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Follow-up study of patients randomized in the scandinavian simvastatin survival study (4S) of cholesterol lowering

The Scandinavian Simvastatin Survival Study (4S) and other randomized clinical trials have demonstrated that cholesterol-lowering treatment with statins improves prognosis in patients with coronary atherosclerosis compared with placebo. The effect of therapy with statins beyond the typical 5 to 6 ye... Full description

Journal Title: The American journal of cardiology 2000, Vol.86 (3), p.257-262
Main Author: Pedersen, Terje R
Other Authors: Wilhelmsen, Lars , Færgeman, Ole , Strandberg, Timo E , Thorgeirsson, Gudmundur , Troedsson, Linda , Kristianson, Johan , Berg, Kåre , Cook, Thomas J , Haghfelt, Torben , Kjekshus, John , Miettinen, Tatu , Olsson, Anders G , Pyörälä, Kalevi , Wedel, Hans
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: New York, NY: Elsevier Inc
ID: ISSN: 0002-9149
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title: Follow-up study of patients randomized in the scandinavian simvastatin survival study (4S) of cholesterol lowering
format: Article
creator:
  • Pedersen, Terje R
  • Wilhelmsen, Lars
  • Færgeman, Ole
  • Strandberg, Timo E
  • Thorgeirsson, Gudmundur
  • Troedsson, Linda
  • Kristianson, Johan
  • Berg, Kåre
  • Cook, Thomas J
  • Haghfelt, Torben
  • Kjekshus, John
  • Miettinen, Tatu
  • Olsson, Anders G
  • Pyörälä, Kalevi
  • Wedel, Hans
subjects:
  • Adult
  • Aged
  • Anticholesteremic Agents - adverse effects
  • Anticholesteremic Agents - therapeutic use
  • Biological and medical sciences
  • Cardiology
  • Cardiovascular disease
  • Cause of Death
  • Coronary Artery Disease - blood
  • Coronary Artery Disease - drug therapy
  • Coronary Artery Disease - mortality
  • Double-Blind Method
  • Drug therapy
  • Female
  • Follow-Up Studies
  • General and cellular metabolism. Vitamins
  • Humans
  • Hypercholesterolemia - blood
  • Hypercholesterolemia - drug therapy
  • Hypercholesterolemia - mortality
  • Male
  • Medical and Health Sciences
  • Medical sciences
  • MEDICIN
  • Medicin och hälsovetenskap
  • MEDICINE
  • Middle Aged
  • Mortality
  • Neoplasms - chemically induced
  • Pharmacology. Drug treatments
  • Risk
  • Scandinavian and Nordic Countries
  • Simvastatin - adverse effects
  • Simvastatin - therapeutic use
  • Survival Rate
ispartof: The American journal of cardiology, 2000, Vol.86 (3), p.257-262
description: The Scandinavian Simvastatin Survival Study (4S) and other randomized clinical trials have demonstrated that cholesterol-lowering treatment with statins improves prognosis in patients with coronary atherosclerosis compared with placebo. The effect of therapy with statins beyond the typical 5 to 6 years’ duration of the trials, in particular regarding the risk of cancer, has not been investigated. This study examines the long-term effects of simvastatin for up to 8 years on cause-specific mortality in patients with coronary heart disease (CHD). We performed an observational, government registry-based study of mortality in the groups originally randomized to simvastatin or placebo in the 4S over an additional 2-year follow-up period, so that the median total follow-up period was 7.4 years (range 6.9 to 8.3 in surviving patients). Randomization took place at outpatient clinics at 94 clinical centers in Denmark, Finland, Iceland, Norway, and Sweden from 1988 to 1989. Of 4,444 patients with CHD, 2,223 and 2,221 were randomized to treatment with placebo or simvastatin therapy, respectively. Patients received treatment with simvastatin, starting at 20 mg/day, with titration to 40 mg/day at 12 or 24 weeks if total cholesterol was >5.2 mmol/L (200 mg/dl), or placebo. After the double-blind period, most patients in both treatment groups received simvastatin as open-label prescription. Of the 1,967 patients originally treated with placebo and surviving the double-blind period, 97 (4.9%) died during the following 2 years. In the group randomized to simvastatin the corresponding number was 74 of the 2,039 survivors (3.6%). Adding these deaths to those occurring during the original trial, the total was 353 (15.9%) and 256 (11.5%) deaths in the groups originally randomized to placebo and simvastatin, respectively. The relative risk was 0.70 (95% confidence interval 0.60 to 0.82, p = 0.00002). The total number of cancer deaths was 68 (3.1%) in the placebo group and 52 (2.3%) in the simvastatin group (relative risk 0.73, 95% confidence interval 0.51 to 0.05, p = 0.087), and the numbers of noncardiovascular and other deaths were similar in both groups. We therefore conclude that treatment with simvastatin for up to 8 years in patients with CHD is safe and yields continued survival benefit.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0002-9149
fulltext: fulltext
issn:
  • 0002-9149
  • 1879-1913
  • 1879-1913
url: Link


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titleFollow-up study of patients randomized in the scandinavian simvastatin survival study (4S) of cholesterol lowering
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creatorPedersen, Terje R ; Wilhelmsen, Lars ; Færgeman, Ole ; Strandberg, Timo E ; Thorgeirsson, Gudmundur ; Troedsson, Linda ; Kristianson, Johan ; Berg, Kåre ; Cook, Thomas J ; Haghfelt, Torben ; Kjekshus, John ; Miettinen, Tatu ; Olsson, Anders G ; Pyörälä, Kalevi ; Wedel, Hans
creatorcontribPedersen, Terje R ; Wilhelmsen, Lars ; Færgeman, Ole ; Strandberg, Timo E ; Thorgeirsson, Gudmundur ; Troedsson, Linda ; Kristianson, Johan ; Berg, Kåre ; Cook, Thomas J ; Haghfelt, Torben ; Kjekshus, John ; Miettinen, Tatu ; Olsson, Anders G ; Pyörälä, Kalevi ; Wedel, Hans ; on behalf of the Scandinavian Simvastatin Survival Study Group ;
descriptionThe Scandinavian Simvastatin Survival Study (4S) and other randomized clinical trials have demonstrated that cholesterol-lowering treatment with statins improves prognosis in patients with coronary atherosclerosis compared with placebo. The effect of therapy with statins beyond the typical 5 to 6 years’ duration of the trials, in particular regarding the risk of cancer, has not been investigated. This study examines the long-term effects of simvastatin for up to 8 years on cause-specific mortality in patients with coronary heart disease (CHD). We performed an observational, government registry-based study of mortality in the groups originally randomized to simvastatin or placebo in the 4S over an additional 2-year follow-up period, so that the median total follow-up period was 7.4 years (range 6.9 to 8.3 in surviving patients). Randomization took place at outpatient clinics at 94 clinical centers in Denmark, Finland, Iceland, Norway, and Sweden from 1988 to 1989. Of 4,444 patients with CHD, 2,223 and 2,221 were randomized to treatment with placebo or simvastatin therapy, respectively. Patients received treatment with simvastatin, starting at 20 mg/day, with titration to 40 mg/day at 12 or 24 weeks if total cholesterol was >5.2 mmol/L (200 mg/dl), or placebo. After the double-blind period, most patients in both treatment groups received simvastatin as open-label prescription. Of the 1,967 patients originally treated with placebo and surviving the double-blind period, 97 (4.9%) died during the following 2 years. In the group randomized to simvastatin the corresponding number was 74 of the 2,039 survivors (3.6%). Adding these deaths to those occurring during the original trial, the total was 353 (15.9%) and 256 (11.5%) deaths in the groups originally randomized to placebo and simvastatin, respectively. The relative risk was 0.70 (95% confidence interval 0.60 to 0.82, p = 0.00002). The total number of cancer deaths was 68 (3.1%) in the placebo group and 52 (2.3%) in the simvastatin group (relative risk 0.73, 95% confidence interval 0.51 to 0.05, p = 0.087), and the numbers of noncardiovascular and other deaths were similar in both groups. We therefore conclude that treatment with simvastatin for up to 8 years in patients with CHD is safe and yields continued survival benefit.
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0ISSN: 0002-9149
1ISSN: 1879-1913
2EISSN: 1879-1913
3DOI: 10.1016/S0002-9149(00)00910-3
4PMID: 10922429
5CODEN: AJCDAG
languageeng
publisherNew York, NY: Elsevier Inc
subjectAdult ; Aged ; Anticholesteremic Agents - adverse effects ; Anticholesteremic Agents - therapeutic use ; Biological and medical sciences ; Cardiology ; Cardiovascular disease ; Cause of Death ; Coronary Artery Disease - blood ; Coronary Artery Disease - drug therapy ; Coronary Artery Disease - mortality ; Double-Blind Method ; Drug therapy ; Female ; Follow-Up Studies ; General and cellular metabolism. Vitamins ; Humans ; Hypercholesterolemia - blood ; Hypercholesterolemia - drug therapy ; Hypercholesterolemia - mortality ; Male ; Medical and Health Sciences ; Medical sciences ; MEDICIN ; Medicin och hälsovetenskap ; MEDICINE ; Middle Aged ; Mortality ; Neoplasms - chemically induced ; Pharmacology. Drug treatments ; Risk ; Scandinavian and Nordic Countries ; Simvastatin - adverse effects ; Simvastatin - therapeutic use ; Survival Rate
ispartofThe American journal of cardiology, 2000, Vol.86 (3), p.257-262
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0Pedersen, Terje R
1Wilhelmsen, Lars
2Færgeman, Ole
3Strandberg, Timo E
4Thorgeirsson, Gudmundur
5Troedsson, Linda
6Kristianson, Johan
7Berg, Kåre
8Cook, Thomas J
9Haghfelt, Torben
10Kjekshus, John
11Miettinen, Tatu
12Olsson, Anders G
13Pyörälä, Kalevi
14Wedel, Hans
15on behalf of the Scandinavian Simvastatin Survival Study Group
title
0Follow-up study of patients randomized in the scandinavian simvastatin survival study (4S) of cholesterol lowering
1The American journal of cardiology
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descriptionThe Scandinavian Simvastatin Survival Study (4S) and other randomized clinical trials have demonstrated that cholesterol-lowering treatment with statins improves prognosis in patients with coronary atherosclerosis compared with placebo. The effect of therapy with statins beyond the typical 5 to 6 years’ duration of the trials, in particular regarding the risk of cancer, has not been investigated. This study examines the long-term effects of simvastatin for up to 8 years on cause-specific mortality in patients with coronary heart disease (CHD). We performed an observational, government registry-based study of mortality in the groups originally randomized to simvastatin or placebo in the 4S over an additional 2-year follow-up period, so that the median total follow-up period was 7.4 years (range 6.9 to 8.3 in surviving patients). Randomization took place at outpatient clinics at 94 clinical centers in Denmark, Finland, Iceland, Norway, and Sweden from 1988 to 1989. Of 4,444 patients with CHD, 2,223 and 2,221 were randomized to treatment with placebo or simvastatin therapy, respectively. Patients received treatment with simvastatin, starting at 20 mg/day, with titration to 40 mg/day at 12 or 24 weeks if total cholesterol was >5.2 mmol/L (200 mg/dl), or placebo. After the double-blind period, most patients in both treatment groups received simvastatin as open-label prescription. Of the 1,967 patients originally treated with placebo and surviving the double-blind period, 97 (4.9%) died during the following 2 years. In the group randomized to simvastatin the corresponding number was 74 of the 2,039 survivors (3.6%). Adding these deaths to those occurring during the original trial, the total was 353 (15.9%) and 256 (11.5%) deaths in the groups originally randomized to placebo and simvastatin, respectively. The relative risk was 0.70 (95% confidence interval 0.60 to 0.82, p = 0.00002). The total number of cancer deaths was 68 (3.1%) in the placebo group and 52 (2.3%) in the simvastatin group (relative risk 0.73, 95% confidence interval 0.51 to 0.05, p = 0.087), and the numbers of noncardiovascular and other deaths were similar in both groups. We therefore conclude that treatment with simvastatin for up to 8 years in patients with CHD is safe and yields continued survival benefit.
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titleFollow-up study of patients randomized in the scandinavian simvastatin survival study (4S) of cholesterol lowering
authorPedersen, Terje R ; Wilhelmsen, Lars ; Færgeman, Ole ; Strandberg, Timo E ; Thorgeirsson, Gudmundur ; Troedsson, Linda ; Kristianson, Johan ; Berg, Kåre ; Cook, Thomas J ; Haghfelt, Torben ; Kjekshus, John ; Miettinen, Tatu ; Olsson, Anders G ; Pyörälä, Kalevi ; Wedel, Hans
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2Anticholesteremic Agents - adverse effects
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5Cardiology
6Cardiovascular disease
7Cause of Death
8Coronary Artery Disease - blood
9Coronary Artery Disease - drug therapy
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13Female
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34Survival Rate
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7Berg, Kåre
8Cook, Thomas J
9Haghfelt, Torben
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abstractThe Scandinavian Simvastatin Survival Study (4S) and other randomized clinical trials have demonstrated that cholesterol-lowering treatment with statins improves prognosis in patients with coronary atherosclerosis compared with placebo. The effect of therapy with statins beyond the typical 5 to 6 years’ duration of the trials, in particular regarding the risk of cancer, has not been investigated. This study examines the long-term effects of simvastatin for up to 8 years on cause-specific mortality in patients with coronary heart disease (CHD). We performed an observational, government registry-based study of mortality in the groups originally randomized to simvastatin or placebo in the 4S over an additional 2-year follow-up period, so that the median total follow-up period was 7.4 years (range 6.9 to 8.3 in surviving patients). Randomization took place at outpatient clinics at 94 clinical centers in Denmark, Finland, Iceland, Norway, and Sweden from 1988 to 1989. Of 4,444 patients with CHD, 2,223 and 2,221 were randomized to treatment with placebo or simvastatin therapy, respectively. Patients received treatment with simvastatin, starting at 20 mg/day, with titration to 40 mg/day at 12 or 24 weeks if total cholesterol was >5.2 mmol/L (200 mg/dl), or placebo. After the double-blind period, most patients in both treatment groups received simvastatin as open-label prescription. Of the 1,967 patients originally treated with placebo and surviving the double-blind period, 97 (4.9%) died during the following 2 years. In the group randomized to simvastatin the corresponding number was 74 of the 2,039 survivors (3.6%). Adding these deaths to those occurring during the original trial, the total was 353 (15.9%) and 256 (11.5%) deaths in the groups originally randomized to placebo and simvastatin, respectively. The relative risk was 0.70 (95% confidence interval 0.60 to 0.82, p = 0.00002). The total number of cancer deaths was 68 (3.1%) in the placebo group and 52 (2.3%) in the simvastatin group (relative risk 0.73, 95% confidence interval 0.51 to 0.05, p = 0.087), and the numbers of noncardiovascular and other deaths were similar in both groups. We therefore conclude that treatment with simvastatin for up to 8 years in patients with CHD is safe and yields continued survival benefit.
copNew York, NY
pubElsevier Inc
pmid10922429
doi10.1016/S0002-9149(00)00910-3