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US approval for a novel cholesterol management combination
20 Feb 2008

Simcor (Niaspan + simvastin), a novel fixed-dose combination of two well-established drugs developed by Abbott, has been approved in the US as a cholesterol therapeutic. It is the first combination of the two compounds to successfully reach the market.

Cholesterol treatment has changed significantly, with a greater awareness of types of cholesterol and the different roles they play in the body. Low density lipoproteins (LDLs), known as ‘bad’ cholesterol, are produced in the liver and carry cholesterol and other lipids around the body. High density lipoproteins (HDLs), the ‘good’ form of cholesterol, are also hepatically-produced and carry cholesterol away from the rest of the body and back to the liver for recycling or degradation. Higher HDL levels indicate lower cholesterol in the bloodstream. High LDL levels are associated with raised cholesterol in the bloodstream, which can attach to blood vessels to form plaques, and increase the risk of heart disease.

Simcor contains Niaspan, an extended-release formulation of niacin that was developed by Abbott, as well as simvastatin, an analogue of lovastatin. Lovastatin was isolated from Aspergillus terreus in the late 1970s. It inhibits HMG-CoA reductase, the rate-controlling enzyme in the cholesterol-producing pathway. Simvastatin, a more potent version, was synthetically derived from lovastatin. It can decrease LDL levels by up to 50%; however, it does not effect HDL and triglyceride levels. Niacin, or nicotinic acid, is a component of the vitamin B complex. It affects all aspects of lipid profiles by lowering LDL levels as well as triglycerides, and by raising HDLs.

The combination of the two independently successful drugs is part of the development of a next generation cholesterol-lowering therapeutics that tackles the whole lipid profile. This will reduce damaging components and increase those that are naturally produced and beneficial, changing the approach to cholesterol and heart disease risk management.

 

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