Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Study shows ACTOS® reduced heart attacks, strokes and deaths in patients with type 2 diabetes

13.09.2005


Landmark data from the PROactive Study, presented today at the 41st meeting of the European Association for the Study of Diabetes (EASD) demonstrated that ACTOS® (pioglitazone HCl) significantly reduced the combined risk of heart attacks, strokes and death by 16% in high-risk patients with type 2 diabetes.

"The PROactive study is the first in the world to prospectively show that a specific oral glucose lowering medication, namely pioglitazone, can significantly improve cardiovascular outcomes by helping to delay or reduce heart attacks, strokes and death in high-risk patients," said John Dormandy, M.D., professor of Vascular Sciences at St. George’s Hospital, London, UK, and chairman of the PROactive Study Steering Committee. "This groundbreaking study gives new hope to people with type 2 diabetes who, despite their attempts to control blood glucose and take medications, fear these life-threatening events."

PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was a randomized, double blind, placebo-controlled outcome study to determine the effects of ACTOS on mortality and morbidity associated with cardiovascular disease progression in more than 5,000 high risk patients with type 2 diabetes when added to standard of care treatment.



Standard of care included the routine use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose-lowering agents such as metformin, sulfonylureas and insulin; antiplatelet drugs such as aspirin, and lipid-modifying medicines such as statins and fibrates.

Compelling Study Results

This study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events of varying clinical importance; and a principal secondary combination endpoint of life-threatening events including death, heart attack and stroke.

The primary endpoint was reduced by 10% but had not reached statistical significance by study end (p=0.095). The principal secondary endpoint of life-threatening events showed that pioglitazone significantly reduced the risk of heart attacks, strokes and death by 16% (p=0.027).

According to Professor Dormandy, these results predict that 10 heart attacks, strokes or deaths will be prevented for every 500 high-risk patients treated with ACTOS® (pioglitazone HCl) over three years. Additional PROactive study results of ACTOS showed:

  • HbA1c levels (a measurement of long-term blood glucose control) were significantly reduced as compared to placebo (p<0.001).
  • Lipid profiles significantly improved by increasing HDL cholesterol ("good" cholesterol) by 9% more than placebo (p<0.001), and reducing triglycerides (a known cardiovascular risk factor) by 13% more than placebo (p<0.001).
  • The LDL/HDL cholesterol ratio ("bad" to "good" cholesterol) was significantly 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 more than produced by placebo.
  • The number of patients needing to have insulin added permanently to their treatment was 50% less than placebo (p<0.001).

The PROactive Study was also designed to further examine the safety of ACTOS in this high-risk patient group. The results demonstrated that adverse events reported in this study were consistent with the known safety profile. Known side effects of ACTOS, including weight gain, edema, non-serious hypoglycemia and heart failure were observed more frequently compared to placebo. However, the benefits of ACTOS in the study outweighed the risks. In addition, there were no reports of acute liver toxicity.

"ACTOS has demonstrated a unique profile in earlier comparative clinical studies by providing benefits beyond glycemic control on markers of cardiovascular risk," commented Dr. Kitazawa, a member of the board of Takeda Pharmaceutical Company, Osaka, Japan. "However, the clinical significance of these effects of pioglitazone was unknown until we knew the exciting news from the PROactive Study. Additional clinical studies are being funded by Takeda to further improve our understanding of how ACTOS enables the results we have seen in the PROactive study, specifically the reduction in risk of heart attacks, strokes and deaths."

Professor Dormandy added, "Until we know how pioglitazone works to provide these life-saving benefits, the beneficial results of PROactive should not be generalized to any other glucose-lowering medication."

Jocelyn M. Gerst | EurekAlert!
Further information:
http://www.ketchum.com

More articles from Studies and Analyses:

nachricht New study from the University of Halle: How climate change alters plant growth
12.01.2018 | Martin-Luther-Universität Halle-Wittenberg

nachricht Disarray in the brain
18.12.2017 | Universität zu Lübeck

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Scientists decipher key principle behind reaction of metalloenzymes

So-called pre-distorted states accelerate photochemical reactions too

What enables electrons to be transferred swiftly, for example during photosynthesis? An interdisciplinary team of researchers has worked out the details of how...

Im Focus: The first precise measurement of a single molecule's effective charge

For the first time, scientists have precisely measured the effective electrical charge of a single molecule in solution. This fundamental insight of an SNSF Professor could also pave the way for future medical diagnostics.

Electrical charge is one of the key properties that allows molecules to interact. Life itself depends on this phenomenon: many biological processes involve...

Im Focus: Paradigm shift in Paris: Encouraging an holistic view of laser machining

At the JEC World Composite Show in Paris in March 2018, the Fraunhofer Institute for Laser Technology ILT will be focusing on the latest trends and innovations in laser machining of composites. Among other things, researchers at the booth shared with the Aachen Center for Integrative Lightweight Production (AZL) will demonstrate how lasers can be used for joining, structuring, cutting and drilling composite materials.

No other industry has attracted as much public attention to composite materials as the automotive industry, which along with the aerospace industry is a driver...

Im Focus: Room-temperature multiferroic thin films and their properties

Scientists at Tokyo Institute of Technology (Tokyo Tech) and Tohoku University have developed high-quality GFO epitaxial films and systematically investigated their ferroelectric and ferromagnetic properties. They also demonstrated the room-temperature magnetocapacitance effects of these GFO thin films.

Multiferroic materials show magnetically driven ferroelectricity. They are attracting increasing attention because of their fascinating properties such as...

Im Focus: A thermometer for the oceans

Measurement of noble gases in Antarctic ice cores

The oceans are the largest global heat reservoir. As a result of man-made global warming, the temperature in the global climate system increases; around 90% of...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

10th International Symposium: “Advanced Battery Power – Kraftwerk Batterie” Münster, 10-11 April 2018

08.01.2018 | Event News

See, understand and experience the work of the future

11.12.2017 | Event News

Innovative strategies to tackle parasitic worms

08.12.2017 | Event News

 
Latest News

White graphene makes ceramics multifunctional

16.01.2018 | Materials Sciences

Breaking bad metals with neutrons

16.01.2018 | Materials Sciences

ISFH-CalTeC is “designated test centre” for the confirmation of solar cell world records

16.01.2018 | Power and Electrical Engineering

VideoLinks
B2B-VideoLinks
More VideoLinks >>>