PRALUENT significantly reduced LDL-C in adults with FH
PRALUENT helped reduce LDL-C in patients with HeFH, when added to maximally tolerated statins1,2
Primary endpoint (ODYSSEY FH I and FH II pooled): Mean percent change in LDL-C from baseline to Week 24
Treatment difference at Week 24 between PRALUENT and placebo in mean LDL-C change from baseline
PRALUENT patients with HeFH saw improvements in other lipid parameters1
Change in baseline in lipid parameters (ODYSSEY FH I and FH II pooled)1†
At 24 Weeks, patients with HeFH on PRALUENT experienced substantial differences in reductions vs placebo in other measured lipid parameters1:
- Total cholesterol -36% (95% CI: -39%, -33%)
- Non-HDL-C -49% (95% CI: -53%, -45%)
- Apo B -42% (95% CI: -45%, -39%)
†A pattern-mixture model approach was used with multiple imputation of missing post-treatment values based on a patient's own baseline value and multiple imputation of missing on-treatment values based on a model including available on-treatment values.
‡Dose was up-titrated to 150 mg Q2W in 196 (42%) patients treated for at least 12 weeks.
When added to other lipid-lowering therapies,
PRALUENT significantly reduced LDL-C in adults with HoFH
ODYSSEY HoFH primary endpoint: Mean percent change
in LDL-C from baseline to Week 12 in patients with HoFH1,3
Treatment difference at Week 12 between PRALUENT and placebo in mean LDL-C change from baseline
PRALUENT patients with HoFH experienced improvements across other lipid parameters1,3
Effect of PRALUENT on lipid parameters in patients with HoFH (percent change from baseline to Week 12)1
At 12 Weeks, patients with HoFH on PRALUENT saw substantial differences in reductions in LS mean vs placebo across all measured lipid parameters1,3:
- Apo B -30% (95% CI: -42%, -17%)
- Non-HDL-C -33% (95% CI: -48%, -18%)
- Total cholesterol -27% (95% CI: -39%, -14%)
Patients with 2 LDL-receptor negative alleles (little to no residual function) had a minimal to absent response to PRALUENT.1
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Before receiving PRALUENT in clinical studies,
Patients with FH had elevated baseline LDL-C— despite the use of multiple therapies1,2
Patient baseline characteristics and demographics in HeFH and HoFH trials
- ||Number of patients on PRALUENT (n=490) compared to placebo (n=245).
- ¶Number of patients on PRALUENT (n=45) compared to placebo (n=24).
- #The diagnosis of HoFH was made by either clinical diagnosis, which included a history of an untreated total cholesterol concentration >500 mg/dL together with either xanthoma before 10 years of age or with a history of total cholesterol >250 mg in both parents, or by genetic testing.
- **In ODYSSEY HoFH, 14% of patients were on lomitapide.
For both HeFH studies and the HoFH study: Patients were taking a maximally tolerated dose of statin with or without other lipid-modifying therapy and required additional LDL-C reduction.1
FH I and FH II (Studies 4 and 5) were 2 multicenter, placebo-controlled, double-blind trials that compared PRALUENT (n=490) with placebo (n=245). The trials were similar with regard to both design and eligibility criteria. All patients had HeFH, were taking a maximally tolerated dose of statin with or without other lipid-modifying therapy, and required additional LDL-C reduction. Patients started on PRALUENT 75 mg every two weeks in addition to existing statin therapy: Up-titration to 150 mg every two weeks occurred at Week 12 in patients (42%) who did not achieve their predefined target LDL-C (<70 mg/dL) at Week 8.1,2
Apo B = apolipoprotein B; FH = familial hypercholesterolemia; HDL-C = high-density lipoprotein cholesterol; HeFH = heterozygous familial hypercholesterolemia; HoFH = homozygous familial hypercholesterolemia; LDL-C = low-density lipoprotein cholesterol.