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Statins controversy in the US: What do the new cholesterol guidelines mean?

03 December 2013 Praful Mehta

The American Heart Association (AHA) and American College of Cardiology (ACC) have again landed themselves in a huge controversy. Earlier this month, they issued new guidelines for the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults.

The new guidelines - which are very different from previous years and have significant implications for medical practice - include new parameters that emphasis patient's global risk (and the way that risk is measured) as a measure of therapeutic intervention. Patient's global risk is defined as the 10-year risk of developing cardiovascular disease (taking into account all known risk factors).

The most controversial change is the scrapping of LDL based treatment targets and the introduction of 7.5% risk threshold. This threshold is lower than any other published guideline for statin prescription for people without a history of heart disease.

In simpler terms, the number of Americans who qualify (under the new guidelines) for statin therapy could double to more than 30 million.

There has been a strong reaction from the scientific and medical community regarding the quality of these recommendations and the data behind them. It has re-ignited the risk-benefit debate on such a radical policy move. These new recommendations mark the biggest shift in cardiovascular disease prevention in 30 years in the United States. You can read some of our research estimating the impact of statin therapy on direct and societal costs in Mexico for some background and comparison.

It is important to highlight that there is a grave concern among healthcare professionals about the real world implications of these recommendations on healthcare practice. Most cardiologists agree that statins can significantly reduce cardiovascular risk in patients with a history of heart disease. However, there is great reluctance to use statins in healthy individuals (who may have some risk factors) when heart disease is likely preventable using diet and exercise. Moreover, healthcare practitioners are worried about motivating people to start (and eventually monitor) statin therapy when they don't have tangible numbers as goals and instead have to rely on a risk calculator (which has its own flaws) to guide treatment strategy.

Both AHA and ACC argue that about 33% of US adults have high cholesterol, and less than half are receiving proper treatment. Elevated cholesterol levels double the risk of heart disease and it remains the number one cause for mortality in the US . They believe that these new guidelines - which are developed on the principles of patient centric therapeutic intervention and use the intensity of statin therapy as a goal of treatment - will be able to address that high level of risk and improve cardiovascular outcomes.

Additionally, the guidelines also recommend statins for people between ages of 40 to 75 years old with type-1 or type-2 diabetes, regardless of whether they have additional heart disease risk factors.

In my opinion, there is no doubt that risk - together with other tangible targets such as LDL - could be used as a tool to drive therapeutic strategy. There is a growing need to reduce the risk of CV disease in population and primary prevention can be a great way to start making that change. However, more research - with real world evidence - is needed to fully understand the implications of such a wide shift in policy.

In the meantime, the debate between prevention and treatment rages on.....

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