The ORlistat and CArdiovascular risk profile in patients with metabolic syndrome and type 2 DIAbetes (ORliCARDIA) study

SUMMARYBackground:Metabolic syndrome (MetSyn) is associated with a marked increase in the risk of cardiovascular disease, especially in patients with type 2 diabetes mellitus (DM).Aim:To investigate the effect of orlistat plus hypocaloric diet (HCD) vs HCD alone on the cardiovascular risk profile in patients with both MetSyn (National Cholesterol Educational Program – NCEP – Adult Treatment Panel III definition) and type 2 DM.Methods:This was a prospective, multicentre, open-label, randomized, controlled study. One hundred and twenty-six patients, free of cardiovascular disease at baseline, were included in the final analysis. Ninety-four (73) patients were treated with orlistat (360 mg/day) and HCD for a 6-month period, while 34 (27) were on HCD alone. Analysis of covariance was used to assess differences between the treatment groups over time.Main outcome measures:Components of the MetSyn criteria assessed were: waist circumference; systolic and diastolic blood pressure; fasting glucose, triglycerides; high-density lipoprotein cholesterol (HDL-C) plus body mass index; glycosylated haemoglobin (HbA1C); homeostasis model for assessment of insulin resistance (HOMA) index; and total and low-density lipoprotein cholesterol (LDL-C).Results:By protocol, all patients had MetSyn at baseline. After a 6 month treatment period there were significant differences between the orlistat plus HCD vs the HCD-alone groups in body weight ( p 0.0001), waist circumference ( p< 0.0001), fasting glucose ( p< 0.0001), HbA1C( p< 0.0001), systolic blood pressure ( p 0.024), total cholesterol ( p< 0.0001), LDL-C ( p 0.034), and HOMA index ( p 0.022), while there were no significant differences in triglycerides and HDL-C. Orlistat was well tolerated. By the end of the study, 65 of the patients on orlistat plus HCD were still meeting the MetSyn criteria and 41 had four to five MetSyn components vs 91 ( p< 0.0001) and 53 ( p 0.017), respectively, of those on HCD alone.Conclusions:Orlistat plus HCD favourably modified several cardiovascular risk factors in patients with both MetSyn and type 2 DM. These effects might partly offset the excess cardiovascular risk and improve outcome in this patient population.