Author + information
- Dean Kereiakes1,
- Norman Lepor2,
- Robert Gerber3,
- L. Veronica Lee4,
- Desmond Thompson5 and
- C. Michael Gibson6
- 1The Christ Hospital, Cincinnati, Ohio, United States
- 2Cedars-Sinai Medical Center/Westside Medical Associates of Los Angeles, Beverly Hills, California, United States
- 3East Sussex Healthcare NHS Trust, Hastings, United Kingdom
- 4Sanofi, Bridgewater, New Jersey, United States
- 5Regeneron Pharmaceuticals, Inc., Tarrytown, New York, United States
- 6Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Patients with prior revascularization are at high risk of further CV events, and may need additional lipid-lowering therapy beyond statins. We assessed the PCSK9 inhibitor alirocumab in patients with prior coronary revascularization (PCI or CABG).
Efficacy data from 8 Phase 3 trials were analyzed in 3 pools per trial design: alirocumab 150 mg every 2 weeks (Q2W) vs placebo; alirocumab 75/150 mg (75 mg Q2W with possible dose increase to 150 mg Q2W at Week 12 based on Week 8 LDL-C) vs placebo; alirocumab 75/150 mg Q2W vs ezetimibe. All trials included background statin therapy. Primary endpoint was % change in LDL-C from baseline to Week 24.
Of 4629 total randomized patients, 2191 (47.3%) had prior revascularization; of these, >50% had history of acute MI, 53–84% were on high intensity statin therapy, mean age was 60-62 years and 71-70% were male (ranges over pooled groups). LDL-C was significantly reduced with alirocumab vs controls, with LS mean±SE reductions of 63.1±1.1% with the 150 mg Q2W dose and 51.5±1.7% and 52.8±1.4% in pools using 75/150 mg Q2W, respectively; other lipids were also reduced (Table). Alirocumab was generally well-tolerated, with a higher injection site reaction frequency vs controls.
Alirocumab resulted in significant reductions in LDL-C and other atherogenic lipids and was generally well-tolerated in high-risk patients with prior revascularization (PCI or CABG). Findings are consistent with other subgroup analyses. A clinical outcomes study of alirocumab is underway in recent ACS patients (NCT01663402).
CORONARY: Lipid Disorders and Management