ry 2 weeks, REPATHA 420 mg once monthly, or placebo for 12 weeks. The trial included 296 patients with atherosclerotic CVD who received REPATHA or placebo as add-on therapy to daily doses of atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg. Among these patients, the mean age at baseline was 63 years (range: 32 to 80 years), 45% were ≥ 65 years old, 33% women, 98% White, 2% were Black, < 1% Asian and 5% Hispanic or Latino. After 4 weeks of statin therapy, the mean baseline LDL-C was 108 mg/dL.
In these patients with atherosclerotic CVD who were on maximum-dose statin therapy, the difference between REPATHA and placebo in mean percent change in LDL-C from baseline to Week 12 was -71% (95% CI: -81%, -61%; p < 0.0001) and -63% (95% CI: -76%, -50%; p ˂ 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. For additional results see Table 3 and Figure 1.
Table 3. Effect of REPATHA on Lipid Parameters in Patients with Atherosclerotic CVD on Atorvastatin 80 mg, Rosuvastatin 40 mg, or Simvastatin 40 mg (Mean % Change from Baseline to Week 12 in Study 1)
Estimates based on a multiple imputation model that accounts for treatment adherence
†140 mg every 2 weeks or 420 mg once monthly yield similar reductions in LDL-C
Figure 1. Effect of REPATHA on LDL-C in Patients with Atherosclerotic CVD when Combined with Statins (Mean % Change from Baseline to Week 12 in Study 1)
Estimates based on a multiple imputation model that accounts for treatment adherence
Error bars indicate 95% confidence intervals
Study 2 was a multicenter, double-blind, randomized, placebo-controlled, 52-week trial that included 139 patients with atherosclerotic CVD who received protocol-determined background lipid-lowering therapy of atorvastatin 80 mg daily with or without ezetimibe 10 mg daily. After stabilization on background therapy, patients were randomly assigned to the addition of placebo or REPATHA 420 mg administered subcutaneously once monthly. Among these patients, the mean age at baseline was 59 years (range: 35 to 75 years), 25% were ≥ 65 years, 40% women, 80% White, 3% Black, 5% Asian, and < 1% Hispanic or Latino. After stabilization on the assigned background therapy, the mean baseline LDL-C was 105 mg/dL.
In these patients with atherosclerotic CVD on maximum-dose atorvastatin therapy with or without ezetimibe, the difference between REPATHA 420 mg once monthly and placebo in mean percent change in LDL-C from baseline to Week 52 was -54 % (95% CI: -65%, -42%; p ˂ 0.0001) (Table 4 and Figure 2). For additional results see Table 4.
Table 4. Effect of REPATHA on Lipid Parameters in Patients with Atherosclerotic CVD on Atorvastatin 80 mg with or without Ezetimibe 10 mg daily (Mean % Change from Baseline to Week 52 in Study 2)
Estimates based on a multiple imputation model that accounts for treatment adherence
Figure 2. Effect of REPATHA 420 mg Once Monthly on LDL-C in Patients with Atherosclerotic CVD on Atorvastatin 80 mg with or without Ezetimibe 10 mg Daily
Estimates based on a multiple imputation model that accounts for treatment adherence
Error bars indicate 95% confidence intervals
14.2 Heterozygous Familial Hypercholesterolemia (HeFH)
Study 3 was a multicenter, double-blind, randomized, placebo-controlled, 12-week trial in 329 patients with heterozygous familial hypercholesterolemia (HeFH) on statins with or without other lipid-lowering therapies. Patients were randomized to receive subcutan |
