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LDL-Cholesterol Lowering for the Primary Prevention of Cardiovascular Disease Among Men with Primary Elevations of LDL-Cholesterol Levels of 190 mg/dL or Above: Analyses from the WOSCOPS 5-year Randomised Trial and 20-year Observational Follow-Up.

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Title: LDL-Cholesterol Lowering for the Primary Prevention of Cardiovascular Disease Among Men with Primary Elevations of LDL-Cholesterol Levels of 190 mg/dL or Above: Analyses from the WOSCOPS 5-year Randomised Trial and 20-year Observational Follow-Up.
Authors: Vallejo-Vaz, AJ
Robertson, M
Catapano, AL
Watts, GF
Kastelein, JJ
Packard, CJ
Ford, I
Ray, KK
Item Type: Journal Article
Abstract: Background -Patients with primary elevations of LDL-C ≥190 mg/dL are at a higher risk of atherosclerotic cardiovascular disease as a result of long-term exposure to markedly elevated LDL-C levels. Therefore, initiation of statin therapy is recommended for these individuals. However, there is a lack of randomised trial evidence supporting these recommendations in primary prevention. In the present analysis we provide hitherto unpublished data on the cardiovascular effects of LDL-C lowering among a primary prevention population with LDL-C ≥190 mg/dL. Methods -We aimed to assess the benefits of LDL-C lowering on cardiovascular outcomes among individuals with primary elevations of LDL-C ≥190 mg/dL without pre-exiting vascular disease at baseline. We carried out post-hoc analyses from the West Of Scotland Coronary Prevention Study (WOSCOPS) randomised, placebo-controlled trial, and observational post-trial long-term follow-up, after excluding individuals with evidence of vascular disease at baseline. WOSCOPS enrolled 6595 men aged 45-64 years, who were randomised to pravastatin 40 mg/d or placebo. In the present analyses, 5529 participants without evidence of vascular disease were included, stratified by LDL-C levels into those with LDL-C <190 mg/dL (n=2969; mean LDL-C 178±6 mg/dL) and those with LDL-C ±190 mg/dL (n=2560; mean LDL-C 206±12 mg/dL).The effect of pravastatin versus placebo on coronary heart disease (CHD) and major adverse cardiovascular events (MACE) were assessed over the 4.9-year randomised-controlled trial phase and on mortality outcomes over a total of 20-years of follow-up. Results -Among 5529 individuals without vascular disease, pravastatin reduced the risk of CHD by 27% (p=0.002) and MACE by 25% (p=0.004) consistently among those with and without LDL-C ±190 mg/dL (p-interaction >0.9). Among individuals with LDL-C ±190 mg/dL, pravastatin reduced the risk of CHD by 27% (p=0.033) and MACE by 25% (p=0.037) during the initial trial phase and the risk of CHD death, cardiovascular death and all-cause mortality by 28% (p=0.020), 25% (p=0.009) and 18% (p=0.004), respectively, over a total of 20-years of follow-up. Conclusions -The present analyses provide robust novel evidence for the short and long-term benefits of lowering LDL-C for the primary prevention of cardiovascular disease among individuals with primary elevations of LDL-C ±190 mg/dL.
Issue Date: 14-Nov-2017
Date of Acceptance: 21-Jul-2017
URI: http://hdl.handle.net/10044/1/50367
DOI: 10.1161/CIRCULATIONAHA.117.027966
ISSN: 0009-7322
Publisher: American Heart Association
Start Page: 1878
End Page: 1891
Journal / Book Title: Circulation
Volume: 136
Issue: 20
Copyright Statement: Copyright © 2017, American Heart Association, Inc.
Sponsor/Funder: Sanofi Aventis
Funder's Grant Number: UKME-15-00020
Keywords: Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Peripheral Vascular Disease
Cardiovascular System & Cardiology
cardiovascular diseases
lipids
lipoproteins
primary prevention
statin therapy
FAMILIAL HYPERCHOLESTEROLEMIA
LDL CHOLESTEROL
CLINICAL EVENTS
STATIN THERAPY
ALL-CAUSE
SAFETY
EFFICACY
RISK
METAANALYSIS
PRAVASTATIN
cardiovascular diseases
lipids
lipoproteins
primary prevention
statin therapy
Anticholesteremic Agents
Cardiovascular Diseases
Cholesterol, LDL
Coronary Disease
Follow-Up Studies
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypercholesterolemia
Male
Middle Aged
Pravastatin
Primary Prevention
Scotland
Humans
Cardiovascular Diseases
Coronary Disease
Hypercholesterolemia
Pravastatin
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Follow-Up Studies
Primary Prevention
Middle Aged
Scotland
Male
Cholesterol, LDL
cardiovascular disease prevention
lipids and lipoproteins
primary prevention
statin therapy
Cardiovascular System & Hematology
1102 Cardiorespiratory Medicine and Haematology
1103 Clinical Sciences
1117 Public Health and Health Services
Publication Status: Published
Online Publication Date: 2017-09-06
Appears in Collections:Faculty of Medicine
School of Public Health