A Monash-led international study has found a cholesterol-lowering drug may offer a more effective and convenient way to protect people at high risk of heart attack and stroke.
The clinical trial 'BROADWAY' tested a once-daily oral medication called Obicetrapib, and found it significantly lowered both LDL cholesterol and lipoprotein(a), [Lp(a)], two key contributors to cardiovascular disease.
The BROADWAY phase 3 trial results were presented by Study lead Professor Stephen Nicholls, Director of Monash University's Victorian Heart Institute and Monash Health's Victorian Heart Hospital as a late-breaking clinical study at the European Atherosclerosis Society Congress in Glasgow, UK, and published in the New England Journal of Medicine (NEJM).
Professor Nicholls said the findings marked an important step forward for patients who have struggled to reach their cholesterol targets with current therapies.
"We know that many people at high risk of heart attack or stroke don't get their cholesterol levels low enough, even on the best available treatments," Professor Nicholls said.
"Obicetrapib offers a promising new option – not only did it lower LDL cholesterol by over 30 per cent, but we also saw a reduction in Lp(a), which is much harder to treat and has been linked to increased heart disease risk."
LDL cholesterol, often referred to as 'bad cholesterol', builds up in blood vessels and increases the risk of heart attack and stroke. Lipoprotein(a), or Lp(a), is a lesser-known but inherited risk factor that can also accelerate artery damage – and unlike LDL, there are currently no widely approved treatments to lower it.
In the BROADWAY trial, more than 2,500 participants with established heart disease or genetic high cholesterol were given either Obicetrapib or a placebo, in addition to their regular cholesterol medications. After 12 weeks, those on Obicetrapib had dropped their LDL cholesterol by 32.6 per cent and Lp(a) by 33.5 per cent on average – many achieved guideline-recommended targets for the first time.
Obicetrapib was also well tolerated, with a safety profile similar to earlier trials.
"This could be a valuable tool in the fight against heart disease," Professor Nicholls said. "It's convenient, it's effective, and it may help close the gap for patients who've run out of options."
About the BROADWAY trial (Randomised Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies)
Funded by NewAmsterdam Pharma, the international BROADWAY trial is investigating the effect of Obicetrapib on lipid levels and aims to characterise its safety and side-effect profile in patients at high risk of cardiovascular events. The multinational, randomised, placebo-controlled trial involves patients with heterozygous familial hypercholesterolemia or a history of atherosclerotic cardiovascular disease who were receiving maximum tolerated doses of lipid-lowering therapy.
The latest NEJM paper involved Monash Victorian Heart Institute, NewAmsterdam Pharma, the University of Amsterdam, Baylor College of Medicine and Texas Heart Institute in Houston, Imperial College London, UT Southwestern Medical Center in Dallas, the Cleveland Clinic, Osaka Medical and Pharmaceutical University, the University of Cambridge, Klinik und Poliklinik fur Kardiologie, Leipzig University in Germany, Medical University of Lodz in Poland, Icahn School of Medicine, Mount Sinai in New York, the University of Milan, Peking University First Hospital in Beijing, the University of Colorado Anschutz Medical Campus, State University of New York, Downstate School of Public Health in New York, and MedPace in Cincinnati.
