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Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial
NYU Langone Med Ctr, NY USA; Brigham and Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA.
Brigham and Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA; Brigham and Womens Hosp, MA 02115 USA.
Oslo Univ Hosp, Norway.
Brigham and Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA; Brigham and Womens Hosp, MA 02115 USA.
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2019 (English)In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 73, no 23, p. 2961-2970Article in journal (Refereed) Published
Abstract [en]

BACK GROUND Data on PCSK9 inhibition in chronic kidney disease (CKD) is limited. OBJECTIVES The purpose of this study was to compare outcomes with evolocumab and placebo according to kidney function. METHODS The FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial randomized individuals with clinically evident atherosclerosis and low-density lipoprotein cholesterol (LDL-C) amp;gt;= 70 mg/dl or non-high-density lipoprotein cholesterol amp;gt;= 100 mg/dl to evolocumab or placebo. The primary endpoint (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization), key secondary endpoint (cardiovascular death, myocardial infarction, or stroke), and safety were analyzed according to chronic kidney disease (CKD) stage estimated from CKD-epidemiology estimated glomerular filtration rate. RESULTS There were 8,077 patients with preserved kidney function, 15,034 with stage 2 CKD, and 4,443 with amp;gt;= stage 3 CKD. LDL-C reduction with evolocumab compared with placebo at 48 weeks was similar across CKD groups at 59%, 59%, and 58%, respectively. Relative risk reduction for the primary endpoint was similar for preserved function (hazard ratio [HR]: 0.82; 95% CI: 0.71 to 0.94), stage 2 (HR: 0.85; 95% CI: 0.77 to 0.94), and stage amp;gt;= 3 CKD (HR: 0.89; 95% CI: 0.76 to 1.05); p(int) = 0.77. Relative risk reduction for the secondary endpoint was similar across CKD stages (p(int) = 0.75)-preserved function (HR: 0.75; 95% CI: 0.62 to 0.90), stage 2 (HR: 0.82; 95% CI: 0.72 to 0.93), stage amp;gt;= 3 (HR: 0.79; 95% CI: 0.65 to 0.95). Absolute RRs at 30 months for the secondary endpoint were -2.5% (95% CI: -0.4% to -4.7%) for stage amp;gt;= 3 CKD compared with -1.7% (95% CI: 0.5% to -2.8%) with preserved kidney function. Adverse events, including estimated glomerular filtration rate decline, were infrequent and similar regardless of CKD stage. CONCLUSIONS LDL-C lowering and relative clinical efficacy and safety of evolocumab versus placebo were consistent across CKD groups. Absolute reduction in the composite of cardiovascular death, MI, or stroke with evolocumab was numerically greater with more advanced CKD. (C) 2019 by the American College of Cardiology Foundation.

Place, publisher, year, edition, pages
ELSEVIER SCIENCE INC , 2019. Vol. 73, no 23, p. 2961-2970
Keywords [en]
atherosclerosis; cardiovascular disease; cardiovascular risk; chronic kidney disease; lipids; PCSK9
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:liu:diva-158544DOI: 10.1016/j.jacc.2019.03.513ISI: 000470830000007PubMedID: 31196453OAI: oai:DiVA.org:liu-158544DiVA, id: diva2:1334915
Note

Funding Agencies|Amgen, Inc.; Janssen Pharmaceuticals; Abbott Laboratories; Clinical Diagnostics; Daiichi-Sankyo; Gilead; GlaxoSmithKline; Roche Diagnostics; Takeda; Novartis; Poxel; Eisai; Genzyme; Pfizer; Amgen; AstraZeneca; National Institute for Health

Available from: 2019-07-03 Created: 2019-07-03 Last updated: 2019-07-03

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