The FDA authorization confirms assertions that two margarines currently on the market can reduce "bad" cholesterols and may cut the risk of heart disease. However it is unlikely that this decision will cause a major shift from a pharmacological to a more dietary-based regime.
With the weight of the FDA on their side, products such as Benecol and Take Control could play a role in delaying clinical treatment in mild hyperlipidemia patients, as an adjunct to pharmacological therapy or assisting in the long term prevention of cardiovascular disease. The two products have their claims backed by numerous studies. Studies have shown that Take Control reduces LDL cholesterol by 10% and Benecol by up to 14%. According to the FDA an equivalent of two servings a day may reduce the risk of heart disease. It is estimated that a 1% reduction in LDL levels or "bad" cholesterol could lead to a 1% drop in the number of heart attacks and deaths.
Heart disease is responsible for more deaths in the US than any other disease. However, only 28.5% of potential hypercholesterolemia patients in the US receive pharmacological treatment, a phenomenon that is attributed to lack of public awareness. The FDA announcement will generate greater consciousness of the problem and allow sufferers to take independent steps to influence their condition.
Statins are the main lipid lowering pharmacological treatments employed, lowering both total and LDL cholesterol levels. Statin use is substantial in the US, prescribed in 81% of pharmacologically treated hypercholesterolemia patients. However their effectiveness varies from 17% up to over 60% with highest dose formulations of the newest statins such as Lipitor 80mg.
However, the FDA announcement is unlikely to cause a shift from pharmacological treatments to a more dietary-based regime. Although patients with abnormally high cholesterol levels are usually provided with dietary and lifestyle advice on how to lower their cholesterol levels, it is acknowledged that dietary advice is relatively poorly adhered to and that the margarines only work as long as they are part of a low fat diet.