A groundbreaking cholesterol-lowering injection, administered just twice annually, could revolutionise heart disease management, its developers have claimed.
New trial data for Leqvio, also known as inclisiran and developed by Novartis, indicates that patients achieved their target cholesterol levels more rapidly than with existing treatments.
Crucially, the jab also led to fewer instances of muscle pain, a side-effect associated with cholesterol-reducing statin medications.
Cholesterol, a fatty substance produced by the liver and present in certain foods, comes in two forms: 'good' cholesterol, which helps remove excess, and 'bad' cholesterol, which can accumulate in arteries, raising the risk of heart attacks and strokes.
Statins are the most common drug used to treat high cholesterol on the NHS.
They reduce the amount of cholesterol the body makes and patients are usually required to take one tablet a day for the rest of their life.
Leqvio works by interfering with genetic material to limit the production of a protein that can increase levels of bad cholesterol.
It is given as an injection, with an initial dose, another at three months and then every six months.
The Novartis trial, known as V-DIFFERENCE, included 898 people who were given a Leqvio injection and a specific high-intensity statin on top of other medicines known as lipid lowering therapies (LLTs) which were suited to their individual needs.
Meanwhile the other group of 872 patients were given a placebo injection and the same high intensity statin, plus other LLTs suited to their needs.
After 90 days, some 85 per cent of patients in the Leqvio group met their cholesterol target compared to 31 per cent in the placebo group.
Ruchira Glaser, global head of the cardiovascular, renal and metabolic development unit at Novartis, said: “Novartis is dedicated to tackling the most challenging problems in cardiovascular disease.
“These results highlight the potential of Leqvio to transform cardiovascular care by improving meaningful patient outcomes.
“V-DIFFERENCE has provided evidence that early use of Leqvio is an effective way to help patients reach their LDL-C goals faster without the need to add other therapies or maximise statin doses.”
The study was also the first to look at Leqvio’s ability to reduce muscle pain, which is a common side effects of statins.
It found patients on Leqvio were 43 per cent less likely to experience muscle-related issues compared to the placebo group.
Ulf Landmesser, chairman of the department of cardiology, angiology and intensive care medicine at German Heart Centre of Charite and Charite University Medicine Berlin, said the trial is the first to focus on patient outcomes.
He added: “These findings are significant as they demonstrate effective options for lipid management improvement in patients at risk, a majority of whom continue to remain above recommended LDL-C levels.”
The latest NHS Health Survey for England estimates the proportion of adults with raised cholesterol was 53 per cent in 2022, up from 43 per cent in 2019.
This was greater among women (56 per cent), compared to men (49 per cent).
The findings of the V-Difference trial will be presented at the European Society of Cardiology (ESC) Congress in Madrid.
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