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FDA Approves First Cholesterol Combo
Reviewed by Michael W. Smith, MD
On Dec. 18, Kos Pharmaceuticals Inc. announced it received FDA approval to sell its combination tablet Advicor to treat high cholesterol. Here is more information.
Brand name: Advicor
Generic name: Extended release niacin/lovastatin
Drug maker: Kos Pharmaceuticals
How it works: Niacin is a B vitamin that, when given in high doses, helps improve the body's cholesterol and triglycerides -- another blood fat. It drops triglycerides and LDL, or bad cholesterol, while it raises levels of HDL, or good cholesterol.
Lovastatin, also known by the brand name Mevacor, is one of the statin drugs that help keep cholesterol at healthy levels.
Kos says that when used together, people may have a greater improvement in their cholesterol than if they took either lovastatin or niacin by itself.
Also, there are some side effects associated with using niacin alone, such as headache, dizziness, facial flushing, warm sensations, and blurred vision. But doctors have suspected that using lower doses of niacin with a statin drug can cut down on the side effects while effectively improving cholesterol.
The tablet will be available in different combinations, delivering 500 mg, 750 mg, or 1,000 mg of niacin with a constant lovastatin dose of 20 mg. The maximum recommended dose is 2,000 mg/40 mg, which is two 1,000 mg/20 mg tablets. Kos notes that with the maximum recommended dose of Advicor, LDL and triglycerides dropped more than 40% each, on average. HDL increased by up to 30%.
Kos says it plans to start selling Advicor in February.
Concerns:
Some people taking this drug in clinical trials had flushing, upset stomach, and rash. It's recommended that people getting this drug have routine liver tests to watch out for possible liver problems.
The drug should not be used during pregnancy or if a woman is nursing. Also, those with an ulcer or liver problems should not use Advicor.
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