Greater Manchester, Salford

Cholesterol-reducing real world study

Pioneering study to test novel cholesterol-lowering treatment in the community and develop new models of care in primary care

Greater Manchester is partnering with industry on pioneering study as the NHS brings a new cholesterol-lowering injection into use.

Greater Manchester-based organisations are collaborating as part of a new study involving 900 patients testing the implementation in primary care of inclisiran, a new drug to reduce LDL cholesterol.

High levels of LDL (low-density lipoproteins) cholesterol make people more likely to suffer a heart attack or stroke. Sustained lowering of LDL cholesterol has been shown to help prevent the development and progression of Atherosclerotic cardiovascular disease (ASCVD), a potentially serious condition. It is caused by a build-up of cholesterol in the blood vessels, known as plaque, and causes narrowing and restriction of blood flow to and from the heart and other vital organs, increasing the risk of heart attack and stroke.

Inclisiran, a first-in-class small interfering RNA therapy, received a licence from the European Commission in December 2020 following the results of a robust clinical development program.  Inclisiran also gained NICE approval on 1 September 2021, recommending the drug for people with high cholesterol who have already had a previous cardiovascular event to reduce their LDL cholesterol, which is a key risk factor for them having another. Trials showed that inclisiran lowers the level of the fatty and harmful substance called LDL cholesterol found in the blood by using RNA interference (RNAi) to boost the liver’s ability to remove it from the blood.

The ground-breaking project, titled Study in Primary care evaluating Inclisiran delivery implementation + enhanced support (VICTORION-SPIRIT) is a collaboration between pharma company Novartis, NHS England and Improvement, NorthWest EHealth, Health Innovation Manchester, and the National Institute for Health Research Applied Research Collaboration Greeter Manchester (NIHR ARC-GM).

Approximately 18 GP practices in Greater Manchester will participate in the implementation research study, recruiting 900 patients. The study will use research to identify the best ways to speed up adoption and spread across the NHS. It aims to support reducing the time it takes to bring new medicines into practice to benefit patients.

As part of the study, patients are given the drug as an initial dose, and follow-up doses at three and nine months. It will be delivered via injection by GP practices, without needing to attend hospital.

The VICTORION-SPIRIT Study will work with GPs and use NorthWest EHealth’s innovative digital technologies to find and recruit potential participants, track the patient journey and provide real-time monitoring. The information gathered will inform recommendations on integrated care delivery models in a primary care setting using inclisiran as part of a suite of NICE approved treatments and non-pharmacological interventions, to reduce LDL cholesterol.

Read about the launch of the VICTORION-SPIRIT study in this news piece

A study in Greater Manchester providing evidence for the implementation of inclisiran in a primary care setting VICTORION-SPIRIT STUDY OVERVIEW: Phase IIIb, multicentre, open label, randomised controlled trial.Study will take place in 18 primary care centres in Greater Manchester, UK. 900 Primary or secondary prevention participants. interventions Include: Inclisiran, Usual Care, Behavioural Support. Objective: To evaluate the implementation of inclisiran in a regional primary care setting in the UK. Evaluate efficacy with standard clinical trial endpoints. Use implementation science methodology to assess patient and HCP satisfaction and healthcare resource utilization. Develop a patient identification report and process evaluation report that will support the launch of inclisiran, along with future novel therapies. Data sources -
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