Complications of Diabetes

The Heart Protection Study

What is the Heart Protection Study (HPS)?

This was a large clinical trial carried out in Oxford, between 1994 and 1997, which looked at the benefits of cholesterol lowering drugs in over 20,000 people who had an increased risk of heart disease. of whom   6,000 had diabetes.

Who sponsored this research?

The Medical Research Council and the British Heart Foundation funded this research.

What was the aim of this study?

Objectives of the study included assessing whether prolonged treatment with a statin to lower cholesterol reduced cardiac death in a wide range of people at increased risk of CHD.

What new information has the study provided?

Cholesterol-lowering treatment with statins does not only reduce the risk of heart attacks but also that of strokes and the need to undergo coronary surgery or other vascular procedures.

Lowering cholesterol may be beneficial even in people with normal cholesterol levels.

A wide range of people appeared to benefit from the intervention which included people aged 40 – 80 years of both sexes.

How many vascular events were prevented during this study?

For every 1,000 patients treated over 5 years, about 70-100 fewer people may have heart attacks, strokes or revascularisation operations.

How many patients had vascular events during the study?

During this treatment period, there were about 4500 major vascular events (included 2000 coronary events and 1000 strokes) and 3000 deaths (1500 from vascular causes and 1500 from other causes).

How many deaths may be prevented?

Between 20-30 per 100 treated over 5 years.

Who may benefit from statin therapy?

The evidence from this study suggests that those with a previous history of heart attack or angina who are aged over 70, and those who have blood total cholesterol levels below 5.0mmol/l or LDL cholesterol levels below 3.0mmol/l, should now be considered for statin treatment.

People with a history of stroke, peripheral vascular disease, or diabetes, regardless of their age, sex or cholesterol level.

How many people had diabetes in this study?

5,963 of the 20,500 who took part had diabetes mellitus.

Why did the study include people who already had vascular disease or diabetes?

It was considered that these people had the highest level of risk and therefore had the most to gain from intervention to reduce risk.

Are there any particular groups who were previously not considered for statin therapy where this new information may help ?

People over the age of 70 years who have coronary heart disease

Those who have a total cholesterol less than 5.0 mmol/l or LDL cholesterol less than 3.0 mmol/l.

Where can I get more information?


Dr Nishan Wijenaike
Consultant Physician
West Suffolk Diabetes Service
September 2003