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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.
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.
Approximately 26 million people live with heart failure worldwide. University of Glasgow researchers have been instrumental in proving the value, in landmark clinical trials, of bisoprolol, candesartan and eplerenone — three of the four classes of drug that reduce mortality, reduce hospitalisation rates and improve quality of life for patients with heart failure. These trials led directly to revision of clinical guidelines on heart failure management globally (including in Europe, USA, UK, Australia and Canada, all published since 2008). The Glasgow researchers have established heart failure as a healthcare priority and encouraged the introduction of specialist heart failure nurses, saving the NHS an estimated £8 million per year. Collectively, these advances have transformed the treatment and survival rates of heart failure patients worldwide.
Impact: Health and welfare, policy and clinical practice; randomised trial evidence has changed the management and outcome of acute coronary syndromes (ACS) globally.
Significance: Advanced anti-platelet and revascularisation therapies have become standards of care worldwide. There have been large (10-50%) reductions in the death rate from coronary heart disease across Europe. Clopidogrel was the second best-selling drug in the USA in 2011.
Beneficiaries: Patients with ACS, clinical practitioners, NHS and healthcare delivery organisations, policy-makers, pharmaceutical companies.
Attribution: Building on prior studies, Fox (UoE) and colleagues led multicentre randomised controlled trials; international trials were co-chaired by Fox with international investigators.
Reach: Global; guideline changes in Europe and USA; applies to the up to 5% of the population who have ACS.
Our research on brain/B-type naturietic peptide (BNP) has helped to diagnose both types of heart failure (systolic and diastolic heart failure) and to identify high-risk aortic stenosis patients for surgery. We were first to demonstrate the value of BNP as a biomarker for left ventricular systolic dysfunction, isolated diastolic dysfunction and for aortic stenosis. BNP testing is now recommended in Guidelines as a screening test for patients with suspected heart failure (Class I recommendation) and in the current European Society of Cardiology consensus statement for diagnosis of diastolic heart failure. The European Society of Cardiology Guidelines have also introduced BNP testing in the management of patients with aortic stenosis (Class IIb recommendation).
Hull researchers conducted the key trial demonstrating that cardiac resynchronization therapy (CRT), a specialised type of pacemaker, significantly reduces morbidity and mortality and improves the quality of life of selected patients with heart failure. CRT has become a cornerstone of treatment for heart failure and a standard recommendation in clinical guidelines world-wide. Over a 5 year period about 40,000 people in the UK have had pacemakers implanted; about 8,000 of these patients would be projected to have died within 5 years if they had not received CRT. The world market for CRT devices is projected to grow to $2.8 billion annually by 2015.
Atrial fibrillation (AF) is the most common chronic heart rhythm disorder, afflicting 1-2% of the total population and up to 10% of individuals aged over 70 years. There is an urgent need for safer and more effective therapies to prevent and treat AF. University of Glasgow researchers have played leading roles in studies that have identified strategies which prevent AF, improved the safety of AF therapies, and proved the clinical efficacy of a novel anticoagulant to reduce the risk of stroke (the major consequence of AF). The findings have rapidly informed recommendations in international guidelines, prompted regulatory amendments of AF therapies and changed prescribing practices. These advances will affect the estimated 12 million Europeans and Americans suffering from AF.
Research on Congenital Adrenal Hyperplasia (CAH) at the University of Sheffield has resulted in both health and commercial impacts. The research has led to a new drug treatment, Chronocort®, being developed for CAH. Chronocort® has been tested in CAH patients with the positive outcome of improved disease control.
Commercial impact arose from the creation of a spin-out company, Diurnal Ltd, in 2004 which has raised investment of £3.8M since 2008, including £0.4M from pharmaceutical industry sources, and (as an SME partner) a €5.6M Framework 7 grant to develop a paediatric treatment for CAH. Diurnal has created five new jobs and has contracts with six UK companies worth £2.7M.
Eculizumab has transformed quality of life and life expectancy for patients with PNH and led to major economic impacts with global drug sales of $1,134 million in 2012 and to Alexion Pharmaceuticals being worth over $19 billion. PNH is a disabling blood disorder that was previously fatal in 50% of patients but with eculizumab survival is comparable to the normal population as well as returning patients to having a normal quality of life. Research in Leeds led to the introduction of eculizumab in 2007. Eculizumab is now approved for clinical use in over 40 countries and for another life threatening disease, atypical haemolytic uraemic syndrome.
Research at UCL firmly established tacrolimus as the optimal calcineurin inhibitor to use in immunosuppressive regimens following liver transplantation. Compared to ciclosporin its use improved graft survival by 6% and patient survival by 7%. Assuming 550 liver transplants per year in the UK since 2008, we can estimate that, with 90% of patients treated with tacrolimus and 10% ciclosporin, tacrolimus-based immunosuppression has resulted in 165 grafts and 192 lives being saved during the period 2008-13.