Background
On November 17th, 1997, the US Food and Drug Administration (FDA) approved that clopidogrel bisulfate (Plavix) could be used for post-myocardial infarction, post-stroke and confirmed peripheral arterial disease (PAD). Due to Polivi's excellent products and excellent academic materials, it took only six months from the submission of the materials to the FDA for approval, which is a very fast process!
Polivi has been widely used in many countries, including America and Europe. It has been listed in China.
Plavix is a platelet aggregation inhibitor with a unique mechanism (ADP receptor antagonism), which specifically and powerfully inhibits ADP-induced platelet aggregation. Used in patients with high risk of ischemic diseases, it can prevent the possibility of recurrence of further events. Its curative effect is better than that of similar products, and it has high safety and good tolerance.
successful large-scale clinical CAPPIE is the key for Polivi to get the fast approval from FDA. CAPRIE test shows that clopidogrel Grebil aspirin is more effective, and it is 8.7% better than aspirin in reducing the relative risk of combined events of ischemic stroke, myocardial infarction or vascular death (P = .43). Compared with aspirin, clopidogrel further reduced the absolute number of events by 26%.
In addition, last year, the American ACC annual meeting published another sensational research achievement, the CURE (Clopidogrel applied to unstable angina pectoris to prevent recurrence) study, which was published in the New England Journal of Medicine in August 21. CURE study included 12,562 patients with acute coronary syndrome. All patients received standard treatment including aspirin, and received poliovir and placebo respectively, and compared the two groups. CURE research shows that the application of Plavix in patients with unstable angina pectoris and non-Q-wave myocardial infarction can reduce the risk of heart attack, stroke and cardiovascular death by 2% (P = .9).
on February 28th, 22, based on the results of clinical trial of CURE, FDA officially approved the antiplatelet aggregation drug Plavix? A new indication is that it can be applied to patients with acute coronary syndrome (unstable angina pectoris and non-Q wave myocardial infarction). The FDA's decision to approve this indication shows that for patients with acute coronary syndrome (ACS), doctors have a drug that can further reduce the short-term and long-term risk of heart attack, stroke or cardiovascular death on the basis of the existing standard treatment including aspirin.
With the aging of society and the improvement of living standards, the incidence and mortality of cardiovascular and cerebrovascular diseases are increasing. According to a recent study, surveys in eight major regions of the world, including developed and developing countries, show that ischemic heart disease and cerebrovascular disease have become the main causes of death. For example, in the United States, cardiovascular disease far exceeds cancer, accounting for 42% of all deaths and becoming the main cause of death. In China, cardiovascular and cerebrovascular diseases have also become one of the common frequently-occurring diseases of the elderly, especially cerebrovascular diseases, with the highest prevalence rate of 4.918/1, people, which is significantly higher than that of western countries.
The high mortality associated with cardiovascular diseases is only one aspect of the problem. More than 7,, patients have some type of cardiovascular disease and become an important group in need of medical care. The direct cost of medical treatment is huge, and the bigger problem is the indirect loss caused by disability (19% of all causes of disability are cardiovascular diseases) and loss of working ability. The impact of cardiovascular diseases on the quality of life is incalculable. Despite the progress of diagnosis and treatment, cardiovascular disease is still an insurmountable problem in developed countries, which is a heavy burden on health care and national economy.
Platelets play a central role in the pathogenesis of acute thrombotic cardiovascular and cerebrovascular events caused by thrombosis caused by atherosclerotic plaque, which has been fully studied. Although there are many drugs available in this field at present, drugs with both efficacy and safety have always been a big challenge for human beings. Now Shanghai Maibai Pharmaceutical Technology Co., Ltd. and Shanghai Anhante Biomedical Technology Co., Ltd. jointly introduce clopidogrel hydrogen sulfate crystal form 1 and clopidogrel benzene sulfonate, which will meet this demand to the greatest extent, which is undoubtedly the gospel for cardiovascular patients.