|
| |
| | ClotCare: Ximelagatran (brand name Exanta) is Leading the Coming Revolution in Stroke Prevention in Atrial Fibrillation ... |
 | | Within approximately one year, it is likely that ximelagatran will replace warfarin as the drug of choice in millions of patients with AF and other conditions that require anticoagulation therapy. | | | Because laboratory monitoring is not necessary, there is concern that patients may discontinue ximelagatran therapy over time without their health care provider knowing that therapy has been stopped. | | | Therefore, ximelagatran at a fixed dose of 36mg twice daily proved, by intention to treat analysis, to be as safe and effective as well-managed warfarin in both trials. |
|
http://www.clotcare.com/clotcare/exanta.aspx
|
|
| |
| | Main Simpler Blood Thinning Medication Found Effective for Preventing Recurrent Blood Clots |
| | 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. | | | According to background information in the article, current therapy for patients with acute venous thromboembolism consists of 5 to 7 days of the anticoagulant heparin overlapped with and followed by long-term, oral anticoagulation with a therapy such as warfarin. | | | The researchers found that the primary efficacy end point of recurrent venous thromboembolism occurred in 26 and 24 patients in the ximelagatran and enoxaparin/warfarin groups, respectively, corresponding to estimated cumulative risks of 2.1 percent and 2.0 percent. |
|
http://www.thebusinessexpert.co.uk/news/Main_76/Simpler-Blood-Thinning-Medication-Found-Effective-for-Preventing-Recurrent-Blood-Clots_25394.html
|
|
| |
| | UIC College of Pharmacy Drug Information Center |
| | The authors concluded that ximelagatran was safe and effective when used for secondary prevention of VTE. | | | (ximelagatran) reduced risk of blood clots following orthopedic surgery by 63 percent compared to enoxaparin in clinical trial. | | | Two milligrams of the subcutaneous form, melagatran, was administered to one group of patients immediately prior to surgery and then 3 mg was given the night after surgery (n=1377). |
|
http://www.uic.edu/pharmacy/services/di/exanta.htm
|
|
| |
| | SPORTIF III |
| | Results of a randomized but open-label trial comparing ximelagatran, a new oral direct thrombin inhibitor, with warfarin therapy suggest the new drug was as effective as the standard anticoagulant in the prevention of stroke and systemic embolic events in patients with atrial fibrillation, with less overall bleeding. | | | Results of the intention-to-treat analysis confirmed the noninferiority of ximelagatran to warfarin treatment for this indication, Halperin said. | | | SPORTIF III: A Long-Term Randomized Trial Comparing Ximelagatran With Warfarin for Prevention of Stroke and Systemic Embolism in Patients With Nonvalvular Atrial Fibrillation |
|
http://www.hartziekten.nl/cardio.nl/ACC2003/LBCTIII/SPORTIFIII.html
|
|
| |
| | ESC: Ximelagatran Reduces Heart-Related Events |
| | He noted that liver-enzyme monitoring, at least for the initial weeks of therapy, would likely be required in future studies with the drug. | | | About 12.7% of patients taking ximelagatran experienced one of the primary trial end points. | | | Other drugs to prevent blood clotting, such as the heparins, require injection, he said, and many patients want something other than a needle. |
|
http://www.pslgroup.com/dg/2396ca.htm
|
|
| |
| | ÊÁÒ¤Áá¾·ÂìâäËÑÇã¨áË觻ÃÐà·Èä·Â ã¹¾ÃкÃÁÃÒªÙ»¶ÑÁÀì :: The Heart ... |
| | The trial is part of an ongoing program of investigation of ximelagatran in a variety of clinical indications. | | | Phase 3 studies have been completed or are ongoing in VTE prevention after orthopedic surgery and stroke prevention in atrial fibrillation, among others. | | | THRIVE Treatment trial: Ximelagatran as effective as enoxaparin/warfarin for long-term VTE prophylaxis |
|
http://www.thaiheart.org/show_news.php?command=newshowfull&id=85
|
|
| |
| | [No title] |
| | Ximelagatran was associated with a favourable outcome with respect to major bleeding and mortality. | | | A comparison of the outcome of clinical endpoints in the 2 treatment groups, demonstrating noninferiority of ximelagatran vs enoxaparin/warfarin, is provided in the table. | | | Ximelagatran was administered to 1241 patients and enoxaparin/warfarin to 1250 patients. |
|
http://www.blackwellpublishing.com/isth2003/abstract.asp?id=7716
|
|
| |
| | ISTH: Exanta (Ximelagatran) May Prevent Deep Vein Thrombosis/Pulmonary Embolism After Knee Surgery |
| | Results of the study comparing the efficacy and safety of Exanta (ximelagatran), (formerly known as H 376/95), with warfarin for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after total knee replacement (TKR) surgery, showed an overall DVT/PE incidence of 19.2 percent with Exanta and 25.7 percent with warfarin. | | | The objective of the study was to compare the efficacy and safety of Exanta with warfarin for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after total knee replacement (TKR) surgery. | | | The randomized, double-blind study involved 680 patients who received seven-12 days of either dose-adjusted warfarin once-a-day starting the evening of surgery or ximelagatran 24 mg given twice-a-day starting on the morning after surgery. |
|
http://www.pslgroup.com/dg/200362.htm
|
|
| |
| | CommentWire by Datamonitor - AstraZeneca: disappointing new data for ximelagatran |
| | Most importantly, the non-inferiority of ximelagatran based on a prespecified margin of 5% was not met, with results demonstrating the superiority of the enoxaparin regimen. | | | October 17, 2003 5:23 PM GMT (Datamonitor) - The latest study of ximelagatran's efficacy in preventing VTE after major orthopedic surgery is the first to have failed to show non-inferiority to a control drug. | | | Major bleeding events were observed in 0.8% of the ximelagatran-treated patients and in 0.9% of the enoxaparin-treated patients. |
|
http://www.commentwire.com/commwire_story.asp?commentwire_ID=4930
|
|
| |
| | ximelagatran After Heart Attack Helps |
| | Patients who took ximelagatran and aspirin reduced their risk of death, non-fatal heart attacks, and severe ischemia by about 25 percent, compared to those in the placebo group. | | | Researchers say more studies are needed to determine the safety and clinical benefits of the drug. | | | New research published in The Lancet (2003;362:789-797) shows taking the drug ximelagatran combined with aspirin may reduce the risk of death and future cardiac events in patients who have had a heart attack. |
|
http://www.indegene.com/Rad/Home/indRad_Ind_News_07-09-2003_1.asp
|
|
| |
| | ESC Congress 2004: Efficacy and safety of ximelagatran confirmed |
| | "The findings from this detailed analysis of the SPORTIF study programme results are very encouraging as they further demonstrate in two independent studies that ximelagatran is both safe and effective in the prevention of stroke for people with atrial fibrillation. | | | It is now available in Germany, Sweden, Portugal and Finland in its first indication: the prevention of venous thromboembolic events (VTE) in patients undergoing elective hip or knee replacement surgery (orthopaedic surgery). | | | Use of ximelagatran was in some patients associated with an elevation of liver enzymes (ALAT >3XULN) which were typically transient, not associated with specific clinical symptoms, and decreased towards normal whether or not treatment was continued or stopped. |
|
http://www.eurekalert.org/pub_releases/2004-08/esoc-ec2_7082904.php
|
|
| |
| | CONTROVERSIAL: ORAL THROMBIN INHIBITOR XIMELAGATRAN (EXANTA) |
| | There are no published data on risk and benefit of post-hospitalisation continuation of prophylaxis with ximelagatran which - as it has been reported to us - the company's medical reps are already supposed to be promoting in rehabilitation clinics. | | | We feel that the prescribed terminology in these trials plays down the relevance of this problem. | | | However, significantly more patients in the ximelagatran group were additionally taking low-dose aspirin (4). |
|
http://www.arznei-telegramm.de/journal/j_0407_a.php3
|
|
| |
| | Biotech Tracker News - AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran) is in phase III clinical trials for the ... |
| | December 04, 2002 AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran) is in phase III clinical trials for the management of venous thromboembolism (VTE). | | | Biotech Tracker News - AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran) is in phase III clinical trials for the management of venous thromboembolism (VTE) | | | THIS INFORMATION IS PROVIDED "AS IS" AND NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED OF ACCURACY, MERCHANTIBILITY FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE ARE MADE WITH RESPECT TO THIS INFORMATION OR TO ANY EXPRESSED VIEWS PRESENTED IN THIS INFORMATION. |
|
http://www.bioportfolio.com/news/biotracker_37.htm
|
|
| |
| | Fixed-dose treatment alternative to warfarin |
| | So far, ximelagatran appears to have no major interactions with food, alcohol or other drugs, and might give doctors more confidence in safely managing patients with atrial fibrillation,' he added. | | | Ximelagatran does not require this kind of monitoring and is given at a fixed dose (36 milligrammes twice-a-day) in all patients. | | | Doctors and patients would warmly welcome a new treatment that is as effective as warfarin in preventing strokes but does away with time-consuming and frequent coagulation monitoring and unpredictable dose adjustments. |
|
http://www.anticoagulationeurope.org/ximelagatran.html
|
|
| |
| | Public Citizen Publications - Testimony before the FDA's Cardiovascular and Renal Drugs Advisory Committee Hearing on ... |
| | [1] This rate will likely be higher in clinical practice as patients excluded from the clinical trials are treated with ximelagatran. ; Importantly, 4.3% of patients had ALTs greater than five times the ULN (0.4% for comparators) and 1.5% had ALTs greater than ten times the ULN (0.1% for comparators). | | | Prevention of stroke and other thromboembolic complications associated with atrial fibrillation | | | In sum, while the drug appears to be effective for this indication, the risks are significant. Below we discuss how the sponsor’s proposed risk management strategy is inadequate. |
|
http://www.citizen.org/publications/release.cfm?ID=7331
|
|
| |
| | Results of first chronic treatment study with oral EXANTA(TM) (ximelagatran) |
| | Patients were given oral 24mg or 36mg fixed-dose ximelagatran initiated the morning after surgery or warfarin initiated in the evening on the day of surgery. | | | "Ximelagatran represents a potential medical breakthrough in the long-term secondary prevention and treatment of venous thromboembolism and it satisfies a clear unmet medical need for long term fixed dose oral anticoagulation treatment, without the need for coagulation monitoring or dosage titration". | | | First chronic treatment study with oral EXANTA (ximelagatran) demonstrates highly significant long term benefit in preventing recurrent venous thromboembolism (VTE) |
|
http://www.eurekalert.org/pub_releases/2002-12/k-rof120902.php
|
|
| |
| | Thrombosis Prevention - Page 3 Of 5: Online Reference For Health Concerns |
| | THRIVE III is a double-blind, multicenter, randomized trial that enrolled 1233 patients who had received anticoagulant therapy for 6 months for venous thromboembolism. | | | Current clinical trials are investigating the efficacy ximelagatran for treatment of venous thromboembolism and atrial fibrillation to prevent stroke. | | | Exanta (ximelagatran) is a novel drug with potential to revolutionize anticoagulant management. |
|
http://www.lef.org/protocols/prtcl-155b.shtml
|
|
| |
| | news item - Ximelagatran as good as warfarin to prevent stroke in AF |
| | Ximelagatran as good as warfarin to prevent stroke in AF | | | The results of a study presented at a US conference indicate that oral ximelagatran (Exanta) is as effective as well-controlled warfarin in the prevention of stroke in patients with atrial fibrillation (AF). | | | Ximelagatran in a fixed daily dose was compared with well-controlled warfarin (INR 2 - 3) in 3407 patients with AF and at least one other risk factor for stroke. |
|
http://www.ukmicentral.nhs.uk/headline/database/story.asp?NewsID=2132
|
|
| |
| | Blood Clots |
| | See "Ximelagatran May be Effective for Treatment of DVT and Stroke Prevention", CME on Medscape dated February 8, 2005 for more information. | | | For example, ALT levels increased to more than 3x ULN in 9.6% of patients receiving ximelagatran vs 2.0% in those receiving enoxaparin/warfarin, but are described as largely asymptomatic. | | | Ximelagatran should not require the frequent monitoring of INR necessary with warfarin and it reported to be insensitive to diet. |
|
http://www.hrpca.org/bloodclots.htm
|
|
| |
| | PRESS RELEASE Study Led by Mount Sinai Researchers on Stroke-Prevention in Patients With Atrial Fibrillation Published ... |
| | SPORTIF III, an open-label trial previously conducted outside North America, found that patients taking ximelagatran experienced no more strokes or bleeding than those on well-controlled warfarin. | | | Results showed that patients treated with ximelagatran (n=1,960) had a 1.6 percent per year chance of having a stroke or systemic embolic event (51 events), compared to a 1.2 percent chance for 1,962 patients treated with warfarin (37 events). | | | Six percent of patients treated with ximelagatran experienced an increase of a liver enzyme called ALT to greater than three times the upper limit of normal, compared to 0.8 percent of patients in the warfarin group. |
|
http://www.marketwire.com/mw/release_html_b1?release_id=80559
|
|
| |
| | Black Triangle: Ximelagatran - Liver concerns |
| | A drug that may offer advantages over warfarin will be of great interest, both commercially and clinically. | | | However, a new drug can carry new risks and concerns are being expressed about liver function abnormalities associated with ximelagatran; as pointed out here some time ago. | | | However, rather more prosaically, it is the name of a new anti-coagulant (A drug which "thins" the blood). |
|
http://www.blacktriangle.org/blog/2003/11/ximelagatran_li.html
|
|
| |
| | News - Fixed-Dose Ximelagatran as Safe, More Effective Than Warfarin for Postoperative Thromboprophylaxis |
| | "The results of our study indicate that fixed-dose ximelagatran, administered without coagulation monitoring, was significantly more effective than warfarin and had similar safety," say the researchers. | | | Unlike warfarin, ximelagatran is rapidly absorbed and converted to active form, and appears to have no clinically relevant interactions with food or drugs. | | | However, warfarin has a delayed onset of action, requires monitoring of coagulation and dose adjustment, and has multiple interactions with food and drugs. |
|
http://www.docguide.com/news/content.nsf/news/8525697700573E1885256DD10037B109
|
|
| |
| | exanta drug information, exanta side effects |
| | AstraZeneca's Investigational Oral Anticoagulant Exanta(TM) (ximelagatran) Reduced Risk of Blood Clots Following Orthopedic Surgery By 63 Percent Compared to Enoxaparin in Clinical Trial. | | | Postoperative efficacy and safety of Exanta_ (ximelagatran) confirmed in wide range of orthopaedic surgery patient... | | | Results of first chronic treatment study with oral EXANTA(TM) (ximelagatran) |
|
http://www.drugs.com/drug/exanta
|
|
| |
| | AAOS On-Line Service - 2004 Annual Meeting Podium Presentations Ximelagatran Provides Greater Prevention of VTE After ... |
| | Methods: Multicenter clinical trial of fixed-dose ximelagatran 24 or 36 mg bid initiated the morning after surgery, or warfarin (target INR 2.5; range 1.8-3.0) initiated the evening of surgery and matched placebo continued for 7-12 days. | | | Objective: To optimize the dose of ximelagatran and compare the efficacy and safety of ximelagatran with warfarin for prevention of VTE in TKR patients. | | | Results: 2301 patients randomized; 2285 received 1 dose of study drug (safety population), and 1851 had adequate venography or symptomatic VTE (evaluable population). |
|
http://www.aaos.org/wordhtml/anmt2004/sciprog/060.htm
|
|
| |
| | Stroke |
| | The drug's manufacturer was applying for FDA approval to market the drug for use in preventing stroke and other thromboembolic complications in early 2004. | | | A new drug called ximelagatran (Exanta) with fewer side effects has been introduced in Europe. | | | Warfarin (Coumadin) has proven to be more effective than aspirin for those with higher risk. |
|
http://www.healthatoz.com/healthatoz/Atoz/ency/stroke.jsp
|
|
| |
| | Ximelagatran - Wikipedia, the free encyclopedia |
| | Several large studies have been conducted to test the efficacy and safety of ximelagatran in patients with | | | A randomized, controlled, dose-guiding study of the oral direct thrombin inhibitor ximelagatran compared with standard therapy for the treatment of acute deep vein thrombosis: THRIVE I. J Thromb Haemost 2003;1:41-7. | | | The efficacy of ximelagatran for these indications has been well-documented. |
|
http://en.wikipedia.org/wiki/Ximelagatran
|
|
| |
| | PJ Online News: Ximelagatran continues to show promise as anticoagulation agent |
| | Ximelagatran was compared with warfarin for the prevention of venous thromboembolism after total knee replacement in a multicentre study of 1,851 patients. | | | A recurrence of venous thromboembolism was seen in 12 out of 612 patients treated with the active agent and 71 out of 611 given placebo. | | | The author of an accompanying editorial welcomed the studies but warned that liver function abnormalities seen in patients treated with ximelagatran, although mostly transient, are of some concern (ibid, p1762). |
|
http://www.pharmj.com/Editorial/20031108/news/ximelagatran.html
|
|
| |
| | ximelagatran |
| | Click here to request further information on Drug News | | | AstraZeneca announced on 23 December 2003, that ximelagatran (EXANTA), a direct thrombin inhibitor, has been approved in France (acting as reference member state for the EU’s Mutual Recognition Procedure) for the prevention of venous thromboembolic events (VTE) in major orthopedic (hip or knee replacement) surgery. | | | Subject to approval, European launches of the product for this indication are expected to take place in 2004. |
|
http://www.ims-global.com/insight/drugs_news/0401/drug_news_040112.htm
|
|
| |
| | Phase III Study Reports the Results of AstraZeneca's Investigational Oral Anticoagulant EXANTA(R) (ximelagatran) ... |
| | Phase III studies with EXANTA have been completed in a number of clinical conditions, and approximately 30,000 patients have been enrolled to date. | | | The objective of EXULT B (EXanta Used to Lessen Thrombosis) was to compare the efficacy of EXANTA with dose-adjusted warfarin (target INR 2.5) for the prevention of venous thromboembolism (VTE) and all-cause mortality in patients having undergone TKR surgery. | | | The THRIVE Treatment (oral direct THRombin Inhibitor ximelagatran for Venous thromboEmbolism) study, a Phase III trial for the therapy of VTE, was also presented at the 45th Annual Meeting of the American Society of Hematology. |
|
http://www.forrelease.com/D20031206/nysa007.P2.12062003140902.08498.html
|
|
| |
| | PJ Online News: Ximelagatran reduces VTE risk |
| | The researchers found that 12 of the 612 patients treated with ximelagatran 24mg twice daily suffered a further VTE by the end of the study, compared with 71 of the 611 patients in the placebo group — a relative risk reduction with ximelagatran of 84 per cent ( P <0.0001). | | | In the thrombin inhibitor in venous embolism (THRIVE III) study, 1,233 patients who had been treated for six months with warfarin after suffering an initial VTE were randomised to receive either ximelagatran or placebo for 18 months. | | | At the 44th meeting of the American Society of Hematology, held in Philadelphia last month, researchers revealed the benefit of treatment with ximelagatran over an extended period and the prolonged risk of recurrence of VTE seen in patients given placebo. |
|
http://www.pharmj.com/Editorial/20030111/news/vterisk.html
|
|
| |
| | PHASE II STUDY DEMONSTRATES PROMISE FOR EXANTA (XIMELAGATRAN) IN REDUCING MAJOR CARDIOVASCULAR EVENTS FOLLOWING ... |
| | This is the first time an oral direct thrombin inhibitor (oral DTI) has been evaluated in long-term treatment of patients following heart attack who are at high risk of arterial thrombotic events, such as further heart attack, stroke or cardiovascular death. | | | AstraZeneca announced today from the European Society of Cardiology (ESC) in Vienna, Austria, that data from a phase II dose-guiding study, ESTEEM*, indicate that oral Exanta (ximelagatran), provides significant additional benefits compared to the current treatment, aspirin, in prevention of major cardiovascular events in patients following an acute myocardial infarction (heart attack). | | | * ESTEEM stands for Efficacy and Safety of the oral Thrombin inhibitor ximelagatran in combination with aspirin, in patiEnts with rEcent Myocardial damage. |
|
http://www.pressi.com/se/release/72033.html
|
|
| |
| | Heart Disease: Ximelagatran Washes Out - The Center for Preventive Medicine |
| | Ximelagatran - a substitute for coumadin that eliminates the need for frequent blood tests and dosage adjustment - has been one of the most anxiously awaited new drugs in development. | | | Heart Disease: Ximelagatran Washes Out - The Center for Preventive Medicine | | | Now an FDA panel has recommended against approving this new... |
|
http://tcpm.organicframework.com/p/162,590.html
|
|
| |
| | EXANTA (XIMELAGATRAN) RECEIVES FIRST APPROVAL |
| | AstraZeneca has received its first regulatory approval for Exanta⢠(ximelagatran) in France for the prevention of venous thromboembolic events in major orthopaedic (hip or knee replacement) surgery. | | | · * METHRO: ME lagatran for THR ombin inhibition in O rthopaedic surgery study that compared injectable low molecular weight heparinsinitiated the evening before surgery, with preoperative (METHRO II) or post-operative (METHRO III) initiation of melagatran (active form) followed by oral ximelagatran in 4,688 patients undergoing total hip or knee replacement. |
|
http://www.astrazeneca.com/pressrelease/1103.aspx
|
|
| |
| | THRIVE III : le Ximelagatran sûr et efficace en prophylaxie prolongée. |
| | Pour GITA I. Extended Secondary Prevention with the Oral Direct Thrombin Inhibitor Ximelagatran for 18 Months after 6 Months of Anticoagulation in Patients | | | Pour une prophylaxie prolongée, la prise d’une dose biquotidienne fixe de Ximelagatran (24 mg) est donc parfaitement efficace et bien tolérée en l’absence d’une quelconque surveillance biologique. | | | THRIVE III : le Ximelagatran sûr et efficace en prophylaxie prolongée. |
|
http://www.gita-thrombose.org/flash-actu/THRIVE.html
|
|
| |
| | Exanta® or Ximelagatran - Direct Thrombin Inhibitor |
| | It is a small compound that is absorbed and converted to the active substance Melagatran. | | | What follows is my previous web page article on this drug prior to the FDA advisory committee ruling. | | | Exanta® or Ximelagatran is an new oral anticoagulant. |
|
http://www.loftusmd.com/Articles/stroke/exanta.html
|
|
|
