Unmet Need in High LDL-C Management

Multiple sources show,

  • 2011-2012 NHANES: A data analysis examined 131 ASCVD patients taking statin therapy, representing 5.87M individuals with ASCVD in the US1,*

  • 1-year retrospective cohort analysis: A review of 740 patients with ASCVD receiving ezetimibe in addition to existing high-intensity statins2,†

Multiple etiologies exist for failure to achieve desired LDL-C, including nonadherence, very high baseline LDL-C, and hyporesponsiveness to therapy.3-5

ASCVD = atherosclerotic cardiovascular disease; NHANES = National Health and Nutrition Examination Survey.

*Patients with ASCVD were defined as those who reported being told by an HCP they had CHD, angina, MI or stroke in the past (PAD and TIA were not captured in the survey). Statin use was self-reported and confirmed at the patient's NHANES visit.

Based on claims analysis from the Inovalon MORE database from 1/1/2013 through 6/30/2014.

Major Cholesterol Treatment Guidelines and Recommendations Reinforce LDL-C Reduction Is the Treatment Target

  • The new NLA and AACE guidelines recommend lowering LDL-C to below 70 mg/dL6,7

  • The ACC/AHA and ADA guidelines state that patients taking high-intensity statin therapy should achieve at least a 50% reduction in LDL-C8,9

AACE = American Association of Clinical Endocrinologists; ACC = American College of Cardiology; ASCVD = atherosclerotic cardiovascular disease; NLA = National Lipid Association.

For patients with clinical ASCVD or HeFH on maximally tolerated statin therapy as an adjunct to diet who require further LDL-lowering

Repatha® Every 2 Weeks + a Statin Helped

Results from a 12-week study in patients with clinical ASCVD. At week 12, 87% to 90% of patients receiving Repatha® 140 mg every 2 weeks + a statin achieved LDL-C < 70 mg/dL. Maximum-dose statins used were atorvastatin 80 mg, rosuvastatin 40 mg, and simvastatin 40 mg.10,11

References: 1. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011-2012. J Clin Lipidol. 2016;10:1109-1118. 2. Data on file, Amgen; 2016. 3. Pijlman AH, Huijgen R, Verhagen SN, et al. Evaluation of cholesterol lowering treatment of patients with familial hypercholesterolemia: A large cross-sectional study in The Netherlands. Atherosclerosis. 2010;209:189-194. 4. Kataoka Y, St John J, Wolski K, et al. Atheroma progression in hyporesponders to statin therapy. Arterioscler Thromb Vase Biol. 2015;35:990-995. 5. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). 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. 6. Orringer CE, Jacobson TA, Saseen JJ, et al. Update on the use of PCSK9 inhibitors in adults: Recommendations from the Expert Panel of the National Lipid Association. J Clin Lipidol. 2017:. 7. Jellinger PS, Handelsman Y, Rosenblit PD, et al. Endocr Pract. 2017 Feb 3.doi: 10.4158/EPl 71764.GL. [Epub ahead of print]. 8. Stone NJ, Robinson JG, Lichtenstein AH, et al. Circulation. 2014;129(suppl 2):Sl-S45. 9. ADA. Clin Diabetes. 2017;35:5-26. 10. Data on file, Amgen; 2015. 11. Repatha® (evolocumab) Prescribing Information, Amgen.


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Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®.

Allergic reactions: Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients treated with Repatha®, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse reactions: The most common adverse reactions (> 5% of Repatha®-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha®-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha® treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha® and placebo, respectively).

Adverse reactions from a pool of the 52-week trial and seven 12-week trials:
Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha®-treated patients and placebo-treated patients were 0.1% and 0%, respectively.

Allergic reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

Neurocognitive events were reported in less than or equal to 0.2% in Repatha®-treated and placebo-treated patients.

In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha® had at least one LDL‑C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha® dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by Repatha® are unknown.

Musculoskeletal adverse reactions were reported in 14.3% of Repatha®-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha® and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha®.

Repatha® is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).

The effect of Repatha® on cardiovascular morbidity and mortality has been published. Inclusion of the results in the approved labeling is under evaluation with the FDA.

Please see full Prescribing Information.

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