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.

IMPORTANT SAFETY INFORMATION

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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 in Primary Hyperlipidemia, including HeFH: The most common adverse reactions (> 5% of Repatha®-treated patients and occurring more frequently than placebo) in clinical trials in primary hyperlipidemia (including HeFH) 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).

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%).

Adverse reactions in the Cardiovascular Outcomes trial: The safety profile of Repatha® in this trial was generally consistent with the safety profile described above in the 12- and 52-week controlled trials involving patients with primary hyperlipidemia (including HeFH). Serious adverse events occurred in 24.8% and 24.7% of Repatha®-treated and placebo-treated patients, respectively. Adverse events led to discontinuation of study treatment in 4.4% of patients assigned to Repatha® and 4.2% assigned to placebo. Common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) included diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients assigned to Repatha® compared with 7.7% in those assigned to placebo.

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

Please see full Prescribing Information.

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