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

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 o... Full description

Journal Title: The Lancet (British edition) 2004, Vol.364 (9436), p.771-777
Main Author: Strandberg, Timo E
Other Authors: Pyörälä, Kalevi , Cook, Thomas J , Wilhelmsen, Lars , Faergeman, Ole , Thorgeirsson, Gudmundur , Pedersen, Terje R , Kjekshus, John
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: London: Elsevier Ltd
ID: ISSN: 0140-6736
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recordid: cdi_swepub_primary_oai_gup_ub_gu_se_80425
title: Mortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S)
format: Article
creator:
  • Strandberg, Timo E
  • Pyörälä, Kalevi
  • Cook, Thomas J
  • Wilhelmsen, Lars
  • Faergeman, Ole
  • Thorgeirsson, Gudmundur
  • Pedersen, Terje R
  • Kjekshus, John
subjects:
  • Adult
  • Aged
  • Analysis
  • Anticholesteremic Agents - therapeutic use
  • atorvastatin
  • average cholesterol levels
  • Biological and medical sciences
  • Cancer
  • cardiac outcomes
  • Cardiac patients
  • Cardiovascular disease
  • Cardiovascular diseases
  • Cholesterol
  • Clinical trials
  • Coronary artery disease
  • Coronary Disease - blood
  • Coronary Disease - mortality
  • Coronary Disease - prevention & control
  • Coronary heart disease
  • Dermatologi och venereologi
  • Dermatology and Venereal Diseases
  • Drugs
  • events
  • Fatalities
  • Finland
  • Follow-Up Studies
  • General aspects
  • Health aspects
  • Health risk assessment
  • Health risks
  • Heart diseases
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
  • Incidence
  • Male
  • Medical sciences
  • Middle Aged
  • Mortality
  • Motivation
  • Neoplasms - epidemiology
  • Neoplasms - mortality
  • Oncology, Experimental
  • Patients
  • placebo-controlled trial
  • pravastatin
  • prevention
  • Product safety
  • randomized controlled-trial
  • Risk factors
  • Scandinavian and Nordic Countries - epidemiology
  • Simvastatin
  • Simvastatin - adverse effects
  • Simvastatin - therapeutic use
  • Statins
  • Statistics
  • Survival
  • Survival Rate
  • Therapy
  • Triglycerides
  • United Kingdom
ispartof: The Lancet (British edition), 2004, Vol.364 (9436), p.771-777
description: 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. 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. 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. 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.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleMortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S)
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creatorStrandberg, Timo E ; Pyörälä, Kalevi ; Cook, Thomas J ; Wilhelmsen, Lars ; Faergeman, Ole ; Thorgeirsson, Gudmundur ; Pedersen, Terje R ; Kjekshus, John
creatorcontribStrandberg, Timo E ; Pyörälä, Kalevi ; Cook, Thomas J ; Wilhelmsen, Lars ; Faergeman, Ole ; Thorgeirsson, Gudmundur ; Pedersen, Terje R ; Kjekshus, John ; for the 4S Group ; 4S Group ; Hjärt-kärlinstitutionen ; Sahlgrenska akademin ; Göteborgs universitet ; Gothenburg University ; Cardiovascular Institute ; Sahlgrenska Academy
descriptionThe 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. 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. 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. 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.
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0ISSN: 0140-6736
1EISSN: 1474-547X
2DOI: 10.1016/S0140-6736(04)16936-5
3PMID: 15337403
4CODEN: LANCAO
languageeng
publisherLondon: Elsevier Ltd
subjectAdult ; Aged ; Analysis ; Anticholesteremic Agents - therapeutic use ; atorvastatin ; average cholesterol levels ; Biological and medical sciences ; Cancer ; cardiac outcomes ; Cardiac patients ; Cardiovascular disease ; Cardiovascular diseases ; Cholesterol ; Clinical trials ; Coronary artery disease ; Coronary Disease - blood ; Coronary Disease - mortality ; Coronary Disease - prevention & control ; Coronary heart disease ; Dermatologi och venereologi ; Dermatology and Venereal Diseases ; Drugs ; events ; Fatalities ; Finland ; Follow-Up Studies ; General aspects ; Health aspects ; Health risk assessment ; Health risks ; Heart diseases ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Incidence ; Male ; Medical sciences ; Middle Aged ; Mortality ; Motivation ; Neoplasms - epidemiology ; Neoplasms - mortality ; Oncology, Experimental ; Patients ; placebo-controlled trial ; pravastatin ; prevention ; Product safety ; randomized controlled-trial ; Risk factors ; Scandinavian and Nordic Countries - epidemiology ; Simvastatin ; Simvastatin - adverse effects ; Simvastatin - therapeutic use ; Statins ; Statistics ; Survival ; Survival Rate ; Therapy ; Triglycerides ; United Kingdom
ispartofThe Lancet (British edition), 2004, Vol.364 (9436), p.771-777
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0Strandberg, Timo E
1Pyörälä, Kalevi
2Cook, Thomas J
3Wilhelmsen, Lars
4Faergeman, Ole
5Thorgeirsson, Gudmundur
6Pedersen, Terje R
7Kjekshus, John
8for the 4S Group
94S Group
10Hjärt-kärlinstitutionen
11Sahlgrenska akademin
12Göteborgs universitet
13Gothenburg University
14Cardiovascular Institute
15Sahlgrenska Academy
title
0Mortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S)
1The Lancet (British edition)
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descriptionThe 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. 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. 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. 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.
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4atorvastatin
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6Biological and medical sciences
7Cancer
8cardiac outcomes
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12Cholesterol
13Clinical trials
14Coronary artery disease
15Coronary Disease - blood
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17Coronary Disease - prevention & control
18Coronary heart disease
19Dermatologi och venereologi
20Dermatology and Venereal Diseases
21Drugs
22events
23Fatalities
24Finland
25Follow-Up Studies
26General aspects
27Health aspects
28Health risk assessment
29Health risks
30Heart diseases
31Humans
32Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects
33Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
34Incidence
35Male
36Medical sciences
37Middle Aged
38Mortality
39Motivation
40Neoplasms - epidemiology
41Neoplasms - mortality
42Oncology, Experimental
43Patients
44placebo-controlled trial
45pravastatin
46prevention
47Product safety
48randomized controlled-trial
49Risk factors
50Scandinavian and Nordic Countries - epidemiology
51Simvastatin
52Simvastatin - adverse effects
53Simvastatin - therapeutic use
54Statins
55Statistics
56Survival
57Survival Rate
58Therapy
59Triglycerides
60United Kingdom
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titleMortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S)
authorStrandberg, Timo E ; Pyörälä, Kalevi ; Cook, Thomas J ; Wilhelmsen, Lars ; Faergeman, Ole ; Thorgeirsson, Gudmundur ; Pedersen, Terje R ; Kjekshus, John
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jtitleThe Lancet (British edition)
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abstractThe 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. 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. 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. 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.
copLondon
pubElsevier Ltd
pmid15337403
doi10.1016/S0140-6736(04)16936-5