The trial REVEAL will examine whether a drug called anacetrapib determination of threat of coronary deaths, heart attacks and other vascular complications can drive. The study will involve 30,000 people who have some form of heart or other disease from the United Kingdom, North America, China, Germany, Italy, Scandinavia and elsewhere.
REVEAL is funded by Merck Sharp & Dohme, which anacetrapib developed. A grant of ￡ 96 million for the cost of these multi-million dollar study at the University of Oxford. This is the largest single research contract ever undertaken by the University.
Professor Andrew Hamilton, Vice Chancellor of the University of Oxford, said: "I am pleased that the Oxford clinical trial Service Unit this important international process is running. The new project on such a massive scale reinforces the Oxford medicine position at the forefront of international research. The University has built up the skills and expertise for many years these complex – and very important – independent clinical research, the results of which may cost millions of lives around the world can. "
CTSU is known for performing major international studies, including the ground-breaking heart protection study that showed that one third of all heart attacks and strokes be safe in people at risk of disease to avoid using Statins lower "bad" LDL-cholesterol. The unit also showed that more intensive lowering of LDL cholesterol with Statins secure additional benefits.
A new type of cholesterol drug
Anacetrapib is a new type of cholesterol treatment, belonging to a known as CETP (cholesteryl ester transfer protein) inhibitors, drug class that is being developed by Merck Sharp & Dohme. It is found for the production of significant reduction in the levels of the blood of "bad" LDL-cholesterol (equivalent to, and besides, who achieved with statin drugs), and the more than doubled from ' good ' HDL cholesterol levels.
Anacetrapib is examined in about 2000 people, of whom approximately 500 have taken for 18 months. In this study, led by a team from Brigham and women's Hospital in Boston, was anacetrapib not associated with adverse effects on one of the most important security endpoints, including blood pressure or other vascular risk factors. The results were reported yesterday in the New England Journal of Medicine and the American Heart Association Conference in Chicago.
Large randomized studies have shown that the risk of heart attacks and strokes lowering LDL-cholesterol by 1 mmol/L for 4 and 5 years with statin therapy by about a quarter cuts, and recent studies suggest that the more intensive LDL lowering of additional benefits can produce. But, despite the use of statins, the risk of heart attacks, strokes and other vascular complications in people who have diseases remains high.
Previous studies have also shown that people with high blood levels of HDL cholesterol tends to be less coronary heart attacks or deaths. However, there is limited evidence of benefits with the drugs that are currently available for raising HDL cholesterol, and widespread use of the most effective of these drugs HDL-raising – which is called niacin-is limited by side effects and poor tolerability.
The new process
Dr. Martin Landray of the University of Oxford, one of the rig researchers of REVEAL, said: "this study may mark the beginning of a new era of cholesterol treatment. Anacetrapib has really dramatic effects on blood levels of cholesterol, even in those already on a statin, and it seems to be well tolerated.
"The key question now is whether this cholesterol changes prevent coronary deaths and heart attacks. It is also crucial to determine whether there is any unexpected side effects in the longer term. The potential is huge, but we have a really large process once-REVEAL is that test. '
Dr. Louise Bowman of the University of Oxford, the other trial investigator, said: "this is a very exciting opportunity to try and improve the lives of the millions of people who have or will develop, heart diseases in the next few years.
"Large studies such as REVEAL are vital if we want to discover new, safe and effective ways to further the suffering caused by heart attacks, strokes and risky heart artery by-pass procedures.
"If the impressive effects of anacetrapib on cholesterol levels are translated into fewer deaths and heart attacks, this treatment has the potential to produce significant benefits to patients."
Reveal is a huge research firm and lasts more than 6 years to complete, with doctors and nurses in approximately 400 hospitals all over the world. It will be the recruitment of 30,000 men and women age 50 with a history of heart attack, stroke or peripheral arterial disease.
CTSU Oxford of the study has designed and is responsible for the coordination and analysis of the results, regardless of the financiers. A Steering Committee of international academic experts, chaired by professor Rory Collins from the University of Oxford, is responsible for the overall functioning of the study.
CTSU will the central coordination centre, with 6 regional coordination centres in the first instance in the United Kingdom, North America, China, Germany, Italy and Scandinavia. The Horn-research group in Boston, under the leadership of professor Eugene Braunwald will coordinate the North American part of the study.
Professor Jeremy Pearson, Associate Medical Director of the British Heart Foundation, said: "this is an important process, under the leadership of BHF-funded researchers. Some drugs increase "good" cholesterol and reduce "bad", but CETP inhibitors do both. This research will show whether this drug can improve survival rates, potential gives new hope for millions of people whose cholesterol levels put them at serious risk of heart disease. "
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