RobThatsMe
Well-known member
Coumadin Education
Coumadin Education
What can we say about Coumadin® that hasn't already been said good 'n bad. Important to know though, is that Coumadin® reduces the body's ability to form blood clots. It can help stop clots from getting larger and new ones from forming but it does not break up (lyse) existing blood clots. The body will break down the clot over time.
The following is from warfarinfo.com
The Legend of Warfarin
It's Rat Poison Isn't It?
About 80 years ago some farmers noticed that their cattle were dying from an unknown cause.
Veterinarians found that they suffered from internal hemorrhages but were not able to find a reason for several years.
At that time farmers cut hay and placed it in silos. The smell of new-mown hay is largely from a chemical known as coumarin.
This particular year was hotter and wetter than usual, resulting in a particularly high coumarin level.
In the silo, the heat, pressure and high coumarin level allowed a chemical reaction to take place which created an anticoagulant.
When the cows ate the silage, their blood was not able to coagulate normally and they bled to death.
There were no large pharmaceutical research centers in those days.
Physicians thought it would be nice if they could give the chemical to people who had blood clots, but they had no way of determining the dose.
So it was used for rat poison (e.g. DECON).
The Wisconsin Alumni Research Foundation supported much of the work, hence the name warfarin.
A farm worker attempted to commit suicide by eating the rat poison. However, it does not work very fast.
He was taken to the hospital where doctors administered vitamin K.
This counteracted the warfarin and the patient recovered. Now doctors knew how to counter an overdose, but they still did not know a correct dose.
Coumadin® (warfarin sodium) was given to President Eisenhower when he had a heart attack in 1956.
Since then it has been one of the most widely prescribed drugs in the United States.
The current generic versions were introduced in 1997 or more recently.
PLEASE NOTE: This is not just a fun story, there is a report of a woman who was not taking warfarin but spread a warfarin-type rat poison weekly without wearing gloves or washing her hands afterwards.
She evidently absorbed enough warfarin through the skin to cause a brain hemorrhage. (A drug interaction may also have been involved.)
The authors state that there are three other cases of absorption of warfarin through the skin causing coagulation problems.
Reference: Abell TL et al. Cutaneous exposure to warfarin-like anticoagulant causing an intracerebral hemorrhage:a case report. J Toxicol Clin Toxicol 1994;32:69-73.
- End
Home Page
Address:
http://www.warfarinfo.com/default.htm
___
Coumadin® Home Page
(also referred to as Bleedadin® by many doctors)
Warfarin is still used as rat poison (in large quantities). Thank goodness, rats don't get their blood tested, so who gives a rats behind when they keel over.
Address:
http://www.coumadin.com
___
Competition for Coumadin® comin' soon?
As posted here last year, a new anticoagulant shows good promise to give Coumadin® a run for its blood thinnin' money....
Different article from the more recent anti-coagulant archives file
Study finds fewer strokes in patients taking Exanta
By Chris Michaud
December 10, 2001
(Reuters)
Enhanced
Far fewer patients with heart rhythm problems suffered strokes (brain attacks) after taking preventive doses of AstraZeneca Plc's experimental anti-clotting pill Exanta than those who took the standard drug warfarin, the company said on Monday.
Interim results of the phase II trial were presented at the annual meeting of the American Society of Hematology (ASH) in Orlando.
The long-term trial involves 125 patients with non-valvular atrial fibrillation (AF) who got regular doses of Exanta and 42 patients who took warfarin to prevent strokes.
Preliminary results found that patients taking Exanta (ximelagatran) suffered 0.9 strokes and 0.4 transient ischemic attacks (TIAs), sometimes called ministrokes, per 100 treatment years, the equivalent of one person taking the drug for a year.
Patients in the ongoing trial were treated for between 21 months and 24 months, the company said.
That compared with 2.6 strokes and 2.6 ministrokes per 100 treatment years for those taking warfarin, a generically available anti-clotting drug sold by Bristol-Myers Squibb Co. under the brand name Coumadin®.
One of the most worrisome side effects from anti-clotting drugs is their tendency to cause excessive bleeding, which can be life-threatening.
In the trial, Astra said incidence of major bleeding was 0.9 per 100 treatment years for Exanta versus 2.6 per 100 treatment years for warfarin.
"That's a small study, but I'm encouraged by the results," said analyst Catherine Arnold of Sanford C. Bernstein.
"Coumadin® has so many issues, in terms of the drugs it interacts with and the extent to which it has to be monitored to be sure it's at the right level, that even if this is the equivalent to Coumadin®, it will still be used extensively in our view in these populations," Arnold said.
"Of course the results will still have to be confirmed," she added. "It will need a larger-scale study."
AstraZeneca's chief executive officer said last week called Exanta, which if cleared would be the FIRST NEW anticoagulant pill in 50 years, a potential breakthrough drug that could generate annual sales of several billion dollars.
"It's a huge breakthrough potentially in the treatment of blood clots," said CEO Tom McKillop of Exanta, which is designed to work by inhibiting thrombin, an enzyme that is vital to blood clotting and one which he noted many companies had tried and failed to block.
Exanta is one of seven potential AstraZeneca "megabrands" each of which McKillop said he expects could generate over $1 billion in annual sales.
The Anglo-Swedish drugmaker is looking to the new medicines to take up the slack once its $6 billion a year ulcer drug Prilosec® loses its U.S. marketing exclusivity and faces competition from generic versions.
Prilosec® is the subject of a patent dispute currently being contested in federal court by AstraZeneca and several smaller drug manufacturers.
Atrial fibrillation, in which two upper heart chambers quiver instead of beating effectively, is found in about 2 million Americans, according to the American Heart Association (AHA).
Blood in the chambers can then clot, and the clot can then travel and become lodged in the brain, causing a stroke.
---
World-Wide media release
Enhanced
December, 10, 2001
New data support the safety and tolerability of the novel oral anticoagulant Exanta® in a range of life threatening clinical indications
The presentation of a range of data at the 43rd American Society of Hematology (ASH) meeting in Orlando this week, provides encouraging evidence to support the efficacy and safety of the novel oral anticoagulant Exanta® in both the long term prevention of blood clot formation and its treatment.
Exanta is set to be the first new oral anticoagulant since the introduction of warfarin over 50 years ago and is currently under investigation in an extensive clinical trials for a number of key therapeutic areas.
The trials, involving more than 20,000 patients in over 30 countries, includes the important SPORTIF II and IV, and THRIVE I and IV, trials presented at ASH.
Long term SPORTIF IV data, in the key indication of stroke prevention in patients with non-valvular chronic atrial fibrillation, show Exanta is well tolerated in patients for up to 24 months, with comparable efficacy to warfarin and the ADDED BENEFIT OF NO NEED FOR DOSE TITRATION OR ROUTINE COAGULATION MONITORING. (*That'll put an end to those PT/INR message board questions).
SPORTIF IV is an open-label continuation of the 12-week randomised phase II dose guiding study SPORTIF II, presented at the European Society of Cardiology (ESC) meeting, September 2001.
The phase III SPORTIF trial, comprising the SPORTIF III and V studies, is the largest-ever trial conducted in atrial fibrillation, with more than 7,200 patients enrolled.
Atrial fibrillation is the most common cardiac arrhythmia in clinical practice, with incidence approximately doubling with each decade of adult life.
It presents as a rhythm disturbance in the atria of the heart, causing an uneven heart beat.
More than two million people are estimated to have atrial fibrillation in the United States and the associated risk of developing a brain attack is high.
A recent European survey also showed that 18% of patients presenting with a first brain attack were found to have atrial fibrillation.
"The SPORTIF IV results are very promising," said Dr. Palle Petersen, Division of Neurological Rehabilitation, Hvidovre University Hospital, Denmark, a lead investigator in the SPORTIF IV trial.
"The fixed dose regimen of Exanta was well tolerated for up to 24 months, without the need for dose adjustment or coagulation monitoring in patients with a medium to high risk of stroke and systemic thromboembolic complications."
Dr Petersen continued, "Anticoagulation treatment with warfarin is effective in reducing the risk of brain attack in patients with atrial fibrillation.
Doctors, however, are often reluctant to treat patients because of the drawbacks of using warfarin. Under-treatment remains the major problem in brain attack prevention for patients with atrial fibrillation."
In addition to the SPORTIF results, data from the THRIVE trial were also presented at ASH. The THRIVE trial investigates the effect of Exanta in the treatment of venous thromboembolism (VTE).
THRIVE I, which investigated Exanta in the treatment of acute deep vein thrombosis (DVT), confirmed that it is a promising effective alternative to warfarin in preventing the progression of a DVT.
THRIVE IV, which examines Exanta in the treatment of pulmonary embolism (PE), also highlighted its promise in the treatment of a stable PE.
Together, these results show that Exanta is effective both in preventing blood clot formation and treatment.
Data were also presented on a U.S. trial investigating the prevention of venous thromboembolism (VTE) after a total hip replacement.
This data for Exanta resulted in safety and tolerability for this patient population. A pre-clinical study on the use of Exanta as a preventative treatment after acute coronary syndrome (ACS) also showed positive results.
Dr. Ian Watts, Global Product Director, said "The data presented here at ASH highlight the extensive clinical trials currently ongoing with Exanta.
We believe that with fixed oral dose regimen and no need for routine coagulation monitoring, Exanta could offer the possibility of simpler anticoagulation for MILLIONS of patients."
___
At the Mayo Clinic
SPORTIF V
Stroke Prevention using ORal Thrombin Inhibition in atrial Fibrillation
A clinical trial currently recruiting participants. The pupose of this study is to determine the safety and effectiveness of H376/95, an anticoagulant (blood thinner medication), compared with Coumadin® (warfarin), another anticoagulant, in the prevention of strokes and blood clots in participants that have atrial fibrillation (irregular heart rhythm).
Enrollment Goal = 20 Enrollment to Date = 6
Eligibility Summary
Age: 18 years or older
Chronic (prolonged), non-valvular (not related to heart valve disease) atrial fibrillation (irregular heart rhythm)
More detailed eligibility criteria...
Requirements
Participants will be in the study from 12 to 28 months. Between 15 and 18 follow-up visits will be required during this time (blood clotting levels will be checked frequently).
Blood tests, physical exams and electrocardiograms or ECG's (a picture of the electrical activity of the heart) will be performed periodically at these visits.
Additional Information
H376/95 is an investigational anticoagulant (blood thinner medication). Coumadin® (warfarin), also an anticoagulant, has been approved by the Food and Drug Administration (FDA) for use in treating atrial fibrillation.
Contacts
Please contact us if you wish to discuss the availability and requirements of this trial. Note: information is subject to change.
Dr. Win Shen
Study Coordinator: Carol Monnet, RN
(507) 284-1797 or pager 127-06087
Locations
This trial is being conducted at the following location(s):
Mayo Clinic Rochester (Minnesota)
Mayo Clinic Jacksonville (Florida)
This trial information updated Nov 29 2001
File trial_93.html last modified: Tuesday, 29-Jan-2002 14:20:02 CST
Mayo Foundation for Medical Education and Research
Coumadin Education
What can we say about Coumadin® that hasn't already been said good 'n bad. Important to know though, is that Coumadin® reduces the body's ability to form blood clots. It can help stop clots from getting larger and new ones from forming but it does not break up (lyse) existing blood clots. The body will break down the clot over time.
The following is from warfarinfo.com
The Legend of Warfarin
It's Rat Poison Isn't It?
About 80 years ago some farmers noticed that their cattle were dying from an unknown cause.
Veterinarians found that they suffered from internal hemorrhages but were not able to find a reason for several years.
At that time farmers cut hay and placed it in silos. The smell of new-mown hay is largely from a chemical known as coumarin.
This particular year was hotter and wetter than usual, resulting in a particularly high coumarin level.
In the silo, the heat, pressure and high coumarin level allowed a chemical reaction to take place which created an anticoagulant.
When the cows ate the silage, their blood was not able to coagulate normally and they bled to death.
There were no large pharmaceutical research centers in those days.
Physicians thought it would be nice if they could give the chemical to people who had blood clots, but they had no way of determining the dose.
So it was used for rat poison (e.g. DECON).
The Wisconsin Alumni Research Foundation supported much of the work, hence the name warfarin.
A farm worker attempted to commit suicide by eating the rat poison. However, it does not work very fast.
He was taken to the hospital where doctors administered vitamin K.
This counteracted the warfarin and the patient recovered. Now doctors knew how to counter an overdose, but they still did not know a correct dose.
Coumadin® (warfarin sodium) was given to President Eisenhower when he had a heart attack in 1956.
Since then it has been one of the most widely prescribed drugs in the United States.
The current generic versions were introduced in 1997 or more recently.
PLEASE NOTE: This is not just a fun story, there is a report of a woman who was not taking warfarin but spread a warfarin-type rat poison weekly without wearing gloves or washing her hands afterwards.
She evidently absorbed enough warfarin through the skin to cause a brain hemorrhage. (A drug interaction may also have been involved.)
The authors state that there are three other cases of absorption of warfarin through the skin causing coagulation problems.
Reference: Abell TL et al. Cutaneous exposure to warfarin-like anticoagulant causing an intracerebral hemorrhage:a case report. J Toxicol Clin Toxicol 1994;32:69-73.
- End
Home Page
Address:
http://www.warfarinfo.com/default.htm
___
Coumadin® Home Page
(also referred to as Bleedadin® by many doctors)
Warfarin is still used as rat poison (in large quantities). Thank goodness, rats don't get their blood tested, so who gives a rats behind when they keel over.
Address:
http://www.coumadin.com
___
Competition for Coumadin® comin' soon?
As posted here last year, a new anticoagulant shows good promise to give Coumadin® a run for its blood thinnin' money....
Different article from the more recent anti-coagulant archives file
Study finds fewer strokes in patients taking Exanta
By Chris Michaud
December 10, 2001
(Reuters)
Enhanced
Far fewer patients with heart rhythm problems suffered strokes (brain attacks) after taking preventive doses of AstraZeneca Plc's experimental anti-clotting pill Exanta than those who took the standard drug warfarin, the company said on Monday.
Interim results of the phase II trial were presented at the annual meeting of the American Society of Hematology (ASH) in Orlando.
The long-term trial involves 125 patients with non-valvular atrial fibrillation (AF) who got regular doses of Exanta and 42 patients who took warfarin to prevent strokes.
Preliminary results found that patients taking Exanta (ximelagatran) suffered 0.9 strokes and 0.4 transient ischemic attacks (TIAs), sometimes called ministrokes, per 100 treatment years, the equivalent of one person taking the drug for a year.
Patients in the ongoing trial were treated for between 21 months and 24 months, the company said.
That compared with 2.6 strokes and 2.6 ministrokes per 100 treatment years for those taking warfarin, a generically available anti-clotting drug sold by Bristol-Myers Squibb Co. under the brand name Coumadin®.
One of the most worrisome side effects from anti-clotting drugs is their tendency to cause excessive bleeding, which can be life-threatening.
In the trial, Astra said incidence of major bleeding was 0.9 per 100 treatment years for Exanta versus 2.6 per 100 treatment years for warfarin.
"That's a small study, but I'm encouraged by the results," said analyst Catherine Arnold of Sanford C. Bernstein.
"Coumadin® has so many issues, in terms of the drugs it interacts with and the extent to which it has to be monitored to be sure it's at the right level, that even if this is the equivalent to Coumadin®, it will still be used extensively in our view in these populations," Arnold said.
"Of course the results will still have to be confirmed," she added. "It will need a larger-scale study."
AstraZeneca's chief executive officer said last week called Exanta, which if cleared would be the FIRST NEW anticoagulant pill in 50 years, a potential breakthrough drug that could generate annual sales of several billion dollars.
"It's a huge breakthrough potentially in the treatment of blood clots," said CEO Tom McKillop of Exanta, which is designed to work by inhibiting thrombin, an enzyme that is vital to blood clotting and one which he noted many companies had tried and failed to block.
Exanta is one of seven potential AstraZeneca "megabrands" each of which McKillop said he expects could generate over $1 billion in annual sales.
The Anglo-Swedish drugmaker is looking to the new medicines to take up the slack once its $6 billion a year ulcer drug Prilosec® loses its U.S. marketing exclusivity and faces competition from generic versions.
Prilosec® is the subject of a patent dispute currently being contested in federal court by AstraZeneca and several smaller drug manufacturers.
Atrial fibrillation, in which two upper heart chambers quiver instead of beating effectively, is found in about 2 million Americans, according to the American Heart Association (AHA).
Blood in the chambers can then clot, and the clot can then travel and become lodged in the brain, causing a stroke.
---
World-Wide media release
Enhanced
December, 10, 2001
New data support the safety and tolerability of the novel oral anticoagulant Exanta® in a range of life threatening clinical indications
The presentation of a range of data at the 43rd American Society of Hematology (ASH) meeting in Orlando this week, provides encouraging evidence to support the efficacy and safety of the novel oral anticoagulant Exanta® in both the long term prevention of blood clot formation and its treatment.
Exanta is set to be the first new oral anticoagulant since the introduction of warfarin over 50 years ago and is currently under investigation in an extensive clinical trials for a number of key therapeutic areas.
The trials, involving more than 20,000 patients in over 30 countries, includes the important SPORTIF II and IV, and THRIVE I and IV, trials presented at ASH.
Long term SPORTIF IV data, in the key indication of stroke prevention in patients with non-valvular chronic atrial fibrillation, show Exanta is well tolerated in patients for up to 24 months, with comparable efficacy to warfarin and the ADDED BENEFIT OF NO NEED FOR DOSE TITRATION OR ROUTINE COAGULATION MONITORING. (*That'll put an end to those PT/INR message board questions).
SPORTIF IV is an open-label continuation of the 12-week randomised phase II dose guiding study SPORTIF II, presented at the European Society of Cardiology (ESC) meeting, September 2001.
The phase III SPORTIF trial, comprising the SPORTIF III and V studies, is the largest-ever trial conducted in atrial fibrillation, with more than 7,200 patients enrolled.
Atrial fibrillation is the most common cardiac arrhythmia in clinical practice, with incidence approximately doubling with each decade of adult life.
It presents as a rhythm disturbance in the atria of the heart, causing an uneven heart beat.
More than two million people are estimated to have atrial fibrillation in the United States and the associated risk of developing a brain attack is high.
A recent European survey also showed that 18% of patients presenting with a first brain attack were found to have atrial fibrillation.
"The SPORTIF IV results are very promising," said Dr. Palle Petersen, Division of Neurological Rehabilitation, Hvidovre University Hospital, Denmark, a lead investigator in the SPORTIF IV trial.
"The fixed dose regimen of Exanta was well tolerated for up to 24 months, without the need for dose adjustment or coagulation monitoring in patients with a medium to high risk of stroke and systemic thromboembolic complications."
Dr Petersen continued, "Anticoagulation treatment with warfarin is effective in reducing the risk of brain attack in patients with atrial fibrillation.
Doctors, however, are often reluctant to treat patients because of the drawbacks of using warfarin. Under-treatment remains the major problem in brain attack prevention for patients with atrial fibrillation."
In addition to the SPORTIF results, data from the THRIVE trial were also presented at ASH. The THRIVE trial investigates the effect of Exanta in the treatment of venous thromboembolism (VTE).
THRIVE I, which investigated Exanta in the treatment of acute deep vein thrombosis (DVT), confirmed that it is a promising effective alternative to warfarin in preventing the progression of a DVT.
THRIVE IV, which examines Exanta in the treatment of pulmonary embolism (PE), also highlighted its promise in the treatment of a stable PE.
Together, these results show that Exanta is effective both in preventing blood clot formation and treatment.
Data were also presented on a U.S. trial investigating the prevention of venous thromboembolism (VTE) after a total hip replacement.
This data for Exanta resulted in safety and tolerability for this patient population. A pre-clinical study on the use of Exanta as a preventative treatment after acute coronary syndrome (ACS) also showed positive results.
Dr. Ian Watts, Global Product Director, said "The data presented here at ASH highlight the extensive clinical trials currently ongoing with Exanta.
We believe that with fixed oral dose regimen and no need for routine coagulation monitoring, Exanta could offer the possibility of simpler anticoagulation for MILLIONS of patients."
___
At the Mayo Clinic
SPORTIF V
Stroke Prevention using ORal Thrombin Inhibition in atrial Fibrillation
A clinical trial currently recruiting participants. The pupose of this study is to determine the safety and effectiveness of H376/95, an anticoagulant (blood thinner medication), compared with Coumadin® (warfarin), another anticoagulant, in the prevention of strokes and blood clots in participants that have atrial fibrillation (irregular heart rhythm).
Enrollment Goal = 20 Enrollment to Date = 6
Eligibility Summary
Age: 18 years or older
Chronic (prolonged), non-valvular (not related to heart valve disease) atrial fibrillation (irregular heart rhythm)
More detailed eligibility criteria...
Requirements
Participants will be in the study from 12 to 28 months. Between 15 and 18 follow-up visits will be required during this time (blood clotting levels will be checked frequently).
Blood tests, physical exams and electrocardiograms or ECG's (a picture of the electrical activity of the heart) will be performed periodically at these visits.
Additional Information
H376/95 is an investigational anticoagulant (blood thinner medication). Coumadin® (warfarin), also an anticoagulant, has been approved by the Food and Drug Administration (FDA) for use in treating atrial fibrillation.
Contacts
Please contact us if you wish to discuss the availability and requirements of this trial. Note: information is subject to change.
Dr. Win Shen
Study Coordinator: Carol Monnet, RN
(507) 284-1797 or pager 127-06087
Locations
This trial is being conducted at the following location(s):
Mayo Clinic Rochester (Minnesota)
Mayo Clinic Jacksonville (Florida)
This trial information updated Nov 29 2001
File trial_93.html last modified: Tuesday, 29-Jan-2002 14:20:02 CST
Mayo Foundation for Medical Education and Research
