Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Launch of major international study to test new drug combination to cut cardiovascular disease

31.05.2006


A major international study to test whether a new combination treatment that increases good “HDL” cholesterol prevents heart attacks and strokes will start to recruit patients later this year, it was announced today (Wednesday 31 May).



It will recruit 20,000 patients with vascular disease from the UK, China and Scandinavia to investigate whether combining niacin with a new drug (MK-0524A) that minimises niacin’s side-effects (chiefly facial flushing) can drive down still further the risk of serious heart attacks and strokes among people already taking treatment to lower their bad “LDL” cholesterol levels effectively.

It is being co-ordinated at Oxford University by the Clinical Trial Service Unit (CTSU), the research unit famous for running huge international studies, including the ground-breaking Heart Protection Study (HPS) which showed that a third of all heart attacks and strokes can be safely avoided in people at risk of vascular disease by using statins to lower LDL cholesterol.


The new study – called HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) – will be funded through a £42million grant to Oxford University by the pharmaceutical company Merck & Co., Inc. (Whitehouse Station, NJ, USA), developers of the combined HDL raising tablet. However, the CTSU has designed the study and will be responsible for coordinating it and analysing its results, independently of the funders.

Large-scale randomised studies have shown that lowering LDL cholesterol by about 1mmol/l for four to five years cuts the risks of heart attacks and strokes by about a quarter, and recent studies suggest that more intensive LDL-lowering can produce extra benefits. Even so, the risk among patients who already have vascular disease remains high, but there is limited scope for lowering LDL cholesterol much more.

So, the Oxford research team are taking a different approach by testing a combination tablet that can enable people to tolerate long-term use of an effective HDL cholesterol-raising treatment.

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 treatment optimised with statin-based therapy. They will then be randomly allocated to receive the new combination HDL-raising tablets (MK-0524A) or matching placebo (dummy) daily for at least four years. Participants will have checks at three and six months, and six monthly thereafter during the study.

The primary objective of the study is to see whether fewer participants given the combination HDL-raising tablet (MK-0524A) have heart attacks, strokes or revascularisation procedures than do those in the placebo arm. The researchers will also be looking at long-term safety of the combination tablet.

“This study of HDL-raising treatment is extremely important, and a natural follow-up to our Heart Protection Study of LDL-lowering therapy” said Dr Armitage “As with HPS, it will involve 20,000 participants at elevated risk of vascular disease so, like HPS, it will be able to give us really reliable results. Vascular disease is a major killer in the developed world and, increasingly, in the developing world. In addition to encouraging preventive lifestyle measures, we need to find even better preventive treatments. This new treatment should produce an average increase in HDL cholesterol of around 20%, which might realistically translate into a reduction of about one fifth in the risk of suffering a heart attack or stroke, or of being killed by vascular disease.”

Margaret Willson | alfa
Further information:
http://www.mwcommunications.org.uk

More articles from Studies and Analyses:

nachricht Europe’s Demographic Future. Where the Regions Are Heading after a Decade of Crises
10.08.2017 | Berlin-Institut für Bevölkerung und Entwicklung

nachricht Scientists reveal source of human heartbeat in 3-D
07.08.2017 | University of Manchester

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Fizzy soda water could be key to clean manufacture of flat wonder material: Graphene

Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.

As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...

Im Focus: Exotic quantum states made from light: Physicists create optical “wells” for a super-photon

Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.

Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...

Im Focus: Circular RNA linked to brain function

For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.

While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...

Im Focus: RAVAN CubeSat measures Earth's outgoing energy

An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.

The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...

Im Focus: Scientists shine new light on the “other high temperature superconductor”

A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.

Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Call for Papers – ICNFT 2018, 5th International Conference on New Forming Technology

16.08.2017 | Event News

Sustainability is the business model of tomorrow

04.08.2017 | Event News

Clash of Realities 2017: Registration now open. International Conference at TH Köln

26.07.2017 | Event News

 
Latest News

A Map of the Cell’s Power Station

18.08.2017 | Life Sciences

Engineering team images tiny quasicrystals as they form

18.08.2017 | Physics and Astronomy

Researchers printed graphene-like materials with inkjet

18.08.2017 | Materials Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>