The strategy of obesity management: the results of All-Russian observational program “Primavera”

Introduction. The prevalence of obesity and associated comorbidities is comparable to the scale of the epidemic. Along with the change in lifestyle, pharmacotherapy is necessary to lead obesity patients to a healthier state.

Aim. The evaluation of efficacy and safety of Reduxin® (sibutramine + microcrystalline cellulose) application among patients with alimentary obesity and comorbidities in routine clinical practice. Analysis of results of Primavera program.

Materials and methods. The observation program Primavera was conducted since November 2012 to July 2015 under the auspices of

Endocrinology Research Centre and the Russian Association of Endocrinologists. The program "Primavera" was attended by 3095 doctors of various specialties and 98.774 patients being treated in 1272 hospitals in 142 Russian cities. The average age of the patients was 39.4 ± 10.4 years, the ratio of male / female – 17.7%/82,3%, the average body mass – 99.1±14.28 kg, the average BMI – 35.7±4.41 kg/m2, the average waist circumstance – 105.7±13.7 cm. The Duration of Reduxine® treatment was determined by the attending physician and ranged from 3 months to 1 year.

Results. The duration of therapy was 3 months for 3% of patients, 6 months for 59.3% of patients, 12 months for 37.7% of patients. The BMI reducing dynamics during 3, 6, 12 months was 3.4±1.53 kg/m2 (average 9.5±4.28 kg), 5.4±2.22 kg/m2 (15.0±6.22 kg), 7.2±3.07 kg/m2 (20.0±8.62 kg) respectively. The average waist circumference reduction for 3, 6 and 12 months was 6.3±4.31 sm, 10.6±6.30 sm, 16.0±8.94 sm, respectively. It was shown that the weight loss during prolonged (more than six months) Reduxine therapy under the supervision of a physician was associated with decreased levels of systolic and diastolic blood pressure and had no affect on heart rate. Adverse events were reported for 4.1% of patients, according to doctors, the cause-effect relationship with the use of Reduxine can be estimated as probable or definite for 1.9% of patients, possible – for 1.7%.

Conclusions. Observation programs allow to implement the principles of active monitoring of the efficacy and safety of the drug in the current clinical practice and to develop a skill of reasonable prescribing. In Primavera program it was shown that the use of Reduxine® (sibutramine+ microcrystalline cellulose) leads to loss of body weight and doesn’t lead to serious adverse effects.

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