Key result
Baseline cholesterol absorption markers are not associated with LDL-C response to ezetimibe/simvastatin in FH.
Why the study?
Subjects with increased cholesterol absorption might benefit more from combining a statin with a cholesterol absorption inhibitor, but whether baseline cholesterol absorption markers are associated with the LDL-C lowering and absorption inhibition response to ezetimibe/simvastatin in familial hypercholesterolemia was uncertain.
Do baseline cholesterol absorption markers predict the LDL-cholesterol lowering response to ezetimibe/simvastatin therapy in patients with familial hypercholesterolemia?
Observational (n=591)
Do baseline cholesterol absorption markers predict the LDL-cholesterol lowering response to ezetimibe/simvastatin therapy in patients with familial hypercholesterolemia?
Baseline cholesterol absorption markers do not predict the LDL-C lowering response to ezetimibe/simvastatin in patients with familial hypercholesterolemia and are not supported as a tool to guide therapy selection.
Answers are grounded in this paper and cite their sources.
Absorption markers should not guide ezetimibe/simvastatin selection in FH; challenges their predictive utility and leaves open alternative biomarkers.
Subjects with increased cholesterol absorption might benefit more from statin therapy combined with a cholesterol absorption inhibitor. We assessed whether baseline cholesterol absorption markers were associated with response to ezetimibe/simvastatin therapy, in terms of LDL-cholesterol (LDL-C) lowering and cholesterol absorption inhibition, in patients with familial hypercholesterolemia (FH). In a posthoc analysis of the two-year ENHANCE trial, we assessed baseline cholesterol-adjusted campesterol (campesterol/TC) and sitosterol/TC ratios in 591 FH patients. Associations with LDL-C changes and changes in cholesterol absorption markers were evaluated by multiple regression analysis. No association was observed between baseline markers of cholesterol absorption and the extent of LDL-C response to ezetimibe/simvastatin therapy (beta = 0.020, P = 0.587 for campesterol/TC and beta<0.001, P = 0.992 for sitosterol/TC). Ezetimibe/simvastatin treatment reduced campesterol levels by 68% and sitosterol levels by 62%; reductions were most pronounced in subjects with the highest cholesterol absorption markers at baseline, the so-called high absorbers (P < 0.001). Baseline cholesterol absorption status does not determine LDL-C lowering response to ezetimibe/simvastatin therapy in FH, despite more pronounced cholesterol absorption inhibition in high absorbers. Hence, these data do not support the use of baseline absorption markers as a tool to determine optimal cholesterol lowering strategy in FH patients. However, due to the exploratory nature of any posthoc analysis, these results warrant further prospective evaluation in different populations.
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Jakulj et al. (2009) conducted an observational in Familial hypercholesterolemia (FH) (n=591). Baseline cholesterol absorption markers (campesterol/TC and sitosterol/TC ratios) in patients on ezetimibe/simvastatin vs. Lower baseline cholesterol absorption markers was evaluated on LDL-cholesterol (LDL-C) lowering response to ezetimibe/simvastatin therapy (beta = 0.020 for campesterol/TC; beta < 0.001 for sitosterol/TC, p=0.587 for campesterol/TC; 0.992 for sitosterol/TC). Baseline cholesterol absorption markers were not associated with LDL-C lowering response to ezetimibe/simvastatin in FH (campesterol/TC beta=0.020, P=0.587; sitosterol/TC beta<0.001, P=0.992).
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