Author + information
- Jennifer Robinsona,b,
- Francois Schielea,b,
- Ulrich Laufsa,b,
- Maddalena Lettinoa,b,
- Velichka Valchevaa,b,
- Sophie Guillonneaua,b,
- Serban R. Iorgaa,b,
- Nadège Narcissea,b and
- Keith Foxa,b
Background: People at particularly high risk of atherosclerotic cardiovascular disease (ASCVD) with uncontrolled low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated statins may benefit from alirocumab (ALI). We examined ALI efficacy/safety among high/very high risk patients with baseline LDL-C >100/70 mg/dL on maximally tolerated statin ± other lipid-lowering therapies.
Methods: Data from 3,545 patients with ASCVD (secondary prevention) or heterozygous familial hypercholesterolemia (primary prevention) with high (20%-<30%) or very high (≥30%) 10-year ASCVD risk (based on ASCVD rates in observational/clinical trials) and with baseline LDL-C >100 mg/dL (or >70 mg/dL, very high only) from 8 Phase 3 trials were pooled by ALI dose and control: Pool 1, ALI 75 mg every two weeks (Q2W) (adjusted to 150 mg Q2W at Week 12 if Week 8 LDL-C ≥70/100 mg/dL, risk dependent) vs placebo; Pool 2, ALI 75/150 mg Q2W vs ezetimibe; Pool 3, ALI 150 mg Q2W vs placebo.
Results: Week 24 percent LDL-C reductions with ALI (least squares [LS] mean difference −55.1 to −59.2 vs placebo, −29.3 vs ezetimibe) were significant (figure) and similar to the overall ODYSSEY population. Week 24 LS mean differences in absolute LDL-C reduction were −74.2 to −75.4 mg/dL vs placebo, −34.2 vs ezetimibe. Incidence of treatment-emergent adverse events was comparable across groups; most common was nasopharyngitis.
Conclusions: These data support the benefits of ALI in high/very high risk patients with baseline LDL-C >100/70 mg/dL.
Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:45 a.m.
Session Title: Advances in Cholesterol Measurement and Management
Abstract Category: 32. Prevention: Clinical
Presentation Number: 1106-059
- 2017 American College of Cardiology Foundation