Researchers from the South Australian Health and Medical Research Institute (SAHMRI) and the Cleveland Clinic have been able to reduce the buildup of cholesterol plaques in the coronary artery walls in high-risk heart patients.
Patients receiving a combination of cholesterol-lowering drug, evolocumab, and a statin, achieved an average level of LDL (‘bad cholesterol’) of just 36.6 mg/dL. This is the lowest level ever achieved in a major trial of cholesterol-lowering drugs.
The results of the GLAGOV trial - directed by Professor Stephen Nicholls, Heart Health Theme Leader at SAHMRI, Cardiologist at the Royal Adelaide Hospital, and Professor of Cardiology at the University of Adelaide and Dr Steven Nissen, chairman of Cardiovascular Medicine at Cleveland Clinic – were presented today at the American Heart Association Scientific Sessions and simultaneously published in the Journal of the American Medical Association.
Taking the gold standard of treatment to the next level
The GLAGOV trial randomly assigned 968 participants to either a statin alone, or a statin together with a monthly self-injection of evolocumab – a cholesterol-lowering drug known as PCSK9 inhibitors. While the patients who were given just the statins achieved an average LDL level, the group who received the combination therapy reduced their LDL by an additional 60 per cent - a significant reduction.
Professor Nicholls said that this study employed a new technique called intravascular ultrasound (IVUS) – which uses a small ultrasound probe to directly measure plaque in the arteries and it showed the following:
- Combination therapy: 64% reduction in plaque
- Statin-only patients: 47% reduction in plaque
Professor Nicholls added that these findings suggest that the large clinical outcome trials currently underway are likely to show major benefits from combination therapy using a PCSK9 inhibitor and a statin compared with a statin alone.
“Although statins are currently the best way to lower cholesterol, or LDL, we are looking to see if we can do even better. This study has shown that cholesterol can be lowered to levels that hadn’t been previously achieved,” he said.
“We desperately need additional therapies to treat our patients with heart disease; this finding brings us one step closer to having another shot on goal.”
“However, it is important to keep mind that this combination therapy may not be for everybody, and in this study we only looked at high-risk heart patients.”
The importance of reducing coronary artery plaque
Plaque that builds up in our arteries impacts on the amount of blood that can flow to the heart. Plaque deposits are made up of cholesterol and other material. When plaques rupture, the plaque material flows through the artery and can cause blood clots. Blood clots in our main arteries can cause heart attack and stroke, so the ability to prevent these issues is significant.
Professor Nicholls added that GLAGOV is another example of where SAHMRI is playing an important leadership role in global clinical trials.