an international study of rimonabant in dyslipidemia with atherogenic risk in abdominally obese patients

Conditions: Dyslipidemia; Obesity

Summary: the purpose of this study is to assess the effect of rimonabant 20 mg on hdl (high density lipoprotein) cholesterol and on tg (triglycerides) plasma levels over a period of one year when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese patients with atherogenic dyslipidemia (low hdl and/or high tg plasma levels). the secondary objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites), safety and tolerability of rimonabant 20 mg.


Eligibility criteria:
inclusion criteria: * male or female patients aged \>= 18 years * waist circumference \> 102 cm in men and \> 88 cm in women * dyslipidemia consisting of: * triglyceridemia \>= 1.5g/l (i.e. 1.69mmol/l) and ≤ 7.0g/l (i.e. 7.90mmol/l) and/or * hdl cholesterol \< 50mg/dl (1.29mmol/l) in women, \< 40mg/dl (1.04mmol/l) in men * if patient with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication (excluding glitazones) and should not be on insulin therapy * written informed consent exclusion criteria: * weight change \> 5 kg within 3 months prior to screening visit * pregnancy or lactation, or women planning to become pregnant * absence of medically approved contraceptive methods for females of childbearing potential * presence of any other condition (e.g. geographic, social...) actual or anticipated, that the investigator feels that would restrict or limit the subject's participation for the duration of the study. * presence of any clinically significant endocrine disease (other than type 2 diabetes) according to the investigator * history of severe depression that could be defined as depression which necessitated the patient to be hospitalized, or patients with 2 or more recurrent episodes of depression or a history of suicide attempt. * presence or history of dsm-iv bulimia or anorexia nervosa- positive test for hepatitis b surface antigen and/or hepatitis c antibody; abnormal tsh level (tsh \> uln or \ 1,500/mm3 and/or platelets \< 100,000/mm3; positive urine pregnancy test in females of childbearing potential. * within 3 months prior to screening visit and between the screening and the inclusion visit: * administration of anti obesity drugs (e.g., sibutramine, orlistat) * administration of other drugs for weight reduction including herbal preparations (phentermine, amphetamines) * thyroid preparations or thyroxine treatment (except in patients on replacement therapy on a stable dose) * if patients with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication for at least 3 months and should not be expected to receive insulin therapy within 12 months: insulin, glitazones * any change in lipid lowering treatment (i.e. introduction of a new drug, change, cessation)- administration of systemic long-acting corticosteroids- prolonged use (more than 1 week) of systemic corticosteroids (or if daily dosage \> 1000 µg equivalent beclomethasone * prolonged administration (more than one week) of antidepressants (including bupropion) * prolonged administration (more than one week) of neuroleptics.

Keywords: dyslipidemia obesity