For adults with clinical ASCVD on
maximally tolerated statin therapy,
who require additional LDL-C lowering

REPATHA® WAS STUDIED
WITH THE MOST
COMMON STATIN TYPES1,2


STUDY 1
trial study charttrial study chart

In a multicenter, double-blind, randomized, placebo-controlled trial:1,3

  • Adult patients (18-80 yrs) requiring additional LDL-C lowering were randomized to statin therapy
  • After a 4-week lipid stabilization period to establish baseline LDL-C, patients were randomized to Repatha® or placebo3
  • Post-lipid stabilization period baseline characteristics for patients with ASCVD on maximum-dose statin therapy (atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg), n = 296:1
    • Mean age = 63
    • Gender = 33% female, 67% male
    • Mean baseline LDL-C* = 108 mg/dL
  • Primary endpoint was mean percent change from baseline in LDL-C at week 12, and secondary endpoints included percent change from baseline in other lipid parameters at week 12 and percent of patients achieving LDL-C < 70 mg/dL2

*Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.2

Key exclusion criteria: patients who experienced one of the following within prior 6 months were excluded: MI/UA, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or stroke; and planned cardiac surgery or revascularization.3


For adults with clinical ASCVD on maximally tolerated statin therapy,

Repatha® Q2W + a statin lowered LDL-C up to 77% more than placebo + a statin1,4

EFFECT OF REPATHA® ON LDL-C IN INDIVIDUAL STATIN ARMS1,4
STUDY 1
Repatha placebo comparison chartRepatha placebo comparison chart

Estimate based on multiple imputation model that accounts for treatment adherence.

  • Repatha® + a maximum-dose statin lowered LDL-C by a mean of 71% compared to a placebo + a statin1
  • Repatha® delivered additional LDL-C reductions regardless of statin type studied1
  • The effect of Repatha® on CV morbidity and mortality has not been determined1

For adults with clinical ASCVD on maximally tolerated statin therapy,

Repatha® Q2W helped up to 90% of patients achieve LDL-C < 70 mg/dL5

PERCENTAGE OF PATIENTS ACHIEVING LDL-C < 70 MG/DL AT WEEK 125
STUDY 1

Repatha®
140 mg Q2W
+

Atorvastatin
80 mg

90%

Rosuvastatin
40 mg

88%

Simvastatin
40 mg

87%
Repatha® 140 mg Q2W
n = 95
  • Mean baseline LDL-C after the lipid stabilization period was 108 mg/dL1

For adults with clinical ASCVD on maximally tolerated statin therapy,

Repatha® Q2W + a statin had an additional impact on other key lipid parameters1

POOLED ANALYSIS OF TREATMENT ARMS FROM STUDY 11
lipid parameters chartlipid parameters chart

Estimate based on multiple imputation model that accounts for treatment adherence.

  • The effect of Repatha® on CV morbidity and mortality has not been determined1

APO = apolipoprotein; HDL = high-density lipoprotein; TC = total cholesterol.

References:

  1. Repatha® (evolocumab) Prescribing Information, Amgen.
  2. Robinson JG, Nedergaard BS, Rogers WJ, et al. JAMA. 2014;311:1870-1882.
  3. Robinson JG, Rogers WJ, Nedergaard BS, et al. J Clin Cardiol. 2014;37:195–203.
  4. Data on file, Amgen[1]; 2015.
  5. Data on file, Amgen[2]; 2015.
IMPORTANT SAFETY INFORMATION
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IMPORTANT SAFETY INFORMATION

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®.

INDICATION

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 not been determined.

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