Ongoing Statin study at Curtin University

STATINS are a group of drugs that block a key liver enzyme, resulting in decreased low density (LDL) cholesterol and increases high density (HDL) cholesterol circulating in the blood stream.

High levels of LDL and low levels of HDL are associated with an increased risk of cardiovascular disease.

Clinical trials over 30 years have shown a consistent reduction in risk of cardiovascular events including death when patients at risk take the drugs regularly.

However few people in these trials were over 60.

Professor Chris Reid of Curtin University says like nearly all drugs, statins may have some adverse side effects.

“The trial aims to give GP confidence to prescribe statins if they are needed, but ensuring the benefits exceed the risks.”

Unwanted side effects are more common in older people and it is not known if these risks outweigh the advantages of statin therapy amongst older people.

A world-first trial, called STAREE (Statin Therapy for Reducing Events in the Elderly) is being run in a collaboration between Curtin University and other universities, to investigate whether cholesterol-lowering medication can prolong good health and maintain independence among older people.

“To be absolutely sure we need 10,000 volunteers over 70. We have 2000 already on the trial and plan to continue to recruit over five years. We need to be certain that the recommendations apply to everybody and that the statins prescribed contribute to a healthy life.

“All statins prescribed are not equal. The first generation statins are less effective than more modern ones. For the trial we have chosen the most commonly prescribed statin in Australia at the most usual dose.

“This study has received no funding from pharmacy manufacturers,” he said.

The placebo controlled trial will test if statins prevent a first heart attack or stroke in older people and improve life expectancy.

In addition it will attempt to find out if the frequency and/or severity of adverse reactions to statins, including the risk of developing diabetes, is higher in older people and whether the drugs impact on their mental and physical abilities.

It is also possible that statins may prevent or delay the onset of dementia.

The trial will test this possibility and provide data to assess the cost effectiveness of prescribing statins for healthy elderly people.

“If people would like to participate in this study, they will be invited to meet with STAREE staff at a clinic. STAREE staff will ask about their medical history and current medication use, take some basic measurements (height, blood pressure etc.) and will be given a pathology request form for blood and urine samples. People will be asked to take a tablet for four weeks and check that your GP is happy for them to participate. This is to ensure that participants are compliant with the need to take the pills,” said Professor Reid.

If people agree to continue in the study they will be required to take statin or placebo tablets every day for five years. This is a double-blind trial. Neither the person nor the study staff will know which of these they are taking.

STAREE staff will regularly phone the person during the study to discuss medical conditions that may arise and the medication they are taking.

People will be required to attend the study clinic annually where they will undergo memory and physical ability tests and physical measurements.

If a person is aged 70 years or older and in good health with no history of heart disease or diabetes and are not currently taken a statin, they may be eligible to take part.

Anyone interested in joining the STAREE trial can phone 1800 770 664 or email staree@monash.edu.au