Study 5 (RUTHERFORD-2)

Study 3 study design Study 3 study design

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

  • 329 adult patients (19-79 yrs) with a clinical diagnosis of HeFH requiring additional LDL-C lowering†,‡ were randomized to Repatha® or placebo1,2

  • Primary endpoint was percent change from baseline in LDL-C at week 122

  • Post-lipid stabilization period baseline characteristics1:

    • Mean age = 51

    • Mean baseline LDL-C = 156 mg/dL

    • Gender = 42% female, 58% male

    • All patients were taking statin therapy

    • Atherosclerotic CVD = 38%

    • High-intensity statin = 76%

Repatha® helped HeFH patients escape high LDL-C with a 61% greater LDL-C reduction than statins alone1

LDL-C treatment difference in Study 5 (RUTHERFORD-2)

Study 5 results Study 5 results
  • Repatha® every two weeks helped up to 68% of patients achieve LDL-C < 70 mg/dL2

  • Repatha® once a month lowered LDL-C an additional 60% when combined with background therapy1

    • Background therapy was statin therapy with or without other lipid-lowering therapies1

    • Mean baseline LDL-C was 156 mg/dL1,*

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

*Baseline was measured after the lipid stabilization period and before administration of first dose of study drug, n = 329.1

At screening, eligible patients included those with HeFH diagnosed by the Simon Broome diagnostic criteria on a stable statin dose with or without other approved lipid-modifying therapy for at least 4 weeks before screening.2

Use of LDL or plasmapheresis within 16 weeks prior to enrollment and treatment with fibrates within 6 weeks of treatment were not allowed. Patients were stratified by other, non-statin lipid-lowering therapy and LDL-C level prior to randomization; in adults, the Simon Broome criteria include an LDL-C of > 190 mg/dL (without therapy) plus clinical criteria (including patient or family history of tendon xanthomas, plus either family history of early CAD or family history of total cholesterol > 290 mg/dL).2,3