Scandinavian Simvastatin Survival Study
Encyclopedia
The Scandinavian Simvastatin Survival Study (also known under the abbreviation 4S) is a multicenter clinical trial
that was performed in 1990s in Scandinavia
.
The objective of the study was to assess effect of a cholesterol
-lowering drug called simvastatin
on mortality and morbidity in a group of 4444 patients with coronary heart disease
, aged between 35 and 70 years.
The patients exhibited moderate hypercholesterolemia
, between 5.5 and 8.0 mmol/l.
The trial showed that treatment of patients suffering from coronary heart disease with simvastatin had a lowering effect on mortality and morbidity.
2223 patients were assigned placebo
and 2221 were assigned simvastatin treatment for a mean period of 5.4 years. There was a 30% relative reduction in the risk of death with simvastatin treatment. The absolute coronary heart disease-mortality was reduced from 8.5% to 5.0%, making the number needed to treat
around 30 (thirty patients would need to be treated to prevent one death). Additionally there was no excess morbidity of non-cardiac deaths from causes like cancer
or suicide
, a concern that has occasionally arisen in respect to the statins.
The treatment of 100 patients for six years would prevent four deaths of the disease and seven non-fatal myocardial infarcts
.
The 4S study turned out to be a milestone in cardiology
and evidence-based medicine
- it was clearly proven that treatment with statins saved lives of patients with coronary heart disease. A host of other large multicenter clinical trials followed that paved way to widespread use of this class of pharmaceuticals.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
that was performed in 1990s in Scandinavia
Scandinavia
Scandinavia is a cultural, historical and ethno-linguistic region in northern Europe that includes the three kingdoms of Denmark, Norway and Sweden, characterized by their common ethno-cultural heritage and language. Modern Norway and Sweden proper are situated on the Scandinavian Peninsula,...
.
The objective of the study was to assess effect of a cholesterol
Cholesterol
Cholesterol is a complex isoprenoid. Specifically, it is a waxy steroid of fat that is produced in the liver or intestines. It is used to produce hormones and cell membranes and is transported in the blood plasma of all mammals. It is an essential structural component of mammalian cell membranes...
-lowering drug called simvastatin
Simvastatin
Simvastatin is a hypolipidemic drug used to control elevated cholesterol, or hypercholesterolemia. Simvastatin is a member of the statin class of pharmaceuticals, is a synthetic derivate of a fermentation product of Aspergillus terreus.-Medical uses:The primary uses of simvastatin is for the...
on mortality and morbidity in a group of 4444 patients with coronary heart disease
Coronary heart disease
Coronary artery disease is the end result of the accumulation of atheromatous plaques within the walls of the coronary arteries that supply the myocardium with oxygen and nutrients. It is sometimes also called coronary heart disease...
, aged between 35 and 70 years.
The patients exhibited moderate hypercholesterolemia
Hypercholesterolemia
Hypercholesterolemia is the presence of high levels of cholesterol in the blood. It is not a disease but a metabolic derangement that can be caused by many diseases, notably cardiovascular disease...
, between 5.5 and 8.0 mmol/l.
The trial showed that treatment of patients suffering from coronary heart disease with simvastatin had a lowering effect on mortality and morbidity.
2223 patients were assigned placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
and 2221 were assigned simvastatin treatment for a mean period of 5.4 years. There was a 30% relative reduction in the risk of death with simvastatin treatment. The absolute coronary heart disease-mortality was reduced from 8.5% to 5.0%, making the number needed to treat
Number needed to treat
The number needed to treat is an epidemiological measure used in assessing the effectiveness of a health-care intervention, typically a treatment with medication. The NNT is the average number of patients who need to be treated to prevent one additional bad outcome...
around 30 (thirty patients would need to be treated to prevent one death). Additionally there was no excess morbidity of non-cardiac deaths from causes like cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
or suicide
Suicide
Suicide is the act of intentionally causing one's own death. Suicide is often committed out of despair or attributed to some underlying mental disorder, such as depression, bipolar disorder, schizophrenia, alcoholism, or drug abuse...
, a concern that has occasionally arisen in respect to the statins.
The treatment of 100 patients for six years would prevent four deaths of the disease and seven non-fatal myocardial infarcts
Myocardial infarction
Myocardial infarction or acute myocardial infarction , commonly known as a heart attack, results from the interruption of blood supply to a part of the heart, causing heart cells to die...
.
The 4S study turned out to be a milestone in cardiology
Cardiology
Cardiology is a medical specialty dealing with disorders of the heart . The field includes diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular heart disease and electrophysiology...
and evidence-based medicine
Evidence-based medicine
Evidence-based medicine or evidence-based practice aims to apply the best available evidence gained from the scientific method to clinical decision making. It seeks to assess the strength of evidence of the risks and benefits of treatments and diagnostic tests...
- it was clearly proven that treatment with statins saved lives of patients with coronary heart disease. A host of other large multicenter clinical trials followed that paved way to widespread use of this class of pharmaceuticals.