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National Lipid Association Releases Updated Recommendations on the Use of PCSK9 Inhibitors at the 15th Annual Scientific Session

Patient-centered recommendations for people needing additional cholesterol reduction

PHILADELPHIA, PA--(Marketwired - May 19, 2017) - The National Lipid Association (NLA) assembled a panel of experts to update its guidance for the use of proprotein convertase subtilisin/kexin type 9 (PCSK9) antibody therapy made in the NLA Recommendations for Patient-Centered Management of Dyslipidemia: Part 2 in 2015.

According to the expert panel, "Recent studies have demonstrated the efficacy of [PCSK9 inhibitors] in reducing LDL cholesterol and non-HDL cholesterol and have confirmed their excellent safety profile."

The expert panel was chaired by Carl Orringer, MD, FNLA, past president of the NLA and associate professor of medicine at the University of Miami School of Medicine, and Terry Jacobson, MD, FNLA, past president of the NLA, professor of medicine, and Director of the Office of Health Promotion and Disease Prevention at Emory University.

The expert panel provided the following recommendations on behalf of the NLA:

                                                                            
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    2017 Recommendations of the NLA Expert Panel on Treatment with PCSK9    
                                 Inhibitors                                 
----------------------------------------------------------------------------
ASCVD                                                                       
1. PCSK9 inhibitor therapy should be considered for ASCVD risk reduction in 
patients with stable atherosclerotic cardiovascular disease, particularly in
those with additional ASCVD risk factors, on maximally-tolerated statin     
therapy +/- ezetimibe, with on-treatment LDL-C ≥70 mg/dL or non-HDL-C 
≥100 mg/dL. Strength A, Quality: High                                 
----------------------------------------------------------------------------
2. PCSK9 inhibitor therapy may be considered to further reduce LDL-C in     
patients with progressive atherosclerotic cardiovascular disease on         
maximally tolerated-statin therapy +/- ezetimibe, and on-treatment LDL-C    
≥70 mg/dL or non-HDL-C ≥100 mg/dL. Strength B, Quality: Moderate
----------------------------------------------------------------------------
Phenotypic FH/LDL-C ≥ 190 mg/dL                                       
3a. PCSK9 inhibitor therapy may be considered to further reduce LDL-C in    
patients age 40-79 years with phenotypic FH, pre-treatment LDL-C ≥ 190
mg/dL, no uncontrolled ASCVD risk factors or other key additional high risk 
markers*, and on-treatment LDL-C ≥ 100 mg/dL or non-HDL-C ≥ 130 
mg/dL on maximal-tolerated statin therapy +/- ezetimibe. Strength B,        
Quality: Moderate                                                           
3b. PCSK9 inhibitor therapy may be considered to further reduce LDL-C in    
patients age 40-79 years with phenotypic FH, pre-treatment LDL-C ≥ 190
mg/dL and the presence of either uncontrolled ASCVD risk factors, key       
additional high risk markers*, or genetic confirmation of familial          
hypercholesterolemia, and on-treatment LDL-C ≥ 70 mg/dL or non-HDL-C  
≥ 100 mg/dL on maximal-tolerated statin +/- ezetimibe. Strength: B,   
Quality: Moderate                                                           
3c. PCSK9 inhibitor therapy may be considered to further reduce LDL-C in    
patients age 18-39 years with phenotypic FH, pre-treatment LDL-C ≥ 190
mg/dL and the presence of either uncontrolled ASCVD risk factors, key       
additional high risk markers*, or genetic confirmation of familial          
hypercholesterolemia, and on-treatment LDL-C ≥ 100 mg/dL or non-HDL-C 
≥ 130 mg/dL on maximal-tolerated statin +/- ezetimibe. Strength: E,   
Quality: Low                                                                
----------------------------------------------------------------------------
3d. PCSK9 inhibitor therapy may be considered to further reduce LDL-C in    
patients with homozygous familial hypercholesterolemia, either of unknown   
genotype, or those known to be LDL receptor defective, on maximal-tolerated 
statin therapy +/- ezetimibe with LDL-C ≥ 70 mg/dL or non-HDL-C       
≥ 100 mg/dL. Strength B, Quality: Moderate                            
----------------------------------------------------------------------------
Very High Risk/Statin Intolerance                                           
4. PCSK9 inhibitor therapy may be considered to further reduce LDL-C in     
selected very high-risk patients who meet the definition of statin          
intolerance (as previously defined by the NLA Statin Expert Panel) and who  
require substantial additional atherogenic cholesterol lowering, despite the
use of other lipid lowering therapies. Strength C, Quality: Low             
----------------------------------------------------------------------------
* Including history of uncontrolled high blood pressure, diabetes, current  
cigarette smoking or family history of premature ASCVD; or additional high  
risk markers (coronary calcium ≥ 300 Agatston units [or ≥ 75th  
percentile for the patient's age, gender and ethnicity]; Lp(a) ≥ 50   
mg/dL using an isoform insensitive assay, hs-CRP ≥ 2 mg/L or CKD      
including albumin/creatinine ratio ≥ 30 mg/g)                         

The other authors on the manuscript are Joseph J. Saseen, PharmD, FNLA, Alan S. Brown, MD, FNLA, Antonio M. Gotto, MD, FNLA, Joyce L. Ross, MSN, CRNP, FNLA, and James A. Underberg, MD, FNLA.

"The National Lipid Association PCSK9 recommendation update provides a comprehensive overview of this class of medication with evidence-based and expert recommendations that allow practitioners to translate the data into high quality patient care," said Orringer, Jacobson and Underberg in a joint statement.

The update is published online in the Journal of Clinical Lipidology.

ABOUT THE NATIONAL LIPID ASSOCIATION
The NLA is a multidisciplinary specialty society focused on prevention of cardiovascular disease and other lipid-related disorders. The NLA's mission is to enhance the practice of lipid management in clinical medicine, and one of its goals is to enhance efforts to reduce death and disability related to disorders of lipid metabolism in patients. Members include physicians (MDs and DOs), as well as clinical team affiliates, from an array of disciplines including PhD researchers, nurses, nurse practitioners, physician assistants, pharmacists, exercise physiologists, and dietitians. For more information, visit lipid.org.

Image Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/Images/Underberg,_James-0936c5a09d16b98e8e95eb1f5eb6ffee.jpg
Image Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/Images/Ross,_Joyce-59cad9e11adf8d3cbc3c28002e93ff55.jpg
Image Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/Images/Gotto,_Antonio-a5a8676f2c9fbda296080ddf17f4ba67.jpg
Image Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/Images/Brown,_Alan-cb55ab3150e6b26ca44ae49ecf1adb10.jpg
Image Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/Images/Saseen_Joe_14_206-c7637a86f6a2bf1ab1e2a3047d30003d.jpg
Image Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/Images/jacobson,_Terry-8d80f31b2b339365a179f7e550167b7e.jpg
Image Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/Images/Orringer,_Carl-830a5170633eac8eb39aacc0e295326d.jpg

Attachment Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/NLA_PCSK9_2017Rec_Infographic-6eea0ee0aeaab99dabfa055d5aeb266f.pdf
Attachment Available: http://www.marketwire.com/library/MwGo/2017/5/18/11G139237/NLA_PCSK9_Update_-_Fact_Sheet-d0b8af5645199474bb93b4440537ba57.pdf

Eric Scott
(904) 885-2171
[email protected]

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