Magazin
2010-01-05
Tokyo and Indianapolis (ots/PRNewswire) - Results from ahealth economic substudy of the TRITON-TIMI 38 clinical trial showedthat among patients with acute coronary syndrome (ACS) managed withpercutaneous coronary intervention (PCI), including stenting,treatment with Efient(R) (prasugrel) compared with brandedclopidogrel (Plavix(R)) was more cost effective, and in most casescost saving. These results were published in Circulation on January5, 2010.(1)
In the pre-specified analysis of 6,705 patients, treatment withprasugrel compared with clopidogrel reduced total hospitalisationcosts over approximately 15 months, not including the cost of studydrugs, by US$530 per patient. This cost offset estimate includesbleeding-related costs that a sensitivity analysis showed were not amajor driver of the overall cost difference between the twotreatments.
The analysis also found that, including cost of the active studydrugs as well as costs associated with the initial and subsequenthospitalisations, treatment with prasugrel compared with clopidogreldecreased cumulative medical costs by US$221 per patient over the14.7-month study. Study drug costs used in the analysis were the netwholesale price as of August 2009, which was US$5.45 per day forprasugrel and US$4.62 per day for clopidogrel.
"Results of the cost-effectiveness analysis showed that treatmentwith prasugrel was highly cost effective and an economically dominantoption," said David J. Cohen, M.D., M.Sc., director of cardiovascularresearch, Saint Luke's Mid America Heart Institute and professor ofmedicine, University of Missouri-Kansas City. "These favourableresults were found in an analysis that considered only the first 30days of treatment, as well as an analysis that considered the timeperiod starting from 31 days through the rest of the follow-upperiod. These analyses are important because the results provide thehealthcare community, including formulary decision makers, with newdata regarding the cost-effectiveness of prasugrel for patients withACS undergoing PCI."
"Dominant" is a health economics term used when a new treatmentyields greater clinical effectiveness at lower costs. In TRITON-TIMI38, prasugrel plus aspirin (ASA) was shown to significantly reducethe rate of a combined endpoint of cardiovascular death, non-fatalheart attack, or non-fatal stroke compared to clopidogrel plus ASA.In addition, patients treated with prasugrel also had significantlyfewer stent thromboses (stent-related blood clots) compared to thosetreated with clopidogrel. These benefits were accompanied by asignificantly higher risk of bleeding, which in some cases werelife-threatening or even fatal in patients treated with prasugrelcompared with clopidogrel.
The analysis also compared prasugrel to generic clopidogrel at ahypothetical cost of US$1 per day. When compared to clopidogrel atthis lower cost, treatment with prasugrel in the subpopulation as awhole was economically dominant (e.g., cost saving) during the first30 days of treatment. After day 31, it continued to be acost-effective therapy relative to many other accepted medicalinterventions.
"The hypothetical comparison with generic clopidogrel isimportant because the patent exclusivity for clopidogrel will expirein the US in 2011 or 2012 and is already facing generic competitionin several countries in the EU. Results from this comparison togeneric clopidogrel will be useful information for the medicalcommunity, especially payers, in the future," said Dr. Cohen, "andsuggest that the overall benefit of prasugrel was still favourablerelative to its higher cost in this setting."
Study Methodology
TRITON-TIMI 38 was a Phase III, randomised, double-blind,head-to-head clinical trial comparing the effects of prasugrel versusclopidogrel in patients with ACS who were managed with PCI, aprocedure to open blockages in heart arteries, including the use ofcoronary stenting. The study enrolled 13,608 patients at 707 trialsites in 30 countries.
The primary endpoint of the study was the combined incidence ofcardiovascular death, non-fatal heart attack or non-fatal strokeduring a median period of at least 12 months following PCI. Patientswere randomly assigned to one of two treatment groups and given aloading dose of either prasugrel 60 mg or the FDA-approved loadingdose of clopidogrel 300 mg, followed by a daily maintenance dose ofeither prasugrel 10 mg or clopidogrel 75 mg. All patients alsoreceived a daily dose of aspirin (75 mg to 325 mg).
The economic analysis was completed using data from 6,705 studypatients enrolled in eight pre-specified countries, including theUnited States, Australia, Canada, France, Germany, Italy, Spain andthe United Kingdom. The primary economic measure was total in-trialcosts including hospitalisation and medication costs. The approach toestimating costs was to multiply counts of resource use(hospitalisations, physician costs, procedures, medications) by priceweights derived from comparable populations of US patients. All costsother than study drug costs were assessed in 2005 US dollars.
About Prasugrel
Daiichi Sankyo Company, Limited, and Eli Lilly and Companyco-developed prasugrel, an oral antiplatelet agent discovered byDaiichi Sankyo and its Japanese research partner, Ube Industries,Ltd. Prasugrel helps keep blood platelets from clumping together anddeveloping a blockage in an artery. The European Commission grantedmarketing authorisation for prasugrel for the prevention ofatherothrombotic events in patients with ACS undergoing PCI.
About Acute Coronary Syndrome
Acute coronary syndrome includes heart attacks and unstableangina (chest pain). Coronary heart disease, which can result in ACS,is the single most common cause of death in the European Union,accounting for more than 741,000 deaths in the EU each year.(2) Inaddition, ACS affects nearly 1.5 million people in the United Statesannually.(3) Heart attack is a major manifestation of coronary heartdisease, which occurs when the arteries become narrowed or clogged bycholesterol and fat deposits. In some cases the plaque can rupture,resulting in a blood clot, which may partially or totally block theblood supply to portions of the heart, resulting in ACS. Many ACSpatients undergo PCI to re-open the artery, which usually includes astent placement.
Important Safety Information about Prasugrel
In the EU prasugrel label, the risk of non-coronary artery bypassgraft (non-CABG) major bleeding, including fatal bleeding, was higherwith prasugrel (2.2 percent incidence) compared with clopidogrel (1.7percent incidence). Compared with the overall study population, ahigher risk of serious bleeding among prasugrel patients was mostevident in three distinct patient populations that are readilyidentifiable: patients who weighed less than 60 kg (132 lbs),patients who were 75 years of age or older and patients who have hada prior transient ischemic attack (TIA) or stroke. Patients whoweighed less than 60 kg, or were 75 years of age or older hadincreased exposure with prasugrel. In the EU prasugrel label, a 5 mgmaintenance dose is recommended for patients who weigh less than 60kg. Prasugrel is generally not recommended for use in patients 75years or older; if treatment is deemed necessary in this age group, a5 mg maintenance dose should be prescribed. Patients with prior TIAor stroke should not be treated with prasugrel.
The EU prasugrel label includes a contraindication for patientswith a history of TIA or stroke, as well as a warning for patientswho weighed less than 60 kg (132 lbs) and patients who are 75 yearsof age or older. For the patients in TRITON-TIMI 38 without theserisk factors, the efficacy of prasugrel compared with clopidogrel onthe primary composite endpoint of CVD, nonfatal MI, or nonfatalstroke was 8.3 percent vs. 11.0 percent, respectively, and consistentwith the significant efficacy benefit observed with prasugrel in theoverall study population. In these same patients, the risk of seriousbleeding was reduced but still higher with prasugrel compared withclopidogrel (2.0 percent vs. 1.5 percent, respectively).
An analysis weighing the risk of major bleeding and the reductionin heart attacks found an overall benefit favouring prasugrelcompared with clopidogrel. For every 1,000 patients treated withprasugrel as compared with clopidogrel, there were 22 fewer patientswith heart attacks and five more with non-CABG-related major bleedingevents.
About Daiichi Sankyo
A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., wasestablished in 2005 through the merger of two leading Japanesepharmaceutical companies. This integration created a more robustorganisation that allows for continuous development of novel drugsthat enrich the quality of life for patients around the world. Areasof primary focus for Daiichi Sankyo research and development arethrombotic disorders, malignant neoplasm, diabetes mellitus, andautoimmune disorders. Equally important to the company arehypertension, hyperlipidemia or atherosclerosis and bacterialinfections. For more information, visit www.daiichisankyo.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of pharmaceutical products by applying the latestresearch from its own worldwide laboratories and from collaborationswith eminent scientific organisations. Headquartered in Indianapolis,Ind., Lilly provides answers - through medicines and information -for some of the world's most urgent medical needs. Additionalinformation about Lilly is available at www.lilly.com.
This press release contains certain forward-looking statementsabout Efient for the reduction of thrombotic cardiovascular events(including stent thrombosis) in patients with acute coronary syndromeundergoing percutaneous coronary intervention and reflects DaiichiSankyo's and Lilly's current beliefs. However, as with anypharmaceutical product, there are substantial risks and uncertaintiesin the process of development and commercialisation. There is noguarantee that future study results and patient experience will beconsistent with study findings to date or that the product will becommercially successful. For further discussion of these and otherrisks and uncertainties, see Lilly's filing with the United StatesSecurities and Exchange Commission and Daiichi Sankyo's filings withthe Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no dutyto update forward-looking statements.
Efient(R) is a registered trademark of Eli Lilly and Company.
Plavix(R) is a registered trademark of Sanofi-Aventis Corp.
P-LLY
(1) Mahoney EM, Wang K, et al. Cost-Effectiveness of Prasugrelversus Clopidogrel in Patients with Acute Coronary Syndromes andPlanned PCI: Results from the TRITON-TIMI 38 Trial. Circulation.2010; 121: 71-79.
(2) British Heart Foundation Health Promotion Research Group.European Cardiovascular Disease Statistics 2008,http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf,Accessed Oct. 15, 2009.
(3) American Heart Association. Heart Disease and StrokeStatistics - 2008 Update. Dallas, TX. American Heart Association.(Pg. 14)
(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO )
ots Originaltext: Eli Lilly and CompanyIm Internet recherchierbar: http://www.presseportal.de
Contact:CONTACT: Derin Denham, Eli Lilly and Company, +1-317-277-6749 (office),+1-317-370-1435 (cell); Dr. Michaela Paudler-Debus, Daiichi Sankyo EuropeGmbH, +49-(0)89-78-08-685 (office), +49-(0)172-845-8974 (cell); ShigemichiKondo, Daiichi Sankyo (Tokyo), +81-3-6225-1126 (office)
New Analysis Showed Efient(R) Cost-Effective Compared with Clopidogrel for Patients with Acute Coronary Syndromes Undergoing PCI
Tokyo and Indianapolis (ots/PRNewswire) - Results from ahealth economic substudy of the TRITON-TIMI 38 clinical trial showedthat among patients with acute coronary syndrome (ACS) managed withpercutaneous coronary intervention (PCI), including stenting,treatment with Efient(R) (prasugrel) compared with brandedclopidogrel (Plavix(R)) was more cost effective, and in most casescost saving. These results were published in Circulation on January5, 2010.(1)
In the pre-specified analysis of 6,705 patients, treatment withprasugrel compared with clopidogrel reduced total hospitalisationcosts over approximately 15 months, not including the cost of studydrugs, by US$530 per patient. This cost offset estimate includesbleeding-related costs that a sensitivity analysis showed were not amajor driver of the overall cost difference between the twotreatments.
The analysis also found that, including cost of the active studydrugs as well as costs associated with the initial and subsequenthospitalisations, treatment with prasugrel compared with clopidogreldecreased cumulative medical costs by US$221 per patient over the14.7-month study. Study drug costs used in the analysis were the netwholesale price as of August 2009, which was US$5.45 per day forprasugrel and US$4.62 per day for clopidogrel.
"Results of the cost-effectiveness analysis showed that treatmentwith prasugrel was highly cost effective and an economically dominantoption," said David J. Cohen, M.D., M.Sc., director of cardiovascularresearch, Saint Luke's Mid America Heart Institute and professor ofmedicine, University of Missouri-Kansas City. "These favourableresults were found in an analysis that considered only the first 30days of treatment, as well as an analysis that considered the timeperiod starting from 31 days through the rest of the follow-upperiod. These analyses are important because the results provide thehealthcare community, including formulary decision makers, with newdata regarding the cost-effectiveness of prasugrel for patients withACS undergoing PCI."
"Dominant" is a health economics term used when a new treatmentyields greater clinical effectiveness at lower costs. In TRITON-TIMI38, prasugrel plus aspirin (ASA) was shown to significantly reducethe rate of a combined endpoint of cardiovascular death, non-fatalheart attack, or non-fatal stroke compared to clopidogrel plus ASA.In addition, patients treated with prasugrel also had significantlyfewer stent thromboses (stent-related blood clots) compared to thosetreated with clopidogrel. These benefits were accompanied by asignificantly higher risk of bleeding, which in some cases werelife-threatening or even fatal in patients treated with prasugrelcompared with clopidogrel.
The analysis also compared prasugrel to generic clopidogrel at ahypothetical cost of US$1 per day. When compared to clopidogrel atthis lower cost, treatment with prasugrel in the subpopulation as awhole was economically dominant (e.g., cost saving) during the first30 days of treatment. After day 31, it continued to be acost-effective therapy relative to many other accepted medicalinterventions.
"The hypothetical comparison with generic clopidogrel isimportant because the patent exclusivity for clopidogrel will expirein the US in 2011 or 2012 and is already facing generic competitionin several countries in the EU. Results from this comparison togeneric clopidogrel will be useful information for the medicalcommunity, especially payers, in the future," said Dr. Cohen, "andsuggest that the overall benefit of prasugrel was still favourablerelative to its higher cost in this setting."
Study Methodology
TRITON-TIMI 38 was a Phase III, randomised, double-blind,head-to-head clinical trial comparing the effects of prasugrel versusclopidogrel in patients with ACS who were managed with PCI, aprocedure to open blockages in heart arteries, including the use ofcoronary stenting. The study enrolled 13,608 patients at 707 trialsites in 30 countries.
The primary endpoint of the study was the combined incidence ofcardiovascular death, non-fatal heart attack or non-fatal strokeduring a median period of at least 12 months following PCI. Patientswere randomly assigned to one of two treatment groups and given aloading dose of either prasugrel 60 mg or the FDA-approved loadingdose of clopidogrel 300 mg, followed by a daily maintenance dose ofeither prasugrel 10 mg or clopidogrel 75 mg. All patients alsoreceived a daily dose of aspirin (75 mg to 325 mg).
The economic analysis was completed using data from 6,705 studypatients enrolled in eight pre-specified countries, including theUnited States, Australia, Canada, France, Germany, Italy, Spain andthe United Kingdom. The primary economic measure was total in-trialcosts including hospitalisation and medication costs. The approach toestimating costs was to multiply counts of resource use(hospitalisations, physician costs, procedures, medications) by priceweights derived from comparable populations of US patients. All costsother than study drug costs were assessed in 2005 US dollars.
About Prasugrel
Daiichi Sankyo Company, Limited, and Eli Lilly and Companyco-developed prasugrel, an oral antiplatelet agent discovered byDaiichi Sankyo and its Japanese research partner, Ube Industries,Ltd. Prasugrel helps keep blood platelets from clumping together anddeveloping a blockage in an artery. The European Commission grantedmarketing authorisation for prasugrel for the prevention ofatherothrombotic events in patients with ACS undergoing PCI.
About Acute Coronary Syndrome
Acute coronary syndrome includes heart attacks and unstableangina (chest pain). Coronary heart disease, which can result in ACS,is the single most common cause of death in the European Union,accounting for more than 741,000 deaths in the EU each year.(2) Inaddition, ACS affects nearly 1.5 million people in the United Statesannually.(3) Heart attack is a major manifestation of coronary heartdisease, which occurs when the arteries become narrowed or clogged bycholesterol and fat deposits. In some cases the plaque can rupture,resulting in a blood clot, which may partially or totally block theblood supply to portions of the heart, resulting in ACS. Many ACSpatients undergo PCI to re-open the artery, which usually includes astent placement.
Important Safety Information about Prasugrel
In the EU prasugrel label, the risk of non-coronary artery bypassgraft (non-CABG) major bleeding, including fatal bleeding, was higherwith prasugrel (2.2 percent incidence) compared with clopidogrel (1.7percent incidence). Compared with the overall study population, ahigher risk of serious bleeding among prasugrel patients was mostevident in three distinct patient populations that are readilyidentifiable: patients who weighed less than 60 kg (132 lbs),patients who were 75 years of age or older and patients who have hada prior transient ischemic attack (TIA) or stroke. Patients whoweighed less than 60 kg, or were 75 years of age or older hadincreased exposure with prasugrel. In the EU prasugrel label, a 5 mgmaintenance dose is recommended for patients who weigh less than 60kg. Prasugrel is generally not recommended for use in patients 75years or older; if treatment is deemed necessary in this age group, a5 mg maintenance dose should be prescribed. Patients with prior TIAor stroke should not be treated with prasugrel.
The EU prasugrel label includes a contraindication for patientswith a history of TIA or stroke, as well as a warning for patientswho weighed less than 60 kg (132 lbs) and patients who are 75 yearsof age or older. For the patients in TRITON-TIMI 38 without theserisk factors, the efficacy of prasugrel compared with clopidogrel onthe primary composite endpoint of CVD, nonfatal MI, or nonfatalstroke was 8.3 percent vs. 11.0 percent, respectively, and consistentwith the significant efficacy benefit observed with prasugrel in theoverall study population. In these same patients, the risk of seriousbleeding was reduced but still higher with prasugrel compared withclopidogrel (2.0 percent vs. 1.5 percent, respectively).
An analysis weighing the risk of major bleeding and the reductionin heart attacks found an overall benefit favouring prasugrelcompared with clopidogrel. For every 1,000 patients treated withprasugrel as compared with clopidogrel, there were 22 fewer patientswith heart attacks and five more with non-CABG-related major bleedingevents.
About Daiichi Sankyo
A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., wasestablished in 2005 through the merger of two leading Japanesepharmaceutical companies. This integration created a more robustorganisation that allows for continuous development of novel drugsthat enrich the quality of life for patients around the world. Areasof primary focus for Daiichi Sankyo research and development arethrombotic disorders, malignant neoplasm, diabetes mellitus, andautoimmune disorders. Equally important to the company arehypertension, hyperlipidemia or atherosclerosis and bacterialinfections. For more information, visit www.daiichisankyo.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of pharmaceutical products by applying the latestresearch from its own worldwide laboratories and from collaborationswith eminent scientific organisations. Headquartered in Indianapolis,Ind., Lilly provides answers - through medicines and information -for some of the world's most urgent medical needs. Additionalinformation about Lilly is available at www.lilly.com.
This press release contains certain forward-looking statementsabout Efient for the reduction of thrombotic cardiovascular events(including stent thrombosis) in patients with acute coronary syndromeundergoing percutaneous coronary intervention and reflects DaiichiSankyo's and Lilly's current beliefs. However, as with anypharmaceutical product, there are substantial risks and uncertaintiesin the process of development and commercialisation. There is noguarantee that future study results and patient experience will beconsistent with study findings to date or that the product will becommercially successful. For further discussion of these and otherrisks and uncertainties, see Lilly's filing with the United StatesSecurities and Exchange Commission and Daiichi Sankyo's filings withthe Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no dutyto update forward-looking statements.
Efient(R) is a registered trademark of Eli Lilly and Company.
Plavix(R) is a registered trademark of Sanofi-Aventis Corp.
P-LLY
(1) Mahoney EM, Wang K, et al. Cost-Effectiveness of Prasugrelversus Clopidogrel in Patients with Acute Coronary Syndromes andPlanned PCI: Results from the TRITON-TIMI 38 Trial. Circulation.2010; 121: 71-79.
(2) British Heart Foundation Health Promotion Research Group.European Cardiovascular Disease Statistics 2008,http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf,Accessed Oct. 15, 2009.
(3) American Heart Association. Heart Disease and StrokeStatistics - 2008 Update. Dallas, TX. American Heart Association.(Pg. 14)
(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO )
ots Originaltext: Eli Lilly and CompanyIm Internet recherchierbar: http://www.presseportal.de
Contact:CONTACT: Derin Denham, Eli Lilly and Company, +1-317-277-6749 (office),+1-317-370-1435 (cell); Dr. Michaela Paudler-Debus, Daiichi Sankyo EuropeGmbH, +49-(0)89-78-08-685 (office), +49-(0)172-845-8974 (cell); ShigemichiKondo, Daiichi Sankyo (Tokyo), +81-3-6225-1126 (office)
Eli Lilly and Company Homepage ,Story,Pressemappe
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