Magazine article Drug Topics

Lipid Modifier Combining Statin and Niacin to Bow in 2002

Magazine article Drug Topics

Lipid Modifier Combining Statin and Niacin to Bow in 2002

Article excerpt


With increasing identification of various atherogenic lipids and a persistent calling for lower target lipid levels, controlling dyslipidemia with monotherapy is becoming less and less realistic. As a result, some pharmaceutical manufacturers are directing a significant portion of their R&D efforts to combination products such as lovastatin and niacin (Advicor, formerly called Nicostatin, Kos Pharmaceuticals).

New studies of combination therapy with low doses of two standard lipid-modulating drugs confirm earlier studies showing that a combo compound is more efficacious than high doses of either drug alone to treat dyslipidemia. Advicor is a once-daily single-tablet formulation of lovastatin and sustained-release niacin. Kos received an approvable letter from the Food & Drug Administration for the product and expects formal approval in December when the patent for lovastatin (Mevacor, Merck) expires. Advicor is aimed at such common disorders as primary hypercholesterolemia and hyperlipidemia.

As Daniel M. Bell, chairman and CEO of Kos, put it during an International Symposium on Drugs Affecting Lipid Metabolism held in New York City, "Kos looks forward to launching Advicor into the fast-- growing $10 billion U.S. cholesterol-- altering market early in 2002."

"Nothing is better than a statin for lowering LDL levels," said Judy W. M. Cheng, Pharm.D., clinical pharmacy specialist in cardiology, Mount Sinai Medical Center, New York City, in an interview. "Aggressive cholesterol lowering with statins can prevent unstable angina and myocardial infarction ... and reduce the need for surgical revascularization."

Since all the statins seem to have a similar mechanism of action and sideeffect profile, she added, "we are still puzzled by what happened to cerivastatin," (Baycol, Bayer), which was removed from the market due to reported deaths. "But we haven't heard of a problem with lovastatin." While it would be wise to monitor patients more carefully when using these drugs, she continued, "the plight of Baycol would not inhibit us from reccommending other statins." Side effects with statins alone are uncommon.

Niacin has always been useful in reducing high LDL levels, but because of its side effects, it is problematic when used in high doses. And it requires physician supervision, Cheng noted. But low-dose niacin plus a statin used singly have helped patients, not only by cutting LDL but also normalizing triglycerides and raising HDL. …

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