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

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.