Magazin
2005-10-07
London (ots/PRNewswire) -
- Takeda's ACTOS(R) (pioglitazone HCl) on Top of StandardTreatment Demonstrates Significant Cardiovascular Benefits
A study published in The Lancet today shows that Takeda's ACTOS(R)(pioglitazone HCl), an oral glucose lowering medication,significantly reduces the combined risk of non-fatal heart attacks,strokes and deaths by an additional 16% on top of standardmedication, such as statins, fibrates, ACE inhibitors, beta blockers,other glucose-lowering medications and anti-platelet drugs, inpatients with type-2 diabetes with high risk of cardiovasculardisease.
This means that for every 48 patients treated with ACTOS overthree years one major cardiovascular event or death can be prevented.
"Seeing pioglitazone improve these cardiovascular outcomes (16%relative risk reduction) is an impressive result especially as thesepatients were already receiving standard treatments including the useof lipid-modifying drugs, anti-hypertensives, aspirin and otherglucose-lowering agents," said Professor Ian Campbell, ConsultantPhysician at Victoria Hospital, Edinburgh, Scotland. He furthercommented: "We look forward to further analyses that I understand arebeing submitted to scientific meetings and to reviews of the resultsin the medical press during the coming year."
Dr Michael George, Managing Director of the Takeda EuropeanResearch and Development Center commented: "In light of theseexcellent results Takeda is working on preparations for a labelchange for ACTOS."
Study design and results as presented at the 41st EASD meetingin Athens on September 12th 2005
PROactive (PROspective PioglitAzone Clinical Trial InMacroVascular Events) was a randomised, double-blind,placebo-controlled outcome study to determine the effects of ACTOS onmortality and morbidity associated with cardiovascular diseaseprogression in more than 5,000 high-risk patients with type-2diabetes when added to their standard treatment. Standard treatmentincluded the use of anti-hypertensives such as ACE inhibitors andbeta blockers; glucose lowering agents such as metformin,sulphonylureas and insulin; antiplatelet drugs such as aspirin andlipid-modifying medicines such as statins and fibrates.
The PROactive study focused on two key endpoints: a primarycombination endpoint of seven different macrovascular events ofvarying clinical importance and a principal secondary combinationendpoint of life-threatening events including non-fatal heartattacks, strokes and deaths.
The primary endpoint was reduced by 10% but had not reachedstatistical significance by the end of the study (p=0.095). However,the principal secondary endpoint of life-threatening events showedthat ACTOS significantly reduced the combined risk of non-fatal heartattacks, strokes and deaths by 16% (p=0.027).
Data from the PROactive Study were presented at the EuropeanAssociation for the Study of Diabetes in Athens last month.
Additional PROactive study results of ACTOS showed:
- HbA1c levels (a measurement of blood glucose control) weresignificantly reduced by 0.5% as compared to placebo (p<0.001).
- Lipid profiles significantly improved by increasing HDLcholesterol ("good" cholesterol) by 9% more than placebo (p<0.001)and reducing triglycerides (a known cardiovascular risk factor) by13% more than placebo (p<0.001).
- The LDL/HDL cholesterol ratio ("bad" to "good" cholesterol) wassignificantly improved (p<0.001). A 2% increase in LDL cholesterol("bad" cholesterol) was observed compared to placebo (p=0.003).
- Systolic blood pressure was significantly decreased (p=0.03);median change of 3 mmHg as compared to placebo.
The PROactive study was also designed to further examine thesafety of ACTOS in this high-risk patient group. The resultsdemonstrated that adverse events reported in this study wereconsistent with the known safety profile. Known side effects ofACTOS, including weight gain, oedema, non-serious hypoglycaemia andheart failure, were observed more frequently in the ACTOS groupcompared to placebo group.
Notes to Editors:
- The PROactive Study was funded by Takeda Pharmaceutical CompanyLimited, the makers of pioglitazone (marketed under the trade nameACTOS) and Eli Lilly and Company.
- The PROactive Study involved 5,238 patients in 19 Europeancountries who had experienced one or more cardiovascular events suchas a heart attack, coronary artery bypass surgery or stroke. Eachpatient was randomly assigned to either ACTOS or placebo in additionto the best standard of usual care and treatments.
- The results on the PROactive Study are available on thePROactive website, www.proactive-results.com. This website issupported by an unrestricted educational grant by TakedaPharmaceutical Company and Eli Lilly and Company.
About ACTOS
Takeda is the originator of thiazolidinedione derivatives, andACTOS (pioglitazone HCl) is a member of the thiazolidinedione classof "insulin-sensitising" agents. Insulin sensitisers help improve thebody's ability to effectively use its own insulin by reducing insulinresistance - a defect identified as a possible cause of type-2diabetes.
ACTOS received its first regulatory approval in July 1999 in theUnited States. By April 2004, more than 32 million prescriptions forACTOS had been filled for over 4.5 million patients in the UnitedStates alone. ACTOS was originally approved by the European MedicinesAgency for the treatment of type-2 diabetes in October 2000 and thelabel was extended in 2003. In Europe, ACTOS is indicated for use as:
- oral monotherapy treatment at doses up to 45 mg in type-2diabetes mellitus patients, particularly overweight patients,inadequately controlled by diet and exercise for whom metformin isinappropriate.
- oral combination treatment at doses up to 45 mg in patients withinsufficient glycaemic control despite maximum tolerated doses witheither metformin (particularly in overweight patients) orsulphonylurea (in patients for whom metformin is not tolerated or iscontraindicated).
About Eli Lilly & Company
Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of first-in-class and best-in-class pharmaceuticalproducts by applying the latest research from its own worldwidelaboratories and from collaborations with eminent scientificorganisations. Headquartered in Indianapolis, USA. Lilly providesanswers - through medicines and information - for some of the world'smost urgent medical needs.
About Takeda
Takeda, located in Osaka, Japan, is a research-based globalcompany with its main focus on pharmaceuticals. As the largestpharmaceutical company in Japan and one of the global leaders of theindustry, Takeda is committed to striving toward better health forindividuals and progress in medicine by developing superiorpharmaceutical products. Additional information about Takeda isavailable through its corporate website, www.takeda.com.
ots Originaltext: TakedaIm Internet recherchierbar: http://www.presseportal.de
Contact:Contacts: Alexander Watson, Ketchum London, +44-(0)7712-675990 (mobile), +44-(0)207-611-3663. David Roberts, Takeda European Marketing Office, +44-(0)207-484-9088 (office)
The Lancet Publishes Groundbreaking Proactive Study Showing Type-2 Diabetes Treatment Significantly Reduces Risk of Non-Fatal Heart Attacks, Strokes and Deaths
- Takeda's ACTOS(R) (pioglitazone HCl) on Top of StandardTreatment Demonstrates Significant Cardiovascular Benefits
A study published in The Lancet today shows that Takeda's ACTOS(R)(pioglitazone HCl), an oral glucose lowering medication,significantly reduces the combined risk of non-fatal heart attacks,strokes and deaths by an additional 16% on top of standardmedication, such as statins, fibrates, ACE inhibitors, beta blockers,other glucose-lowering medications and anti-platelet drugs, inpatients with type-2 diabetes with high risk of cardiovasculardisease.
This means that for every 48 patients treated with ACTOS overthree years one major cardiovascular event or death can be prevented.
"Seeing pioglitazone improve these cardiovascular outcomes (16%relative risk reduction) is an impressive result especially as thesepatients were already receiving standard treatments including the useof lipid-modifying drugs, anti-hypertensives, aspirin and otherglucose-lowering agents," said Professor Ian Campbell, ConsultantPhysician at Victoria Hospital, Edinburgh, Scotland. He furthercommented: "We look forward to further analyses that I understand arebeing submitted to scientific meetings and to reviews of the resultsin the medical press during the coming year."
Dr Michael George, Managing Director of the Takeda EuropeanResearch and Development Center commented: "In light of theseexcellent results Takeda is working on preparations for a labelchange for ACTOS."
Study design and results as presented at the 41st EASD meetingin Athens on September 12th 2005
PROactive (PROspective PioglitAzone Clinical Trial InMacroVascular Events) was a randomised, double-blind,placebo-controlled outcome study to determine the effects of ACTOS onmortality and morbidity associated with cardiovascular diseaseprogression in more than 5,000 high-risk patients with type-2diabetes when added to their standard treatment. Standard treatmentincluded the use of anti-hypertensives such as ACE inhibitors andbeta blockers; glucose lowering agents such as metformin,sulphonylureas and insulin; antiplatelet drugs such as aspirin andlipid-modifying medicines such as statins and fibrates.
The PROactive study focused on two key endpoints: a primarycombination endpoint of seven different macrovascular events ofvarying clinical importance and a principal secondary combinationendpoint of life-threatening events including non-fatal heartattacks, strokes and deaths.
The primary endpoint was reduced by 10% but had not reachedstatistical significance by the end of the study (p=0.095). However,the principal secondary endpoint of life-threatening events showedthat ACTOS significantly reduced the combined risk of non-fatal heartattacks, strokes and deaths by 16% (p=0.027).
Data from the PROactive Study were presented at the EuropeanAssociation for the Study of Diabetes in Athens last month.
Additional PROactive study results of ACTOS showed:
- HbA1c levels (a measurement of blood glucose control) weresignificantly reduced by 0.5% as compared to placebo (p<0.001).
- Lipid profiles significantly improved by increasing HDLcholesterol ("good" cholesterol) by 9% more than placebo (p<0.001)and reducing triglycerides (a known cardiovascular risk factor) by13% more than placebo (p<0.001).
- The LDL/HDL cholesterol ratio ("bad" to "good" cholesterol) wassignificantly improved (p<0.001). A 2% increase in LDL cholesterol("bad" cholesterol) was observed compared to placebo (p=0.003).
- Systolic blood pressure was significantly decreased (p=0.03);median change of 3 mmHg as compared to placebo.
The PROactive study was also designed to further examine thesafety of ACTOS in this high-risk patient group. The resultsdemonstrated that adverse events reported in this study wereconsistent with the known safety profile. Known side effects ofACTOS, including weight gain, oedema, non-serious hypoglycaemia andheart failure, were observed more frequently in the ACTOS groupcompared to placebo group.
Notes to Editors:
- The PROactive Study was funded by Takeda Pharmaceutical CompanyLimited, the makers of pioglitazone (marketed under the trade nameACTOS) and Eli Lilly and Company.
- The PROactive Study involved 5,238 patients in 19 Europeancountries who had experienced one or more cardiovascular events suchas a heart attack, coronary artery bypass surgery or stroke. Eachpatient was randomly assigned to either ACTOS or placebo in additionto the best standard of usual care and treatments.
- The results on the PROactive Study are available on thePROactive website, www.proactive-results.com. This website issupported by an unrestricted educational grant by TakedaPharmaceutical Company and Eli Lilly and Company.
About ACTOS
Takeda is the originator of thiazolidinedione derivatives, andACTOS (pioglitazone HCl) is a member of the thiazolidinedione classof "insulin-sensitising" agents. Insulin sensitisers help improve thebody's ability to effectively use its own insulin by reducing insulinresistance - a defect identified as a possible cause of type-2diabetes.
ACTOS received its first regulatory approval in July 1999 in theUnited States. By April 2004, more than 32 million prescriptions forACTOS had been filled for over 4.5 million patients in the UnitedStates alone. ACTOS was originally approved by the European MedicinesAgency for the treatment of type-2 diabetes in October 2000 and thelabel was extended in 2003. In Europe, ACTOS is indicated for use as:
- oral monotherapy treatment at doses up to 45 mg in type-2diabetes mellitus patients, particularly overweight patients,inadequately controlled by diet and exercise for whom metformin isinappropriate.
- oral combination treatment at doses up to 45 mg in patients withinsufficient glycaemic control despite maximum tolerated doses witheither metformin (particularly in overweight patients) orsulphonylurea (in patients for whom metformin is not tolerated or iscontraindicated).
About Eli Lilly & Company
Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of first-in-class and best-in-class pharmaceuticalproducts by applying the latest research from its own worldwidelaboratories and from collaborations with eminent scientificorganisations. Headquartered in Indianapolis, USA. Lilly providesanswers - through medicines and information - for some of the world'smost urgent medical needs.
About Takeda
Takeda, located in Osaka, Japan, is a research-based globalcompany with its main focus on pharmaceuticals. As the largestpharmaceutical company in Japan and one of the global leaders of theindustry, Takeda is committed to striving toward better health forindividuals and progress in medicine by developing superiorpharmaceutical products. Additional information about Takeda isavailable through its corporate website, www.takeda.com.
ots Originaltext: TakedaIm Internet recherchierbar: http://www.presseportal.de
Contact:Contacts: Alexander Watson, Ketchum London, +44-(0)7712-675990 (mobile), +44-(0)207-611-3663. David Roberts, Takeda European Marketing Office, +44-(0)207-484-9088 (office)
Takeda
