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https://clinicaltrials.gov/ct2/show/NCT01990911.Cholesterol-cutting injections may cut risk of heart attacks
A new, currently unlicensed drug treatment that works by
‘silencing’ genes can help to halve levels of low-density
lipoprotein (LDL) cholesterol with just two injections per
year, according to a study. The findings come from the
largest clinical trial to date of the cholesterol-lowering
drug inlcisiran, which helps patients to reduce their LDL
cholesterol, or so-called ‘bad cholesterol’.
In a phase III study of more than 1 600 patients with
increased risk of cardiovascular disease and taking statins,
researchers found that giving regular but infrequent doses
of the drug helped to reduce LDL cholesterol by half on
average. Researchers believe the drug could help more
patients who are unable to take statins or who fail to take
their current cholesterol-lowering medication properly.
Professor Kausik Ray, from Imperial College London
School of Public Health and principle investigator of the
Orion-11 trial, presented the findings this week during a
late-breaking session at the European Society of Cardiology
Congress 2019 in Paris. ‘The cumulative effects of long-term
uncontrolled LDL cholesterol continue to place millions of
people at increased cardiovascular risk,’ explained Ray. He
added that the treatment provided assurance that cholesterol
can be lowered ‘in a sustained fashion over the long term with
an infrequent dosing regimen’.
In the trial, 1 617 patients received infrequent injections
of inclisiran (300 mg) over the course of a year – at the start,
then three months later, and then every six months.
The new data show that patients taking the treatment had
sustained reductions in their cholesterol levels (by an average
of 50%) over the course of 18 months, compared to patients
on statins and taking a placebo injection. In addition, the
treatment was shown to be safe over the period, with few
adverse events. The findings will now be submitted to a peer-
reviewed journal, where the full study findings, including
limitations, will be published.
Currently, millions of patients in the UK are eligible
to take cholesterol-lowering medications, such as statins,
every day to reduce their LDL cholesterol levels, and reduce
their long-term risk of cardiovascular disease. But many
patients may not take their medication as advised – taking
it infrequently or failing to take it at all – meaning the
treatment is not as effective due to poor adherence.
To tackle the problem of poor patient adherence, scientists
are exploring new classes of longer-lasting treatments
that could be delivered less frequently, but maintain the
therapeutic effect of daily medication. One of these drugs is
the PCSK9 inhibitors, part of a class of drugs called RNA
interference therapies (siRNA). These treatments target key
proteins, effectively silencing the genes that produce it.
The PCSK9 protein breaks down receptors on the surface
of liver cells that help to remove LDL cholesterol from the
blood. But short fragments of RNA – the molecule that
carries information from the genes to the cell’s protein-
making machinery – can be used to target and ‘silence’
the gene that encodes the protein, stopping PCSK9 from
being made and so stopping the receptors on the cells from
being broken down. The result is a sustained reduction in
cholesterol levels.
Inclisiran is not currently available in the UK and needs
to be approved by the UK regulator before it could be made
available on the NHS. However, the latest findings add to
growing evidence that shows that the treatment is safe and
effective in patients. Ray added: ‘This is a ground-breaking
new approach for preventing atherosclerotic cardiovascular
disease, with exciting implications at a population health
level.’
Source:
Medical Brief 2019