."

In a survey commissioned by the American Diabetes Association and the American College of Cardiology, 90% of physicians reported that people with diabetes are "very" or "extremely" likely to have a cardiovascular event, and of the 17 million people living with diabetes, 65% will die from a heart attack or stroke(1). "ADVENT corroborates previously published evidence that therapeutic doses of niacin can be efficacious in the management of dyslipidemia in diabetics. Especially for people with diabetes, it's not only LDL, or 'bad' cholesterol, that matters. The other lipid parameters -- HDL and triglycerides -- need to be treated as well. Statins alone often do not normalize the lipid pattern," added Dr. Grundy.

The Arterial Disease Multiple Intervention Trial (ADMIT), published in the Journal of the American Medical Association in September 2000, also found therapeutic doses of niacin to be safe for the management of triglycerides and low HDL levels in people with diabetes.

"The ADVENT study clearly shows Niaspan's therapeutic utility in diabetics, most of whom have cardiovascular disease," said Adrian Adams, President and CEO, Kos Pharmaceuticals, Inc. "The compelling data from this and other recent studies should provide excellent support for our sNDA submission for diabetic dyslipidemia and help maintain Niaspan's robust prescription and market share growth."

Niaspan is contraindicated in patients with a known hypersensitivity to niacin or any component of this medication, significant or unexplained hepatic dysfunction, active peptic ulcer disease or arterial bleeding. The most common adverse event with Niaspan is flushing. Other adverse events include headache, abdominal pain, diarrhea, dyspepsia, nausea, vomiting and rash. As liver function can be affected by Niaspan, periodic testing may be required. Patients who drink large amounts of alcohol should use Niaspan with caution. Equivalent doses of immediate-release niacin should not be substituted directly for Niaspan. Patients may experience a dose-related rise in blood glucose. Diabetic or potentially diabetic patients should be observed closely. Adjustment of diet and/or hypoglycemic therapy may be necessary. Niacin together with a statin may increase the risk of myopathy and a serious but rare condition referred to as rhabdomyolysis.

Kos Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical company engaged in developing, commercializing, manufacturing and marketing proprietary prescription products for the treatment of chronic diseases. The Company's principal product development strategy is to reformulate existing pharmaceutical products with large market potential to improve safety, efficacy, or patient compliance. The Company currently markets Niaspan and Advicor(TM) for the treatment of cholesterol disorders. Kos is developing additional products and has proprietary drug delivery technologies in solid- dose and aerosol metered-dose inhalation administration.

Certain statements in this press release, including statements relating to the expected continued growth of the Niaspan product, are forward-looking and are subject to risks and uncertainties. These risks and uncertainties include the ability of the Company to maintain the size of its sales force, the Company's ability to market its Niaspan product, the Company's ability to meet the conditions necessary to obtain funding under its funding arrangements, the validity, scope and enforceability of its patents, the effect of conditions in the pharmaceutical industry and the economy in general, as well as certain other risks. A more detailed discussion of risks attendant to the forward- looking statements included in this press release is set forth in the "Forward-Looking Information: Certain Cautionary Statements" section of the Company's Annual Report on Form 10-K for the period ended December 31, 2001, filed with the Securities and Exchange Commission (SEC), and in other reports and documents filed with the SEC.

References:
(1) Heart Disease Weekly; 21 July 2002


SOURCE: Kos Pharmaceuticals, Inc.

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