Large Randomised Lipid Modification Trials View Homepage


Ontology type: schema:MonetaryGrant     


Grant Info

YEARS

2006-2016

FUNDING AMOUNT

3154690 GBP

ABSTRACT

Heart disease and stroke are the leading causes of death and disability in the developed and developing world. Blood fats (cholesterol) along with smoking and blood pressure are major causes of these problems. CTSU has run a series of large trials of cholesterol lowering using statins which have provided clear evidence of the benefits of such treatment. Statins lower the blood cholesterol and have been shown to substantially reduce the risk of heart attacks and stroke in a wide variety of people at high-risk of these conditions. These studies have resulted in worldwide changes in clinical practice and very widespread use of statins. However, despite the benefits of statin treatment, some people remain at risk of heart disease and stroke. Further research is required on the long term benefits and risks of therapy in different groups and newer lipid modifying drugs are needed to provide additional benefits. The effects of these newer drugs on the background of statin treatment are likely to be modest so evidence is required from very large randomised studies in order to provide reliable answers about the benefits or otherwise. Technical Summary Along with smoking and blood pressure, blood lipids are a major cause of cardiovascular disease, which remains the leading cause of morbidity and mortality in the developed and developing world. Higher levels of LDL cholesterol and lower levels of HDL cholesterol are associated with higher risks of coronary heart disease. This programme continues the long-running series of large scale trials of lipid modification (both LDL-lowering and HDL-raising) that have been coordinated by CTSU over the last two decades. These studies include the MRC/BHF Heart Protection Study (1993-2001) which assessed the effects of a statin versus placebo in 20,000 high risk patients, SEARCH (1998-2008) which compared more intensive versus standard dose statin, SHARP (2003-2010) which assessed statin plus ezetimibe versus placebo in 9000 patients with chronic kidney disease, HPS2-THRIVE (2006-2012) which assessed niacin and REVEAL (2011-ongoing) which is assessing anacetrapib. These studies and associated meta-analyses (including those conducted by CTSU) have resulted in widespread use of statins, which effectively lower LDL cholesterol, for the primary and secondary prevention of cardiovascular disease. However, there have been questions about their long-term safety and efficacy in different populations. Although statins are widely available and highly cost-effective, some patients remain at high risk despite statin use, thus additional safe treatments to modify risk are needed. Attention is now turning to newer drugs which modulate lipids by other mechanisms. The effects of such additional treatments on top of statins are likely to be modest, so large-scale randomised evidence is required to assess their effects reliably. The HPS2-THRIVE trial assessed the effects of niacin (a lipid-modifying drug used for 50 years) on a background of statin therapy in 25,000 high cardiovascular risk patients from the UK, Scandinavia and China. Niacin raises HDL and lowers LDL-cholesterol but the effects are small. HPS2-THRIVE showed no cardiovascular benefit with niacin and, furthermore, niacin caused substantial harms, including increased diabetes, infections and bleeding. The results led to the niacin preparation being withdrawn. The HPS3-TIMI-55-REVEAL study is currently testing the value of a new inhibitor of the cholesteryl ester transfer protein which raises HDL cholesterol and lowers LDL cholesterol substantially. Over 30,000 patients from Europe, North America and China who are at high cardiovascular risk and already on effective statin treatment have been randomised to receive anacetrapib or placebo and are currently being followed up. Studies of other promising lipid-modifying drugs are also being considered. More... »

URL

http://gtr.rcuk.ac.uk/project/2E9C42EF-5F40-469B-B17D-B28BE745DCB8

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