By: Amrita Singh, PharmD Candidate c/o 2015
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Last November, the American College of Cardiology and the American Heart Association released new lipid guidelines, which will transform the way we manage our patients with hyperlipidemia. Earlier, lipid management was based on the ATP-III guidelines, which emphasized the use of several lipid-lowering medications to reach target levels of low-density lipoprotein (LDL). The new guidelines, announced on November 12th, have thrown out the classic numerical goals such as LDL less than 100 mg/dL and focus on treating patients based on their risk for a cardiovascular event.1
According to writers of the new lipid guidelines, no evidence from clinical trials exists to support treating patients to a specific target.2 In fact, “trials showed that lowering LDL-C and raising high density lipoprotein cholesterol did not necessarily lower risk.”3 They also noted that using LDL targets may lead to over treating patients with non-statin therapies.2 While targeting specific LDL levels is no longer essential, the levels will still be important in assessing the benefit of a particular dose of statin.2
The new guidelines still maintain the importance of healthy lifestyle modifications such heart-healthy diets, decreased sodium intake, and increased physical activity.4 When it comes to lipid management, the guidelines recognize four groups of individuals most likely to benefit from statin therapy: patients with atherosclerotic cardiovascular disease, patients with LDL levels of 190 mg/dL or higher, patients 40 to 75 years old with type 2 diabetes, and patients 40 to 75 years old with an estimated 10-year risk of cardiovascular disease of 7.5% or higher.4 The 10-year risk is based on a global risk assessment tool created by the same individuals who developed the new lipid guidelines, and can be accessed through the American Heart Association at
my.americanheart.org/cvriskcalculator. The risk calculator evaluates the risk for an individual’s first cardiovascular event as well as stroke. Factors contributing to risk calculation include sex, age, race, cholesterol levels, blood pressure, diabetes, and smoking.
According to the new guidelines, in patients with atherosclerotic cardiovascular disease who have no contraindications or adverse events due to statins, high-intensity statin therapy should be started to achieve a minimum of 50% reduction in LDL cholesterol. High-intensity statin therapy includes rosuvastatin 20 to 40 mg or atorvastatin 80 mg. At a lower treatment level, moderate intensity statins include atorvastatin 10 mg, rosuvastatin 10 mg, simvastatin 20 to 40 mg, pravastatin 40 mg, or lovastatin 40 mg.2
In patients with LDL levels of 190 mg/dL or higher, a high-intensity statin should be initiated. Patients 40 to 75 years old with type 2 diabetes should be started on a moderate-intensity statin to achieve a 30% to 49% reduction in LDL cholesterol. If the patient’s 10-year risk is higher than 7.5%, using a high-intensity statin could be considered. In patients 40 to 75 years old with an estimated 10-year risk of cardiovascular disease of 7.5% or higher, a moderate or high-intensity statin is recommended.2
Recommendations for statin therapy in these four defined groups were based on randomized, controlled clinical trials which showed that benefits achieved from statin treatment outweighed risks of adverse events.2 For those patients who do not meet the criteria of the four defined groups, the guidelines recommend evaluating other factors which may justify initiating statin therapy. These factors include a family history of cardiovascular disease, C-reactive protein levels above 2 mg/L, evidence of calcification on a coronary artery, and an ankle-brachial index less than 0.9.2
After implementing the new guidelines, it is estimated that the percentage of adults on statin therapy will double from 15% to 30%.4 Patients initiated on statin therapy should have their lipid profiles evaluated 4 to 12 weeks after the initiation of treatment to ensure the statin is achieving its appropriate level of reduction in LDL cholesterol. Serum creatinine kinase levels should also be monitored in patients at high risk for statin-induced myopathy, and if patients are experiencing muscle pain, a different low-dose statin may be more appropriate.2
As expected, the departure from LDL cholesterol targets has met a vast deal of controversy. Many critics argue that target cholesterol levels were common goals not dictators of therapy.1 In addition, the global risk assessment tool used to determine the likelihood of a CV event is derived from data obtained through cohort studies which some claim to be outdated.2 In addition, the new guidelines give no recommendation for managing those patients who cannot tolerate statin therapy.1 Treating to goal cholesterol levels had been the mainstay in lipid control and departure from these set values leaves greater room for clinical judgment.
SOURCES:
- Page, MR. Pharmacy Times. The New Lipid Guidelines: An In-Depth Look. http://www.pharmacytimes.com/news/The-New-Lipid-Guidelines-An-In-Depth-Look. Accessed Feb 3, 2014.
- Vega, CP. Medscape PHARMACISTS. ACC, AHA Update Guidelines for Treatment of High Cholesterol CME/CE. http://www.medscape.org/viewarticle/813659. Accessed Feb 3, 2014.
- Krumholz HM, Hines HH. Target cardiovascular risk rather than cholesterol concentration. BMJ. 2013; 347:f7110. doi: http://dx.doi.org/10.1136/bmj.f7110. Accessed Feb 3, 2014.
- Mitka, Mike. Groups Release New, Updated Guidelines to Reduce Heart Disease Risk Factors. JAMA. 2013: 310(24):2602-4. doi:10.1001/jama.2013.284084. Accessed Feb 3, 2014.
