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Reduksin
 According to WHO, the early 21st century saw about 20 or 25% of the adults being overweight and 40 to 50% having excess body weight. The number of Russians having their body mass index (BMI) over 27 kg/m2 amounts to about 50% of the adult population. Institute of Nutrition RAMS data show that 24% of the Russians (35 million people) are overweight, and only 10% of these call for medical assistance from an endocrinologist.
At the meantime, excess weight is the major factor for diabetes type II: 80 to 90% of those diagnosed with diabetes are also living with excess weight. Excess weight gives an increase of sudden death risk by 2.8, cardiac insufficiency by 1.9, and coronary heart disease by 1.5 times.
| There are loads of products intended for treatment of excess weight and its associated disorders. They are generally quite pricey and hardly affordable. Fortunately, in our country we have a registered and a recommended for use home-made drug product Reduxine (sibutranine). |
Sibutramine’s pharmacological effect consists of a selective inhibition of serotonin and noradrenaline reuptake in synapses of human central nervous system.
As a result of serotonin accumulation in interneuronic space, the sense of fullness is intensified and prolonged and consequently the quantities of food consummation are reduced. This is just one of the mechanisms of action of the drug product which supports development of inappetence and facilitates reinforcement of proper eating behavior of the patient.
The studies show that 87% of the patients adhere to the eating behavior following Sibutramine therapy.
At the same time, while activating β-3 and β-2 adrenergic receptors of fat cells, the drug stimulates the process of thermogenesis by initiating lipolysis and increasing energy production.
Meta-analysis of a few randomized placebo controlled studies of Sibutramine’s efficiency, which included overweight patients (with average BMI of 30-40 kg/m2) during 3-24 months, has shown a decrease in body weight by 5% and more in 19 to 57% of the patients. Decrease of body weight by 10 or more per cent has also been observed in 19 to 39% of the patients.
Product studies show that the highest positive results are observed with a long-term Sibutramine therapy. In general, three out of five patients treated with Sibutramine during 12 months, lose more than 5% of body weight, and three out of eight lose 10% or more.
| In connection with considerable growth of excess weight among teenagers, it is important to note the product’s proved efficiency in this category of patients. Thus, in a one-year comparative study conducted by Berkowitz R.I. et al, which included 488 overweigh teenagers, it has been shown that using Sibutramine it is possible to reach bigger loss of body weight compared to the group of patients who have been recommended to use non-pharmacological methods of excess weight treatment only. |
In the group of teenagers treated with Sibutramine, BMI dropped credibly by 2.2 – 3.5 kg/m2, and body weight by 7.2 – 9.7 kg, and waist-to-hip ratio also decreased. Also, along with improvement of sensitivity to insulin, positive changes in the lipid spectrum were observed: triglycerides concentration dropped while HDL level rose.
We have conducted our own study of efficiency and safety of Reduxine administration in overweight patients. The study was run in the 2nd Endocrinology Division of MMU GB No. 6 in Samara (the study was led by: MD A. F. Verbovoy, Professor, holder of endocrinology chair in Samara SMU, N.I. Shvetsova, chief of endocrinology department of MMU GB No. 6).
The study involved 72 patients: 50 of these were presenting with diabetes Type II, and 22 with excess weight not showing carbohydrate metabolism disorders, aged between 40 and 60 years, with average BMI of 37±0.011 and average blood pressure of 130/80 Mmhg. The group consisted of 21 male and 51 female patients.
For the purpose of body weight loss they were administered 10 to 15 mg of Reduxine once per day during 12 weeks.
The group was divided into 3 subgroups:
- 30 patients presenting with diabetes were administered 10 mg of Reduxine once per day for 12 weeks;
- 20 patients presenting with diabetes were administered 15 mg of Reduxine once per day in the morning for 12 weeks;
- 22 overweight patients were administered 10 mg of Reduxine once per day for 12 weeks;
All the patients have undergone initial, weekly and final (at a 12 weeks timepoint) tests: body mass, BMI and blood pressure.
From the results of the study a conclusion can be drawn that Reduxine is an effective and safe to use drug product.
In 30 of the patients with diabetes Type II and 22 overweight patients who were administered 10 mg of Reduxine, a credible weight loss was observed by 8.6 ± 0.017 kg, BMI by 4.9±0.01 kg/m2. Blood pressure sustained no major changes, 130/80 Mmhg on the average. No adverse events were observed.
20 patients with diabetes Type II who were administered 15 mg of Reduxine, were demonstrating a more significant body mass loss by 14.6±0.0012 on the average. No side-effects were observed. Blood pressure parameters remained at 130/80 Mmhg.
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