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New Cholesterol Treatment Guideline: Implications for Pharmacy Practice

M. Scott Hardy, PharmD, BCACP
Mayo Clinic

Scottsdale, Arizona


Daniel Saldivar, PharmD Candidate 2014

Midwestern University College of Pharmacy

Glendale, Arizona


Aleasha Bryant, PharmD Candidate 2014

Midwestern University College of Pharmacy

Glendale, Arizona


Christopher Barnett, PharmD Candidate 2014

Midwestern University College of Pharmacy

Glendale, Arizona


Mehal Shah, PharmD Candidate 2014

Sullivan University College of Pharmacy

Louisville, Kentucky


6/19/2014

US Pharm. 2014;39(6):HS8-HS10.

ABSTRACT: The 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol takes an evidence-based approach that stresses the reduction of cardiovascular risk. As a result of this emphasis on clinically meaningful endpoints, the guideline focuses on agents with the highest-quality evidence, namely, high-intensity statin therapy. Other agents recommended in previous guidelines did not have sufficient evidence for inclusion. The new guideline recommends that moderate- or high-intensity statins be used in four populations: patients with a history of cardiovascular disease, elevated cholesterol, diabetes mellitus, or high cardiovascular risk according to Pooled Cohort Equations. Pharmacists can play a critical role in helping patients understand the new recommendations.

For more than 10 years, a key guideline for treatment of high cholesterol in the United States was the Adult Treatment Panel III (ATP III), published by the National Heart, Lung, and Blood Institute (NHLBI) in 2002 and updated in 2004. The NHLBI was long expected to publish an ATP IV guideline, but instead collaborated with the American College of Cardiology and the American Heart Association (ACC/AHA) to create an entirely new guideline specifically based on the highest-quality evidence. This new guideline was published in November 2013.1

Critical Questions

Guided by the literature, the ACC/AHA based their recommendations on three critical questions (CQs)1:

1. What is the evidence for LDL cholesterol (LDL-C) and non–HDL-C goals for secondary prevention of atherosclerotic cardiovascular disease (ASCVD)?

2. What is the evidence for LDL-C and non–HDL-C goals for primary prevention of ASCVD?

3. For primary and secondary prevention, what is the impact on lipid concentrations, effectiveness, and safety of specific cholesterol-modifying drugs used for lipid management in general and selected subgroups?

To address CQs 1 and 2, the ACC/AHA assessed the goals set forth in ATP III (e.g., LDL-C <70 mg/dL for secondary prevention, non–HDL-C ≥30 mg/dL).1 After reviewing the literature, the Expert Panel found that there was no good evidence for treatment goals of <70 or <100 mg/dL.1 The best evidence from trials showing cardiovascular risk reduction was based on a variety of targets.1

To answer CQ3, the ACC/AHA examined multiple studies covering both single agents and combination therapies.1 The Expert Panel found evidence of cardiovascular risk reduction with statins, fibrates, niacin, bile acid sequestrants, ezetimibe, and omega-3 fatty acids.1 Of these, statins showed the greatest benefit when used both as a single agent and in combination.1 Plant stanols and sterols did not have sufficient evidence of cardiovascular risk reduction.1

Comparison of Guidelines

The new guideline has a slightly more complicated process for determining the prescribing of statins for cholesterol management. It is not the simple “treat the number”–based approach used in the past. Previously, the steps for deciding the need for treatment intervention were relatively straightforward.

In ATP III, step 1 was to assess the patient’s coronary heart disease (CHD) risk (symptomatic carotid artery disease, diabetes, or clinical CHD).2 Such patients were automatically placed in the high-risk treatment category. Step 2 was for patients who did not meet the qualifications for step 1; quantification was based on risk factors including smoking, family history of CHD, hypertension, low HDL, and age.2 Patients with two or more risk factors were categorized as “high,” “moderately high,” or “moderate risk” based on their Framingham Risk Score, and those with fewer than two risk factors were categorized as “low risk.”2 Each treatment category was assigned an LDL goal, an LDL concentration at which to initiate lifestyle changes, and an LDL concentration at which drug therapy should be started.2

ATP III relied on treating the patient’s numbers; each patient fit into a category and was treated accordingly. The 2013 guideline takes a much different approach, in that more clinical judgment is required of the physician. In the 2013 guideline, the first step is to determine whether a patient falls into one of the four major statin-benefit groups1:

1. Presence of clinical ASCVD (history of acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack, or peripheral arterial disease related to atherosclerosis)

2. Presence of LDL-C >190 mg/dL and age >21 years

3. Age 40 to 75 years with diabetes (type 1 or 2) and LDL-C 70 to 189 mg/dL without ASCVD

4. Age 40 to 75 years with no ASCVD or diabetes, but with LDL 70 to 189 mg/dL and estimated 10-year ASCVD risk ≥7.5%.

For patients who fit one of these four categories, statin treatment should be initiated at either high intensity or moderate intensity, depending upon which category is met. High-intensity statin therapy is a dosage that lowers LDL-C by an average of ≥50%, whereas moderate-intensity therapy lowers LDL-C by 30% to 50%. See TABLE 1 .1


Another major change in the 2013 guideline is the departure from the Framingham risk-assessment tool. Instead, a new risk-assessment tool, the Pooled Cohort Equations, was developed by the Risk Assessment Work Group. The Pooled Cohort Equations are used to calculate the 10-year risk of ASVCD.1,3 This assessment is recommended only for those patients who do not fall into group 1 or group 2. It estimates the 10-year risk only for patients aged 40 to 75 years. The Pooled Cohort Equations risk-assessment tool is available at http://my.americanheart.org/cvriskcalculator.3

In patient groups 1 and 2, high-intensity statin therapy should be initiated, if tolerated; otherwise, moderate-intensity statin therapy is recommended.1 In groups 3 and 4, the patient’s Pooled Cohort Equations 10-year risk should be calculated.1 High-intensity statin therapy is recommended for group 3 patients with diabetes and 10-year risk ≥7.5%; for those with diabetes and risk <7.5%, moderate-intensity statin therapy is recommended.1 In group 4, moderate- to high-intensity statin therapy is recommended based on the provider’s judgment.1

Effects on Clinical Practice

Pharmacists should expect an increase in the number of patients taking statins, especially high-intensity therapies. The Pooled Cohort Equations risk calculator relies heavily on age, such that any white male aged ≥63 years or female aged ≥71 years will qualify for statin therapy even if other factors such as blood pressure, cholesterol, and smoking are optimal. This translates to increased pharmacist intervention in terms of communicating with the patient about side effects or checking for potential drug interactions between the statin and other medications. This also creates the opportunity for more pharmacy-run clinics with lipid management to be opened, allowing pharmacists to provide services such as checking patient cholesterol and liver-enzyme concentrations to ensure adherence to and safety of statin regimens.

The ATP III guidelines recommended many different add-on treatments (niacin, fenofibrate, etc.) if a statin alone was not getting a patient’s cholesterol to goal. The new guidelines advise that statin therapy be optimized prior to using add-on medications. This may require that pharmacists intervene with physicians who are unfamiliar with the new guidelines, offering suggestions for optimizing one statin treatment rather than having the patient on multiple types of cholesterol-lowering agents. Thus, pharmacists should become familiar with tables of equivalent statin regimens in order to make suggestions to increase a statin dosage or switch patients to a statin that may better help them reach their goals.

Statins are not well perceived by patients; a stigma exists surrounding these medications. Because of this, many patients will be reluctant to start a high-intensity statin medication, such as atorvastatin or rosuvastatin. It is the pharmacist’s duty to educate the patient and ease any worries the patient may have. Not only is it important to provide thorough patient counseling when the patient first picks up the medication, it is equally important to follow up with the patient.

Lifestyle modifications, which are inherent in the new cholesterol treatment guideline, are addressed in a separate guideline.4 Pharmacists should take the opportunity to offer potential lifestyle changes to all at-risk patients who do not qualify for statin therapy, including those with diabetes who are younger than 40 years and those with LDL showing an upward trend.4

Conclusion

The 2013 ACC/AHA guideline is a radical departure from ATP III. Pharmacists can play a pivotal role in helping patients understand the changes inherent in the new guideline, and in addressing their concerns, as well.

REFERENCES

1. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. November 12, 2013 [Epub ahead of print].
2. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143-3421.
3. Goff DC Jr, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. November 12, 2013 [Epub ahead of print].

4. Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. November 12, 2013 [Epub ahead of print].

To comment on this article, contact rdavidson@uspharmacist.com.

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