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4S TRIAL |
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|---|---|
| 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 Cardiomegaly 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 |