Sibutramine is recommended, together with a low-calorie diet and exercise, for patients with nutritional obesity, with an initial body mass index (BMI) greater than or equal to 30 kg/m2 , or in patients with a BMI greater than or equal to 27 kg/m2 with other known risk factors such as type II diabetes or dyslipidemia . It helps reduce body weight by inducing a feeling of satiety after eating a smaller amount of food and increasing the body's energy expenditure even with minimal exertion. It has also been used as an antidepressant .
Sibutramine 15mg is a serotonin and noradrenaline reuptake inhibitor. It works by affecting the reuptake of the neurotransmitters 5-hydroxytryptamine (called serotonin) and noradrenaline into nerve cells in the brain. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. By blocking their reuptake, sibutramine increases the amount of these neurotransmitters in the brain. The increased levels of neurotransmitters in the brain help patients feel fuller after meals and help reduce their food intake.
Sibutramine was voluntarily withdrawn by the manufacturer from the European and American markets in 2010 (it had been used in the treatment of obesity for 13 years). Its mechanism of action was to suppress food intake and at the same time increase energy expenditure . Its withdrawal occurred due to the long-term SCOUT study (Sibutramine Cardiovascular Outcomes Trial), which showed a higher incidence of non-fatal myocardial infarctions and strokes in the intervention group compared to placebo. These drugs should not be used in particular by patients with coronary artery disease, congestive heart failure, ischemic peripheral artery disease, arrhythmias or cerebrovascular diseases (stroke or TIA). All patients had to be regularly monitored due to the possibility of an increase in blood pressure or pulse. Patients who did not lose at least 5% of their body weight during 3 months of taking sibutramine should discontinue treatment. The maximum duration of treatment should not exceed one year.
Sibutramine contains Serotonin and Norepinephrine (both substances are very effective, norepinephrine puts the body under stress and thus pushes it to break down fat, serotonin, on the contrary, calms it down and thus tries to suppress hunger). It is a medicine for obese patients who have no history of cardiovascular disease and are unable to reduce their weight through diet and exercise. It acts centrally, in the brain, where the signal of hunger is generated. It has no addictive or psychostimulant effects.
Sibutramine was initially reviewed by the Agency in 1999 and 2002 following concerns about its safety, particularly its adverse cardiovascular effects (increased blood pressure and heart rate). At that time, the CHMP concluded that the benefits of sibutramine in the treatment of obesity and overweight outweighed its risks. However, the Committee also asked the company that makes Meridia, Abbott Laboratories, to start a study of sibutramine in patients with cardiovascular risk factors, particularly with regard to the medicine’s safety. The Committee also asked the company to provide a six-month update on the progress of this study.
As a result, the company launched the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study in 2002 to determine the impact of weight loss following sibutramine on cardiovascular events in a large group of overweight and obese patients at high cardiovascular risk. The study compared sibutramine with placebo (a dummy treatment) and looked not only at how much weight patients lost, but also at the incidence of cardiovascular events such as myocardial infarction, stroke and cardiac arrest. In total, around 9,800 patients were followed for six years.
Although the full data from the SCOUT study have not yet been analysed, the Data Safety Monitoring Board (a body of independent experts appointed to regularly review the results of clinical trials) informed the Agency in October 2009 of preliminary data showing that sibutramine is associated with several cardiovascular problems.
Based on these data, the German Medicines Agency (BfArM) has triggered a re-examination under Article 107 of Directive 2001/83/EC. They have requested the CHMP to assess the impact of the new data on the benefit-risk balance of sibutramine and to prepare an opinion on whether the marketing authorisation for sibutramine-containing products should be maintained, varied, suspended or revoked across the EU.
The CHMP noted that the SCOUT study showed an increased risk of serious cardiovascular events (such as myocardial infarction or stroke) in patients with known cardiovascular disease who took sibutramine.
Most patients in the SCOUT study would not normally receive sibutramine because sibutramine is contraindicated in patients with cardiovascular disease. However, the Committee considered that the increased risk may also apply to patients who may be prescribed sibutramine, as obese and overweight patients are more likely to be at risk of cardiovascular disease.
Finally, taking into account all studies with sibutramine in the treatment of obesity, the CHMP noted that the weight loss achieved after treatment with sibutramine is modest compared with patients treated with placebo, with patients losing on average two to four kilograms more than with placebo. The Committee also noted that it is unclear whether this weight loss effect can be maintained once treatment with sibutramine has ended.
Based on the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of sibutramine-containing medicines do not outweigh their risks and therefore recommended that the marketing authorisations for sibutramine-containing medicines be suspended throughout the EU. The suspension will remain in force until the company provides sufficient data to identify a group of patients for whom the benefits of sibutramine clearly outweigh its risks.
Sibutramine was originally marketed as a suitable alternative to other classic anorectic drugs. Due to the increase in heart rate and blood pressure caused by sibutramine , an increased risk of cardiovascular events (heart attack or stroke) was noted. Another disadvantage of this drug was that if obese patients lost weight, they began to gain weight again very quickly after its discontinuation. Adverse effects occur mainly at the beginning of treatment within the first 4 weeks. Their frequency decreases over time. They are usually not serious, do not lead to discontinuation of treatment and are transient.
In general, they are usually not severe and do not lead to discontinuation of treatment. Their frequency disappears within the first 4 weeks.
Sibutramine is a synthetic halogenated compound similar to amphetamine , which was previously an ingredient in prescription drugs intended for the treatment of obesity. Medicines containing it have been available in Slovakia since 2000. Following concerns about the safety of sibutramine, particularly in terms of side effects on the cardiovascular system, the European Medicines Agency (EMA) completed a six-year review of its safety and efficacy in 2010.
Specified substances are more likely to be consumed by athletes with an intention other than to enhance athletic performance. In such cases, a reduction in punishment is possible after explaining and demonstrating the use of sibutramine without the intention of enhancing performance.
Although it is not a performance-enhancing substance, due to scientific evidence that the use of sibutramine poses a real health risk, the World Anti-Doping Agency (WADA) included it in Group S6 on the List of Prohibited Substances in 2006. Stimulants (substances prohibited during competition).
Although medicines containing sibutramine have been withdrawn from the Slovak market, medicines that were sold outside the EU are being illegally imported into Europe. According to the State Institute for Drug Control, weight loss medicines are among the most frequently illegally offered. "Slimming pills" containing sibutramine are being sold on the Internet in large quantities. Consumption of these products can lead not only to serious health problems (e.g. cardiac arrhythmia, high blood pressure, stroke, myocardial infarction), but also to unintentional use of a prohibited substance and a positive doping test.
What are the recommendations for prescribers and patients?
In the Slovak Republic, all drugs where it is the main ingredient have been withdrawn from the market. These include Reductil, Lindax, Sibutral or Sibutramín-Teva. So if you come across any of these drugs, avoid them at all costs , as they are illegal . At the time of writing this review, I came across several websites that offered Sibutramine. Most often under the name MEGA Sibutramine , or Sibutramine 20 mg. In most cases, not only the manufacturer was missing, but also the exact composition, country of origin and other important information. Taking such drugs can cause serious health complications. For this reason, avoid them.
I must admit, I was very pleasantly surprised by the positive reviews from users praising the effects of Sibutramine. However, I also came across a relatively large number of posts regarding the above-mentioned side effects, which selected individuals only confirmed. The most common were stomach upset, dry mouth, but I also registered more serious complications related to kidney problems.
As you can see, Sibutramine is not a safe way to lose weight. So, if you care about your health, try taking nutritional supplements that contain purely natural substances .
Weight loss drugs, such as Sibutramine, are attractive to many, but their side effects should not be forgotten. Therefore, if you are considering something similar, visit your doctor first and discuss all your options with him.
If you are only worried about a few extra pounds, a small adjustment to your diet and the inclusion of physical activities will be enough. However, severe overweight and obesity not only mean limitations in everyday life, but also health problems.
If someone promises you quick weight loss without any effort, be careful and check everything carefully. Yes, it is of course a tempting idea, but losing weight is not that easy.
It is one of the parts of a comprehensive lifestyle change aimed at achieving weight loss. However, it is especially important for people with sedentary jobs, who are recommended to exercise daily for at least 30 minutes . Of the individual activities, combining strength training with aerobic activity has proven to be the most effective, as a result of which you will not lose muscle mass, but fat reserves. Moreover, if you also supplement physical activity with adjusting your eating habits, you are well on your way to success.
Adjusting your diet to minimize your intake of refined sugars , i.e. sweet snacks or white bread, is certainly important, but meal planning, including portion control, is also important. So if you are serious about losing weight, start a food diary or install one of the applications on your mobile phone (I recommend Calorie Tables), where you will write down individual foods and also physical activity. The connection between consistent food recording and weight loss is confirmed by a review study published in the Journal of the Academy of Nutrition and Dietetics. Yes, it is time-consuming and "annoying" at first, but the desired weight loss will be the well-deserved reward.
One of the factors increasing the risk of obesity is insufficient sleep . As a result , metabolism slows down, insulin and cortisol levels increase, which contribute to fat storage. The effect of sufficient sleep on weight loss is proven by the results of a study in the American Journal of Epidemiology, which included 83,377 men and women. People who slept 5-6 hours a day gained more weight, which also increased the risk of obesity. Stressful situations also lead to weight gain . Let's face it, you've probably fought stress with a bar of chocolate at least once. This is not surprising, since stress triggers the release of cortisol. When it stays in the bloodstream for a longer period of time, it can lead to an increase in cravings for sweets, and therefore weight gain. This statement is again proven by an 8-week intervention program aimed at better stress management, after which the participants achieved the desired reduction in BMI.
Losing weight without a specific diet plan undoubtedly has many advantages, the biggest of which is the financial aspect. Complete diet programs, including food packages, are often not the cheapest thing. On the other hand, if you are just starting to get interested in a healthy lifestyle, you will definitely not regret this investment. You will not have to learn to count calories , spend several hours compiling a menu or choosing suitable foods in the store. The most famous diets undoubtedly include low-carb, protein and boxed diets. However, intermittent fasting also has its importance, which will help in cases where you have been losing weight for a long time and weight loss has stopped or slowed down significantly. You can choose from several different models depending on the duration of the fasting period, so-called fasting.
Before you decide on any of the weight loss drugs, first try the above-mentioned methods, which do not cost you anything. Currently, you have a large number of diets to choose from, both for vegans, vegetarians, and meat lovers. If you do decide to reach for any of the drugs, give preference to those whose distribution is approved by the ŠÚKL - State Institute for Drug Control. Avoid drugs containing sibutramine and other prohibited weight loss drugs and consult your doctor about the others.
Sukl.cz - https://www.sukl.cz/otazky-a-odpovedi-k-pozastaveni-registrace-leciv
Steroidy.eu - https://www.steroidy.eu/index.php?route=product/product&product_id=459
EshopKamagra - https://www.eshopkamagra.sk/produkt/sibutramin-20mg/
Antidoping.sk - https://www.antidoping.sk/data/files/611_sibutramine.pdf
Answers are generated by artificial intelligence from information on our website and may contain errors.
