Mortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S)
Cast your vote
You can rate an item by clicking the amount of stars they wish to award to this item.
When enough users have cast their vote on this item, the average rating will also be shown.
Your vote was cast
Thank you for your feedback
Thank you for your feedback
AuthorsStrandberg, Timo E
Cook, Thomas J
Pedersen, Terje R
MetadataShow full item record
CitationLancet 2004, 364(9436):771-7
ÚtdrátturBACKGROUND: 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.
Lu00FDsingTo access publisher full text version of this article. Please click on the hyperlink in Additional Links field
- Follow-up study of patients randomized in the Scandinavian simvastatin survival study (4S) of cholesterol lowering.
- Authors: Pedersen TR, Wilhelmsen L, Faergeman O, Strandberg TE, Thorgeirsson G, Troedsson L, Kristianson J, Berg K, Cook TJ, Haghfelt T, Kjekshus J, Miettinen T, Olsson AG, Pyörälä K, Wedel H
- Issue date: 2000 Aug 1
- Long-term effectiveness and safety of pravastatin in 9014 patients with coronary heart disease and average cholesterol concentrations: the LIPID trial follow-up.
- Authors: LIPID Study Group (Long-term Intervention with Pravastatin in Ischaemic Disease).
- Issue date: 2002 Apr 20
- Reducing the risk of coronary events: evidence from the Scandinavian Simvastatin Survival Study (4S).
- Authors: Kjekshus J, Pedersen TR
- Issue date: 1995 Sep 28
- MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial.
- Authors: Heart Protection Study Collaborative Group.
- Issue date: 2002 Jul 6
- Simvastatin for secondary prevention of all-cause mortality and major coronary events in patients with mild chronic renal insufficiency.
- Authors: Chonchol M, Cook T, Kjekshus J, Pedersen TR, Lindenfeld J
- Issue date: 2007 Mar