If you are experiencing any of these symptoms, you may have statin intolerance.

What are statins?

Statins are a class of cholesterol lowering medication therapies that have been extensively evaluated in controlled clinical trial studies. These medications have been consistently shown to reduce the risk of a first cardiovascular event including heart attack, stroke, and death from heart disease. Also, the drugs can reduce recurrent (two or more) cardiovascular events in people with a prior heart attack, or other acute coronary syndromes that result from a reduction in blood flow to the heart muscle, or stroke. In addition, studies show statins have helped reduce the total amount of deaths worldwide overall from cardiovascular diseases.

Who needs statins?

Among people who have not had a cardiovascular event like a heart attack or stroke, or a heart procedure such as a coronary angioplasty, or coronary artery bypass surgery (CABG), statin therapy lowers the risk or likelihood of a first event in individuals. This patient population includes those with:

• High concentrations of low density lipoprotein cholesterol (LDL-C), also known as “bad cholesterol” ranging from 155 to 232 mg/dL
• Moderate elevations of LDL-C ranging from 130 to 190 mg/dL who have low levels of high density lipoprotein cholesterol (HDL-C), also known as “good cholesterol” (less than 45 mg/dL for men and less than 47 mg/dL for women)
• Hypertension
• Low levels of LDL-C (less than 130 mg/dL)
• Whole body inflammation as measured by blood levels of high-sensitivity C-reactive protein (hs-CRP)

Why take statins?

The reduction in risk using statin therapy can range from an average of 25 to 44 percent. After one or more cardiovascular events, statin therapy lowers the risk or likelihood of another event by 25 to 40 percent.

Higher intensity statin therapy (high dosage of more effective LDL-C lowering medications) is more effective in lowering risk than low to moderate intensity statin therapy (low dosage or less effective LDL-C lowering medications).

Unfortunately, many patients hospitalized for an acute or sudden onset cardiovascular event are not being prescribed high intensity statin therapy as we reported in January 2015 in the Journal of the American College of Cardiology (JACC) from an analysis of Medicare participants. Since the majority of individuals treated with a statin have another event, we have been conducting studies to investigate whether the addition of other cholesterol lowering therapies to high intensity statin are more effective than high intensity statin therapy for the reduction of a recurrent cardiovascular event.

What is statin intolerance?

Unfortunately, statins have side effects that make them intolerant to 10 to 20 percent of individuals. These side effects fall into several main categories: (1) adverse skeletal muscle complaints; (2) memory or cognitive impairment; (3) liver abnormalities; and (4) allergic responses. In order to improve detection and accurate diagnosis of skeletal muscle adverse events, I served as one of three committee members for the first National Lipid Association task force on statin muscle complaints, and chairperson of the second task force. In our 2014 report, our major efforts were directed towards precise definitions of the different forms of muscle adverse events, the development of a scoring system to improve the accuracy of the diagnosis of muscle complaints, and provide guidance to health care professionals concerning the interactions of statins with other medications that may increase this risk of muscle injury and other conditions that make the muscles more at risk for muscle adverse events.

Currently, I am working with collaborators at the University of Alabama Birmingham validating the clinical scoring system for diagnosis of adverse muscle complaints.

At The Mount Sinai Hospital, our research team that also includes Donald Smith, MD, we are conducting clinical studies that evaluate alternative cholesterol lowering therapies for individuals who have not been able to tolerate statins due to adverse muscle complaints. The main emphasis of our team’s work has been with the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. This therapy is a human monoclonal antibody to PCSK9, which is a protein that accelerates the breakdown of the LDL receptor or major liver pathway for removing cholesterol from the bloodstream. Currently, our team is completing our fourth clinical trial of individuals who have statin adverse muscle complaints.

Through our research efforts, there is a concerted effort to improve identification and accurate diagnosis of individuals who have the major form of statin intolerance and provide solutions through minimizing drug interactions, and the use of existing and newer cholesterol lowering medications in order to lower the burden of cardiovascular diseases.

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Robert S. Rosenson, MD, is a Professor of Medicine (Cardiology) at Icahn School of Medicine at Mount Sinai, and Director of the Cardiometabolic Unit at The Mount Sinai Hospital.

References:

1. Rosenson RS, Kent ST, Brown TM, Farkouh ME, Levitan EB, Yn H, Sharma P, Safford MM, Kilgore M, Munter P, Bittner V. Underutilization of high intensity statin therapy following hospitalization for coronary heart disease. J Am Coll Cardiol 2015 (in press).
2. Rosenson RS, Baker S, Jacobson T, Kopecky S, Parker B. An assessment of statin muscle safety task force: 2014 update. J Clin Lipidol 2014;8:S58-71.
3. Stroes E, Colquhoun D, Sullivan D, Civeira F, Rosenson RS, Watts GF, Bruckert E, Cho L, Kent R, Knusel B, Xue A, Scott R, Wasserman SM, Rocco; GAUSS-2 Investigators. J Am Coll Cardio. 2014;63:2451-2458.