�Data from a Phase II study of an investigational dose designed to block formation of blood line clots demonstrate potential for added auspices against a second heart attack or stroke among patients world Health Organization are already taking state of the art prevention therapy, according to researchers at the Duke Clinical Research Institute.
While the results of the study did non show a statistically important difference in ischemic events among any of the four doses of apixaban evaluated, trends emerged that support farther study, the scientists said.
Apixaban, one of several new anti-platelet agents under exploitation, targets the activity of Factor Xa, an enzyme involved in the process of rake coagulation. Physicians say the need for safer, better anticoagulants is critical because current therapies fall short of therapeutical goals or are difficult to pull off because they increase the risk of bleeding.
"One of the nearly vexing problems in cardiology is identifying the correct combination of drugs that can subdue clot formation but non increase the risk of serious hemorrhage," said study lead John Alexander, M.D., a heart specialist at Duke University Medical Center, world Health Organization presented the findings at the European Society of Cardiology meeting in Munich.
Millions of patients worldwide take anti-clotting drugs on a regular ground. Most are prescribed empirin, clopidogrel (likewise known as Plavix or Iscover) and/or warfarin.
"Warfarin is clearly effective as an anticoagulant, only it is especially hard to pull off properly and safely," Alexander said. "What's driving research in this area is the fact that although aspirin and clopidogrel both offer spunk attack patients important auspices against blood clots, there is still room for improvement. Studies show that a significant number of patients taking aspirin and clopidogrel volition still have some sort of job related to a blood clot. Adding warfarin just increases the likelihood of bleeding 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 goods and services of apixaban in 1,715 patients from 14 countries end-to-end Europe and North America who had suffered a recent spirit attack. Roughly two-thirds of the patients had undergone angioplasty to clear plugged arteries and 99 pct of them were pickings either empirin or acetylsalicylic acid and clopidogrel.
The study (called APPRAISE) was designed to identify the optimal dose of apixaban. Participants were randomized into one of four doses of apixaban or a placebo. Researchers tracked the incidence of bleeding and recurrent kernel attack, accident, chest pain requiring hospitalization or additional procedures or death from cardiovascular problems for the following six-spot months.
At the end of the field, researchers discovered a non-statistically significant movement suggesting that patients taking apixaban along with their regular treatment had a lower incidence of heart attack, stroke, chest pain or decease from cardiovascular problems than patients pickings a placebo.
But bleeding was an issue, especially among those taking the higher doses of the drug (10 milligrams twice daily or 20 milligrams erst daily). Investigators discontinued those two blazonry of the study because patients were experiencing unsufferable rates of bleeding. Patients in the remaining munition of the study (2.5 milligrams twice daily or 10 milligrams once daily) also experienced more bleeding than those pickings a placebo.
Investigators say that while the results ar not conclusive, they do warrant further study.
"The information show adding 5 or 10 milligrams of apixaban to a regimen of aspirin or aspirin and clopidogrel in patients hoping to keep a s heart attack may offer therapeutic potency," says Alexander. "But this needs to be definitively demonstrated in a statistically significant mode in magnanimous, well-controlled studies."
Apixaban is under development at Bristol-Myers Squibb, the company that sponsored the study.
Alexander and Wallentin have both received inquiry support from Bristol-Myers Squibb.
Source: Michelle Gailiun
Duke University Medical Center
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