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Over the past 20 years, the University of Oxford's Clinical Trial Service Unit (CTSU), within the Nuffield Department of Population Health (NDPH), has conducted some of the world's largest trials and collaborative meta-analyses of trials of antiplatelet therapy, including aspirin, that have together had a major ongoing and incremental impact on the treatment and prevention of cardiovascular disease. They have helped ensure that antiplatelet therapy is widely used both in the acute care of patients with heart attacks and for the secondary prevention of heart attacks and strokes in high-risk patients. This research has been recognised as the gold standard for international guidelines, and has been instrumental in changing prescribing labelling for aspirin.
More than half of UK adults aged over 45 years have high cholesterol levels, the major modifiable risk factor for cardiovascular disease (CVD). Over the past 20 years, University of Glasgow researchers have led numerous landmark clinical trials establishing the benefits of statins for CVD prevention. High-profile international clinical guidelines on lipid lowering cite these studies in the key evidence base for recommendations to guide statin use, demonstrating the considerable influence this work exerts on current clinical practice and public health. This has driven the global uptake of statins and provided the evidence-base for CVD risk assessment and prevention strategies that are now implemented worldwide. The use of statins has transformed patient care, provided a cost-effective prevention strategy for healthcare providers and made major contributions to the falling CVD mortality rates across Europe and the US.
Over the past ten years, the prescription of cholesterol-lowering statins has soared and they are now the most prescribed drugs in the UK and the US. However, this has raised concerns about inappropriate prescribing. University of Glasgow research has been pivotal in addressing this issue and has triggered revision of major international guidelines to stratify patients in the general population for statin therapy and guide statin use in the rheumatoid arthritis patient population. The identification of a statin-associated risk for diabetes prompted the European Medicines Agency and the US Food & Drug Administration to revise safety labelling for all classes of statins. This risk is now communicated to the 27 million patients in the UK and US who are prescribed statins.
Randomised placebo-controlled trials (RCTs) are the most robust way to demonstrate the effectiveness of medical therapies. The University of Glasgow's Robertson Centre for Biostatistics (RCB) is internationally renowned for its biostatistical input and leading roles on landmark RCTs of cardiovascular therapies. The findings of the BEAUTIFUL and SHIFT studies underpinned European and UK regulatory approval for a novel use of the heart-rate-lowering drug ivabradine, potentially preventing thousands of hospital admissions for heart failure every year. The IONA trial supported UK approval of generic versions of another heart drug (nicorandil), thereby enhancing cost-effectiveness for the NHS. The BEAUTIFUL, SHIFT, DOT-HF and CAPRICORN trials provided the evidence base for US, European and UK guideline recommendations, steering best practice for treatment of patients with heart disease worldwide.
Impact: Health and welfare; the GRACE risk score (derived using data from 102,000 patients with acute coronary syndrome (ACS) in 30 countries) identifies high-risk ACS patients more effectively than do alternative methods.
Significance: GRACE is now a reference standard and has resulted in international guideline changes. It is estimated to save 30-80 lives for every 10,000 patients presenting with non-ST elevation ACS.
Beneficiaries: Patients with ACS; the NHS and healthcare delivery organisations.
Attribution: All work was led by Fox (UoE) with co-chair Gore (University of Massachusetts) and was developed from Edinburgh-based studies.
Reach: Worldwide: guidelines adopted in more than 55 countries; >10,000 downloads of app.
Patients with evidence of heart failure following acute myocardial infarction (AMI) have a particularly poor prognosis, with substantially increased risk of death and subsequent cardiovascular events. The Acute Infarct Ramipril Efficacy (AIRE) Randomised Controlled Trial (RCT) was an international trial designed and led by the University of Leeds. AIRE demonstrated, for the first time, that early treatment of patients with clinical evidence of heart failure following AMI with the angiotensin converting enzyme inhibitor (ACEI) ramipril significantly improved survival and quality of life compared with placebo treated patients. The strategy of early initiation of ACEI is now a cornerstone in the management of patients suffering from AMI, leading to a global improvement in post-AMI outcomes.
QRISK is a new algorithm which predicts an individual's risk of cardiovascular over 10 years. It was developed using the QResearch database and is in routine use across the NHS. It is included in national guidelines from NICE and the Department of Health and in the GP quality and outcomes framework. It is incorporated into > 90% of GP computer systems as well as pharmacy and secondary care systems. The web calculator has been used >500,000 times worldwide. ClinRisk Ltd was incorporated in 2008 to develop software to ensure the reliable widespread implementation of the QRISK algorithm into clinical practice.
The Acute Infarct Ramipril Efficacy (AIRE) multicentre international trial, conceived, designed, led and coordinated by Leeds was the first to show that use of early angiotensin converting enzyme Inhibitor (ACEI) therapy in patients with signs and symptoms of heart failure after an acute myocardial infarction (AMI) is associated with significantly longer survival and better quality of life. Further Leeds research showed the beneficial effects persisted long-term. The strategy of early initiation of ACEI is now a fundamental and routine part of the management of patients after AMI and has contributed to better survival and quality of life for patients around the world.
The Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT; Co-Chairman, Professor Sever) was an investigator designed and led multinational study in which different blood pressure-lowering and lipid-lowering treatment strategies were investigated in an attempt to define optimal programmes for intervention to prevent cardiovascular disease in hypertensive subjects. The outcomes of both the antihypertensive arm and the lipid arm of the trial defined the benefits of more contemporary treatments for hypertensive subjects, including calcium channel blockers, angiotensin converting enzyme inhibitors and statins, which have been incorporated into national and international guidelines (including NICE), and have impacted on current clinical practice in the prevention of cardiovascular disease worldwide.
University of Sheffield research which evaluated the clinical and cost-effectiveness of statins for the primary and secondary prevention of cardiovascular events has directly led to an additional 3.3 million people in England and Wales becoming eligible for this treatment. Statins have been shown to reduce the risk of future cardiovascular events, such as heart attacks and stroke.
Guidance on statin prescribing in England and Wales, issued by the National Institute for Health and Care Excellence (NICE) Appraisal Committee in January 2006 was informed by our research report. Following this guidance the number of patients receiving statins has increased year on year with the number of prescriptions increasing by 29% between 2007 and 2011, enabling these patients to benefit from reduced risk of heart attacks and stroke and CVD related deaths.