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For Kage Lei: the potential risk of drug provoke a controversial - drugs - pharmaceutical industrie by na b





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For Kage Lei: the potential risk of drug provoke a controversial - drugs - pharmaceutical industrie by
Article Posted: 01/23/2011
Article Views: 161
Articles Written: 2638
Word Count: 904
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For Kage Lei: the potential risk of drug provoke a controversial - drugs - pharmaceutical industrie


 
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On behalf of Kage Lei (ticagrelor, Brilinta) research results in Europe in 2009 Heart disease Association Annual Conference (ESC) was first published on, then, cardiovascular treatment in the United States Annual Conference (TCT) and the American Heart Association Annual Conference (AHA) also discussed a number of products on the secondary research findings. Today, AstraZeneca has submitted to the FDA's new drug application product.

In the highly competitive anti-platelet drugs on the market, as a new type of oral anti-platelet drugs for Kage Lei reduce cardiovascular diseases such as heart disease incidence and lower in patients with acute coronary syndrome Cardiovascular disease deaths rate. Therefore, the success of its R & D has become the focus of industry attention. However, recently, from the Baylor College of Medicine in Houston, Dr. NealKleiman but in 2010 the United States Cardiovascular Research Technology Conference (CRT) on to remind clinicians: Despite the potential for Kage Lei is a drug, but it must not ignore the potential dangerous.

Anti-thrombosis drug selling Recent years, with social and economic development and improvement of living standards, the incidence of thrombus-like illness is increasing year by year, and the growing aging population has also helped to further expand this market. Myocardial infarction is the most deadly diseases, cerebral infarction is the highest morbidity diseases, malignant diseases which are directly related with thrombosis. Therefore, today the development of anti-thrombosis drug market very fast, has become the world's most popular areas of drug development.

According IMSHealth statistics show that in 2008 global anti-thrombosis drug market Sell Amounting to approximately 18 billion U.S. dollars, compared with the previous year, an increase of 16%. In China, as of September 2009 for nearly 4 years, the hospital antithrombotic drugs purchase cost from 2.3 billion up to 5.2 billion, an average annual growth rate of 32%. 4 years, the market soared more than doubled, with fairly good development trend.

Clinically, anti-thrombosis drugs consists of antiplatelet agents, anticoagulants and thrombolytic drugs three kinds of enzymes, of which both anti-platelet medication, treatment and prevention effects, and therefore anti-thrombotic drugs in the main category . This stage, dominated the anti-platelet drugs on the market in the United States Bristol-Myers Squibb and Sanofi-Aventis of France jointly developed clopidogrel (clopidogrel, clopidogrel, Plavix, Iscover). In recent years, global sales of the product rose steadily, and now has become the world's second best-selling prescription drugs.

To the pursuit of those who poured cold water basin
In addition, the July 10, 2009, FDA also approved by the United States and Japan Lilly Pharmacy Sankyo Co., Ltd. developed a new type of co-thrombosis prophylaxis Pulagelei (prasugrel, Effient) of the listing application, which is expected to be only the first major competition of drug clopidogrel.

AstraZeneca began development in 1999 for the Kage Lei, November 2009, the company submitted to the U.S. FDA new drug application for the product. Although the market has two drugs preconceptions, but only for Kage Lei is the first of combined oral reversible P2Y12 adenosine diphosphate receptor antagonist, an advantage that it rather the market potential.

However, in the CRT of a debate on anti-platelet drugs on, Kleiman, entitled "Why I am not keen for Kage Lei," the report stated: "This only drugs currently developed, and experiments know it's effective dose and important effect, but also understand that it has acceptable toxicity levels. but I am most concerned about is that while we believe in the product as fanatical pursuit of the degree holders. because I believe that fanatical pursuit a drug will lead us to use reason and caution when it is not enough, this is likely to undermine the benefits of the drug itself. "

From the Duke Clinical Research Institute of the participants?? RobertHarrington concerns Dr. Kleiman said he was surprised, "for Kage Lei data from the Uppsala Clinical Research Center and Duke Clinical Research Association, two academic institutions After careful and independent analysis obtained. The key findings of the two institutions are open simultaneously, the lower the mortality rate of staff leaving to study a very deep impression. "experiment as PLATO Cooperation Researchers, he explained.

PLATO experiments were carried out between 2006 and 2008, including 43 countries, a, 862-center, randomized, double-blind, multicenter study included a total of 18,624 cases of hospitalization due to acute coronary syndromes patients. All patients were given aspirin or aspirin plus clopidogrel for Kage Lei of two anti-platelet therapy. The results showed that for the Kage Lei group compared with clopidogrel, patients can significantly reduce the primary end point events, including myocardial infarction, stroke or cardiovascular death, and severe bleeding complications did not increase.

In the study, the largest Adverse reactions Is a life-threatening bleeding, the two drugs were not significantly different between. While a ONSET / OFFSET studies have indicated that the role of clopidogrel for the Kage Lei and different ways. Clopidogrel effect on platelet irreversible, therefore, platelets for up to one week will remain intact, but stop for Kage Lei treatment, the effect can be reduced or reversed soon, it will be a day or two platelet increased. This difference on the surgery the patient's excessive bleeding is very important.

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