Talk on randomised trials with a focus on design/methodological aspects
Professor Colin Baigent BM BCh FRCP FFPH is and MRC Career Scientist, Deputy Director of the Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) at the University of Oxford, and Honorary Consultant in Cardiovascular Epidemiology. His main interest is in cardiovascular epidemiology, and most particularly the design, conduct and application of large-scale randomised trials in cardiovascular disease. He has coordinated some of the world’s largest collaborative meta-analyses of randomised trials, typically with individual participant data, resulting in landmark papers that have helped determine the effects of aspirin (and other antiplatelet drugs), fibrinolytic therapy, and statins in different types of patients. Most recently, his group’s work on the cardiovascular hazards of non-steroidal anti-inflammatory drugs (NSAIDs) led to changes in the European Medicines Agency’s guidance on the use of high-dose diclofenac in patients at high risk of cardiac disease.
His group has also contributed to a better understanding of cardiovascular disease in patients with renal impairment through the Study of Heart and Renal Protection (SHARP). This investigator-led randomised trial is the largest ever in patients with moderate-to-severe chronic kidney disease (CKD), recruiting 9438 patients in nearly 400 hospitals in 18 countries. The results showed that lowering cholesterol with the combination of simvastatin 20mg and ezetimibe 10mg daily reduced the risk of cardiovascular disease in patients with CKD, chiefly by reducing atherosclerotic events, but did not reduce the rate of loss of glomerular filtration rate among the 6000 patients who were not receiving maintenance dialysis treatment at baseline. This benefit was achieved without any increased risk of adverse effects. The results confirmed that LDL cholesterol is a cause of atherosclerosis in patients with CKD, even though most do not have hypercholesterolaemia, and has led their classification as ‘high risk’ in most treatment guidelines and, as a consequence, much wider use of LDL-lowering therapy among them.