background
1997165438+10 month 17 day, the US Food and Drug Administration (FDA) approved that clopidogrel bisulfate (Polivir) can be used for peripheral arterial disease (PAD) after myocardial infarction, stroke and diagnosis. Due to Polivi's excellent products and excellent academic materials, it took only six months from submission of materials to FDA approval, which is a very fast process!
Polivi has been widely used in many countries, including the United States and Europe. It has been listed in China.
Plavix is a platelet aggregation inhibitor, which has a unique mechanism of action (ADP receptor antagonism) and strong specificity, and 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, with high safety and good tolerance.
Successful large-scale clinical CAPPIE is the key for Polivi to get FDA approval quickly. CAPRIE test showed that clopidogrel was more effective than aspirin, and it was 8.7% better than aspirin in reducing the relative risk of combined events of ischemic stroke, myocardial infarction or vascular death (P = 0.043). Compared with aspirin, clopidogrel further reduced the absolute number of events by 26%.
In addition, another sensational research achievement, CURE (application of clopidogrel to prevent recurrence of unstable angina pectoris), was published in the New England Journal of Medicine in August 2006.5438+0. 65,438+02,562 patients with acute coronary syndrome participated in the CURE study. All patients received standard treatment including aspirin, poliovirus and placebo respectively, and the two groups were compared. 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 20% (P = 0.00009).
On February 28th, 2002, based on the clinical trial results of CURE, FDA officially approved the antiplatelet drug Plavix? A new indication is that it can be applied to patients with acute coronary syndrome (unstable angina pectoris, 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 risks of heart attack, stroke or cardiovascular death on the basis of existing standard treatments, including aspirin.
With the aging of society and the improvement of living standards, the incidence and mortality of cardiovascular and cerebrovascular diseases are increasing day by day. 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 49 1.8/65438+ 10,000 people, which is significantly higher than that of western countries.
The high mortality rate associated with cardiovascular diseases is only one aspect of the problem. More than 7,000,000 patients suffer from some type of cardiovascular disease and become an important group in need of medical care. The direct cost of medical care is huge, and the bigger problems are the indirect loss caused by disability (19% of all disability causes are cardiovascular diseases) and the loss of work ability. The impact of cardiovascular diseases on the quality of life is incalculable. Despite the progress in diagnosis and treatment, cardiovascular disease is still an insurmountable problem in developed countries and a heavy burden on medical care and national economy.
Platelets play a central role in the pathogenesis of acute thrombotic cardiovascular and cerebrovascular events caused by atherosclerotic plaque thrombosis, which has been fully studied. Although there are many drugs in this field at present, drugs with both efficacy and safety have always been a major challenge for human beings. Now Shanghai Maibai Pharmaceutical Technology Co., Ltd. and Shanghai Anhante Biomedical Technology Co., Ltd. jointly launch clopidogrel bisulfate 1 crystal form and clopidogrel benzene sulfonate, which will meet this demand to the greatest extent and is undoubtedly good news for cardiovascular patients.