Alirocumab substantially reduced low-density lipoprotein cholesterol in adults aged <65, ≥65 to <75, ≥75 years.
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Alirocumab substantially reduced low-density lipoprotein cholesterol, regardless of hypertension or smoking.
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Alirocumab was well tolerated in all subgroups.
Background
Age, smoking, hypercholesterolemia, and hypertension are major risk factors for atherosclerotic cardiovascular disease.
Objective
We examined whether the effects of alirocumab on low-density lipoprotein cholesterol (LDL-C) differed according to age, hypertension, or smoking status.
Methods
Data were pooled from 10 Phase 3 ODYSSEY randomized trials (24–104 weeks’ duration) in 4983 people with heterozygous familial hypercholesterolemia (FH) or non–familial hypercholesterolemia (3188 on alirocumab, 1795 on control [620 on ezetimibe and 1175 on placebo]). Most participants received concomitant maximum tolerated statin therapy. In 8 trials, the alirocumab dose was increased from 75 mg every 2 weeks (Q2W) to 150 mg Q2W at Week 12 if predefined risk-based LDL-C goals were not achieved at Week 8 (≥70 mg/dL in very high cardiovascular risk; ≥100 mg/dL in moderate or high cardiovascular risk). Two trials compared alirocumab 150 mg Q2W vs placebo. The efficacy and safety of alirocumab were assessed post hoc in subgroups stratified by age (<65, ≥65 to <75, ≥75 years) and baseline hypertension or smoking status.
Results
Alirocumab reduced LDL-C by 23.7% (75/150 mg vs ezetimibe + statin) to 65.4% (150 mg vs placebo + statin) from baseline to Week 24 vs control. Subgroup analyses confirmed no significant interactions in response to alirocumab between age group, hypertension, or smoking status. Overall rates of treatment-emergent adverse events were similar between alirocumab and control groups.
Conclusions
In this pooled analysis from 10 trials, alirocumab led to substantial LDL-C reductions vs control in every age group and regardless of hypertension or smoking status. Alirocumab was well tolerated in all subgroups.
Part of these data were presented at the American College of Cardiology 65th Annual Scientific Session, Chicago, IL, USA (April 3, 2016) and the World Heart Federation World Congress of Cardiology & Cardiovascular Health 2016 (June 4–7), Mexico City, Mexico.
