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Life-saving anti-cholesterol drug recommended on NHS thanks to groundbreaking clinical trials

Published: 02 September 2021

A groundbreaking drug to combat heart disease could soon be offered on the NHS, following an innovative programme of clinical trials delivered by the NIHR Clinical Research Network (CRN).

The National Institute for Health and Care Excellence (NICE) is recommending that inclisiran, a treatment to lower cholesterol, should be offered to patients who have already had a stroke or heart attack and are not responding to other cholesterol-lowering treatments.

The drug would be delivered as a twice-yearly injection to eligible patients with prior experience of heart attack or stroke - potentially replacing the need to take statins daily, while saving thousands of lives a year.

The NICE recommendations follow the findings of the ORION programme of clinical studies, an innovative collaboration between the NIHR CRN, NHS England, Oxford University and the pharmaceutical company Novartis. Participants were identified via NHS Digital screening patient records and invited to attend screening visits at one of 40 national trial centres embedded in community settings.

Heart disease is the second biggest cause of death in the UK, with over three million people currently suffering from atherosclerotic cardiovascular disease and two and a half million relying on statins to lower their cholesterol.

However results from clinical trials show that inclisiran can halve bad cholesterol in just two weeks, with the potential to save up to 30,000 lives over the next decade if made available on the NHS. If inclisiran were to be given to 300,000 patients annually, it could help prevent up to 55,000 heart attacks and strokes.

Dr Paul Clift, NIHR CRN National Specialty Lead for Cardiovascular Disease, said, “The announcement of NICE approval for inclisiran is a welcome development.

“Inclisiran was studied extensively through the ORION programme of clinical studies, which recruited participants through NHS clinics, with research delivery supported by the NIHR Clinical Research Network. This is a great example of how the NIHR partnered with the NHS can advance novel therapies for the management of heart disease for patients in this country.”

Dr Piers Clifford, Industry Lead for the NIHR Cardiovascular National Specialty Group, added, “The ORION series of research trials have clearly demonstrated that inclisiran is a game-changing drug in the treatment of patients with a high cholesterol. It results in astonishing reductions in blood cholesterol, far exceeding that achieved by high dose statins, with virtually no side effects.

“It is gratifying that NICE is recommending its use and this clearly demonstrates the benefits to patients of well conducted clinical trials as part of a major NIHR CRN collaboration with Novartis, NHS England and Oxford University.”

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