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The Collaborative Atorvastatin Diabetes Study (2004), led by researchers at the University of Manchester (UoM), established the efficacy of statin therapy in the prevention of atherosclerotic cardiovascular disease (CVD) among patients with diabetes. The research challenged the previously held view that, since CVD risk is markedly raised in people with diabetes even when blood cholesterol levels are normal, statins were unlikely to be beneficial for this group. These key findings have informed clinical guidelines governing the use of statin therapy in the UK (NICE, SIGN) and internationally (American Heart Association and the American Diabetes Association, ESC, EAS), ensuring that statins are now considered for all diabetic patients.
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.
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.
The University of Oxford's United Kingdom Prospective Diabetes Study (UKPDS) was a landmark 30-year clinical trial, reported in over 80 academic research papers between 1983 and 2008. It showed beyond doubt that diabetic complications, previously thought to be inevitable consequences of the condition, could be delayed or prevented by improved treatment from the time of diagnosis. These findings have had a profound influence on the management of type 2 diabetes, clinical guidelines, and standards of care, and have reduced diabetes-related complications worldwide, lowering the incidence of blindness, kidney failure, amputation, heart attack and stroke.
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.
Caulfield co-led and was a principal investigator (PI) on Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT). Hitman co-led and was a PI on Collaborative AtoRvastatin Diabetes Study (CARDS). These studies dramatically changed national and international guidance for diabetes, hypertension and cholesterol, leading to widespread and far-reaching changes in management of common and potentially fatal risk factors. For example, the proportion of hypertensive patients in England with good BP control (<140/90) rose from 52% in 2006 to 62% in 2011; the mean total cholesterol level of the population has fallen by 0.5 Mmol/L between 1998 and 2011.
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.
Studies coordinated by the University of Oxford's Clinical Trial Service Unit (CTSU) within the Nuffield Department of Population Health (NDPH) have strongly influenced the labelling of statin medication internationally, treatment guidelines, and the resulting changes in prescribing have contributed to reductions in mortality and morbidity from heart attack and ischaemic stroke in many countries. CTSU's randomised trials and meta-analyses of trials have shown that lowering low-density lipoprotein (LDL) cholesterol safely reduces the risk of heart attacks, strokes and revascularisation procedures in a wide range of people, and work conducted in collaboration with the NDPH's Health Economic Research Centre has provided clear evidence of cost-effectiveness of statins.
In response to the gap between standards and the reality of preventive cardiovascular disease (CVD) health care delivered across Europe, Imperial College researchers developed an innovative nurse-led, multidisciplinary, family centred, CVD prevention programme (EUROACTION) and led its evaluation in hospital and general practice across 8 European countries. We showed that patients and their families in our programme can achieve healthier lifestyles and better risk factor management compared to usual care and these differences were sustained out to one year. We then adapted our learning from EUROACTION for the NHS, by integrating secondary and primary prevention into one community service (MYACTION), and managing cardiovascular disease as a family of diseases with common antecedents. To train doctors, nurses and allied professionals to deliver MYACTION we created an MSc in Preventive Cardiology which is now in its 6th year. EUROACTION is now recommended as an evidence based model of care in current European CVD prevention guidelines, and MYACTION is being commissioned by the NHS in London, and Galway, Republic of Ireland, and by the Western Isles Health Board. Our research has impacted directly on the development and delivery of high quality preventive care in both Europe, and the NHS, and on the training of doctors, nurses and allied health professionals in preventive cardiology.
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.