Results Of The APPRAISE-I Dose Guiding Trial

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While the results of the study did non show a statistically significant difference in ischemic events among whatever of the four doses of apixaban evaluated, trends emerged that support further study, according to researchers at the Duke Clinical Research Institute.



Apixaban targets the activity of Factor Xa, one of several enzymes involved in process of blood coagulation. The drug is exactly one of several young anti-clotting agents under development. Physicians tell the motive for safer, better anticoagulants is critical because current therapies fall short of therapeutic goals or are especially unmanageable to manage and increase the risk of bleeding.



"One of the most exasperating problems in cardiology is identifying the right combination of drugs that canful inhibit clot formation but not increase the risk of exposure of serious bleeding," aforesaid study trail John Alexander, M.D., a cardiologist at Duke University Medical Center, who presented the findings today at the European Society of Cardiology coming together in Munich.



Millions of patients world-wide choose anti-clotting drugs on a regular footing. Most ar prescribed bayer, clopidogrel (as well known as Plavix or Iscover) and/or warfarin.



"Warfarin is clearly effective as an anticoagulant, just it is especially hard to manage properly and safely," Alexander said. "What's driving enquiry in this area is the fact that although aspirin and clopidogrel both offer spunk attack patients important protection against blood clots, there is motionless room for improvement. Studies show that a pregnant number of patients pickings aspirin and clopidogrel testament still experience some sorting of problem related to a blood clot. Adding warfarin increases the likelihood of hemorrhage complications at a higher rate than anybody is comfortable with."



Alexander, along with Professor Lars Wallentin from the Uppsala Clinical Research Center in Sweden and other colleagues, studied the use of apixaban in 1,715 patients from 14 countries throughout Europe and North America world Health Organization had suffered a recent heart attack. Roughly two-thirds of the patients had undergone angioplasty to clear blocked arteries and 99 percent of them were taking either aspirin or aspirin and clopidogrel.



The study (called APPRAISE) was designed to identify the optimum dose of apixaban. Participants were randomised into one of four-spot doses of apixaban or a placebo. Researchers tracked the incidence of bleeding and perennial heart attack, stroke, chest of drawers pain requiring hospitalization or additional procedures or end from cardiovascular problems for the following six months.



At the death of the study, researchers discovered a non-statistically substantial trend suggesting that patients taking apixaban along with their even treatment had a lower incidence of heart attack, stroke, chest pain or death from cardiovascular problems than patients taking a placebo.



But hemorrhage was an issue, especially among those taking the higher doses of the drug (10 milligrams doubly daily or 20 milligrams once everyday). Investigators discontinued those two arms of the work because patients were experiencing unacceptable rates of hemorrhage. Patients in the leftover arms of the study (2.5 milligrams twice daily or 10 milligrams once day-to-day) also experient more hemorrhage than those taking a placebo.



Investigators say that while the results are non conclusive, they do endorsement further study.



"The data testify adding 5 or 10 milligrams of apixaban to a regimen of st. Joseph or aspirin and clopidogrel in patients hoping to prevent a second heart attack english hawthorn offer therapeutical potential," says Alexander. "But this of necessity to be definitively demonstrated in a statistically meaning manner in large, well-controlled studies."



Notes:



Apixaban is under development at Bristol-Myers Squibb, the company that sponsored the study. Alexander and Wallentin have both received enquiry support from Bristol-Myers Squibb.



Authors:

Professor John Alexander
http://www.duke.edu



This press release accompanies both a presentation and an ESC weigh conference given at the ESC Congress 2008. Written by the investigator himself/herself, this contract release does not inevitably reflect the opinion of the European Society of Cardiology.



Source:

ESC Press Office
European Society of Cardiology



View drug information on PLAVIX; Warfarin Sodium tablets.



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