WARNING: BLEEDING RISK
Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur during the starting period and with a higher dose (resulting in a higher INR). Risk factors for bleeding include high intensity of anticoagulation (INR >4.0), age ≥65, highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, serious heart disease, anemia, malignancy, trauma, renal insufficiency, concomitant drugs (see PRECAUTIONS), and long duration of warfarin therapy. Regular monitoring of INR should be performed on all treated patients. Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shorter duration of therapy. Patients should be instructed about prevention measures to minimize risk of bleeding and to report immediately to physicians signs and symptoms of bleeding (see PRECAUTIONS: Information for Patients).
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NEWS HIGHLIGHTSMedia Articles Related to Jantoven (Warfarin)
Alternative to Warfarin May Cut Risk of Bleeding
Source: MedicineNet Atrial Fibrillation Specialty [2009.11.16]
Title: Alternative to Warfarin May Cut Risk of Bleeding
Category: Health News
Created: 11/15/2009 4:10:00 PM
Last Editorial Review: 11/16/2009
Oldest Heart Patients May Get Most From Warfarin
Source: MedicineNet Atrial Fibrillation Specialty [2009.09.01]
Title: Oldest Heart Patients May Get Most From Warfarin
Category: Health News
Created: 8/31/2009 4:10:00 PM
Last Editorial Review: 9/1/2009
Aspirin as effective as warfarin and safer in stroke prevention
Source: The Doctors Lounge - Neurology
Intracranial stenosis is caused by atherosclerosis - fatty deposits that build up on the inner walls of the arteries and restrict blood flow.
Published Studies Related to Jantoven (Warfarin)
Thrice weekly warfarin administration in haemodialysis patients. [2009.10]
BACKGROUND: Medication adherence in haemodialysis patients is often challenging due to a high pill burden, complex and dynamic medication regimens and limited patient self-interest in care. The purpose of this study was to investigate the time within target INR and safety profile of thrice weekly warfarin administration in haemodialysis patients with a clinical indication for anticoagulation and documented nonadherence to medications... CONCLUSION: In this pilot study, thrice weekly warfarin appears to be a safe and feasible dosing strategy in a select patient population. A randomized controlled trial of thrice weekly warfarin is warranted.
Dabigatran versus warfarin in patients with atrial fibrillation. [2009.09.17]
BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor... 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.) 2009 Massachusetts Medical Society
Use of Warfarin in People with Low Glomerular Filtration Rate or on Dialysis. [2009.09.09]
Abstract Atrial fibrillation, venous thromboembolism, and access malfunction are common clinical problems in dialysis patients that prompt consideration of warfarin therapy. Atrial fibrillation appears to be more common in people with low glomerular filtration rate (GFR) or on dialysis than in the general population, but the risk of stroke in this population is not known...
Practical application of the 10-mg warfarin initiation nomogram. [2009.09]
Initiation of warfarin therapy is a clinical challenge. A 10-mg warfarin initiation nomogram was recently validated in a randomized controlled trial... The 10-mg nomogram effectively results in an early therapeutic international normalized ratio with a good safety profile in 'real-life' daily practice.
Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. [2009.08.15]
BACKGROUND: In patients with non-valvular atrial fibrillation, embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. We assessed the efficacy and safety of percutaneous closure of the LAA for prevention of stroke compared with warfarin treatment in patients with atrial fibrillation... INTERPRETATION: The efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. Although there was a higher rate of adverse safety events in the intervention group than in the control group, events in the intervention group were mainly a result of periprocedural complications. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with non-valvular atrial fibrillation. FUNDING: Atritech.
Clinical Trials Related to Jantoven (Warfarin)
Duloxetine - Warfarin Pharmacodynamic Study [Completed]
To evaluate the blood clotting effects of multiple doses of warfarin at steady state when
taken at the same time as multiple doses of duloxetine as measured by changes in the
International Normalised Ratio.
Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters [Completed]
This study examines whether low intensity, dose adjusted warfarin prolongs the time to
mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of
bleeding.
Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin) [Recruiting]
Several human genes affect how medications are metabolized by the body. It is believed that
knowledge of variations of these genes can help health care providers better manage an
anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems
with bleeding or the development of blood clots. This study is designed to evaluate if
genetic testing can improve warfarin initiation better than usual care.
Oral Vitamin K for Warfarin Associated Coagulopathy [Active, not recruiting]
Excessive prolongation of the international normalized ratio (INR) occurs frequently in
patients taking warfarin; in fact, about one in six INR values is above the desired range.
Excessive prolongation of the INR is clinically important because the risk of bleeding
approximately doubles for each one point increase in the INR beyond the usual therapeutic
range. Thus, treatment strategies which rapidly and reliably lower an excessively prolonged
INR into the desired range have the potential to reduce bleeding. When taken by patients with
INR values between 4. 5 and 10, a small dose of oral vitamin K (1 mg to 2. 5mg) reduces the INR
into the desired INR range in about 75% of cases within 24 hours of its administration. If
warfarin is simply withheld, and no vitamin K is given, about 25% of patients will have an
INR in the desired range at 24 hours. However, vitamin K is rarely given to such patients. In
a recent survey carried out by our group, less than 20% of such patients would have been
given low dose oral vitamin K by a group of physicians who regularly supervise warfarin
therapy.
The most common treatment for excessive prolongation of the INR is to simply withhold
warfarin and allow the INR to fall into the therapeutic range. Although this strategy is
effective its safety has never been adequately examined. In fact, recent evidence suggests
that patients with INR values of more than 6. 0 who are treated with simple warfarin
withdrawal have a risk of major bleeding of 4% in the two weeks after they develop their
prolonged INR.
When asked why they did not give oral vitamin K to a non-bleeding patient who has an
excessively prolonged INR, physicians generally give one of three reasons: (1)They are not
convinced that oral vitamin K reduces bleeding. (2) They are concerned that oral vitamin K
may cause thrombosis. (3) In contrast with simply withholding warfarin, giving oral vitamin K
requires a patient to visit the physician, and the physician must have a supply of vitamin
K.
We hypothesize that the routine practice of not administering oral vitamin K to patients with
excessively prolonged INR values is causing patients to have major, life-threatening and
fatal bleeds. To convince physicians that oral vitamin K should be administered to all
non-bleeding patients with INR values of more than 4. 5, we propose a study which we
anticipate will demonstrate that oral vitamin K reduces bleeding, does not cause thrombosis,
and can be administered at home without direct physician supervision.
To accomplish these goals, we propose a multinational, double-blind, placebo-controlled
trial. We will randomize patients with INR values between 4. 5 and 10. 0 to receive 1. 25 mg of
oral vitamin K or placebo and follow them for bleeding and thrombosis. Patients with INR
values of more than 10. 0 will receive a single 1. 25 mg dose of oral vitamin K.
Successful completion of this study will establish a treatment standard supported by clinical
data which will, in turn, change the way that patients taking warfarin who present with an
excessively prolonged INR are treated.
A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers [Completed]
GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test
the extent of the GW679769 affect on Warfarin levels in humans.
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