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Sibutramine is the first slimming drug approved by SDA (State Administration of Medical Supplies) and listed in China. It has a world-leading technology and a unique dual-action mechanism. In the past 30 years, only two drugs, sibutramine and orlistat, were approved by the FDA in June19971and officially listed in the United States in February 1998. Sibutramine has been identified as the first choice for weight loss by European CPMP (Monopoly Drug Committee). Qumei is developed in strict accordance with the following requirements of WHO for diet pills:
1, the principle of uniform weight loss, weight loss control in 0.5- 1kg/ week.
2, not only lose weight, but also maintain weight loss for a long time.
3. You can reduce obesity complications while losing weight.
Attachment: FDA guidelines for approval and use of diet pills (key points)
First, Qumei's project background
1) Obesity has become an increasingly serious social medical problem: the number of obese patients in the world has been increasing in five years. At present, there are at least 200-500 million obese people in the world, and the number of overweight people is about 1 100 million (body mass index >: 23); At the age of 20, there are about 300 million overweight and obese people (body mass index >; 25) More than 40 million. Overweight/obesity can be accompanied by serious diseases such as cardiovascular and nutritional metabolism. At present, the medical community has listed obesity, AIDS, drug abuse and alcoholism as the four major social medical problems in the world. The incidence of hypertension, hyperlipidemia, diabetes, coronary heart disease and stroke recognized by the medical community has been proved to be related to overweight/obesity, and this terrible quintet may be the number one killer threatening human health and life safety in 2 1 century. Therefore, the World Health Organization (WHO) has confirmed that obesity is a disease and announced to the whole world that "obesity will become the world's primary health problem".
2) Facing the increasingly serious obesity problem, it is becoming more and more difficult to develop effective and safe weight-loss drugs. Although the early-developed diet pills solved the problem of effectiveness, they have been plagued by drug dependence, addiction and heart damage, so that the FDA of the United States first cancelled fenfluramine/dextrofenfluramine in the market, and on this basis, CPMP (Monopoly Drug Committee) of Europe cancelled three diet pills, namely, Fentamine, amfepramone, Mazindol, Proprietary and so on 13, so that there are basically no safe and effective diet pills in the world. On the other hand, FDA has strengthened the requirements for the declaration and approval of diet drugs. Although all the major pharmaceutical companies in the world have aimed at the market gap of diet pills and invested heavily in research and development of diet pills, most of them have run aground due to the extremely strict safety requirements of FDA. In the past 30 years, FDA has banned many diet pills, but at the same time, it has not approved any new diet pills to go on the market.
Current situation of domestic weight loss market
1, there are few kinds of diet pills, and the main varieties with obvious side effects are mazindol, fenfluramine, dexfenfluramine and fluramine, which are strictly restricted by SDA because of their side effects such as excitability and damage to heart valves.
2. There are many kinds of diet health foods, which exaggerate the curative effect and confuse the market; Most health foods have no real weight loss effect; The Ministry of Health has rectified the market of slimming health products and formulated new regulations on the management of health food.
3. In recent 20 years, amfepramone, mazindol and fluramine have been widely used in China, but they have gradually withdrawn from the market because of their central excitability and addiction. The use of the latter is restricted in China because it is related to heart valve diseases and is banned by FDA. At present, weight-loss health care products are highly respected in China, which is related to the endless stream of advertisements.
In fact, consumers should be most aware of the weight loss effect of health care products. The FDA of the United States has strict regulations on the promotion of health care products, and only the ingredients and content are allowed to be marked, and there can be no words about the weight loss effect.
Some domestic manufacturers exaggerate the weight loss effect of health care products and make false propaganda, which is very misleading to consumers. With the national publicity on the standardization of health care products, new weight-loss drugs with real weight-loss function will become the mainstream of weight-loss products market. While many multinational pharmaceutical companies are frustrated in investing in diet pills, sibutramine (Qumei), which was developed by a German company at a cost of more than $65.438 billion, shows unparalleled advantages: its mechanism of action is advanced, it can effectively control the intake of excess fat, and at the same time, with the increase of energy consumption, it can obviously enhance the decomposition of body fat. It is the only one in the world that can simultaneously target the root cause of obesity (energy intake >: energy consumption), so the weight loss effect is very obvious. After strict effectiveness and safety tests by more than 6,000 patients in six countries, including the United States, Germany, France and Britain, it finally became the first new weight-loss drug approved by the FDA in the past 30 years, and brought nearly $200 million in sales to a multinational pharmaceutical company in Germany in the first half of the year, which quickly became one of the company's four biggest products. Because of its definite curative effect and reliable safety, the drug soon became the first choice in the European and American weight loss markets.
Taiji Group Co., Ltd. cooperates sincerely with Chongqing Pharmaceutical Industry Research Institute. While assiduously digesting foreign technology, they strictly follow the SDA (China Drug Administration) regulations. After three years of research and obtaining a number of patented technologies, they obtained the right to operate Qumei in June 2000. Became the first diet drug approved by SDA (National Medicine Zhunzi [X20000364]). July 2000 16, the first batch of Qumei finished products rolled off the assembly line; On July 22nd, 2000, Taiji Group held the first auction of drug distribution rights in China. For the first time, it used standardized legal procedures to select dealers. More than 200 contracts were signed at the auction, with a total contract fund of 220 million yuan and a market service deposit of 38 million yuan. In August, 2000, 46 regional distributors and more than 500 distributors listed Qumei in more than 30,000 pharmacies, and more than 300 hospitals recommended Qumei to patients. In August, Qumei's monthly sales exceeded 1 100 million yuan. In September, Taiji Group launched a nationwide campaign of 6.5438+0.5 million "obese people" to lose weight and deliver medicines for free. During the National Day, Taiji Group launched a five-star service for pharmaceutical companies for the first time. 500 telephone calls and 654.38+0000 Taiji employees sent holiday greetings and inquiries to 654.38+050,000 consumers who delivered medicines for free.
The listing of Qumei in China will greatly promote people to treat weight loss rationally and choose weight loss products rationally.
Second, the scientific nature of losing weight at a constant speed
The speed of losing weight has always been a hot topic discussed by people, including medical scientists.
The harm of losing weight quickly
Most obese people have the fear and impatience to lose weight, so most obese people are keen on the temporary satisfaction brought by rapid weight loss. However, the adverse consequences and harm brought by rapid weight loss far outweigh its benefits.
It is found that rapid weight loss is generally achieved through diarrhea (dehydration), which only reduces the water content of the body, and has no real weight loss effect on the existing adipose tissue itself, and the weight will rebound quickly by eating and drinking water. Dehydration is a dangerous way to lose weight: water is an important part of the human body and has the function of maintaining the balance of the human environment. After dehydration, the internal environment is destroyed, and the human body loses the function of keeping balance with the outside world, leading to metabolic disorder and toxin accumulation in the body, further aggravating the internal environment disorder and forming a vicious circle. At the same time, diarrhea can lead to gastrointestinal dysfunction, skin loss of elasticity, and a large loss of nutrients. Such dieters often have dizziness, fatigue, anorexia, decreased resistance, listlessness, collapse, and even death in severe cases. Repeated rapid weight loss and rebound bring not only physical harm to obese people, but also more obese people will lose confidence in losing weight, thus causing greater psychological pressure.
A large number of studies show that proper weight loss speed, rather than rapid weight loss, is beneficial to obese people, so that the body can better adapt to the balance problem brought about by weight loss. Scientific weight loss speed is uniform, but too slow weight loss speed will lead people to lose confidence in weight loss. Therefore, WHO (World Health Organization) has stipulated the principle of sustained weight loss of 0.5- 1Kg/ week. This is a scientific and acceptable weight loss rate.
◇ Qumei lose weight at a constant speed
The weight loss rate of Qumei is kept between 0.5- 1Kg/ week, which meets the unified weight loss requirements of WHO. Moreover, tramadol's sustained and moderate weight loss has many good effects on diabetes and cardiovascular diseases, which can reduce the risk factors of obesity complications. Qumei's continuous weight loss lies in its continuous and moderate fat-reducing effect. By increasing the metabolic rate of fat and improving inappropriate appetite, we can achieve the goal of losing weight. Its dual weight-loss model gives consideration to both ends of energy balance, and it is the most scientific and ideal weight-loss drug in the world at present.
Third, physical and chemical characteristics
The molecular formula is c17h26cin-ACI.h20.
(product description: white crystal, solubility 2.9mg/m/lph=5.2)
Fourth, pharmacological and pharmacodynamic characteristics.
1, through in vivo metabolite M 1, M2.
2. Inhibit the reuptake of 5-HT, NA and DA to a lower degree.
Step 3 cut down on food intake
It has the function of generating heat.
5, reduce subcutaneous and visceral fat
6. reduce TC, TG and LDL.
Verb (abbreviation of verb) double-acting mechanism
Trimetaxel is an inhibitor of 5-HT and norepinephrine reuptake, and it achieves the goal of losing weight through innovative weight loss mechanism:
Burning fat
By inhibiting the reuptake of norepinephrine or adrenergic B3 receptor, the energy consumption of brown adipose tissue increases. A large number of clinical experiments show that trimethoprim can increase the fat metabolism rate by 65438 08 times. The important principle of "burning" excess fat in the form of heat production to make Qumei lose weight.
Control calorie intake
By inhibiting 5-HT reuptake, people can reduce hunger, and effectively control calorie intake without affecting normal intake of nutrients and meeting physiological needs.
This two-pronged principle makes Qumei unique in diet pills and is the basic content of the new concept of weight loss.
Qumei is the only slimming drug with dual slimming mechanism in the world.
Vi. Pharmacokinetic indicators
Tmax (prototype) =1.2ht1/2 =11h.
tmax(M 1、M2)= 2.5-3.6h t 1/2 = 14- 19h
The main excretory route is the kidney (77%)
The peak time of blood drug concentration is relatively short, but the elimination time is relatively long. Taking medicine once a day can ensure the effective blood drug concentration.
Seven, clinical efficacy
Weight loss effect
A large number of clinical trials at home and abroad show that tramadol has a significant weight loss effect, which generally appears after taking tramadol for 4 weeks, and loses an average weight of 7kg after 3 months (12 weeks). Most dieters are satisfied with the effect of losing weight. Griffiths and others in the United States used dual-energy X-ray receiver to analyze human body composition, and found that the slimming function of this product is mainly to reduce fat content.
Clinical trials show that at least 90% dieters who take trimethoprim have moderate weight loss (weight loss ≥ 10%), and most dieters are satisfied with the weight loss effect.
Comparison of weight loss effect and absolute weight loss (at home and abroad)
Compared with similar clinical studies at home and abroad, the results are very similar.
The clinical trial results of domestic Ruijin Hospital show that taking 10mg/ day is effective for 4 weeks, and 12 weeks enters a stable treatment period, with an average weight loss of 7 kg in 24 weeks and an average weight loss of 0.5 kg per week in the initial stage of treatment, which meets the requirements of FDA for healthy weight loss.
After the experiment, the weight changes of the subjects were followed up. The results show that most of the subjects can maintain the weight loss effect for a long time after stopping taking drugs on the premise of changing the high-fever and high-fat diet and bad living habits.
Reduce waistline
Reduce waist circumference and hip circumference, reduce waist-hip ratio, and reduce excess fat in the body.
A randomized, double-blind, placebo-controlled trial for obese patients with type II diabetes showed that after taking tramadol 15mg/d 12 weeks, obese patients lost mainly fat rather than muscle. X-ray bone densitometer (DEXA) showed that 70% of patients' soft tissues were fat, and the whole body fat tissue decreased by 65438±0.8kg, while the placebo group only decreased by 0.2 kg (P
Improve blood lipid
Comprehensive analysis of percentage changes of blood lipids (1 1 study)
The results showed that compared with the whole trimethoprim treatment group, the treatment group had obvious effects of reducing TG, CHOL, LDL and increasing HDL (P < 0.05), and this effect was enhanced with the enhancement of weight loss effect.
1. Liu Yueshuan, male, 46 years old, lives at No.5-408 Jingxinxin, Hexi District, Tianjin (Tel: 022-28227408). The patient participated in the clinical trial of slimming drugs in the General Hospital of Tianjin Medical University from/KLOC-0 to June, 1999. His weight before treatment was 100 kg, and he lost 25 kg after taking the medicine for half a year. At the same time, the body weight decreased obviously, and the blood lipid was also improved obviously: (unit: mmol/L) Before and after blood lipid treatment, the cholesterol was 4.45 3.32, and the triglyceride was 2.01.1. The above changes show that the probability of patients suffering from diabetes and cardiovascular diseases is greatly reduced.
2. Xue, male, aged 36, lives at No.49, longshui town Road, Dazu District, Chongqing (pager 129-8 155277). The patient participated in the clinical trial of the Second Affiliated Hospital of Chongqing Medical University in June 1999. He weighed 78.5 kg before treatment and lost weight 15.5 kg after taking medicine for half a year. At the same time, the body weight was obviously reduced, and the blood lipid was also obviously improved: (unit: mmol/L) Before and after blood lipid treatment, cholesterol was 4.88 3.05438+0 triglyceride 2. 13 1.28. The above changes show that the probability of patients suffering from diabetes and cardiovascular diseases is greatly reduced.
◇ Preventive effect on obesity related diseases
The ultimate index of FDA's evaluation of diet pills is to prevent serious complications caused by obesity (such as cardiovascular disease) and reduce risk factors (hypertension, hyperlipidemia, etc.). Clinical experiments show that the weight loss effect of tramadol can be maintained for a long time, and the widespread use of tramadol can greatly reduce the risk factors of cardiovascular diseases related to obesity.
Safety and tolerance
Incidence rate of major adverse reactions (%)
The most common adverse reaction is dry mouth, and other adverse reactions rarely occur. Adverse reactions are mild and short-lived, and most of them last for about a week. Patients are easily tolerated and do not need to stop taking drugs.
More than 6,000 clinical trials in six countries, including the United States, Britain, Germany and France, and the clinical application of nearly one million patients for two years, have not found serious adverse reactions such as drug dependence, heart valve injury and pulmonary hypertension that people are worried about.
Eight, the safety of Qumei
◇ Approved by FDA and CPMP in Europe.
Because of the sensitivity of the safety of diet pills, since the successful synthesis of this product abroad in the late 1980s, foreign pharmaceutical and medical scientists have conducted a large number of long-term animal toxicology and human safety tests, which lasted for ten years, with more than 6,000 clinical research cases, fully evaluating the short-term and long-term safety, making this product an outstanding representative of drug safety research. Because several diet pills such as Fenfen (Fenfluramine, Fentamine, amfepramone and Moyndole) were banned by the FDA in 1997, the FDA was very cautious and harsh in approving the safety of diet pills. 1June, 1997,165438+1October, the product was approved by the FDA in the United States, becoming the first safe diet drug approved by the FDA in 30 years, and was successfully listed in the United States in February, 1998. In the same year, the product was approved by CPMP (European Monopoly Drug Committee) and allowed to be listed in Europe.
Globally recognized security
Since 1998, the product has been marketed in Europe and America, and tens of millions of obese people have taken it and successfully lost weight. No important side effects harmful to human health have been found, and its safety has been fully verified and recognized worldwide. Since its launch, the sales volume of this product in Europe and America has increased rapidly with an annual growth rate of 50%, and it has become the best-selling slimming drug popular in Europe and America. Because of its unprecedented weight loss effect and safety, this product has a very broad application prospect and is expected to become the leading product in weight loss drugs.
Security testing in China.
Foreign pharmacologists have studied the safety of this product for 10 years. Since 1996, Chinese scientists have conducted long-term toxicological tests on animals with this product, and no worrying toxic reactions have been found. From1June 5, 1999 to1October, the product was approved by the State Administration of Pharmaceutical Products of China to carry out effectiveness and safety tests in China to explore the effectiveness and safety of the product for China people. Clinical trials in Ruijin Hospital of Shanghai Second Medical University, Affiliated Hospital of Shandong Medical University, Second Affiliated Hospital of Chongqing Medical University and General Hospital of Tianjin Medical University have conducted large-scale safety and effectiveness tests on obese people from different regions in China. Half a year's clinical research shows that the product has the same effectiveness and safety for China people, and has been recognized by domestic pharmaceutical and medical scientists. At the same time, Taiji Group applied to SDA and was approved to be listed in China in July 2000, becoming the first slimming drug approved by SDA and the first multicenter randomized double-blind clinical trial in strict accordance with GCP (Clinical Trial Specification).
Appendix 1: FDA guidelines for approval and use of diet pills (key points)
-US Food and Drug Administration: US Food and Drug Administration
-SDA: State Administration of Medical Products (China)
1, the ideal goal of weight loss is to reduce the basic weight 10%.
2. The curative effect of losing 5% weight is recognized as effective.
3. Efficacy evaluation includes two aspects: weight loss effect and time to maintain effective weight loss effect.
4. In the early stage of weight loss treatment, in order to avoid the adverse effects of excessive weight loss on the body, it is advisable to lose 0.5 kg per week on average.
5, the improvement of complications should be included in the evaluation of drug efficacy.
6. The clinical trial period of drug effectiveness and safety shall be at least 1 year.
7. Obesity drugs take a long time to treat.
Appendix II: The Harm of Obesity
American nutritionists' research shows that people who weigh more than normal 10% (overweight) are compared with normal weight.
The probability of suffering from hypertension is 6 times higher;
The probability of heart disease is high 1.5 times;
The risk of diabetes is five times higher;
The risk of gallstones is 2.5 times higher;
The probability of suffering from irregular menstruation is 3 times higher;
The probability of suffering from knee arthritis is 6 times higher;
If people over 45 are overweight,
The standard 10%, then if you exceed 1 kg every day, your life will be 29 days shorter.