It is reported that as of 20 13, 12, 3 1, 1609 cases of adverse reactions/events of trimetazidine were reported in the national ADR database, of which 2 1 cases were serious, accounting for1.of the total reported cases. At the same time, trimetazidine is a specific substance banned in sports competitions, and it was banned in the World Anti-Doping Agency (WADA) only in June 20 14.
During the period of 1978, trimetazidine developed by Sylvia Pharmaceutical Factory in France was approved for listing in France, and now trimetazidine has been listed in more than 90 countries around the world. In 2000, trimetazidine was listed in China. At present, there are three dosage forms: tablets (20 mg), sustained-release tablets (35 mg) and capsules (20 mg), involving 12 pharmaceutical manufacturers. A year has passed, and how does trimetazidine perform in China market? Now, make a brief review.
The domestic cardiovascular drug market continues to grow.
According to the statistical report of the National Health Service Research of the Ministry of Health of China, the prevalence rate of coronary heart disease in China is about 4.6‰, and more than 500,000 people die of sudden cardiac death every year. With the arrival of China's aging society, the aging population is accelerating, and the incidence of coronary heart disease in China is increasing year by year, reaching more than 8 million people, thus driving the market demand for such drugs.
According to the statistics of drug use in public hospitals in national key cities, in 20 14 years, the amount of clinical drug use for cardiovascular diseases in China reached131500 million yuan, an increase of 10.85% over the previous year. It shows that cardiovascular drugs are playing an increasingly prominent role in hospital terminals and retail markets. Among cardiovascular drugs, systemic medication for heart disease plays an important role in improving cardiac and systemic hemodynamics, increasing energy supply of myocardial tissue, reducing myocardial energy consumption, nourishing myocardium and optimizing energy metabolism. In 20 14 years, the amount of drugs used in the cardiac system of public hospitals in key cities nationwide reached 4.682 billion yuan, an increase of 10. 14% over the previous year. This makes the domestic cardiovascular clinical drug market continue to grow. Among them, the top 10 varieties accounted for 9 1% of this subclass, while the top five varieties such as trimetazidine, alprostadil, creatine phosphate, compound coenzyme and isosorbide mononitrate accounted for 80% of this subclass, forming a high concentration.
Especially in recent two years, with the extensive use of fatty acid oxidation inhibitors, drugs such as trimetazidine and ranolazine have been paid attention to in clinic. After the expiration of many pharmaceutical chemistry patents, generic drugs were developed, which further showed the clinical value of these drugs.
Trimetazidine market growth slows down.
After CFDA released the 62nd ADR information announcement, the growth rate of trimetazidine slowed down compared with previous years. Although trimetazidine has been fully affirmed by doctors and patients after nearly 40 years of clinical use, it is the only new drug recommended by experts of the European Heart Association to resist myocardial ischemia and hypoxia metabolism, and it has been recognized by dealers and consumers after being listed in China. However, in the academic propaganda of manufacturers in previous years, the effect of its drugs on myocardial nutrition was greatly exaggerated, and its side effects were less introduced. Clinically, there have been drugs widely used in addition to symptoms. After CFDA released the 62nd ADR information announcement, it made corrections in time.
With the strengthening of the management system of adverse drug reactions/incidents reported by China's drug regulatory authorities, the reporting and monitoring of adverse drug reactions have been standardized, the drug risks have been effectively controlled in time, and the safety of public medication has been guaranteed.
According to the official website database of CFDA, so far, CFDA has approved 20 enterprises to produce and operate trimetazidine products, of which 18 has the approval documents for the production of APIs; 12 furniture has the production approval of trimetazidine preparation.
In 20 14, the consumption of trimetazidine in public hospitals in national key cities reached 239 million yuan, an increase of 8.05% over the previous year and a decrease of 3.5 percentage points compared with the growth rate in 20 13. Among the top five manufacturers of trimetazidine preparations in the market, "Wanshuangli" by Sylvia and "Fengle" by Beijing Jialin Pharmaceutical showed a steady growth trend, with an increase of 2.09 percentage points and 0. 14 percentage points respectively; However, the market share of tablets produced by Beijing Wansheng Xavier, Shandong Ruiyang Genketong and Yuanda Pharmaceutical (China) decreased by 0.8 1%, 0.82% and 0.58% respectively compared with the previous year. It is predicted that the domestic trimetazidine preparation market will still show a steady downward trend in 20 15 years. Clinically, trimetazidine plays an important role in the symptomatic treatment of patients with angina pectoris or intolerable stable angina pectoris, and still has great market potential.