NEW ORLEANS — Reductions in non-HDL and apolipoprotein B corresponded to reductions in major adverse CV events, according to an analysis of 10 trials from the ODYSSEY program.
Michael H. Davidson, MD, FACC, FNLA, and colleagues analyzed 4,983 participants of 10 phase 3 studies of alirocumab (Praluent, Sanofi/Regeneron) as an add-on to statin therapy. Of the study population, 3,182 were assigned alirocumab, 1,174 were assigned placebo and 618 were assigned ezetimibe (Zetia, Merck).
Michael H. Davidson
The researchers evaluated the effect of changes in lipid parameters on major adverse CV events. Davidson, from the department of medicine, University of Chicago Medicine, presented the findings for non-HDL and ApoB at the National Lipid Association Scientific Sessions.
Major adverse CV events were defined as CHD death, nonfatal MI, ischemic stroke or unstable angina requiring hospitalization. Follow-up covered 6,699 patient-years.
The researchers previously reported that reduction in LDL corresponded to reduced risk for major adverse CV events in this population, which Davidson characterized as high risk, with approximately 70% having existing CVD.
There were 104 major adverse CV events observed, occurring a mean of 36 weeks after baseline.
Davidson, a member of the Cardiology Today Editorial Board, and colleagues found that lower levels of non-HDL conferred a lower risk for major adverse CV events (HR per 42 mg/dL reduction = 0.77; 95% CI, 0.65-0.93; HR per 50% reduction from baseline = 0.71; 95% CI, 0.52-0.97).
A similar pattern was seen for lower levels of ApoB (HR per 27 mg/dL reduction = 0.72; 95% CI, 0.6-0.86; HR per 50% reduction from baseline = 0.68; 95% CI, 0.54-0.85), Davidson said.
“There were a small number of events, hence [CIs] are broad,” Davidson said. “What we can say is that we’re seeing [reductions in major adverse CV] events directly related to both lower on-treatment and greater percent reduction of non-HDL and ApoB. These are very encouraging data.”
The ongoing ODYSSEY OUTCOMES trial of approximately 18,000 patients should have enough events to draw a more conclusive relationship between changes in lipid parameters and effect on CV events, and to evaluate alirocumab’s effect on outcomes, Davidson said. – by Erik Swain
Davidson MH, et al. Late-Breaking Presentations. Presented at: National Lipid Association Scientific Sessions; May 19-22, 2016; New Orleans.
Disclosure: The study was funded by Sanofi and Regeneron. Davidson reports receiving consultant/advisory board fees from Amgen, Lipimedix, Merck, Regeneron and Sanofi.