Stroke Re

Editorial
# The Lancet, Vol 368, page 2034

One of the most promising new approaches in cardiovascular medicine hit the buffers on Dec 2 when Pfizer announced the stopping of its phase III clinical trial development of torcetrapib. Only days previously, the company had announced its hope to have the drug licensed next year in the USA. Torcetrapib was the lead compound in a new class of inhibitors of cholesterol ester transfer protein (CETP). Inhibition of this enzyme increases concentrations of HDL-cholesterol. The hope was that the combination of a statin (to reduce simultaneously concentrations of LDL-cholesterol) with a CETP inhibitor would further decrease the risk of atherothrombotic´cardiovascular events. Observational studies and randomised trials (with a fibrate or nicotinic acid) have shown that HDL-cholesterol concentrations are inversely associated with cardiovascular risk.

The company’s announcement followed routine scrutiny by the data and safety monitoring board for the ILLUMINATE study. This trial was a large international randomised study of torcetrapib plus atorvastatin versus atorvastatin alone in 15 000 patients with or at risk of coronary heart disease. There had been 82 deaths in the torcetrapib plus atorvastatin group, compared with 51 deaths in the group taking atorvastatin.

Why the Pfizer combination caused excess deaths is not known. A hint comes from a recent study of torcetrapib with atorvastatin, in which systolic blood pressure was slightly higher in the patients taking the combination than in those taking the single agent. Another view is that somehow HDL-cholesterol becomes dysfunctional after CETP inhibition.

The big question is whether the excess deaths observed in ILLUMINATE indicate a class eff ect for CETP inhibitors. Two other companies are studying CETP inhibitors in clinical trials, but data are not yet available. It would be intriguing to know whether and how patients in these studies are being informed about the demise of torcetrapib.

www.thelancet.com Vol 368 December 9, 2006

Saturday, 3 June 2006, 23:07 GMT 00:07 UK

A pill could increase the levels of "good" cholesterol

A major international trial has been set up to see whether a treatment to increase so-called "good" cholesterol can prevent heart attacks and strokes.

"Good" cholesterol - high density lipoproteins (HDL) - cuts heart disease risk removing fat from the circulation.

The treatment, designed to increase levels of HDL, will be given alongside drugs to reduce "bad" cholesterol, which can raise the risk of disease.

A team at Oxford University is leading the trial involving 20,000 volunteers.

To be eligible for the trial patients must be aged between 50 and 80 with a history of heart attack, stroke or peripheral artery disease.

Around 7,500 men and women will be recruited from the UK with people from China and Scandinavia making up the rest of the participants.

The main ingredient in the trial drug is niacin, which has been found to increase levels of HDL by between a fifth and a quarter as well as decreasing dangerous fatty substances called triglycerides.

"The trial will be in people at risk of future heart problems despite the fact that their LDL cholesterol has been lowered" Dr Jane Armitage, Trial leader

But patients have found it difficult to take niacin long-term because it produces an uncomfortable side-effect of flushing.

To combat this effect, niacin has been combined with another drug, which blocks the release of prostaglandin D2 - the substance which produces the flushing effect.

The team at the Clinical Trials Unit at Oxford previously carried out the landmark Heart Protection Study which showed a third of all heart attacks and strokes could be avoided in people at risk of vascular disease by using statins to lower "bad" cholesterol or low density lipoproteins (LDL).

Large-scale trials have shown that lowering LDL for four to five years cuts the risk of heart attacks and stroke by a quarter.

But the risk among patients who already have vascular disease remains high even with the use of statins and there is limited scope for reducing LDL much more so researchers are starting to look at ways of also increasing HDL.

'The next step'

Dr Jane Armitage who is leading the trial said: "The difficulty has been that there haven't been good quality drugs that raise HDL very much.

"The trial will be in people at risk of future heart problems despite the fact that their LDL cholesterol has been lowered.

"If it's shown to work the epidemiology suggests it will be possible for people at lower risk of heart problems to benefit," she said.

Professor Gilbert Thompson, a lipidology expert at Imperial College said treatments which raise HDL were the "next step" in cholesterol research.

"It seems a perfectly reasonable approach but it won't necessarily give you a straight answer about HDL because niacin also lowers triglyceride. But it will be a good trial.

Dr Anthony Wierzbicki, Chair of Heart UK Scientific Medical and Research Committee, said looking for ways of raising HDL in addition to lowering LDL was the next logical step.

"There are a number of trials looking at this that are either under way or starting soon all following the protocol of adding HDL-raising agents to baseline statin therapy in a variety of patient populations."

A group of drugs called CETP inhibitors have also been shown to increase levels of "good" cholesterol and are currently in clinical trials.

Source: BBC
http://news.bbc.co.uk/1/hi/health/5029616.stm

Linda Brookes, MSc

Presenter: Peter H. Jones, MD (Baylor College of Medicine, Houston, Texas)

The results of the COMParative Effects on Lipid Levels of Niaspan and statins versus other lipid therapies (COMPELL) trial showed that in patients at high risk for cardiovascular events, low-density lipoprotein (LDL)-cholesterol levels can be lowered to goal and high-density lipoprotein (HDL)-cholesterol levels raised without the need for high doses of statin medications, the investigators believe. In the COMPELL study, low-dose combination therapy with extended-release niacin (Niaspan; Kos Pharmaceuticals, Cranbury, New Jersey) and either atorvastatin or rosuvastatin reduced LDL cholesterol, apolipoprotein (apo) B, and non-HDL cholesterol comparably to reductions with moderate-to-high doses of rosuvastatin monotherapy or ezetimibe-simvastatin fixed-dose combination tablet over 12 weeks.^[1] In addition, the niacin plus statin combinations had greater benefits for HDL cholesterol, HDL2, triglycerides, and lipoprotein(a) [Lp(a)] than either of the other 2 regimens.

Treatment

The objective of COMPELL, a phase 4, open-label, parallel-group efficacy trial sponsored by Kos, was to compare the effect of a statin plus niacin or ezetimibe vs a statin alone. The treatments used were niacin in combination with atorvastatin or rosuvastatin, ezetimibe-simvastatin fixed-dose combination, and rosuvastatin monotherapy. Treatment was given over 12 weeks and included low-to-moderate doses of atorvastatin or rosuvastatin vs moderate-to-high doses of rosuvastatin or ezetimibe-simvastatin. Doses were increased at 4 and/or 8 weeks (Table 1), and lipids were measured at baseline, week 8, and week 12 visits, with safety evaluations done at each 4-weekly visit.

Table 1. Dose Regimens (mg/day) at Randomization

Weeks	Niacin + Atorvastatin	Niacin + Rosuvastatin	Ezetimibe- Simvastatin	Rosuvastatin
1-4	500/20	500/10	10/20	10
5-8	1000/20	1000/10	10/20	20
9-12	2000/40	1000/20	10/40	40

A total of 292 patients were enrolled at 32 US centers, with an average age of 58 years, 29% aged ≥ 65 years, about 50% women, 84% white, and mean body mass index 29 kg/m². Mean baseline lipid values were LDL 5.1 mmol/L (197 mg/dL), HDL 1.3 mmol/L (50 mg/dL), and triglycerides 1.9 mmol/L (171 mg/dL). After washout, screening, and qualification, patients were randomized to:

• Atorvastatin plus niacin (n = 60);
  
  
• Rosuvastatin plus niacin (n = 65);
  
  
• Ezetimibe-simvastatin (n = 72); or
  
  
• Rosuvastatin monotherapy (n = 73).

Results

No difference was seen between treatment groups in percentage of LDL-cholesterol lowering from baseline to 8 weeks or 12 weeks, the primary endpoint of the study (Table 2). Greater effects with the statin plus niacin combinations were seen on HDL cholesterol and triglycerides at 12 weeks compared with ezetimibe-simvastatin or rosuvastatin monotherapy.

Table 2. Percentage of Changes in LDL Cholesterol, HDL Cholesterol, and Triglycerides at Week 12

Regimen	LDL Cholesterol	HDL Cholesterol	Triglycerides
Niacin + atorvastatin	-56	+22	-47
Niacin + rosuvastatin	-51	+24	-40
Ezetimibe-simvastatin	-57	+10*	-33*
Rosuvastatin	-53	+7*	-25*

HDL = high-density lipoprotein; LDL = low-density lipoprotein

*P < .05 vs atorvastatin + niacin

At 8 weeks, low-dose niacin plus either atorvastatin (20 mg) or rosuvastatin (10 mg) had already lowered LDL cholesterol by about 50%, Dr. Jones noted. The statin plus niacin combinations lowered apo B, non-HDL, and total/HDL cholesterol comparably to ezetimibe-simvastatin or rosuvastatin (Table 3).

Table 3. Percentage of Changes in apo B, Non-HDL Cholesterol, and Total Cholesterol/HDL Cholesterol at Week 12

Regimen	Apo B	Non-HDL Cholesterol	Total Cholesterol/ HDL Cholesterol
Niacin + atorvastatin	-49	-55	-50
Niacin + rosuvastatin	-46	-49	-48
Ezetimibe-simvastatin	-45	-54	-47
Rosuvastatin	-42	-50	-43

Apo = apolipoprotein; HDL = high-density lipoprotein

*P < .05 vs atorvastatin + niacin

A trend toward an increase in Lp(a) was seen with ezetimibe-simvastatin and rosuvastatin monotherapy, whereas both statin-niacin combinations showed a significant reduction in Lp(a) compared with the 2 non-niacin therapy groups. The statin plus niacin combinations showed no difference vs the other treatment groups in effects on small HDL particles (HDL3), but large HDL particles (HDL2) were significantly increased by the statin-niacin combinations.

Table 4. Percentage of Changes in Lp(a), HDL2, and HDL3 at Week 12

Regimen	Lp(a)	HDL2	HDL3
Niacin + atorvastatin	-14	+93	+5
Niacin + rosuvastatin	-5	+102	+10
Ezetimibe-simvastatin	+7*	+41*	+6
Rosuvastatin	+18*	+31*	+5

HDL2 = large high-density lipoprotein particles; HDL3 = small high-density lipoprotein particles; Lp(a) = lipoprotein(a)

*P < .05 vs atorvastatin + niacin

Safety and Tolerability

All drug regimens were generally well tolerated, with similar rates of adverse events (55% to 67%) and serious adverse events (3% to 4%) on all treatment arms. Approximately 90% of patients on ezetimibe-simvastatin or rosuvastatin completed the trial vs approximately 75% to 80% of patients on statin plus niacin combinations. Most discontinuations in patients on the niacin-containing regimens were due to flushing or other cutaneous reactions. These may have been related to a low rate (60%) of aspirin use in the study, Dr. Jones suggested.

No drug-related myopathy (myalgia plus elevated creatine kinase > 10 x upper limit of normal [ULN]) was observed, and no patient had asymptomatic creatine kinase elevation > 5 or > 10 x ULN. One patient receiving rosuvastatin had a reversible liver enzyme elevation > 3 x ULN on 2 successive measurements. Small increases in fasting glucose (+3 to +5 mg/dL) were observed with the nicotinic acid-statin combinations, but at 12 weeks there was no change in hemoglobin A1c levels. A slight increase in uric acid (approximately 0.1 mg/dL) occurred in patients on the statin plus niacin treatments compared with no change or a decrease (0.4-0.5 mg/dL) in other groups.

Implications

"The bottom line of the COMPELL study is that we can lower LDL cholesterol substantially, by 50% to 55%, with statins, but what we cannot do with statins is increase HDL-cholesterol and lower triglycerides," Dr. Jones commented later. "In patients who need substantial triglyceride lowering and HDL increases, the COMPELL study shows that you can double or triple your increase in HDL cholesterol, and you can improve your triglyceride lowering by at least 50% by adding niacin to statin therapy," he said. "So for patients who need more than LDL-cholesterol lowering, for raising HDL cholesterol and lowering triglycerides, niacin extended-release is a safe and very effective drug in combination for clinicians to consider."

He continued:

Niacin is the best HDL-cholesterol raising drug right now. Fenofibrate is good, but not as good as niacin, and the statins have only a modest effect. The cholesteryl ester transfer protein (CETP) inhibitors will come along in the next couple of years, and they can raise HDL more than any of these other drugs, but we do not have any real data to back up the benefits of raising HDL by that method. We at least have some clinical trial evidence that niacin is a safe and effective medication. We have the results of the HDL Atherosclerosis Treatment Study (HATS) trial^[2]; we have data on angiographic regression using niacin; and we have data on niacin from the Coronary Drug Project,^[3,4] so we know that niacin has benefits. So until the data about CETP inhibition come out, we think niacin, especially niacin extended-release, is the best for raising HDL cholesterol. Eventually the 2 ways of raising HDL cholesterol will have to be compared, but that will not happen for several years, and in the meantime we have the AIM HIGH and the HPS-THRIVE studies.

Ongoing Trials of Statin Plus Niacin

The AIM HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL-cholesterol/High Triglyceride and Impact on Global Health Outcomes) and HPS-THRIVE (Heart Protection Study 2 Treatment of HDL to Reduce the Incidence of Vascular Events) phase 3 trials are each investigating whether treating multiple lipid abnormalities with a statin plus niacin combination is more effective in reducing coronary heart disease (CHD) risk than statin therapy alone in patients with established cardiovascular disease.

AIM-HIGH, a US-Canadian multicenter, randomized, double-blind, parallel-group, controlled clinical trial, is comparing extended-release niacin plus simvastatin with simvastatin alone over a median follow-up of 4 years at comparable levels of on-treatment LDL cholesterol in patients with atherogenic dyslipidemia, ie, low HDL cholesterol (≤ 40 mg/dL) and high triglycerides (≥ 150 mg/dL). The study will enroll an estimated 3300 men and women aged > 45 years old. The primary composite clinical endpoint is CHD death, nonfatal myocardial infarction (MI), ischemic stroke, or hospitalization for high-risk acute coronary syndrome with objective evidence of ischemia (troponin-positive or ST-segment deviation). A secondary endpoint is the composite of CHD death, nonfatal MI, or ischemic stroke. Follow-up will extend through 2010. AIM HIGH is sponsored by the National Heart, Lung, and Blood Institute with additional support from Kos Pharmaceuticals.

HPS2-THRIVE is studying a new combination tablet containing extended-release niacin plus a specific blocker of prostaglandin D2 to prevent the flushing associated with niacin. HPS2-THRIVE will recruit 20,000 men and women aged between 50 and 80 years who have a history of MI, stroke, or peripheral arterial disease, one third of whom will also have diabetes. Patients will first have their LDL-cholesterol treatment optimized with statin-based therapy, and then they will be randomly allocated to receive the new combination HDL-raising tablets or matching placebo daily for ≥ 4 years. Centers in the United Kingdom, China, and Scandinavia are participating in the study, which is being coordinated at Oxford University, Oxford, United Kingdom, under a grant from Merck & Co., Inc. (Whitehouse Station, New Jersey), developer of the combined HDL-cholesterol raising tablet, MK-0524A. MK-0524A is also being studied in a combination tablet with simvastatin.

References

1. McKenney JM, Jones PH, Bays HE, et al. Comparative lipid effects of combination therapy with a statin and extended-release niacin versus statin plus ezetimibe versus a statin alone. Atherosclerosis. 2006;7(suppl):174. Abstract Tu-W27:4.
2. Brown G, Zha X-Q, Chait A, et al. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med. 2001;345:1583-1592. Abstract
3. Coronary Drug Project report on clofibrate and niacin. Atherosclerosis. 1978;30:239-240. Abstract
4. Canner PL, Berge KG, Wenger NK, et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986;8:1245-1255. Abstract

Source: MedScape
http://www.medscape.com/viewarticle/541811

Related Links:
Systematic review of dietary intervention trials to lower blood total cholesterol in free-living subjects

31 May 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.”

(ends)

Note: Cholesterol is a type of fat, called a lipid, present in blood and in cell membranes. Low density lipoprotein (LDL) cholesterol is often called “bad” cholesterol because it is taken up by the artery walls, leading to the narrowing of the vessels which causes heart attacks and strokes. On the other hand, high density (HDL) cholesterol is call “good” cholesterol because it removes cholesterol from the circulation, thus protecting against vascular disease. The average total blood cholesterol level for adults in developed countries is about 5.5 mmol/l, which typically reflects LDL cholesterol levels of about 3.5 to 4.0 mmol/l and HDL cholesterol levels of about 1.0 mmol/l. The balance between the levels of LDL and HDL cholesterol is vital.

Further information:

Margaret Willson Tel: +44(0)1536 772181. Mobile: +44(0)7973 853347.

Email: m.willson@mwcommunications.org.uk

Source: Oxford Clinical Trial Service Unit (CTSU)
http://www.ctsu.ox.ac.uk/pressreleases/2006-05-31/hps2-thrive-press-release

Related Links:
Merck Co.
MedScape

10.10.06, 12:00 AM ET

TUESDAY, Oct. 10 (HealthDay News) -- In the future, quick, effective wound control could come from a tube.

Researchers say they're developing a clear gel that covers an injury and immediately stops bleeding.

The gel has only been tested in rodents, and no one knows whether it will work in humans. But if it does, the product could turn out to be a major advance for both surgeons and ordinary people.

"If you are out camping, and you cut your hand, you could carry a tube of this and squirt it on your hand and stop bleeding," explained Rutledge Ellis-Behnke, an investigator at the Massachusetts Institute of Technology and lead author of a new study on the gel.

While doctors have devised ways to stop it, bleeding remains a serious challenge during surgery.

Compression -- the same approach used to encourage blood clotting in a nosebleed or paper cut -- is one strategy. Cauterization -- frying the ends of blood vessels -- is another.

Surgeons also turn to clot-boosting drugs and even use the main ingredient in "Super Glue" to close wounds.

Ellis-Behnke and his colleagues accidentally came across another possible solution while testing ways to reconnect severed parts of the brain. "We noticed that all the bleeding stopped in the brain when we put the material in," he said.

The gel in question creates a barrier of peptides -- tiny bits of protein -- when placed on a wound. The researchers tested the gel on hamsters, using it to treat wounds to the brain, liver, spinal cord, muscle and femoral artery.

The study was published Tuesday in the online edition of Nanomedicine.

The researchers, from MIT and Hong Kong University, found the gel worked within 15 seconds to stop bleeding.

It's not clear just how it works, but researchers don't think it's causing the blood to clot, since that process takes 1 to 2 minutes. "We could find out that it's just a physical barrier," Ellis-Behnke said.

Later, the gel -- which is clear and looks like water -- disintegrates into amino acids, the building blocks of proteins.

According to Ellis-Behnke, the gel could potentially be used to stop a variety of kinds of bleeding. "In every surgery, about 50 percent of the time is spent controlling bleeding. If you could use this in a lot of those surgeries, you could reduce the time it takes to do the surgery and reduce the amount of blood you have to put in that person," he said.

He added that the gel might even help preserve severed limbs by reducing bleeding as they await reattachment to the body, he said.

The next step is to test the gel on a larger animal, pigs, Ellis-Behnke said. He estimated it may take three to five years before the product reaches the human market.

As for the cost, Ellis-Behnke doesn't expect the gel to be very expensive. Ellis-Behnke does not have a direct financial stake in the product's success, although MIT does.

Currently, doctors are testing another anti-bleeding product -- an intravenous drug known as NovoSeven that appears to boost blood clotting.

The new gel isn't intravenous and can require surgeons to open up parts of the body to get to the bleeding areas, noted Dr. Mary Pat McKay, director of the George Washington University Center for Injury Prevention and Control.

McKay, who's familiar with the findings of the new study, added that it's not entirely clear what happens to the gel over time once it is applied to a wound.

Still, the gel could help patients, especially those who fail other treatments, McKay said. She added that it could also prevent patients from needing extensive transfusions.

"It has some real potential," she said. "But it's pretty far away from being used in humans."


More information
There's more on wound control at the State University of New York.


Source: Forbes
http://www.forbes.com/forbeslife/health/feeds/hscout/2006/10/10/hscout535429.html

Saturday, 23 September 2006, 23:21 GMT
By Jane Elliott

One device tears toilet paper

When Owain Morgan needed to come up with a design to help people who had suffered a stroke, he turned to his own family for inspiration.

His grandmother and uncle had both had strokes and talking to them he realised something as simple as a device to help them tear toilet and kitchen paper with one hand could make a big difference to their lives.

"It didn't really occur to me before talking to them that this might be a problem for people - that something so simple could help," said 18-year-old Owain, an apprentice from South Wales.

There are more than 450,000 people living in the UK who, as a result of a stroke, need to rely on others to help with simple everyday tasks like these.

Challenge

In a bid to raise awareness of the problem and do something to help those who have had a stroke, the UK defence and aerospace group, BAE Systems set their apprentices the challenge of designing devices to make lives easier.

The teams had either to develop a mechanical aid to help people who had paralysis of a limb to do everyday activities, or design an electrical aid to help those with speech problems (dysphasia) communicate in everyday situations.

Strokes can leave people with disabilities

The entries were whittled down to a shortlist of four.

Project manager John Flemming said his group of apprentices had come up with a device to aid the rehabilitation of muscular movement.

They worked with physios at Bucknall Hospital, in Stoke-on-Trent, who are currently trialling the invention.

"The idea was to help rehabilitate both the arm and the shoulder by helping to reintroduce tension back through use.

"It will then help reduce muscle wastage as well as reducing the chances of the patient suffering from oedema."

All these devices have been devised with the view of enhancing the freedom of choice and independence of the person who has had the stroke

Professor Alan Wing

Lucy Thatcher, who co-ordinated her team's entry, said their device was designed to help patients to communicate more easily with their carers.

She said both carer and patient could be given an LED (Light Emitting Diode) box that would alert the carer when there was a problem.

Attaching four symbols, such as the picture of a cup or an emergency symbol to both devices, could allow the patient not only to say they needed help, but why.

"This could be particularly useful in the first stages when the patients' dysphasia can be the most severe.

"It allows the patient to buzz if there is an emergency and allows the carer to rush in if it is an emergency and to know, if not, what their needs are," said Lucy.

Kitchen aid

Another team, under project manager Carl Dodd, designed a board with a multitude of kitchen implements designed to make chopping, grating, mashing and paring possible with just one hand.

Chopping is difficult with only one hand

"We knew nothing about stroke when we started, but we did lots of research and now we know lots about it.

"We went out with questionnaires and asked people what would be useful for them.

"We designed the devices and when we had finished them we took them to one of the ladies who was helping us for her to trial them.

"She made her comments and then we changed them."

Professor Alan Wing, professor of human movement in the department of psychology, at the University of Birmingham, said many people were unaware of the long-term effects of stroke on the body and that these devices could help improve their quality of life.

"All these devices have been devised with the view of enhancing the freedom of choice and independence of the person who has had the stroke. This is very important.

"Hopefully, after the competition, some of these designs will then be developed and be available for use.

"There is one school of thought that says people who have had strokes should not be given devices like this too early on, but six months after a stroke the recovery is slowing down and these devices could be very helpful," he said.

Results

Alex South, volunteer co-ordinator at The Stroke Association, said it was delighted with the range of devices produced.

"Stroke is the leading cause of severe disability in the UK and each device would go some way in helping to improve the life of a stroke survivor.

"All of the teams involved have gained a lot from the challenge and have learnt more about what it is like to actually live with the effects of stroke."

The winning team will be announced on 29 September.

During the year BAE Systems also hopes to raise £850,000 for the Stroke Association.

Source: BBC
http://news.bbc.co.uk/1/hi/health/5323536.stm

By THE ASSOCIATED PRESS
Published: February 24, 2005

A drug that keeps hemophiliacs from bleeding to death could also prove to be the first effective treatment for the most lethal and crippling type of stroke, the kind caused by a burst blood vessel in the brain, researchers are reporting today.

In an international study, the researchers said, stroke victims given the drug - recombinant activated factor VIIa, a clot-forming drug sold as NovoSeven - were one-third less likely to die and three times as likely to survive without severe disability.

But Dr. Stephan A. Mayer, a stroke specialist at Columbia University Medical Center who led the study, said that the drug needed more study and that it would be at least two years before the maker, Novo Nordisk, applied for Food and Drug Administration approval for this purpose.

Most of the 700,000 strokes in the United States each year are caused by a clot that cuts off the flow of blood to the brain. Over the past decade, the clot-busting drug T.P.A., or tissue plasminogen activator, has been effective in treating many of them.There has been no effective treatment for the 10 percent to 15 percent of strokes caused by bleeding in the brain.

More than half the victims die within a year, and only one in five recover well enough to regain mobility.

The researchers tested NovoSeven, which has been on the market since 1999 as a treatment for hemophilia, against bleeding strokes. The findings are reported today in The New England Journal of Medicine. The study was financed by Novo Nordisk; Dr. Mayer gets consulting fees from the company.

The study was conducted at 73 hospitals in 20 countries. Researchers assigned 399 patients to get the drug or a placebo. Patients who took the drug within four hours of the onset of a stroke had about half the amount of bleeding in their brain.

After three months, 18 percent of those who took the drug had died, compared with 29 percent of those in the other group.

The drug had side effects. Seven percent of patients who received it suffered heart attacks or strokes caused by blood clots, compared with 2 percent of those in the other group. But most recovered.

"The benefit definitely outweighs the risk," said Dr. Marc R. Mayberg, chairman of the Stroke Council of the American Heart Association. Dr. Mayberg had no role in the study.


Source: New York Times
http://www.nytimes.com/2005/02/24/health/24stroke.html

Related links:
Novo Nordisk
NovoSeven
European Medicines Agency
FDA
NovoSeven for Traumatic Coagulopathy
NovoSeven Drug information

September 6 - It sounds frightening and bleeding in the brain is a scary type of stroke. But, now a new therapy is working wonders.

Intracerebral hemorrhaging, or brain bleeding, is a scary type of stroke. It makes up 15 percent of all strokes, and there are no effective treatments for it. Ninety percent of patients are dead within a month if it's a large hemorrhage in a deep brain structure. But now, a new therapy seems to stop the bleeding in its tracks.

These houses are the fruits of Clifford Golatt Jr.'s labor. For more than 20 years, he worked as a brick mason. But he went from laying bricks to laying in a hospital bed after having a stroke five months ago.

"Just went dead all of sudden," Golatt says. "That's when I knew I was having a stroke, you know. I told them I was having a stroke, and they thought I was telling a fib, but I wasn't."

Clifford suffered an intracerebral hemorrhage, a type of stroke that's often fatal and has no effective treatments.

"It's about the most frustrating situation you can imagine," Christiana Hall, M.D., a neurologist at the Medical College of Georgia in Augusta, tells Ivanhoe.

Dr. Hall is one researcher from 100 sites worldwide studying the clotting drug NovoSeven. If it is given within the first few hours after a stroke, it seems to stop the hemorrhage in its tracks.

"The earlier we can get to patients with hemorrhage, the better opportunity they will have for recovery," Dr. Hall says.

Golatt's scan at the time of stroke and after showed the hemorrhage had hardly grown. He was part of the study and doesn't know yet if actually received NovoSeven or a placebo drug. But he was paralyzed on the right side of his body when he came into the hospital. Five days later, he was able to lift that side. And now he's walking!

"The new treatment, I don't know what it was about, but I think I'm doing great," Golatt says.

Even though he would really like to be back building houses, he admits, "I think I was one of the lucky ones." Just being able to walk alongside houses without his cane and with his best friend Marilynn is enough for now.

A small previous study showed NovoSeven led to better patient outcomes and reduced the number of deaths. If the current study also proves it's effective, it could become FDA approved for widespread use, much like how the drug TPA has become the gold standard for ischemic stroke patients with a clot.

NovoSeven is already an approved treatment for some hemophiliacs.

Source: ABCnews
http://abclocal.go.com/kfsn/story?section=health&id=4535073