Author + information
- Robert J. Weissa,b,
- Seth Bauma,b,
- Dirk Bloma,b,
- Jean Bergerona,b,
- Gisle Langsleta,b,
- Santosh Sanganalmatha,b,
- Julia Yanga,b,
- Jonas Mandela,b and
- Prediman Shaha,b
Background: Patients (Pts) with atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH) are at high cardiovascular risk. Despite maximally tolerated dose (MTD) of statin, many have high levels of low-density lipoprotein cholesterol (LDL-C). We present the efficacy and safety of alirocumab (ALI) in ASCVD and/or HeFH patients on MTD of statin +/- other lipid lowering therapies from 5 placebo (PL)-controlled Phase 3 trials (≥52 Weeks [W]).
Methods: Pts with (n=2449) vs without ASCVD (n=1050) were pooled from FH I, FH II, HIGH FH, LONG TERM and COMBO I. HeFH pts with (n=575) vs without ASCVD (n=682) were pooled from all except COMBO I (no HeFH recruited). ALI was given at 75/150 mg once every two weeks (Q2W) (3 trials) or at 150 mg Q2W (2 trials). Efficacy endpoints included % LDL-C change from baseline to W24 by ALI dose.
Results: Mean baseline LDL-C of pts with and without ASCVD for ALI was 120.1 (vs PL 122.8) mg/dL and 142.1 (vs 148.3) mg/dL, respectively. Mean baseline LDLC of HeFH pts with and without ASCVD on ALI was 148.1 (vs PL 151.0) mg/dL and 155.9 (vs 148.3) mg/dL, respectively. LDL-C % reduction from baseline at W24 ranged 46.8-51.3% for ALI 75/150 mg and 54.1-61.8% for ALI 150 mg in groups analysed (Fig 1) and sustained for ≥52W. Overall safety was similar in ALI vs PL in all groups with nasopharyngitis and injection site reactions observed most frequently for ALI.
Conclusions: ALI for ≥52W was highly efficacious and well-tolerated in ASCVD and HeFH pts on MTD of statin.
Poster Hall, Hall C
Saturday, March 18, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Advances in Lipid Management
Abstract Category: 3. Acute and Stable Ischemic Heart Disease: Therapy
Presentation Number: 1203-308
- 2017 American College of Cardiology Foundation