Comparing remnant lipoprotein cholesterol measurement methods to evaluate efficacy of ezetimibe/statin vs statin therapy.

Autor: Toth PP; CGH Medical Center, Sterling, IL, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: Peter.Toth@cghmc.com., Bays HE; Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA., Brown WV; Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA., Catapano AL; Department of Pharmacological and Biomolecular Sciences, University of Milan, Multimedica IRCCS, Milan, Italy., Davidson MH; The University of Chicago, Pritzker School of Medicine, Chicago, IL, USA., Farnier M; Lipid Clinic, Point Médical, and Departement of Cardiology, CHU Dijon-Bourgogne, Dijon, France., Tomassini JE; Global Clinical Development, Merck Research Laboratories, Merck & Co, Inc, Kenilworth, NJ, USA., Jensen E; Global Clinical Development, Merck Research Laboratories, Merck & Co, Inc, Kenilworth, NJ, USA., Polis AB; Global Clinical Development, Merck Research Laboratories, Merck & Co, Inc, Kenilworth, NJ, USA., Tershakovec AM; Global Clinical Development, Merck Research Laboratories, Merck & Co, Inc, Kenilworth, NJ, USA.
Jazyk: angličtina
Zdroj: Journal of clinical lipidology [J Clin Lipidol] 2019 Nov - Dec; Vol. 13 (6), pp. 997-1007.e8. Date of Electronic Publication: 2019 Sep 11.
DOI: 10.1016/j.jacl.2019.09.001
Abstrakt: Background: Elevated remnant lipoprotein cholesterol (RLP-C) levels increase cardiovascular disease risk. However, RLP-C measurement methods are not standardized, leading to variations across studies.
Objective: To evaluate the effect of ezetimibe (Eze) + statins vs statin monotherapy on RLP-C using immunoseparation (IM), vertical auto profile (VAP) ultracentrifugation, and calculated RLP-C measurement methods.
Methods: This post hoc analysis evaluated data pooled from 3 first-line (all-statin [simvastatin 10/20/40/80 mg] vs Eze + statin [Eze 10 mg + simvastatin]) and 2 second-line (statin [atorvastatin uptitrated to 40/80 mg] vs statin + Eze [atorvastatin 20/40 mg + Eze 10 mg]) studies. Similarity of RLP-C methods was evaluated using Pearson correlation coefficients and Bland-Altman plots. RLP-C changes and percent changes from baseline were measured by all 3 methods in first-line and VAP and calculated methods in second-line studies.
Results: Correlations between methods were generally moderate to strong for RLP-C levels, changes, and percent changes across treatment groups (r = 0.29-0.79) but with little evidence of agreement by Bland-Altman plots. Baseline RLP-C levels for Eze + statin vs all-statin groups were lower by IM (14.0 vs 14.0) compared with VAP (36.9 vs 35.9) and calculated (32.8 vs 33.3) methods. RLP-C changes (mg/dL) and percent changes from baseline were significantly greater (P < .01) with Eze + statins vs statins by VAP, calculated, and IM methods (between-treatment differences: -5.0 and -12.0, -2.0 and -5.4, and -1.5 and -12.1, respectively) in first-line, and VAP and calculated methods (between-treatment differences: -5.0 and -19.9 and -2.0 and -7.3) in second-line studies.
Conclusion: Although the 3 methods showed little agreement, each supported Eze + statins for achieving greater RLP-C reductions vs statin monotherapy; variability of results reinforces urgent need to standardize RLP-C measurements.
(Copyright © 2019. Published by Elsevier Inc.)
Databáze: MEDLINE
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