THE ROLE OF MULTIFACTORIAL APPROACH TO TREATMENT OF OBESITY IN FEMALES

Background: Obesity is characterized by an increased risk of diabetes mellitus, coronary heart disease, arterial hypertension and reproductive system disorders, which makes it necessary to implement multifactorial correction of metabolic disturbances.

Aim: To analyze diet intake structure of patients with obesity, efficacy and safety of sibutramine monotherapy and sibutramine/metformin combination therapy in the formation of adequate nutritional stereotypes and reduction of bodyweight.

Materials and methods: Eighty-two obese women aged 18 to 49 years (mean age 29.7±5.7 years) were included into this observational study. Inclusion criteria: women aged 18 to 49 years, with waist circumference>80 cm, body mass index (BMI)>27 kg/m², triglyceride level>1.7  mmol/L and/or low-density lipoprotein cholesterol>3.8  mmol/L, and/or high-density lipoprotein cholesterol<1.29 mmol/L. Exclusion criteria in this study were presence of severe somatic and endocrine disorders. The control group consisted of 35 healthy women aged 18 to 49 years (mean age 28.7±5.6 years). All patients were recruited within the observational program PrimaVera.

 Results: Analysis of dietary intake in female obese patients showed an excess of daily energy intake of 650±250 kcal compared to that in subjects with normal BMI and normal waist circumference. Seventy one percent of patients had excessive expectations from treatment duration and desired weight loss. For control of their eating behavior, 52 patients were administered Reduxin® (sibutramine+cellulose microcristallic) 10 mg daily. Other 30 patients (24 women with a history of carbohydrate metabolism disturbances during pregnancy and 6 women who had delivered babies with birth weight of above4 kg) were administered Reduxin® 10 mg and metformin 500  mg daily, with weekly dose increase by 500  mg to the final dose of 1500 mg daily. The treatment lasted for 24  weeks. Daily caloric intake decreased by 24±4% from baseline (p<0.05) on monotherapy and by 28±7% from baseline (p<0.05) on combination therapy. Average weight loss comprised -8.9±1.6 kg(p<0.05) under monotherapy and 9.7±1.5 kg(p<0,05) under combination therapy. Reduction in waist circumference amounted to 11.4±1.8 cm(p<0.05) under monotherapy and 14.1±1.5 cm(p<0.05) under combination therapy. Physical activity (data from pedometers) increased by 6.9±1.8 thousand steps (p<0.05) in the monotherapy group and 7.2±2.0 thousand steps (p<0.05) in the combination therapy group. After 24 weeks of treatment 48.3% of females had their libido increased, 35.4% reported an increase in their self-consciousness as a sexual partner. Menstrual cycle was normalized in 83.8% of patients and restoration of ovulation in 75.8%. There were no significant adverse effects with Reduxin® 10 mg monotherapy and its combination with metformin 1500 mg.

Conclusion: Obesity should be considered mostly as a result of imbalanced dietary intake. Treatment with Reduxin® 10 mg and combination therapy with Reduxin® 10 mg and metformin 1500 mg for 6 months resulted in reduction of daily caloric intake, control of eating behavior, target weight loss, reduced abnormalities in reproductive system and sexual problems. The results obtained indicate that 6 months of Reduxin® 10 mg and combination therapy with Reduxin® 10 mg and metformin 1500 mg are effective and safe.