Contents
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Obesity and type 2 diabetes mellitus (DM2) are recognized as non-communicable epidemics of the XNUMXst century. WHO estimates, there are more than 1,9 billion overweight people worldwide (BMI >27 kg/m2), of which 600 million people are obese (BMI >30 kg/m2). It is known that with an increase in body weight, the risk of developing type 2 diabetes increases. Studies have shown that overweight people have a 2 times higher risk of developing DM2,5 (and 6 times higher in obese people) than those with normal body weight.
In the treatment of obesity, centrally acting drugs such as sibutramine are used. On the pharmaceutical market, this remedy is produced under various trade names, and two drugs are quite often heard – Goldline and Reduxin. What is the difference between these tools and which one is better – we will tell in the article.
The drug and its characteristics | Goldline | Reduxin |
Active substance | sibutramine hydrochloride monohydrate | sibutramine hydrochloride monohydrate; microcrystalline cellulose |
Form of issue | Capsules | Capsules |
Manufacturer | Izvarino Pharma (Russia) | Ozon (Russia) |
Cost | 1300 rub. for 30 capsules | 1600 rub. for 30 capsules |
Both drugs are available by prescription.
Why do we need drugs for weight loss?
Weight loss drugs are used in two situations:
alimentary obesity with BMI ≥30 kg/m2;
alimentary obesity with BMI ≥ 27 kg/m2 in combination with type 2 diabetes mellitus or lipid metabolism disorders.
Statistics shows: more than 2/3 of patients with type 2 diabetes are overweight, and more than 50% are obese. The higher the degree of obesity, the lower the quality of life. With an increase in body weight, the risk of developing complications from the cardiovascular system and other organs also increases.
According to modern concepts, in the complex therapy of type 2 diabetes mellitus in obese patients, drugs for weight loss are necessarily used. The goal of therapy is to achieve normal body weight and maintain it at the desired level, and therefore to prevent the development of complications.
Obesity, like T2DM, is a chronic disease requiring lifelong treatment. Interestingly, not only doctors, but also patients themselves recognize the need to take medications. Survey conducted in 2016 showed: 57,4% of people are willing to take medication for weight loss.
Until recently, it was believed that prescribing drugs for weight loss is possible only for obesity (BMI ≥30 kg / m2). But practice has shown that this tactic is not entirely justified. Current clinical guidelines Specifiedthat such drugs can also be used for overweight (BMI ≥ 27 kg/m2) if it is combined with other risk factors, such as type 2 diabetes.
In practical endocrinology, sibutramine is prescribed for weight loss along with metformin. The dosage and duration of therapy is determined by the doctor, taking into account the severity of the course of the disease.
How the drugs work
Sibutramine in the composition of both drugs belongs to the means of central action. It is a prodrug and does not work immediately, but only after undergoing transformation in the body. Sibutramine releases primary and secondary metabolites that inhibit the reuptake of monoamines – and acts primarily on serotonin and norepinephrine.
Sibutramine:
increases the activity of central receptors for serotonin and norepinephrine;
creates a feeling of fullness;
reduces the need for food;
increases body heat production;
affects brown adipose tissue.
The chain of these reactions leads to weight loss and then to the normalization of blood lipid levels. During therapy, the concentration of “good” fats (HDL) increases and the level of “bad” fats (LDL, cholesterol and triglycerides) decreases.
Godline and Reduxin contain one active ingredient – sibutramine, so their effect on metabolism is similar. Both drugs lead to weight loss and stabilization of blood lipid levels. But Reduxin also contains cellulose. It acts as an enterosorbent – it binds and removes:
microorganisms (bacteria, protozoa, fungi) and waste products;
exogenous and endogenous toxins;
allergens
xenobiotics;
exchange products.
Pharmacokinetics (speed of distribution and absorption of active substances) for drugs is similar – the addition of cellulose does not have a significant effect.
Important! Medicines are prescribed only when non-drug methods (diet, physical activity) have been ineffective, and weight loss was less than 5 kg within three months.
Evaluation of the effectiveness of anti-obesity drugs
A search in the Cochrane Library database shows that sibutramine is recognized as a fairly effective drug from the standpoint of evidence-based medicine. IN review from 2016 there is evidence that the drug really works. However, the authors emphasize that sibutramine often leads to adverse reactions from the cardiovascular system, and therefore requires special attention to patients.
In another review the authors reviewed the effect of sibutramine in people with arterial hypertension on the background of obesity. It turned out that the drug effectively copes with the task, but often leads to an increase in blood pressure – which is dangerous for this category of patients.
Russian scientists share the opinion of foreign colleagues. In the review article it is emphasized that sibutramine really gives a good result. The authors of the article refer to a study that lasted for two years and showed that weight loss during therapy is an average of 11,3 kg. About 54% of the subjects lost more than 10% of their body weight, which led to an improvement in the quality of life.
It is worth noting that the Russian Goldline and Reduxin are generics (analogues) of the foreign original drug Meridia. The high efficiency of this tool demonstrated in multicenter randomized clinical trials – which cannot be said about generics. Comparative studies on the similarities and differences between Goldline and Reduxin, not carried out.
Application Scheme
Despite minor differences in composition, Goldline and Reduxin are prescribed according to the same scheme:
Daily – once a day.
The minimum daily dosage is 10 mg (with poor tolerance – 5 mg).
The dosage is set by the doctor, taking into account the tolerability of the drug and the severity of the clinical effect.
Capsules should be taken at the same time in the morning on an empty stomach, without chewing and drinking plenty of water. The drug can be drunk after meals, however, the rate of its absorption is reduced by 30%. This is not critical, since sibutramine is a long-acting drug and is not expected to have an immediate effect.
The dosage of the drug is increased to 15 mg per day, if within four weeks the weight has not decreased by 5% or more. If the patient does not respond well to therapy, treatment should not continue for more than three months – other approaches should be sought. But even with good tolerance and sufficient clinical effect, therapy should not last more than two years. There is no data on the safety of the drug with longer use.
Treatment with sibutramine must be combined with diet and exercise. Only an integrated approach allows you to lose weight and improve the quality of life.
Adverse Reactions
Undesirable symptoms are the same for Goldline and Reduxin. Usually they occur in the first 4 weeks of admission and subside over time.
The most common reactions are:
CNS: insomnia, dizziness, paresthesia, headache (rare).
Cardiovascular system: palpitations, increased blood pressure, reddening of the skin, deterioration of varicose veins.
Digestive system: loss of appetite, dry mouth, nausea.
Skin: increased perspiration.
With the abolition of the drug, sometimes there is a headache or increased appetite.
In general, adverse reactions are moderately expressed and are reversible: they disappear completely after completion of therapy.
In the first two months of treatment, all patients are advised to monitor blood pressure and heart rate every two weeks. If the drug is well tolerated, then this should be done monthly. If the level of blood pressure twice during repeated measurement exceeds 145/90 mm Hg. Art., treatment should be stopped.
In the medical literature, there are many references to the fact that sibutramine-based drugs are dangerous and should not be used to treat obesity. However, the FDA does not confirm such statements. The International Organization for Quality Control of Medicines conducted research and found out: sibutramine really cannot be called a safe drug, but you should not unequivocally refuse it. The authors of the study particularly emphasized the fact that the most common adverse reactions (rhythm disturbances and increased blood pressure) occur in people with obesity and before taking sibutramine.
Russian scientists agree with foreign colleagues: the use of sibutramine is possible, but it must be justified. In other words, do not take the drug without a doctor’s prescription.
Противопоказания
Goldline and Reduxin are not applied in the presence of such conditions:
obesity caused by organic causes – for example, hypothyroidism;
severe eating disorders, such as anorexia nervosa or bulimia;
mental illness;
generalized tics;
severe diseases of the heart and blood vessels – for example, coronary artery disease, some forms of arrhythmia, congenital malformations;
severe pathology of the liver and kidneys;
benign prostatic hyperplasia;
angle-closure glaucoma;
any type of addiction – alcohol, drugs, pharmacological;
individual intolerance.
Goldline and Reduxin are prohibited during pregnancy and lactation. Women treated with sibutramine are advised to use reliable contraception.
Weight loss drugs are not used in children and adolescents under 18 years of age and over the age of 65 years – their safety has not been proven in these categories of patients.
Goldline and Reduxin are not prescribed together with other agents acting on the central nervous system (for example, antidepressants or antipsychotics), MAO inhibitors and tryptophan.
Goldline and Reduxin affect psychomotor reactions. It is forbidden to drive a car and operate mechanisms during treatment.
Conclusions
To sum up:
Goldline and Reduxin are drugs for weight loss. They are prescribed in complex therapy for obesity and type 2 diabetes.
Goldline and Reduxin contain one active ingredient – sibutramine, and their effect on the body is similar. The composition of Reduxin also includes cellulose, which works as an adsorbent – it removes pathogens and toxins. Cellulose enhances the beneficial effect of the drug, but does not affect the rate of its absorption and distribution in the body.
Goldline and Reduxin are generics of the original foreign drug Meridia. The clinical efficacy of the original has been proven in tests. Comparative studies on the similarities and differences between the original and generics, as well as analogues among themselves, have not been conducted.
Adverse reactions and contraindications are the same for both drugs.
Attention! This material is subjective, is not an advertisement and does not serve as a guide to the purchase. Before buying, you need to consult with a specialist.