20 years of statins: how they changed heart health forever

Heart attack survivor Kenneth O’Loughlin is cheering the life-saving results of the landmark LIPID study pioneered by University of Sydney researchers at the NHMRC Clinical Trials Centre (CTC).

Following a heart attack in 1991, Mr O’Loughlin joined the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) study—the first to investigate the survival effects of statins (cholesterol lowering medication) in lowering average cholesterol levels in people who had experienced a cardiovascular event such as angina or a heart attack.

The findings of the LIPID study changed heart health in Australia forever by significantly reducing the prevalence of strokes and heart attacks.

Whereas previous studies had looked at using statins to reduce cholesterol in people who had high blood cholesterol levels, the LIPID trial focussed on people with more average blood readings.

The LIPID trial was an ambitious, long-running landmark Australian study – to this day, one of the largest run in the country.

It also led directly to changes in clinical practice in Australasia and around the world, as well as statins being subsidised by the PBS for these patients in Australia.

The study was first published in the prestigious international journal the New England Journal of Medicine in October 1998.

Professor John Simes, Director of the NHMRC CTC said: “At the time, a ground-breaking clinical trial was underway in Norway, looking at whether lowering high cholesterol with statins could reduce deaths in people with elevated cholesterol levels.

“We wanted to see if this approach could have the same effect on a much larger group of people – those with average cholesterol readings.

“The focus at the time was primarily on people with high cholesterol, when in fact, even more people with normal cholesterol levels suffer a cardiac event over time.

“The study showed that taking statins for 6 years reduced death from cardiovascular disease by 24 percent, and overall mortality by 23 percent.”

The LIPID study, with more than 9,014 participants from across Australia and New Zealand, involved a total of 87 major hospitals in Australia and New Zealand and set the benchmark for the conduct of similar trials in Australia and globally.

Kenneth O’Loughlin was 44 when he had his first heart attack in 1991.

Fairfield resident Kenneth O’Loughlin, now 71, was 44 when he had his first heart attack in 1991. Though it was only 27 years ago, his outlook was much bleaker then than it is today.

He joined the recently started National Heart Foundation study, the LIPID trial, funded by Bristol-Myers Squibb, and coordinated by Australia’s NHMRC Clinical Trials Centre at the University of Sydney.

Today, Mr O’Loughlin is still taking his statin, and is fit and well, with his cholesterol level under control.

Mr O’Loughlin said, “The benefit of being part of this study is that I’ve had the best care possible, from top experts from the start.

“I’d say to anyone who has the opportunity to participate in a clinical trial to go for it — where else can you get the best care at no cost, and not only during the trial, but afterwards as well? They not only look after your problem, they also monitor you for any side-effects of the treatment, which means that they look after your general health as well - it’s been a wonderful opportunity.”

Professor Anthony Keech of the NHMRC CTC said that the trial had an immediate impact for the large group of people involved.

“It changed the whole approach to treating cholesterol based on people’s level of risk rather than their actual cholesterol level alone.

“There is now clear evidence that treatment with statins after a heart attack have improved the outlook of millions around the world”.

Chair of the LIPID Study Professor Andrew Tonkin of Monash University said: “LIPID has also helped foster 25 further statin trials worldwide, which continue to improve the prospects of patients with coronary heart disease and diabetes.

“Long term follow-up of the trial has demonstrated the benefits of treatment are maintained for decades and without any increase in adverse effects from cancer or deaths from other causes.

“While the majority of study participants were around 60 at the time the trial commenced, the statin-lowering approach significantly increased their chances of having a longer and better life.”

Fast facts: the LIPID study

• The LIPID study was the first to look at the use of statins in people with normal cholesterol levels who had experienced a major cardiovascular event
• The LIPID study results were first published in the New England Journal of Medicine in October 1998
• Pravastatin treatment for 6 years was found to reduce death from cardiovascular disease by 24 percent, and overall mortality by 23 percent.
• Long-term follow-up has shown that this improved survival rate continues for almost two decades, largely due to prevention of cardiovascular deaths
• Long-term treatment with statins is not associated with an increase in the rates of new cancers or death
• The results of the LIPID study have meant that statin treatment is now subsidised for Australian patients.

The NHMRC Clinical Trials Centre was established in 1988 with the aim of improving global healthcare outcomes through quality clinical and methodological research. Specialising in Oncology, Cardiovascular, Diabetic and Neonatal research, the CTC is also a world leader in the management of complex, rigorous, long-term trials, both in Australia and with our global partners.