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Reducing the risk of coronary events : evidence from the Scandinavian Simvastatin Survival Study ( 4S ) . The Scandinavian Simvastatin Survival Study ( 4S ) was designed to evaluate the effects of cholesterol reduction with simvastatin on mortality and morbidity in patients with coronary artery disease ( CAD ) . A total of 4,444 patients with angina pectoris or previous myocardial infarction and serum cholesterol levels of 213-310 mg/dl ( 5.5-8.0 mmol/liter ) while treated with a lipid-lowering diet were randomly assigned to double-blind treatment with simvastatin or placebo . Over the 5.4 years of median follow-up , simvastatin produced changes in total cholesterol , low density lipoprotein ( LDL ) cholesterol , and high density lipoprotein ( HDL ) cholesterol of -25 % , -35 % , and +8 % , respectively , with minimal adverse effects . A total of 256 patients ( 12 % ) in the placebo group died compared with 182 ( 8 % ) in the simvastatin group , a risk reduction of 30 % ( p = 0.0003 ) attributable to a 42 % reduction in the risk of coronary death . Noncardiovascular causes accounted for 49 and 46 deaths in the placebo and simvastatin groups , respectively . Major coronary events were experienced by 622 patients ( 28 % ) in the placebo group and 431 patients ( 19 % ) in the simvastatin group , corresponding to a risk reduction of 34 % ( p < 0.00001 ) . This risk was also significantly reduced in subgroups consisting of women and patients of both sexes aged > or = 60 years . Other benefits of treatment included a 37 % reduction ( p < 0.00001 ) in the risk of undergoing myocardial revascularization procedures . Simvastatin was beneficial regardless of whether patients had a history of myocardial infarction or whether they were smokers or had hypertension . ( ABSTRACT TRUNCATED AT 250 WORDS )
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Intervention_Pharmacological
simvastatin
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Intervention_Physical
lipid-lowering diet
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Intervention_Pharmacological
simvastatin
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Intervention_Control
placebo
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Outcome_Mortality
mortality
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Outcome_Other
morbidity
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Outcome_Physical
total cholesterol , low density lipoprotein ( LDL ) cholesterol
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Outcome_Physical
high density lipoprotein ( HDL ) cholesterol
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Outcome_Adverse-effects
adverse effects .
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Outcome_Mortality
died
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Outcome_Adverse-effects
Noncardiovascular causes
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Outcome_Mortality
deaths
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Outcome_Physical
Major coronary events
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Outcome_Physical
risk reduction
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Outcome_Physical
risk of undergoing myocardial revascularization procedures .
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Participant_Condition
coronary artery disease ( CAD ) .
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Participant_Sample-size
4,444
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Participant_Condition
angina pectoris
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Participant_Condition
myocardial infarction
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Participant_Condition
serum cholesterol levels
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Participant_Sample-size
256
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Participant_Sex
women
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Participant_Sex
both sexes