Although there has been much discussion and debate over the last month, the updated and long-awaited blood cholesterol guidelines published by the American College of Cardiology (ACC) and the American Heart Association (AHA) have generally been welcomed by physicians (see here for an overview by DRG's Joseph Dwyer and Stefanie Matlok). And, similar to many other analysts, we believe that these new guidelines will certainly lead to an increase in statin use. By eliminating defined LDL cholesterol goals and expanding the definition of patients that are at high cardiovascular risk, treatment guided by the new guidelines is applicable to a greater number of patients.

However, while we do expect an increase in statin use, we do not believe the increase will be as great as some analysts are predicting. We do not expect any change to happen overnight; the new guidelines are a radical departure from its numbers-centric predecessor, and it will take time to shift entrenched medical practices. Furthermore, as with most guidelines, we believe that physicians will use their individual judgment when assessing patient risk. The majority of cardiologists that we interview tell us that they do not take guidelines literally because patients differ sufficiently that you can't be too literal, and that they regard the guidelines not as a cookbook but rather a guide.

We also note that the new guidelines outline a more individualized approach to treatment and that enforcement of these guidelines is expected to have a large impact on how patients are treated, particularly in tailoring the intensity of statin treatment to an individual's risk. The guidelines should aid in the identification of patients deemed most likely to benefit from statin therapy according to their cardiovascular risk. However, like almost every risk score calculator used in clinical practice, this risk calculator is coming under criticism, this time for overestimating risk.

What will the guidelines mean for non-statin therapies?

The conditions for incorporating more widespread use of statins seem to be particularly favorable when taking into consideration the wide availability of low cost generic statins. However, the new guidelines could mean that non-statin lipid-modifying therapies are pushed even further into the background.  While statin use is positively backed up by extensive outcomes data, the same cannot be said for other lipid-modifying products, such as the Zetia franchise, niacin-based drugs or fenofibrate products.

But, what does this mean for highly anticipated emerging therapies like the CETP inhibitors and the PSCK9 inhibitors?

We believe that a demonstration of benefit and risk reduction in their large cardiovascular outcomes trials should ensure more widespread uptake of these novel agents than initially thought because these new therapies are being investigated on top of statin therapy. Therefore, by increasing the number of statin treated patients, we could see an expansion in the patient population that could potentially receive these novel therapies. Outside the statin arena there is also considerable room for uptake of novel lipid-modifying therapies among statin-intolerant patients and patients that are refractory to statin treatment.

Senior Analyst Graeme Green and Senior Director Conor Walsh are part of the Cardiovascular, Metabolic and Renal Disorders team at Decision Resources Group.

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