The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity

Secondary objectives:

• to study the structure of the population of patients with the diet induced obesity with body mass index (BMI) 30 kg/m2 or diet induced obesity with BMI ≥27 kg/m2 associated with type 2 diabetes mellitus in respect of comorbidities and concomitant treatment to determine the areas for further investigations.
• to introduce the elements of control of adverse cardiovascular risks into the routine clinical practice: questionnaire concerning enrollment criteria for Reduxine treatment initiation, algorithm of Reduxine administration and treatment efficacy and safety monitoring (assessment schedule).
• to assess the effects of the treatment of overweight and obesity with Reduxine on patients' quality of life parameters.

The Time Frame: the follow up of the study patients will be performed during six month to one year. Exception - premature discontinuation from the study.

The scheduled visits of the patients to the investigational centres are: Week0 (inclusion of the patient), Week 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and Week 48.

Inclusion criteria

• Men and women of 18-65 years of age to whom, in the doctor's opinion, the on-label use of Reduxine is indicated.
• Patient's desire and ability to participate in the program and fulfill the doctor's instructions designed to achieve the treatment goal and the program requirements compliance.
• Signed informed consent form for participation in the program.

Exclusion criteria

• Patients under age of 18 or older than 65;

Current or the history of:

• coronary artery disease (e.g. angina, myocardial infraction);
• congestive heart failure;
• tachycardia;
• peripheral arterial occlusive disease;
• arrythmia;
• Uncontrolled arterial hypertension >145/90 mm Hg;
• Hypersensitivity to sibutramine or any components of Reduxine®;
• Current use of monoamineoxidase inhibitors (IMAO) or their use within the last 2 weeks;
• Current use of other central acting weight reducing drugs or their use within the last 2 weeks;
• Use on other drugs affecting the central nervous system (e.g. antidepressants, neuroleptics); tryptophan-containing drugs indicated for sleep disturbance;
• Severe eating disorder (anorexia nervosa or bulimia);
• Mental disease;
• Gilles de la Tourette syndrome (generalized tics);
• Body mass index ≤30 kg/m2 or ≤27 kg/m2 in the presence of concomitant diseases (dyslipidemia, diabetes);
• Organic cause of obesity (e.g. hypothyrosis);
• Thyrotoxicosis;
• Sever liver and/or kidney function abnormality;
• Benign prostatic hyperplasia;
• Phaeochromocytoma;
• Narrowangle glaucoma;
• Documented pharmacologic, drug or alcohol addiction;
• Pregnancy and lactation;
• Refusal to sign the informed consent form for participation in the program;
• Participation in a clinical study of any new drug product within 90 days prior to the screening visit.