New guidelines issued Tuesday by the American Heart Association (AHA) and the American College of Cardiology (ACC) specify new risk factors for using cholesterol-lowering statin medicines. Experts estimate that if followed in practice, the recommendations could increase the number of patients on statin therapy by more than two-fold.
Neil Stone, chair of the expert panel that produced the new recommendations, said the guidance "represents a departure from previous guidelines because it doesn’t focus on specific target levels of [LDL] cholesterol...although the definition of optimal LDL cholesterol has not changed. Instead, it focuses on defining groups for whom LDL lowering is proven to be most beneficial." Panel member Donald Lloyd-Jones added that while lowering LDL cholesterol remains a key goal, the focus is now on the risk reduction achieved with statins.
Specifically, the guidelines recommend to more broadly assess a patient’s risk for cardiovascular diseases and prescribe moderate- or high-intensity statin therapy to patients with either cardiovascular disease, an LDL level of 190 mg/dL or higher, patients with type 2 diabetes who are between 40 and 75 years of age, and patients with an estimated 10-year risk of cardiovascular disease of 7.5 percent or higher who are between 40 and 75 years of age. The new guidelines recommend to remain on statin therapy irrespective of LDL cholesterol levels, eliminating a need for frequent blood testing. "The emphasis is to try to treat more appropriately," said Stone, adding "we're going to give statins to those who are the most likely to benefit."
Under the new guidelines, which were based on an analysis of the results of randomised controlled trials, doctors may also consider switching some patients to a higher dose of statins to derive greater benefit. Stone noted that the panel chose to focus on statins "because their use has resulted in the greatest benefit and the lowest rates of safety issues. No other cholesterol-lowering drug is as effective as statins." Stone added that there is a role for other cholesterol-lowering drugs, for example, in patients who suffer side effects from statins.
The new guidelines may lead to increased use of high potency statins, such as AstraZeneca's Crestor (rosuvastatin) and higher doses of Pfizer's Lipitor (atorvastatin), which is now available generically. Meanwhile, use of lower-dose generic statins and non-statin cholesterol medicines, such as Merck & Co.'s Zetia (ezetimibe) and AbbVie's Tricor (fenofibrate), could be reduced. "Non-statins didn't provide enough risk prevention," Stone noted, adding that there has been "over treatment by drugs not proven to add incremental benefit."
Doctors say the new approach will limit how many people with low heart risks are put on statins simply because of a cholesterol number. Yet under the new advice, 33 million Americans, 44 percent of men and 22 percent of women, would meet the threshold to consider taking a statin. Under the current guidelines, statins are recommended for only about 15 percent of adults. "It will be controversial, there's no question about it. For as long as I remember, we've told physicians and patients we should treat their cholesterol to certain goal levels," said Cleveland Clinic cardiologist Steven Nissen. "There is concern that there will be a lot of confusion about what to do," Nissen remarked.
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