New drugs being tested in Europe?

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I was asked the other day if I heard of anything about a new anticoagulant. No I haven't. Is it an anticoagulant that your referring too?
 
yeah, something that would replace Warfarin/Coumadin that prevents strokes, but doesn't have vit K interaction, clots faster, and is suposedly much more stable. I think he might have been a bit overy optimistic, but my surgeon was from France so he pays a lot of attention to what is going on over there and has many peers there.
 
I know there are tests going on with certain drugs, but from what I'm hearing, and I have not been able to prove it, something is going on in Europe with something. I can't even get a name. I hate to say it, but we've held hopes up for a long time that a replacement would come along. Many looked promising in mice, but when applied to humans, destroyed their liver.

If I ever catch the name and where it's at, I'll surely post it, but it may be a long time before it's here in the U.S.
 
There is at least one anticoagulant currently in (and recruiting for) US trials for Atrial Fibrillation, which is the long-term-use testing that any new anticoagulant will have to undergo before it can even think to be tried for efficacy with mechanical valves. That puts new ACT compounds for mechanicals a minimum of five-plus years in the future, possibly even for trials.

Best wishes,
 
One drug that has just been approved in the US is a platelet inhibitor anticoagulant similar to Plavix (clopidogrel). It's called Effient (prasugrel), and has the same warnings and indications as Plavix, but has a slightly better profile in preventing cardiac episodes. It's expected to cost even more than Plavix (which is not cheap), at least at the beginning.

This isn't likely to become a valve ACT prescription.

Best wishes,
 
Outcome of "new" anti-coagulant ........................

Outcome of "new" anti-coagulant ........................

under study in Ontario.

Friend underwent knee replacement surgery and was put on a new clot controlling/preventing, an anti-coagulent drug under "study". Patient developed severe pain in groin, the leg not operated on experienced 'severe" swelling, in other words a clot. Clot was not diagnosed as such for several days. Had this clot migrated she would be dead.

These details are second hand, patient's husband too upset and anxious and can't remember the name of the drug being "studied".

I don't imagine it will still be "studied"--it doesn't work.
 
There are two, one that was approved a few months ago and a newer one still being studied for approval.

No anticoagulant works all the time. For example, Atrial Fibrillation causes a 6% chance of stroke. Use of Coumadin knocks it down to about 3%. Coumadin's about as good as it gets, but if you're in that 3%...

Best wishes,
 
The other day there was a story on the local (philly) news about a new drug trial that Lankenau is part of it's called Dabigatran it is just being studied for Afib Heres a link about it from the hospitals site http://www.mainlinehealth.org/wtn/Page.asp?PageID=WTN000906
...The three-year study by German pharmaceutical manufacturer Boehringer Ingelheim (BI) was the largest stroke prevention trial ever conducted among patients with atrial fibrillation. Involving 18,113 patients in 44 countries, the clinical trial compared results of the new drug against those of Coumadin / Warfarin. About 5,000 of these patients were from the U.S., including participants recruited from Lankenau Hospital....
 
is this the drug your referring to ?
New blood-thinning stroke drug could save lives and cut reliance on warfarin

A new blood-thinning drug to prevent strokes could replace a commonly used treatment based on rat poison for thousands of patients. The drug called Pradaxa is one-third more effective at reducing the risk of stroke and blood clots in at-risk patients than warfarin, and cuts deaths by 15 per cent.

Warfarin, which is still used in large doses to kill vermin, has been a routine medication for preventing strokes since the 1950s. But it is inconvenient for patients because careful monitoring and regular blood tests are needed to prevent excessive bleeding from cuts or stomach ulcers, requiring frequent clinic visits.

It can also interact badly with other drugs and certain foods, including green vegetables and grapefruit. The new drug, Pradaxa, works by reversing and inhibiting the effects of thrombin, which is the substance responsible for clotting.
New possibilities: A drug that could revolutionise stroke sufferers' lives has been discovered

New possibilities: A drug that could revolutionise stroke sufferers' lives has been discovered

Patients taking capsules twice a day do not have to be constantly checked for signs of overdosing, can eat what they like and it is much easier to use alongside other medicines.

Results from a major trial today showed Pradaxa was 34 per cent better at reducing the risk of stroke and blood clots in at-risk patients than well-controlled warfarin.

Fatal strokes were also reduced by 15 per cent when patients were given the drug More than 18,000 patients aged around 71 from 44 countries took part in the three year RE-LY (randomised evaluation of long term anticoagulant therapy) trial.

All suffered from atrial fibrillation, a heart rhythm disorder that greatly increases the risk of stroke. They were randomly assigned to treatment either with Pradaxa or warfarin.

The findings were presented yest(sun) at the European Society of Cardiology's annual meeting in Barcelona, Spain, and published online in the New England Journal of Medicine.

Professor Stuart Connolly, one of the leading investigators from McMaster University in Hamilton, Canada, said 'The results exceeded all our expectations.

'We now have an oral treatment which offers superior protection from stroke with less bleeding and without the need for routine monitoring.'

At present the drug, also known as dabigatran, is only licensed in the UK for the treatment of orthopaedic patients at risk of clotting after surgery and taken for up to four weeks.

The drug's makers Boehringer Ingelheim are planning to apply next year for permission to use it for the prevention of stroke when patients would have to take it for life. However, the high cost of Pradaxa means it will have to assessed by the Government's drug rationing body to determine whether it can be widely used in the NHS.

Daily treatment will cost around £4.20 at current prices whereas warfarin costs around £1 for a month's supply, plus clinic visits. Dr Adrian Brady, consultant cardiologist at Glasgow Royal Infirmary, said 'This is the greatest step forward in anticoagulation therapy for over 50 years.

'The results presented today could mean the end of warfarin, known by many as rat poison, for many patients - no more anticoagulation clinics, no more blood tests, no more watching what you need to eat and drink.

'Patients and their doctors will be eagerly examining these findings with a view to switching from warfarin to this new drug once it is licensed.'

Atrial fibrillation (AF) affects more than half a million people in the UK and is a leading cause of stroke. Around 150,000 people in the UK suffer a stroke each year.

Professor Peter Weissberg, medical director of the British Heart Foundation, said the new drug looked promising but further trials were needed to establish its potential.

He said: 'It's the first oral warfarin alternative that's been through a phase 3 clinical trial without showing severe toxicity.

'There are more oral agents in the pipeline and this type of therapy might lead to a rise in the numbers being treated.

'The health economists are going to have to see if the lives saved and the hassle saved are worth the extra costs' he added.

Dr Keith Muir, medical advisor for The Stroke Association said 'Warfarin is a highly effective treatment when indicated for stroke prevention, but it is underused, often because of safety concerns or the need for regular blood tests to monitor its effects.

'The RE-LY trial indicates that dabigatran may offer a useful alternative to warfarin for stroke prevention in some circumstances, but the trial highlights both pros and cons that mean its place isn't yet clear.

'The trial only involved people who could equally well have taken warfarin, and anyone currently taking warfarin should continue it unless advised by their doctor.'
 
Pradaxa results appear to be encouraging

Pradaxa results appear to be encouraging

Hi Jeff
Thanks for posting the most interesting results for an "easier way" to control/prevent clots.

A day or two ago I heard tests/studies on several drugs had been discontinued. Spelled phonetically one was pronoxa an anti-coagulent and when I Googled for it I didn't find anything. Obviously mis-spelled.

Recently a friend was given an anti-coagulant easier to manage than warfarin and developed a clot in her groin.

The two words are so similar I wonder if the Pradaxa study has been terminated.
Sandra
 
Last edited:
lance said:
Hi Jeff
Thanks for posting the most interesting results for an "easier way" to control/prevent clots.

A day or two ago I heard tests/studies on several drugs had been discontinued. Spelled phonetically one was pronoxa an anti-coagulent and when I Googled for it I didn't find anything. Obviously mis-spelled.

Recently a friend was given an anti-coagulant easier to manage than warfarin and developed a clot in her groin.

The two words are so similar I wonder if the Pradaxa study has been terminated.
Sandra
Click to expand...

Pradaxa and Dabigatran (the drug I posted) are the same drug. I'm not sure if it is the same drug your friend had problems with, (chances are it IS the same drug since they are already using it for hip and knee surgeries)but this study has not been stopped. They have been doing a few reports on it the past few days because the results are just coming out now.
Unfortunately none of the anticoagulants completely stop clots or strokes from forming, they just greatly reduce the risks of it happening. From the reports I've read the rates of clots (remember this is one being tested for AFIB, not valves) with pradaxa are very close to that w/ warfarin, but the chances of bleeding are less. (at a correct dose)and it doesn't required monthly testing ect.
Here are the results from the study Seth gave the link to.
"Results Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051).

Conclusions In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600 [ClinicalTrials.gov] .) "

BTW The median duration of the follow-up period was 2.0 years


According to this article http://www.pharmafocus.com/cda/focusH/1,2109,21-0-0-SEP_2009-focus_news_detail-0-493134,00.html other drugs being studied now are
"The new results could speed Pradaxa (dabigatran etexilate) through approval in the indication ahead of rivals, which include Bayer and J&Js Xarelto (rivaroxaban), Pfizer and Bristol-Myers Squibb's apixaban, and Merck & Co's betrixaban"
 
Thanks Lynn

Thanks Lynn

If I understood the news cast correctly I probably jumped to the wrong conclusion. Study stopped/terminated could have meant the drugs are approved and the studies successful--no need to continue the testing.
Thanks for the info.
Interestingly the new anti-coagulant being studied was prescribed following knee replacement surgery to prevent clots.
 
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