Problem Coronary heart disease
Format Double-blinded multi-center RCT
Treatment Simvastatin
Control Placebo
Population 4,444 patients
Inclusion criteria Inclusion Criteria: Prior MI and/or angina pectoris
Total cholesterol 212-309 mg/dL (5.5-8.0 mmol/L)
TAG 227 mg/dL (2.5 mmol/L) or less
Exclusion criteria Premenopausal women of childbearing potential
Secondary hypercholesterolaemia
Unstable or Prinzmetal angina, tendon xanthomata
Planned coronary artery surgery or angioplasty
Myocardial infarction during the preceding six months
Antiarrhythmic therapy
Congestive heart failure requiring treatment
Persistent atrial fibrillation
Haemodynamically important valvular heart disease
History of completed stroke
Impaired hepatic function
Partial ileal bypass
History of drug or alcohol abuse
Poor mental function
Other serious disease
Current treatment with another investigational drug
Hypersensitivity to 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.
Follow-up Median 5.4 years
Primary endpoint All-cause mortality
Secondary endpoint(s) Major adverse coronary events
PTCA/CABG procedures
Survival without atherosclerotic event (event-free survival)
Any coronary event
Non-MI acute CHD events
Details .
Brief summary: SImva reduces death,MI,revasc in angina/MI patients
PAPER: Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S)
Date 19 Nov 1994
Journal Lancet. 1994 Nov 19;344(8934):1383-9.
Information Reduced
-All-cause mortality
-Fatal coronary events
-Myocardial revascularisation procedures
PAPER: Baseline serum cholesterol and treatment effect in the Scandinavian Simvastatin Survival Study (4S)
Date 20 May 1995
Journal Lancet. 1995 May 20;345(8960):1274-5.
Information Similar reductions in risk for all quartiles of baseline HDL/LDL
PAPER: Safety and tolerability of cholesterol lowering with simvastatin during 5 years in the Scandinavian Simvastatin Survival Study.
Date 14 Oct 1996
Journal Arch Intern Med. 1996 Oct 14;156(18):2085-92.
Information Very low risk of myopathy
No significant risk of hepatitis