n January 2014, I wrote a blog regarding the recommendations for statins. At the time, the old guidelines – Adult Treatment Panel IV (ATP-IV) – were replaced by the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines on the treatment of blood cholesterol to reduce atherosclerosis cardiovascular risk in the adult population; these guidelines were published online on November 12, 2013 in Circulation. As diabetes educators, these guidelines allowed us to specifically address the patient populations who would benefit from statin. One of those patient populations included patients with diabetes. In summary, a practitioner could ask (1) is the patient between 40 and 75 years of age AND (2) does s/he have type 1 or type 2 diabetes? If so, then statin therapy would be beneficial for the individual. With a moderate-intensity statin, the desired goal would be a 30 to 40 percent reduction in low density lipoprotein (LDL) concentrations, whereas a high-intensity statin would provide a 50 percent reduction in LDL concentrations.
Since the 2013 publication, practitioners have wondered about the role of non-statin therapy for these patient populations. In June 2016, the ACC published an expert consensus decision pathway of non-statin therapy. As an overview of the guidelines, ezetimibe (or Zetia) is the first-line, non-statin option followed by a bile acid sequestrant. More recently approved options, such as PCSK-9 inhibitors, could be used as monotherapy or in combination with ezetimibe, if the patient has atherosclerotic cardiovascular disease (ASCVD) or a LDL concentration equal to or above 190 mg/dL.
Among patients with diabetes, evaluation of the patient’s progress with a statin should be done before adding another agent
As diabetes educators, we are making decisions on a patient’s cholesterol regimens or answering specific questions with our team members and patients. Specifically, among patients with diabetes, evaluation of the patient’s progress with a statin should be done before adding another agent. Has the patient achieved more than a 50% reduction in LDL concentration from baseline? Or is LDL concentration less than 100 mg/dL? If the answer is no to either question, then a diabetes educator can evaluate adherence with statin therapy, counsel on intensifying lifestyle modifications, and/or recommend additional steps in controlling risk factors (i.e., cigarette smoking, blood pressure).
If these steps do not provide adequate control, then a non-statin therapy could be considered after evaluating ASCVD risk and reviewing the potential for adverse events or drug-drug interactions. If a non-statin therapy is warranted, ezetimibe is first-line for patients with diabetes. Ezetimibe is available as an oral, once-daily formulation and comes in combination with simvastatin and atorvastatin. It helps to lower LDL concentration and is generally well tolerated. As a second-line option, bile acid sequestrants could be considered. There are three available products: colestipol, colesevelam and cholestyramine. These drugs require high pill burden and are not patient friendly due to large pill size or powder for mixture. A major disadvantage of these agents is the potential of drug-drug interactions through binding; patients with high triglycerides (i.e., above 400 mg/dL) should not be prescribed a bile acid sequestrant.
In my clinical practice, we may consider starting ezetimibe, particularly in combination with simvastatin or atorvastatin, but it is dependent on the patient’s insurance coverage. However, we have a patient population that is 80 percent Medicaid and Medicare, so we are more likely to evaluate adherence, encourage more lifestyle modifications, and control additional risk factors. Overall, there is more information for us to consider in clinical practice regarding non-statin therapy. What are your thoughts of these recommendations? Are you recommending ezetimibe in practice? Or another agent?
About the Author
Jennifer Clements received her Doctorate of Pharmacy from Campbell University in 2006 and completed a primary care residency at a Veterans Affairs Medical Center in 2007. She is also a certified diabetes educator and board certified in pharmacotherapy. Currently, she is the Interim Chair and Associate Professor in the Department of Pharmacy Practice at Presbyterian College School of Pharmacy.