Statin-intolerant administration
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Repatha® in statin-intolerance

  • 37% additional LDL-C reduction vs ezetimibe*2
  • 46% of patients achieved LDL-C <70 mg/dl (<1.8 mmol/l) at the mean of Weeks 10 and 122

GAUSS-2 was an international, multicentre, double-blind, randomised, ezetimibe-controlled, 12-week study in 307 patients who were statin-intolerant or unable to tolerate an effective dose of a statin.†2

*Results correspond to Repatha® 140 mg every two weeks with daily oral placebo.
Co-primary endpoints were mean percent change from baseline in LDL-C at the mean of 10 and 12 weeks and 12 weeks alone. Co-secondary efficacy endpoints at the same time points included change from baseline in LDL-C, percent of patients with LDL-C <70 mg/dl, and percent change from baseline in non–high-density lipoprotein cholesterol (HDL-C), apolipoprotein B, total cholesterol/HDL-C ratio, apolipoprotein B/apolipoprotein A-I ratio, lipoprotein(a), triglycerides, HDL-C, and very low-density lipoprotein (VLDL-C). Lipid-lowering therapy was used by 33% of patients; 18% received a low-dose statin. Patients included in this study were intolerant to at least 2 statins. Baseline mean LDL-C for patients receiving Repatha® was 192 mg/dl (4.97 mmol/l) and 195 mg/dl (5.04 mmol/l) in the comparator group. Mean LDL-C levels at the mean of weeks 10 and 12 were 86.6 mg/dl
(2.24 mmol/l) for the Repatha® group and 155.9 mg/dl (4.03 mmol/l) in the comparator group.
In the study, 2690 recent MI patients received Repatha®, 2254 of whom achieved LDL-C levels <55 mg/dl.
§25% RRR reported as the key secondary endpoint: composite of cardiovascular death, MI or stroke. HR: 0.75; 95% CI: 0.62-0.91; p=0.003. ARR: 3.2%; 95% CI: 1.2-5.2.
ACS = Acute coronary syndrome; ARR = Absolute risk reduction; CV = Cardiovascular; EAS = European Atherosclerosis Society; ESC = European Society of Cardiology; EVOPACS = EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes; GAUSS = Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects; LDL-C = Low-density lipoprotein cholesterol; MI = Myocardial infarction; PCSK9 = Protein convertase subtilisin/kexin type 9; Q2W = Every 2 weeks; QD = Every day; RRR = Relative risk reduction.
  1. Repatha® (evolocumab) Summary of Product Characteristics. Last revised: 31 March 2021.
  2. Stroes E, et al. J Am Coll Cardiol. 2014;63:2541-8.
  3. Gencer B, et al. JAMA Cardiol. 2020;5(8):1-6. Main paper & Supplementary appendix.

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