Mortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S)

2.50
Hdl Handle:
http://hdl.handle.net/2336/14666
Title:
Mortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S)
Authors:
Strandberg, Timo E; Pyörälä, Kalevi; Cook, Thomas J; Wilhelmsen, Lars; Faergeman, Ole; Thorgeirsson, Gudmundur; Pedersen, Terje R; Kjekshus, John
Citation:
Lancet 2004, 364(9436):771-7
Issue Date:
28-Aug-2004
Abstract:
BACKGROUND: The effects of cholesterol-lowering treatment with statins on mortality and risk of cancer beyond the usual 5-6-year trial periods are unknown. We extended post-trial follow-up of participants in the Scandinavian Simvastatin Survival Study (4S) to investigate cause-specific mortality and incidence of cancer 5 years after closure of the trial. METHODS: 4S was a randomised double-blind trial of simvastatin or placebo in patients with coronary heart disease, serum total cholesterol 5.5-8.0 mmol/L, and serum triglycerides 2.5 mmol/L or lower. The double-blind period lasted for a median of 5.4 years (range for survivors 4.9-6.3) and ended in 1994. After the trial, most patients in both groups received open-label lipid-lowering treatment. National registers were used to assess mortality and causes of death and cancer incidence in the original treatment groups for a median total follow-up time of 10.4 years (range for survivors 9.9-11.3). Analysis was by intention to treat. FINDINGS: 414 patients originally allocated simvastatin and 468 assigned placebo died during the 10.4-year follow-up (relative risk 0.85 [95% CI 0.74-0.97], p=0.02), a difference largely attributable to lower coronary mortality in the simvastatin group (238 vs 300 deaths; 0.76 [0.64-0.90], p=0.0018). 85 cancer deaths arose in the simvastatin group versus 100 in the placebo group (0.81 [0.60-1.08], p=0.14), and 227 incident cancers were reported in the simvastin group versus 248 in the placebo group (0.88 [0.73-1.05], p=0.15). Incidence of any specific type of cancer did not rise in the simvastatin group. INTERPRETATION: Simvastatin treatment for 5 years in a placebo-controlled trial, followed by open-label statin therapy, was associated with survival benefit over 10 years of follow-up compared with open-label statin therapy for the past 5 years only. No difference was noted in mortality from and incidence of cancer between the original simvastatin group and placebo group.
Description:
To access publisher full text version of this article. Please click on the hyperlink in Additional Links field
Additional Links:
http://www.sciencedirect.com/science/article/B6T1B-4D62DWF-13/2/ba324a41bd213cb30286ebcba69fc233

Full metadata record

DC FieldValue Language
dc.contributor.authorStrandberg, Timo E-
dc.contributor.authorPyörälä, Kalevi-
dc.contributor.authorCook, Thomas J-
dc.contributor.authorWilhelmsen, Lars-
dc.contributor.authorFaergeman, Ole-
dc.contributor.authorThorgeirsson, Gudmundur-
dc.contributor.authorPedersen, Terje R-
dc.contributor.authorKjekshus, John-
dc.date.accessioned2007-11-22T09:29:01Z-
dc.date.available2007-11-22T09:29:01Z-
dc.date.issued2004-08-28-
dc.date.submitted2007-11-22-
dc.identifier.citationLancet 2004, 364(9436):771-7en
dc.identifier.issn0140-6736-
dc.identifier.pmid15337403-
dc.identifier.doi10.1016/S0140-6736(04)16936-5-
dc.identifier.urihttp://hdl.handle.net/2336/14666-
dc.descriptionTo access publisher full text version of this article. Please click on the hyperlink in Additional Links fielden
dc.description.abstractBACKGROUND: The effects of cholesterol-lowering treatment with statins on mortality and risk of cancer beyond the usual 5-6-year trial periods are unknown. We extended post-trial follow-up of participants in the Scandinavian Simvastatin Survival Study (4S) to investigate cause-specific mortality and incidence of cancer 5 years after closure of the trial. METHODS: 4S was a randomised double-blind trial of simvastatin or placebo in patients with coronary heart disease, serum total cholesterol 5.5-8.0 mmol/L, and serum triglycerides 2.5 mmol/L or lower. The double-blind period lasted for a median of 5.4 years (range for survivors 4.9-6.3) and ended in 1994. After the trial, most patients in both groups received open-label lipid-lowering treatment. National registers were used to assess mortality and causes of death and cancer incidence in the original treatment groups for a median total follow-up time of 10.4 years (range for survivors 9.9-11.3). Analysis was by intention to treat. FINDINGS: 414 patients originally allocated simvastatin and 468 assigned placebo died during the 10.4-year follow-up (relative risk 0.85 [95% CI 0.74-0.97], p=0.02), a difference largely attributable to lower coronary mortality in the simvastatin group (238 vs 300 deaths; 0.76 [0.64-0.90], p=0.0018). 85 cancer deaths arose in the simvastatin group versus 100 in the placebo group (0.81 [0.60-1.08], p=0.14), and 227 incident cancers were reported in the simvastin group versus 248 in the placebo group (0.88 [0.73-1.05], p=0.15). Incidence of any specific type of cancer did not rise in the simvastatin group. INTERPRETATION: Simvastatin treatment for 5 years in a placebo-controlled trial, followed by open-label statin therapy, was associated with survival benefit over 10 years of follow-up compared with open-label statin therapy for the past 5 years only. No difference was noted in mortality from and incidence of cancer between the original simvastatin group and placebo group.en
dc.language.isoenen
dc.publisherLancet Publishing Groupen
dc.relation.urlhttp://www.sciencedirect.com/science/article/B6T1B-4D62DWF-13/2/ba324a41bd213cb30286ebcba69fc233en
dc.subject.meshAnticholesteremic Agentsen
dc.subject.meshCoronary Diseaseen
dc.subject.meshHydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects/*therapeutic useen
dc.subject.meshNeoplasmsen
dc.subject.meshScandinavia/epidemiologyen
dc.subject.meshSimvastatinen
dc.subject.meshSurvival Rateen
dc.titleMortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S)en
dc.typeArticleen
dc.identifier.eissn1474-547X-
dc.identifier.journalLanceten
dc.format.digYES-

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