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Exanta Replacing Coumadin?
Posted by Howie
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Howie
Exanta Replacing Coumadin? October 23, 2003 10:51AM |
The last reports I remember seeing seemed to indicate that the Exanta trials were going well which might lead to Exanta replacing coumadin (warfarin) resulting in not having to get your blood checked often as is currently required with coumadin. I am hoping it might be approved next year. Does anyone have a feel for when Exanta might be available to the public if all continues to go well?
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exanta
Re: Exanta Replacing Coumadin? October 23, 2003 12:28PM |
there is some concern that may delay itsrelease due to elevated liver enzymes caused by the drug-see press release below-jerry
1 September 2003
PHASE II STUDY DEMONSTRATES PROMISE FOR EXANTA (XIMELAGATRAN) IN REDUCING MAJOR CARDIOVASCULAR EVENTS FOLLOWING MYOCARDIAL INFARCTION (MI)
ESTEEM* study indicates potential for Exanta in new cardiovascular indication
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). 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.
Results from ESTEEM show that oral Exanta, the first in a new class of oral direct thrombin inhibitors (oral DTIs), significantly reduces the risk of death, recurrent heart attack or attacks of severe chest pain from 16.3 per cent to 12.7 per cent (all dose groups combined) during six months treatment in combination with aspirin, equating to a reduction of risk by 24 per cent (hazard ratio 0.76; p=0.036) compared with aspirin alone.
The promising efficacy results from ESTEEM are very exciting as they show the first proof of the efficacy for Exanta in this new indication, and provide a strong foundation for possible future development of Exanta in this and other arterial indications in which there is a high unmet medical need, says Dr Hamish Cameron, Vice President, Head of Exanta, AstraZeneca. We will now focus on incorporating the efficacy and safety results from ESTEEM alongside those seen in the extensive phase III clinical programme to date, to establish the overall benefit-risk profile for Exanta in the key indications under investigation.
ESTEEM, a phase II multi-centre, multinational, placebo-controlled, double-blind dose-guiding study, involved randomisation of 1883 patients within 14 days of a heart attack to six months treatment twice daily of either oral Exanta 24, 36, 48 or 60 mg twice daily or placebo. All patients received 160mg aspirin once daily.
Overall, a favourable safety profile was seen for Exanta in terms of bleeding and general adverse events. There was no significant difference in major bleeding events between the Exanta and placebo treatment groups (1.8 per cent Exanta vs 0.9 per cent placebo). Total bleeding (major and minor) was higher in the Exanta group, but was comparable to rates seen in recent trials of long-term warfarin or other agents, and increased in a dose-related manner.
Laboratory blood tests in the study showed an increased incidence of liver enzyme elevations** in patients receiving Exanta, compared with those receiving placebo, as observed in phase III studies. Elevated liver enzymes were seen in 6.5 per cent of patients at the lowest dose, 24mg, while elevations were seen in 12.2 13 per cent of patients at the higher doses. An incidence of elevated bilirubin levels above twice the upper limit of normal (> 2XULN) combined with ALAT above three times the upper limit of normal (> 3XULN) occurred in 0.6 per cent of patients in the Exanta group, compared with 0.2 per cent of patients in the placebo group. As seen in phase III Exanta studies, these ALAT elevations decreased towards baseline with treatment continuation or discontinuation and were not typically associated with specific clinical symptoms. These findings are under evaluation together with safety results from the full Exanta clinical study programme in order to establish the overall benefit-risk profile for the product.
Chronic phase III studies to date also demonstrate a positive benefit-risk profile for Exanta. The first full presentation of the SPORTIF III*** study will take place at the ESC Congress 2003 tomorrow (Tuesday 2 September) and will confirm the potential for Exanta to meet an unmet medical need in the important stroke prevention in AF indication - AF is a factor behind 15 per cent of all strokes.
Exanta has completed phase III studies in a number of indications and around 30,000 patients have been enrolled in the Exanta clinical trial programme to date. Exanta is the first oral anticoagulant to reach late stage clinical trials since the development of warfarin 60 years ago.
Regulatory submission for the major indications of stroke prevention in atrial fibrillation and treatment and long-term prevention of VTE remain on track for late 2003. The current worldwide market for antithrombotics is $9.6 billion.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
The ESTEEM study is due to be published in The Lancet on 6 September 2003.
Further enquires to:
Media Enquiries:
Steve Brown, +44 (0) 207 304 5033
Investor Enquiries:
Mina Blair-Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
Exanta is a trademark of the AstraZeneca group of companies.
ESTEEM Business Media Teleconference
Professor Lars Wallentin, lead ESTEEM Investigator, will be available to provide an overview of the key study findings and answer questions via a teleconference at 11.00am UK time (GMT + 1) on Monday 1 September. Dr Hamish Cameron, Vice President and Head of Exanta, from AstraZeneca, will also be available. To join this call, please dial +44 (0) 1296 480 100 before 11.00am UK on Monday, 1st September quoting access code C635099 to the operator. Slides and further information will be available from 10.30am UK on 1st September, via www.astrazenecapressoffice.com
Editors Notes:
* ESTEEM stands for Efficacy and Safety of the oral Thrombin inhibitor ximelagatran in combination with aspirin, in patiEnts with rEcent Myocardial damage. ESTEEM involved 1883 patients at 191 hospitals in 18 countries during 20012002. The study compared Exanta in combination with the current standard treatment, aspirin, to placebo (aspirin alone).
** An increase in ALAT > 3 x ULN was seen in 6.5 per cent, 12.9 per cent, 12.2 per cent and 13.0 per cent of patients in the 24, 36, 48 and 60mg Exanta groups, respectively, compared with 1.3 per cent in the placebo group.
***SPORTIF stands for Stroke Prevention by ORal Thrombin Inhibitor in atrial Fibrillation, and is the largest-ever stroke prevention study in atrial fibrillation to date.
The SPORTIF III study is due to be presented in full at the ESC Congress 2003 at 12.00 on Tuesday 2 September 2003.
SPORTIF III topline data was first presented in a hotline session at the 52nd Scientific Session of the American College of Cardiology Congress (ACC) in Chicago on 2 April 2003. SPORTIF III involves 3407 patients from 259 centres in 23 countries across Europe, Australia and Asia in which 36mg fixed dose oral Exanta twice daily was compared with dose-adjusted warfarin (INR 2.0-3.0) once daily.
1 September 2003
PHASE II STUDY DEMONSTRATES PROMISE FOR EXANTA (XIMELAGATRAN) IN REDUCING MAJOR CARDIOVASCULAR EVENTS FOLLOWING MYOCARDIAL INFARCTION (MI)
ESTEEM* study indicates potential for Exanta in new cardiovascular indication
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). 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.
Results from ESTEEM show that oral Exanta, the first in a new class of oral direct thrombin inhibitors (oral DTIs), significantly reduces the risk of death, recurrent heart attack or attacks of severe chest pain from 16.3 per cent to 12.7 per cent (all dose groups combined) during six months treatment in combination with aspirin, equating to a reduction of risk by 24 per cent (hazard ratio 0.76; p=0.036) compared with aspirin alone.
The promising efficacy results from ESTEEM are very exciting as they show the first proof of the efficacy for Exanta in this new indication, and provide a strong foundation for possible future development of Exanta in this and other arterial indications in which there is a high unmet medical need, says Dr Hamish Cameron, Vice President, Head of Exanta, AstraZeneca. We will now focus on incorporating the efficacy and safety results from ESTEEM alongside those seen in the extensive phase III clinical programme to date, to establish the overall benefit-risk profile for Exanta in the key indications under investigation.
ESTEEM, a phase II multi-centre, multinational, placebo-controlled, double-blind dose-guiding study, involved randomisation of 1883 patients within 14 days of a heart attack to six months treatment twice daily of either oral Exanta 24, 36, 48 or 60 mg twice daily or placebo. All patients received 160mg aspirin once daily.
Overall, a favourable safety profile was seen for Exanta in terms of bleeding and general adverse events. There was no significant difference in major bleeding events between the Exanta and placebo treatment groups (1.8 per cent Exanta vs 0.9 per cent placebo). Total bleeding (major and minor) was higher in the Exanta group, but was comparable to rates seen in recent trials of long-term warfarin or other agents, and increased in a dose-related manner.
Laboratory blood tests in the study showed an increased incidence of liver enzyme elevations** in patients receiving Exanta, compared with those receiving placebo, as observed in phase III studies. Elevated liver enzymes were seen in 6.5 per cent of patients at the lowest dose, 24mg, while elevations were seen in 12.2 13 per cent of patients at the higher doses. An incidence of elevated bilirubin levels above twice the upper limit of normal (> 2XULN) combined with ALAT above three times the upper limit of normal (> 3XULN) occurred in 0.6 per cent of patients in the Exanta group, compared with 0.2 per cent of patients in the placebo group. As seen in phase III Exanta studies, these ALAT elevations decreased towards baseline with treatment continuation or discontinuation and were not typically associated with specific clinical symptoms. These findings are under evaluation together with safety results from the full Exanta clinical study programme in order to establish the overall benefit-risk profile for the product.
Chronic phase III studies to date also demonstrate a positive benefit-risk profile for Exanta. The first full presentation of the SPORTIF III*** study will take place at the ESC Congress 2003 tomorrow (Tuesday 2 September) and will confirm the potential for Exanta to meet an unmet medical need in the important stroke prevention in AF indication - AF is a factor behind 15 per cent of all strokes.
Exanta has completed phase III studies in a number of indications and around 30,000 patients have been enrolled in the Exanta clinical trial programme to date. Exanta is the first oral anticoagulant to reach late stage clinical trials since the development of warfarin 60 years ago.
Regulatory submission for the major indications of stroke prevention in atrial fibrillation and treatment and long-term prevention of VTE remain on track for late 2003. The current worldwide market for antithrombotics is $9.6 billion.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
The ESTEEM study is due to be published in The Lancet on 6 September 2003.
Further enquires to:
Media Enquiries:
Steve Brown, +44 (0) 207 304 5033
Investor Enquiries:
Mina Blair-Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
Exanta is a trademark of the AstraZeneca group of companies.
ESTEEM Business Media Teleconference
Professor Lars Wallentin, lead ESTEEM Investigator, will be available to provide an overview of the key study findings and answer questions via a teleconference at 11.00am UK time (GMT + 1) on Monday 1 September. Dr Hamish Cameron, Vice President and Head of Exanta, from AstraZeneca, will also be available. To join this call, please dial +44 (0) 1296 480 100 before 11.00am UK on Monday, 1st September quoting access code C635099 to the operator. Slides and further information will be available from 10.30am UK on 1st September, via www.astrazenecapressoffice.com
Editors Notes:
* ESTEEM stands for Efficacy and Safety of the oral Thrombin inhibitor ximelagatran in combination with aspirin, in patiEnts with rEcent Myocardial damage. ESTEEM involved 1883 patients at 191 hospitals in 18 countries during 20012002. The study compared Exanta in combination with the current standard treatment, aspirin, to placebo (aspirin alone).
** An increase in ALAT > 3 x ULN was seen in 6.5 per cent, 12.9 per cent, 12.2 per cent and 13.0 per cent of patients in the 24, 36, 48 and 60mg Exanta groups, respectively, compared with 1.3 per cent in the placebo group.
***SPORTIF stands for Stroke Prevention by ORal Thrombin Inhibitor in atrial Fibrillation, and is the largest-ever stroke prevention study in atrial fibrillation to date.
The SPORTIF III study is due to be presented in full at the ESC Congress 2003 at 12.00 on Tuesday 2 September 2003.
SPORTIF III topline data was first presented in a hotline session at the 52nd Scientific Session of the American College of Cardiology Congress (ACC) in Chicago on 2 April 2003. SPORTIF III involves 3407 patients from 259 centres in 23 countries across Europe, Australia and Asia in which 36mg fixed dose oral Exanta twice daily was compared with dose-adjusted warfarin (INR 2.0-3.0) once daily.
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