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Topic: Exanta


In the News (Thu 23 Oct 14)

  
  Exanta™ better anticoagulant than warfarin™ - The Doctors Lounge(TM)
Exanta is an oral direct thrombin inhibitor that does not require monitoring of coagulation or dose adjustment.
Exanta was given 36 mg twice daily, starting the morning after surgery, with warfarin therapy started the evening of the day of surgery.
Oral Exanta at a dose of 36 mg twice daily was found superior to warfarin with respect to the primary composite end point of venous thromboembolism and death from all causes (20.3 percent vs. 27.6 percent; P=0.003).
www.thedoctorslounge.net /pharmalounge/articles/exanta   (655 words)

  
 Postoperative efficacy and safety of Exanta™ (ximelagatran) confirmed in wide range of orthopaedic surgery patient ...
Exanta was launched in Germany on 21st June in this first indication, involving a regimen with an early postoperative start of treatment, with a first 3mg subcutaneous dose administered 4 — 8 hours after the completion of surgery, followed by oral Exanta 24mg twice daily for up to 11 days.
Exanta is the first oral therapy in the new class of direct thrombin inhibitors (DTIs) which protects patients against thrombosis.
Exanta is currently under regulatory review in the E.U. for chronic-use indications including the prevention of stroke and other thromboembolic complications associated with atrial fibrillation and the treatment and long-term secondary prevention of venous thromboembolism (VTE).
www.medicalnewstoday.com /medicalnews.php?newsid=9786&nfid=rssfeeds   (699 words)

  
 Exanta® or Ximelagatran - Direct Thrombin Inhibitor
Exanta® or Ximelagatran is a new oral anticoagulant.
Exanta® interferes with thrombin which is the final step in the activation of the clotting pathway.
Exanta® was associated with fewer strokes and systemic emboli (though not statistically significant) and less bleeding (statistically significant) than those patients who were on Coumadin.
www.loftusmd.com /Articles/stroke/exanta.html   (848 words)

  
 EXANTA (XIMELAGATRAN) RECEIVES FIRST APPROVAL
Exanta is the first oral treatment in a new World Health Organisation class of direct thrombin inhibitors (DTIs) and is the first new oral anticoagulant approved since the introduction of warfarin almost 60 years ago.
Exanta benefits from administration as a fixed oral dose, has a rapid onset and offset of action and shows low potential for food and drug interactions.
The approval of Exanta for this first indication in France is based on the METHRO study programme, involving an early postoperative start of Exanta treatment, with initial injectable dosing administered at least four hours after the completion of surgery, followed by oral Exanta 24mg twice daily for up to 11 days.
www.astrazeneca.com /pressrelease/1103.aspx   (673 words)

  
 ximelagatran
Under this procedure, Exanta was approved for prevention of blood clots in people undergoing hip- or knee-replacement surgery in nine countries in May 2004.
One of the strong points of Exanta is that it is not metabolized by the liver.
Since the significance of this effect on liver enzymes cannot be adequately evaluated until after the drug is released and used in a wider patient population, routine monitoring of liver enzymes would be prudent during the first months of treatment.
www.warfarinfo.com /ximelagatran.htm   (4851 words)

  
 Drug Development Technology - Exanta Oral Direct Thrombin Inhibitor for the Prevention and Treatment of Thromboembolism
The efficacy and safety of Exanta in the prevention of VTE in patients undergoing major orthopaedic surgery has been investigated in a series of large-scale phase III trials.
The US EXULT (Exanta Used to Lessen Thrombosis) trial in 2,301 patients, in which Exanta was compared with warfarin for VTE prophylaxis following knee replacement surgery, showed the incidence of VTE was 20.3% in the Exanta group compared with 27.6% for those on warfarin.
Exanta's superior efficacy profile compared with standard anticoagulant therapies (enoxaparin/warfarin) is accompanied by a good safety profile with respect to clinically significant bleeding.
www.drugdevelopment-technology.com /projects/exanta   (895 words)

  
 Biotech Tracker:  Exanta Continues to Move Forward
The subjects were randomized to receive either Exanta 36 mg twice daily for 6 months, or subcutaneous enoxaparin 1 mg/kg twice daily for a minimum of 5 days followed by warfarin (requiring blood monitoring) for 6 months.
The goal of this program was to determine whether Exanta is noninferior to standard enoxaparin/warfarin (enoxaparin is often used in lieu of unfractionated heparin in the initial management strategy) in the prevention of recurrent venous thromboembolism (VTE) at 6 months.
Exanta’s association with a disproportionately increased incidence of serum alanine aminotransferase (ALT) elevation (9.6 of Exanta recipients versus 2.0% of enoxaparin/warfarin recipients) was observed.
www.bioportfolio.com /news/biotracker_200.htm   (902 words)

  
 Biotech Tracker:  Exanta Excitement Builds
Further data from the SPORTIF trials support the claim that Exanta’s benefits are similar to those of warfarin in the management of the thrombotic complications of atrial fibrillation.
Additionally, a separate study shows that Exanta plus aspirin is superior to aspirin alone for the prevention of major cardiovascular events during 6 months of treatment in patients having had a recent myocardial infarction (MI, heart attack).
As important was the finding that despite no coagulation monitoring or dose titration for the Exanta group, SPORTIF V major bleeding rates were 2.4% for the Exanta group and 3.1% for the warfarin group, a difference that was not statistically significant.
www.bioportfolio.com /news/biotracker_202.htm   (1095 words)

  
 First oral anticoagulant in new class of direct thrombin inhibitors, Exanta™
Exanta is the first oral anticoagulant since the introduction of warfarin almost 60 years ago, and is the product of over 20 years’ research and development at AstraZeneca.
Exanta has been the subject of the largest clinical study programme in anticoagulation to date, involving around 30,000 patients.
In the US, FDA submissions were filed in December 2003 for use of Exanta in prevention of VTE in patients undergoing knee replacement surgery as well as for prevention of stroke and other thromboembolic complications associated with atrial fibrillation and long-term secondary prevention of VTE after standard treatment for an episode of VTE.
www.medicalnewstoday.com /medicalnews.php?newsid=9724   (862 words)

  
 ClotCare: AstraZeneca Decides to Withdraw Exanta
AstraZeneca has informed regulatory authorities of its decision to withdraw Exanta and is now communicating with all prescribers and healthcare professionals to advise them that no new patients should be started on Exanta.
The small number of current Exanta patients should be contacted by their doctor and reviewed promptly to avoid any unplanned discontinuation of therapy.
Exanta is marketed for up to 11 day use in prevention of venous thromboembolic events (VTE) in patients undergoing elective hip or knee replacement surgery.
www.clotcare.com /clotcare/astrazenecapullsexanta.aspx   (719 words)

  
 Exanta - pivitol data from largest ever phase III stroke prevention trial announced at ACC
Furthermore, a statistically significant RRR of 41% (p=0.018) was demonstrated for Exanta compared with well-controlled warfarin in patients who remained on treatment for the duration of the study (OT population).
The combined rate of major and minor bleeding events was found to be significantly lower for Exanta than warfarin (475 vs 554 events; p=0.007) and there was no significant difference in all cause mortality between the Exanta and warfarin groups, despite Exanta's lack of coagulation monitoring and fixed dose regimen.
Exanta is currently under phase III investigation and is the first oral anticoagulant to reach late clinical development in more than 50 years — since the development of warfarin.
www.eurekalert.org /pub_releases/2003-04/k-e-p040203.php   (1136 words)

  
 Exanta-AP article - www.protein.org.uk
Exanta acts faster and does not have the blood monitoring or diet drawbacks.
Recurrent clots were found in 12 patients in the Exanta group and 71 in the comparison group, a reduction of 84 percent.
Aside from the obvious interest in the success of Exanta is the point about risk of clotting after coming off warfarin for six months...
www.protein.org.uk /forum/index.php?showtopic=545   (1181 words)

  
 FURTHER DATA SUPPORTS SAFETY AND EFFICACY OF ORAL DIRECT THROMBIN INBIBITOR, EXANTA (XIMELAGATRAN) IN PREVENTION OF ...   (Site not responding. Last check: 2007-11-03)
Exanta is in development as the first oral treatment in a new class of direct thrombin inhibitors (DTIs) to prevent and treat thrombosis, one of the largest causes of morbidity and mortality in the western world.
The outcome of the EU regulatory submission for Exanta for prevention of VTE in patients undergoing elective hip or knee replacement surgery is expected shortly.
Exanta is the first oral anticoagulant to reach late-stage clinical development in almost 60 years, and has been the subject of the most extensive clinical development programme to date, involving approximately 30,000 patients.
www.pressi.com /int/release/81411.html   (873 words)

  
 Exanta, a New Blood Thinner May Enter the Market Shortly
In May 2004, Exanta was approved by the European regulatory authorities for the short-term indication, the prevention of blood clots in patients undergoing hip- or knee-replacement surgery.
Exanta is the first of a new class of drugs called direct thrombin inhibitors.
Even though 51 of the Exanta patients suffered from a stroke or other serious clotting episode, as compared to 37 of the coumadin patients, the findings were not considered statistically significant.
www.therubins.com /ideas/exanta.htm   (1562 words)

  
 Heart Info
The drug, sold as Exanta (ximelagatran), is a potential replacement for Coumadin (warfarin), which can, among other things, prevent stroke in people with the heartbeat abnormality known as atrial fibrillation.
The American researchers found the incidence of stroke was slightly higher for those who took Exanta -- 1.6 percent per year, compared to 1.2 percent for those who took Coumadin.
The second study compared Coumadin against Exanta in nearly 5,000 Europeans with deep vein thrombosis -- blood clots in the legs, arms or pelvis.
www.heartinfo.org /ms/news/523878/main.html   (1000 words)

  
 Exanta™, New Anticoagulant Launched - Heart Disease and other cardiovascular conditions on MedicineNet.com
Exanta™ (ximelagatran), a new anticoagulant and the first oral treatment in the new class of direct thrombin inhibitors (DTIs), is launched today in Germany in its first indication: the prevention of venous thromboembolic events (VTE) in elective hip or knee replacement surgery (orthopaedic surgery).
It was developed to provide a solution to the significant unmet medical need for a new, predictable and well-tolerated oral therapy for patients at risk of thrombosis, one of the major causes of cardiovascular morbidity and mortality in the developed world.
The approved label for Exanta in the E.U. is based on the METHRO III (MElagatran for THRombin inhibition in Orthopaedic surgery) study, which compared post-operative initiation of melagatran (active form of Exanta) followed by oral ximelagatran in 4,688 patients undergoing total hip or knee replacement.
www.medicinenet.com /script/main/art.asp?articlekey=33742   (922 words)

  
 MedicinaGeriatrica.com.ar - New Anti-Clotting Drug Shows Mixed Results
The risk of major bleeding was much lower for the Exanta group -- 1.3 percent vs. 2.2 percent for the Coumadin group.
Further clinical trials are unlikely to settle the issue because Exanta has already been tested in trials including more than 18,000 people, said Dr. Victor Gurewich, a professor of medicine at Harvard Medical School and the author of an accompanying editorial.
That analysis shows that in terms of dollars and cents, substituting Exanta for Coumadin would not be cost-effective for people with atrial fibrillation who have a low risk of bleeding complications, Gage said.
www.medicinageriatrica.com.ar /viewnews.php?id=EEpZAppAFEZpsgReIt   (878 words)

  
 Exanta effective for preventing blood clots and stroke - The Doctors Lounge(TM)
Exanta effective for preventing blood clots and stroke
Ximelagatran (Exanta) was found to be as effective as other common therapies for preventing stroke and recurrent blood clots.
CHICAGO - A medication that could simplify anticoagulation therapy, ximelagatran, was found to be as effective as other common therapies for preventing stroke and recurrent blood clots, according to studies in the February 9 issue of JAMA.
www.thedoctorslounge.net /neurology/articles/exanta_stroke/index.htm   (1386 words)

  
 Exanta.com
It is important that patients do not stop Exanta treatment without consulting their doctor.
For patients currently taking Exanta physicians should consider switching the patient to an alternative anticoagulant while taking account of individual patient circumstances and ensuring uninterrupted anticoagulation.
Exanta is a registered trademark of the AstraZeneca group of companies.
www.exanta.com   (305 words)

  
 A Blood-Thinning Blockbuster? - Forbes.com   (Site not responding. Last check: 2007-11-03)
The first study found that Exanta reduced blood clots 26% more than the standard treatment, warfarin, in 2,301 patients who had undergone total knee replacement surgery.
In that study, Exanta was given to patients for 18 months after they were treated for blood clots in their legs with heparin, an injectible drug used to treat blood clots in hospitals, and Coumadin.
That means that doctors might start giving Exanta to patients for long periods of time after surgery, or after a blood clot is found.
www.forbes.com /home/2002/12/09/cx_mh_1209azn.html   (879 words)

  
 Results of first chronic treatment study with oral EXANTA(TM) (ximelagatran)
Notably, these long term results demonstrate that the clinical potential for EXANTA in effective secondary prevention of thromboembolic events is achieved without an increased risk of bleeding.
The EXULT A* study, also presented at ASH, demonstrates that fixed oral dose EXANTA administered post-operatively, is superior in efficacy to warfarin for total DVT and/or PE and/or all-cause mortality (20.3%, EXANTA vs 27.6%, warfarin, p=0.03).
EXANTA is the first oral direct thrombin inhibitor (Oral DTI) under phase III investigation and is the first oral anticoagulant to reach late clinical development in more than 50 years - since the development of warfarin.
www.eurekalert.org /pub_releases/2002-12/k-rof120902.php   (1000 words)

  
 New Landmark Study Confirms Potential for Exanta (ximelagatran) in Prevention of Stroke in Atrial Fibrillation   (Site not responding. Last check: 2007-11-03)
SPORTIF V was designed as a non-inferiority(c) study to compare oral Exanta with the current standard treatment, dose-adjusted warfarin in preventing stroke and systemic embolic events (SEE) in atrial fibrillation, and the results support the findings of the SPORTIF III study.
The primary efficacy endpoint was met, showing that fixed dose twice daily 36mg oral Exanta is non-inferior to dose-adjusted warfarin in preventing stroke and SEE: 51 Exanta patients with events (1.6%/yr) vs 37 for warfarin (1.2%/yr), confirming non-inferiority based on the same criteria used in the SPORTIF III study.
When the results from both studies are pooled, 91 patients with events were seen for Exanta compared with 93 for warfarin (1.6%/yr vs 1.6%/yr), supporting the efficacy of Exanta in prevention of strokes and thromboembolic events in patients with atrial fibrillation.
www.forrelease.com /D20031111/1003388.html   (668 words)

  
 Exanta, - News and Comment for the Pharmaceutical Industry : PharmiWeb
Exanta is the first oral anticoagulant since the introduction of warfarin The approved label in the EU for Exanta in this indication involves an early
In May 2004, Exanta was approved by the European regulatory authorities Exanta has since been made available in nine European countries and Argentina.
Exanta (ximelagatran) manufactured by AstraZeneca®, showed a superior ability to prevent venous thromboembolism when compared to the standard drug warfarin.
www.findoutwebsite.com /?q=exanta   (489 words)

  
 Scrip's Target World Drug Delivery News
The surprise decision is based on a single report of severe liver injury in a patient in the EXTEND study.
Exanta (ximelagatran) was marketed in 12 countries for up to 11-day use in prevention of venous thromboembolic events (VTE) in patients undergoing elective hip or knee replacement surgery, and already carried details on its label of raised liver enzymes in some patients.
Rather than direct thrombin inhibitors like Exanta and AZD0837, it seems that the next anticoagulant agent approved could be from the Factor Xa inhibitor class.
www.pjbpubs.com /uploads/content/scrip/breaking_news.htm   (706 words)

  
 New Landmark Study Confirms Potential For Exanta™ (Ximelagatran) In Prevention of Stroke in Atrial Fibrillation
study presented today, support the potential for Exanta™ (ximelagatran), the first oral treatment in a new class of direct thrombin inhibitors (DTIs), to be an effective and reliable replacement for warfarin in the prevention of stroke and systemic embolic events in patients with atrial fibrillation (AF), without the limitations of warfarin treatment.
When the results from both studies are pooled, 91 patients with events were seen for Exanta™ compared with 93 for warfarin (1.6 per cent per year vs. 1.6 per cent per year), supporting the efficacy of Exanta™ in prevention of strokes and thromboembolic events in patients with AF.
Exanta™ is the first oral anticoagulant to reach late stage clinical development in almost 60 years, and has been the subject of the most extensive clinical study program to date, involving around 30,000 patients.
www.astrazeneca.ca /en/news/release.asp?id=2003111701   (1373 words)

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