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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12 064 survivors of myocardial infarction: A double-blind randomised trial
The Lancet, Volume 376, No. 9753, Year 2010
Notification
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Description
Lowering of LDL cholesterol reduces major vascular events, but whether more intensive therapy safely produces extra benefits is uncertain. We aimed to establish efficacy and safety of more intensive statin treatment in patients at high cardiovascular risk. We undertook a double-blind randomised trial in 12 064 men and women aged 18-80 years with a history of myocardial infarction. Participants were either currently on or had clear indication for statin therapy, and had a total cholesterol concentration of at least 3·5 mmol/L if already on a statin or 4·5 mmol/L if not. Randomisation to either 80 mg or 20 mg simvastatin daily was done centrally using a minimisation algorithm. Participants were assessed at 2, 4, 8, and 12 months after randomisation and then every 6 months until final follow-up. The primary endpoint was major vascular events, defined as coronary death, myocardial infarction, stroke, or arterial revascularisation. Analysis was by intention to treat. This study is registered, number ISRCTN74348595. 6031 participants were allocated 80 mg simvastatin daily, and 6033 allocated 20 mg simvastatin daily. During a mean follow-up of 6·7 (SD 1·5) years, allocation to 80 mg simvastatin produced an average 0·35 (SE 0·01) mmol/L greater reduction in LDL cholesterol compared with allocation to 20 mg. Major vascular events occurred in 1477 (24·5) participants allocated 80 mg simvastatin versus 1553 (25·7) of those allocated 20 mg, corresponding to a 6 proportional reduction (risk ratio 0·94, 95 CI 0·88-1·01; p=0·10). There were no apparent differences in numbers of haemorrhagic strokes (24 [0·4] vs 25 [0·4]) or deaths attributed to vascular (565 [9·4] vs 572 [9·5]) or non-vascular (399 [6·6] vs 398 [6·6]) causes. Compared with two (0·03) cases of myopathy in patients taking 20 mg simvastatin daily, there were 53 (0·9) cases in the 80 mg group. The 6 (SE 3·5) reduction in major vascular events with a further 0·35 mmol/L reduction in LDL cholesterol in our trial is consistent with previous trials. Myopathy was increased with 80 mg simvastatin daily, but intensive lowering of LDL cholesterol can be achieved safely with other regimens. Merck; The Clinical Trial Service Unit also receives funding from the UK Medical Research Council and the British Heart Foundation. © 2010 Elsevier Ltd.
Authors & Co-Authors
Thompson, John R.
Unknown Affiliation
Andrews, Gavin A.
Unknown Affiliation
Castro, Kenneth G.
Unknown Affiliation
Burke, Andrew
Unknown Affiliation
Rose, Geofferey Alan
Unknown Affiliation
Kerr, Michael Patrick
Unknown Affiliation
Donnelly, Richard J.
Unknown Affiliation
Kooner, Jaspal Singh
Unknown Affiliation
Lloyd, Michael Shane
Unknown Affiliation
Johnston, James Cameron
Unknown Affiliation
Miller, David H.
Unknown Affiliation
Wierzbicki, Anthony S.
Unknown Affiliation
Parkin, Donald Maxwell
Unknown Affiliation
Knott, Kristopher D.
Unknown Affiliation
Green, Jane W.
Unknown Affiliation
Heron, Jon E.
Unknown Affiliation
Jones, Nev
Unknown Affiliation
Roberts, Megan C.
Unknown Affiliation
Barnes, Peter John
United Kingdom, Salford
Salford Royal Hospital
Pond, Constance Dimity
Unknown Affiliation
Bonner, Ashley Joel
Unknown Affiliation
Davies, E. A.
Unknown Affiliation
Horton, Sarah C.
Unknown Affiliation
Tomlinson, Laurie A.
Unknown Affiliation
Hawkins, Lesley
Unknown Affiliation
Brennan, Geraldine M.
Unknown Affiliation
Hunter, John A.
Unknown Affiliation
McNeilly, Allan S.
Unknown Affiliation
Farrer, Matthew J.
Unknown Affiliation
Williams, Lyn Keoki
Unknown Affiliation
Doig, Christopher James
Unknown Affiliation
Martin, Seth S.
Unknown Affiliation
Fox, Caroline S.
Unknown Affiliation
Dixon, Simon
Unknown Affiliation
Patel, Rita
Unknown Affiliation
Watkins, Hugh C.
Unknown Affiliation
Taylor, Andrew Mayall
Unknown Affiliation
Donaldson, Debra D.
Unknown Affiliation
Townend, Jonathan N.
Unknown Affiliation
Stuart, Robert K.
Unknown Affiliation
David W. Murray, David W.
United Kingdom, Burton Upon Trent
Queen's Hospital Burton
Smith, Andrew Malvern
Unknown Affiliation
Gilbert, Sarah C.
Unknown Affiliation
Stacey, Dawn
Unknown Affiliation
Campbell, Christina A.
Unknown Affiliation
McDonnell, Marie E.
Unknown Affiliation
West, Lori J.
Unknown Affiliation
Little, Susan J.
Unknown Affiliation
Barber, John C.K.
Unknown Affiliation
Thomas, Rebecca L.
Unknown Affiliation
Gould, Michael K.
Unknown Affiliation
Roberts, David Hesketh
United Kingdom, Blackpool
Blackpool Victoria Hospital
Davies, Christina
United Kingdom, Blackpool
Blackpool Victoria Hospital
Williamson, Martin S.
United Kingdom, Blackpool
Blackpool Victoria Hospital
Clements, Mark S.
Unknown Affiliation
Lindley, Richard Iain
United Kingdom, Edinburgh
Western General Hospital
Webb, David R.
United Kingdom, Edinburgh
Western General Hospital
Markie, David M.
United Kingdom, Edinburgh
Western General Hospital
Johnston, Atholl Edward Johnny
United Kingdom, Edinburgh
Western General Hospital
Hogan, Joseph W.
Unknown Affiliation
Price, Susanna
Unknown Affiliation
Bray, Christopher M.
United Kingdom, Oxford
Clinical Trial Service Unit and Epidemiological Studies Unit
Anderson, Craig S.
United Kingdom, Oxford
Clinical Trial Service Unit and Epidemiological Studies Unit
Cobb, Laura K.
United Kingdom, Oxford
Clinical Trial Service Unit and Epidemiological Studies Unit
Corbett, Mark A.
United Kingdom, Oxford
Clinical Trial Service Unit and Epidemiological Studies Unit
Harwood, Catherine Anne
United Kingdom, Oxford
Clinical Trial Service Unit and Epidemiological Studies Unit
Miller, J. Paul
United Kingdom, Oxford
Clinical Trial Service Unit and Epidemiological Studies Unit
Baigent, Colin
Unknown Affiliation
Bowman, Louise J.
Unknown Affiliation
Clarke, Robert Joseph
Unknown Affiliation
Collins, Rory
Unknown Affiliation
Dunachie, Susanna J.
Unknown Affiliation
Landray, Martin J.
Unknown Affiliation
Majoni, Sandawana William
Unknown Affiliation
Murray, Christopher J.L.
Unknown Affiliation
Rahimi, Kazem
Unknown Affiliation
Turnbull, Clare A.
Unknown Affiliation
Walter, Klaudia
Unknown Affiliation
Harding, Peter J.
Unknown Affiliation
Charles, Anthony G.
Unknown Affiliation
Hurt, Chris Nicholas
Unknown Affiliation
Peto, Richard R.
Unknown Affiliation
FitzGerald, J. Mark
Unknown Affiliation
Statistics
Citations: 440
Authors: 83
Affiliations: 15
Identifiers
Doi:
10.1016/S0140-6736(10)60310-8
ISSN:
01406736
Research Areas
Disability
Noncommunicable Diseases
Study Design
Cohort Study
Participants Gender
Male
Female