2.
Short-term administration of orlistat reduced daytime triglyceridemia in obese women with the metabolic syndrome.
Tzotzas, T, Samara, M, Constantinidis, T, Tziomalos, K, Krassas, G
Angiology. 2007;(1):26-33
Abstract
The objective of this prospective, controlled, randomized study was to evaluate the effect of orlistat administration for 10 days on daytime capillary triglyceridemia in obese women with metabolic syndrome (MetSyn). Thirty-two obese, nondiabetic women with MetSyn were evaluated. The presence of MetSyn was defined according to the National Cholesterol Education Program (NCEP)-Adult Treatment Panel III (ATP III) criteria. Patients were randomized into 2 similar groups: group A (orlistat), mean age 50.1 -/+ 8.2 years, received a low-calorie diet combined with orlistat 120 mg tid for 10 days and group B (control), mean age 51.2 -/+ 9.1 years, received only the low-calorie diet for the same period of time. Anthropometric, lipids, and parameters of insulin resistance were measured before and after 10 days of intervention. Capillary triglycerides (TGc) were measured at 6 different time points during the day and daytime triglyceridemia was expressed as area under the curve of TGc (AUC-TGc). Most anthropometric measurements (body weight, body mass index, waist circumference, and percentage of fat mass) and most metabolic parameters (total cholesterol [TC], fasting venous triglycerides [TGfv], high-density lipoprotein cholesterol [HDL-C] levels, fasting glucose [FG], fasting insulin [FI], and homeostasis model for assessment [HOMA] for insulin resistance index) decreased significantly in both groups, while waist-to-hip ratio (WHR) and systolic (SBP) and diastolic blood pressure (DBP) did not change significantly in both groups and low-density lipoprotein cholesterol (LDL-C) levels decreased only in the orlistat group. Following minimal weight loss, TGc at most time points and AUC-TGc were significantly reduced only in group A. In group A, AUG-TGc decreased by 17% from 36.4 -/+11.8 to 30.2 -/+9.9 mmol/Lxh(-1) (p < 0.001), and this reduction was significantly greater compared with the control group (p < 0.05) and remained significant after percentage of weight loss was taken into account. This decrease of AUC-TGc significantly correlated with the decrease of HOMA index (p < 0.05, r = 0.39) and the decrease of TGfv (p < 0.001, r = 0.62). The tolerability of orlistat was very good and side effects were transient and of minimal intensity. In conclusion, short-term administration of orlistat significantly reduced daytime triglyceridemia in obese, nondiabetic women with MetSyn. This reduction could offer cardiovascular benefits in these high-risk patients. Long-term studies with more patients are needed to reach definite conclusions.
3.
The ORLIstat and CArdiovascular risk profile in patients with metabolic syndrome and type 2 DIAbetes (ORLICARDIA) Study.
Didangelos, TP, Thanopoulou, AK, Bousboulas, SH, Sambanis, CL, Athyros, VG, Spanou, EA, Dimitriou, KC, Pappas, SI, Karamanos, BG, Karamitsos, DT
Current medical research and opinion. 2004;(9):1393-401
Abstract
BACKGROUND 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), HbA(1C) (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.