A pooled analysis of studies found a consistent, robust reduction in low-density lipoprotein cholesterol (LDL-C) with alirocumab across a wide range of ages regardless of hypertension or smoking status, according to
This pooled analysis included 10 randomized, phase 3 ODYSSEY studies, wherein researchers evaluated participants with heterozygous familial hypercholesterolemia or nonfamilial hypercholesterolemia (N=4983). Participants received alirocumab (n=3188), ezetimibe (n=620), or placebo (n=1175).
Age at entry in the trials was organized into 3 groups by age: <65 years (n=3241), ≥65 to <75 years (n=1437), or ≥75 years (n=305). Participants included in the MONO trial (NCT01644474) were at moderate cardiovascular disease (CVD) risk. Those included in the ALTERNATIVE trial (NCT01709513) were statin intolerant and at moderate, high, or very high CVD risk. Participants in the remaining 8 clinical trials were at high or very high CVD risk.
There were significant reductions in LDL-C from baseline to week 24 with 75/150 mg alirocumab compared with ezetimibe plus statin (23.7%), as well as 150 mg alirocumab compared with placebo plus statin (65.4%).
There were no significant interactions in LDL-C response to alirocumab between age groups or by hypertension or smoking status.
There was no difference in effect on the proportion of participants who were at very high CVD risk and participants with high CVD risk.
Limitations of this study included minor variations in baseline characteristics in treatment groups because the participants were not stratified at randomization according to age group, hypertension, or smoking status. In addition, the participants in this study were mostly white and male.
The results of this study affirm the efficacy of alirocumab in significantly reducing LDL-C levels in patients regardless of age, hypertension status, and smoking status. The overall rates of treatment-emergent adverse events were similar between alirocumab, ezetimibe, and placebo. External validation needs to be carried out with women and other ethnic groups.
Disclosure: This clinical trial was supported by Sanofi and Regeneron Pharmaceuticals, Inc. Please see the original reference for a full list of authors’ disclosures.
Raal FL, Tuomilehto J, Sposito AC, et al. Treatment effect of alirocumab according to age group, smoking status, and hypertension: Pooled analysis from 10 randomized ODYSSEY studies [published online June 29, 2019]. J Clin Lipidol. doi:10.1016/j.jacl.2019.06.006