Dr Jane Armitage of the CTSU, one of the principal investigators, explained: "It has long been known that higher levels of good HDL cholesterol are correlated with lower risks of heart disease. Unfortunately, there is little evidence to date that raising HDL cholesterol with drugs is beneficial. Most studies have used fibrates, which raise HDL only modestly and results have been mixed.
"We have known for a long time that niacin is a very effective HDL raising agent. It increases HDL cholesterol by between a fifth and a quarter, as well as decreasing dangerous fatty substances in the blood called triglycerides by between a fifth and a third. But, the only large randomised study of niacin was conducted long before the introduction of statins, and patients find it difficult to take niacin long-term because it produces an uncomfortable side-effect of flushing. This flushing is caused by niacin dilating blood vessels in the skin through stimulating the release of a substance called prostaglandin D2.
"What Merck has done is to combine their own extended-release niacin with a specific blocker of prostaglandin D2 to make MK-0524A. Early studies with daily doses of this new combination in a few thousand people have shown that it substantially increases HDL cholesterol levels and is well tolerated with much lower frequency and intensity of flushing."
HPS2-THRIVE will recruit men and women aged between 50 and 80 with a history of heart attack, stroke or peripheral arterial disease. Up to 7,000 of these people will also have diabetes. Oxford's CTSU will be the central co-ordinating centre, with three regional co-ordinating centres in the UK, China and Scandinavia. About 7,500 people will be recruited in the UK, 7,500 in China and 5,000 from Denmark, Norway, Finland and Sweden.
Potentially eligible patients who agree to take part will first have their LDL cholesterol
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Contact: Margaret Willson
m.willson@mwcommunications.org.uk
44-153-677-2181
Clinical Trial Service Unit, Oxford University
30-May-2006