Effect of Alirocumab, a Monoclonal Proprotein Convertase Subtilisin/Kexin 9 Antibody, on Lipoprotein(a) Concentrations (a Pooled Analysis of 150 mg Every Two Weeks Dosing from Phase 2 Trials)
Key result
Alirocumab cuts Lp(a) levels by ~30% versus placebo.
- P<0.0001
- n=185
Why the study?
Lipoprotein(a) is an independent cardiovascular risk factor with limited treatment options, necessitating evaluation of alirocumab's effect on Lp(a) levels.
Does alirocumab 150 mg Q2W reduce Lp(a) concentrations in patients with hypercholesterolemia on background lipid-lowering therapy?
Comparison
Alirocumab 150 mg every 2 weeks vs placebo
Design
Pooled analysis of 3 double-blind randomized placebo-controlled phase 2 trials
Follow-up
8 or 12 weeks
Authors
Discussion
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Implication
Supports alirocumab 150 mg Q2W for Lp(a) lowering in hypercholesterolemia; confirms effect largely independent of LDL-C in meta-analysis.
Study Design
Type
RCT (n=185)
Blinding
double-blind
Randomization
randomized
Structured PICO
Does alirocumab 150 mg Q2W reduce Lp(a) concentrations in patients with hypercholesterolemia on background lipid-lowering therapy?
P
Population
185 patients with hypercholesterolemia on background lipid-lowering therapy from 3 pooled phase 2 trials, followed for 8 or 12 weeks.
I
Intervention
Alirocumab 150 mg every 2 weeks (Q2W) for 8 or 12 weeks
C
Comparator
Placebo
O
Outcome
Percentage change in Lipoprotein(a) [Lp(a)] concentrations from baselinesurrogate
Main Result
Absolute Event Rate: -30.3% vs -0.3%
p-value: p=<0.0001
Alirocumab 150 mg every 2 weeks significantly reduces Lp(a) levels in patients with hypercholesterolemia, with reductions largely independent of LDL-C lowering.
Cite This Study
Gaudet et al. (2014) conducted an RCT in hypercholesterolemia (n=185). alirocumab vs. placebo was evaluated on reduction in Lipoprotein(a) from baseline (p=<0.0001). Alirocumab 150 mg every 2 weeks significantly reduced Lipoprotein(a) levels from baseline compared with placebo (-30.3% vs -0.3%, p<0.0001).