The West of Scotland Coronary Prevention Study (also known as WOSCOPS) was a landmark

randomized controlled trial A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical ...

, published in 1995, that investigated the effects of

pravastatin Pravastatin, sold under the brand name Pravachol among others, is a statin medication, used for preventing cardiovascular disease in those at high risk and treating abnormal lipids. It is suggested to be used together with diet changes, exerc ...

, a

cholesterol-lowering drug Lipid-lowering agents, also sometimes referred to as hypolipidemic agents, cholesterol-lowering drugs, or antihyperlipidemic agents are a diverse group of pharmaceuticals that are used to lower the level of lipids and lipoproteins, such as choleste ...

, on

primary prevention Preventive healthcare, or prophylaxis, is the application of healthcare measures to prevent diseases.Hugh R. Leavell and E. Gurney Clark as "the science and art of preventing disease, prolonging life, and promoting physical and mental health a ...

coronary heart disease Coronary artery disease (CAD), also called coronary heart disease (CHD), or ischemic heart disease (IHD), is a type of cardiovascular disease, heart disease involving Ischemia, the reduction of blood flow to the cardiac muscle due to a build-up ...

(CHD) in men with

hypercholesterolemia Hypercholesterolemia, also called high cholesterol, is the presence of high levels of cholesterol in the blood. It is a form of hyperlipidemia (high levels of lipids in the blood), hyperlipoproteinemia (high levels of lipoproteins in the blood), ...

. Conducted in the early 1990s, this study provided critical evidence on the benefits of statins in reducing cardiovascular events in individuals without a history of CHD. It concluded that statin treatment reduced CHD events by 31% after nearly five years of treatment.

Background

Cardiovascular disease, particularly CHD, is a leading cause of death globally. High

low-density lipoprotein Low-density lipoprotein (LDL) is one of the five major groups of lipoprotein that transport all fat molecules around the body in extracellular water. These groups, from least dense to most dense, are chylomicrons (aka ULDL by the overall density ...

(LDL) cholesterol levels are a well-established risk factor for developing CHD. While previous studies had demonstrated the benefits of lipid-lowering agents in patients with existing CHD, the WOSCOPS was one of the first large-scale trials to evaluate the efficacy of statins for primary prevention in individuals without a prior history of cardiovascular events.

Study design

WOSCOPS was a multicenter, randomized, double-blind, placebo-controlled trial conducted in Scotland. The study enrolled 6,595 men aged 45 to 64 years (average 55 years) with elevated total cholesterol levels (average 272 mg/dl) and LDL cholesterol levels (average 192 mg/dL) and no previous history of myocardial infarction. The enrollment period was from February 1989 through September 1991. Participants were randomly assigned to receive either pravastatin (40 mg daily) or a placebo. The primary endpoint was the incidence of nonfatal myocardial infarction and death from CHD. Secondary endpoints included all-cause mortality, coronary revascularization procedures, and stroke. The patients were followed an average of 4.9 years after enrollment. Patient medical records and the national death registry were used to determine clinical results.

Key findings

The results of the WOSCOPS, published in 1995, demonstrated several significant benefits of pravastatin therapy for the primary prevention of CHD: * Reduction in CHD events: Men treated with pravastatin had a 31% reduction in the risk of nonfatal myocardial infarction or death from CHD compared to those receiving the placebo. * Decreased all-cause mortality: There was a 22% reduction in all-cause mortality in the pravastatin group. * Fewer revascularization procedures: In the pravastatin group, the need for coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) was reduced by 37%. * Lower incidence of stroke: Pravastatin therapy was associated with a trend towards a reduction in the incidence of stroke but was not considered statistically significant.

Clinical implications

The findings of the WOSCOPS had substantial implications for the prevention of CHD. This trial added to the evidence that the incidence of CHD can be reduced with statin therapy. Long-term follow-up demonstrated a sustained reduction in death and coronary events.

Long-term impact

The WOSCOPS was a pivotal trial that contributed to the broader acceptance and use of statins in the primary prevention of cardiovascular disease. Its findings have been corroborated by subsequent studies and meta-analyses, reinforcing the role of statins in reducing the risk of CHD in various populations.

References