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Efficacy and Safety...
Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial
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- Charytan, David M. (author)
- NYU Langone Med Ctr, NY USA; Brigham and Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA
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- Sabatine, Marc S. (author)
- Brigham and Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA; Brigham and Womens Hosp, MA 02115 USA
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- Pedersen, Terje R. (author)
- Oslo Univ Hosp, Norway
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- Im, KyungAh (author)
- Brigham and Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA; Brigham and Womens Hosp, MA 02115 USA
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- Park, Jeong-Gun (author)
- Brigham and Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA; Brigham and Womens Hosp, MA 02115 USA
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- Pineda, Armando Lira (author)
- Amgen Inc, CA USA
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- Wasserman, Scott M. (author)
- Amgen Inc, CA USA
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- Deedwania, Prakash (author)
- Vet Affairs Cent Calif Healthcare Syst, CA USA
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- Olsson, Anders G. (author)
- Univ Calif San Francisco, CA USA
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- Sever, Peter S. (author)
- Linköpings universitet,Institutionen för hälsa, medicin och vård,Medicinska fakulteten
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- Keech, Anthony C. (author)
- Imperial Coll London, England; Univ Sydney, Australia
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- Giugliano, Robert P. (author)
- Brigham and Womens Hosp, MA 02115 USA; Harvard Med Sch, MA 02115 USA; Brigham and Womens Hosp, MA 02115 USA
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(creator_code:org_t)
- ELSEVIER SCIENCE INC, 2019
- 2019
- English.
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In: Journal of the American College of Cardiology. - : ELSEVIER SCIENCE INC. - 0735-1097 .- 1558-3597. ; 73:23, s. 2961-2970
- Related links:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- atherosclerosis; cardiovascular disease; cardiovascular risk; chronic kidney disease; lipids; PCSK9
Publication and Content Type
- ref (subject category)
- art (subject category)
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Charytan, David ...
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Sabatine, Marc S ...
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Pedersen, Terje ...
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Im, KyungAh
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Park, Jeong-Gun
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Pineda, Armando ...
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Wasserman, Scott ...
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Deedwania, Praka ...
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Olsson, Anders G ...
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Sever, Peter S.
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Keech, Anthony C ...
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Giugliano, Rober ...
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- MEDICAL AND HEALTH SCIENCES
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Linköping University