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Effect of orlistat on weight loss, hormonal and metabolic profiles in women with polycystic ovarian syndrome: a randomized double-blind placebo-controlled trial.
Moini, A, Kanani, M, Kashani, L, Hosseini, R, Hosseini, L
Endocrine. 2015;(1):286-9
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The role of orlistat combined with lifestyle changes in the management of overweight and obese patients with polycystic ovary syndrome.
Panidis, D, Tziomalos, K, Papadakis, E, Chatzis, P, Kandaraki, EA, Tsourdi, EA, Katsikis, I
Clinical endocrinology. 2014;(3):432-8
Abstract
OBJECTIVE Obesity is frequently present in women with the polycystic ovary syndrome (PCOS) and aggravates insulin resistance (IR) and hyperandrogenemia. We aimed to assess the effects of orlistat combined with lifestyle changes in overweight and obese women with PCOS and body mass index (BMI)-matched controls. DESIGN Prospective study. PATIENTS We studied 101 women with PCOS (age 26·1 ± 6·4 years, BMI 34·5 ± 5·9 kg/m(2) ) and 29 BMI-matched women with normal ovulating cycles. All women were instructed to follow a low-calorie diet to exercise and were treated with orlistat 120 mg tid for 6 months. MEASUREMENTS Metabolic and endocrine characteristics of PCOS, blood pressure (BP) and lipid profile. RESULTS A significant and comparable reduction in BMI was observed in women with PCOS and controls. Systolic and diastolic BP decreased only in women with PCOS. Serum low-density lipoprotein cholesterol levels decreased in both women with PCOS and controls; however, this reduction was greater in controls. In contrast, serum high-density lipoprotein cholesterol levels did not change in women with PCOS and decreased in controls. Serum triglyceride levels decreased significantly and to a comparable degree in the two groups. Similarly, markers of IR improved significantly and to a comparable degree in women with PCOS and controls. Serum testosterone levels and the free androgen index decreased significantly in women with PCOS and did not change in controls. CONCLUSIONS Orlistat combined with lifestyle changes induces substantial weight loss in women with PCOS, resulting in improvements in IR, hyperandrogenemia and cardiovascular risk factors.
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Obesity, weight loss, and the polycystic ovary syndrome: effect of treatment with diet and orlistat for 24 weeks on insulin resistance and androgen levels.
Panidis, D, Farmakiotis, D, Rousso, D, Kourtis, A, Katsikis, I, Krassas, G
Fertility and sterility. 2008;(4):899-906
Abstract
OBJECTIVE To investigate the combined effect of diet and orlistat, for 24 weeks, on anthropometric features, hormonal parameters, and indices of insulin resistance in obese women with polycystic ovary syndrome (PCOS) and in obese women without the syndrome. DESIGN Prospective clinical study. SETTING Department of obstetrics and gynecology in a major university in Greece. PATIENT(S): Eighteen selected women with PCOS were matched for age and body mass index with 14 obese control women. INTERVENTION(S): Subjects were prescribed an energy-restricted diet, and orlistat (120 mg, 3 times per d) was administered to all subjects for 24 weeks. MAIN OUTCOME MEASURE(S): At baseline, week 12, and week 24, after an overnight fast, blood samples were collected, and serum levels of FSH, LH, PRL, T, Delta(4)A, DHEAS, 17 alpha-hydroxyprogesterone, sex hormone-binding globulin, glucose, and insulin were measured. RESULT(S): Testosterone levels were significantly decreased with treatment in women with PCOS; this decrease was attributed to the first trimester, whereas T levels did not change during the second 12-week period. In women with PCOS, insulin levels and HOMA-IR values were decreased during the first 12 weeks, whereas no significant change was observed during the second trimester. CONCLUSION(S): Orlistat administration, combined with diet, for 24 weeks, resulted in significant weight loss and improvement of insulin resistance in obese women, with or without PCOS. Moreover, T levels were significantly decreased in women with PCOS. There appears to be a trend during the first 12-week period for greater improvement of metabolic and hormonal parameters in women with PCOS.
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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.
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Does metabolic syndrome mitigate weight loss in overweight Mexican American women treated for 1-year with orlistat and lifestyle modification?
Pinkston, MM, Poston, WS, Reeves, RS, Haddock, CK, Taylor, JE, Foreyt, JP
Eating and weight disorders : EWD. 2006;(1):e35-41
Abstract
AIMS: To investigate the effects of a pharmacotherapy (orlistat) plus lifestyle management (OLM) intervention on weight loss in Mexican American women with and without metabolic syndrome (MS). METHODS One hundred and seven female participants aged 21-65 years and of Mexican origin were randomized to either OLM or a wait-list control group (WLC) for one year. The lifestyle interventions were tailored to exhibit features of the Mexican culture. Within each group, subjects with MS were compared to those without MS to assess whether its presence mitigates weight loss. Risk factors for MS also were assessed. RESULTS Participants with MS in the OLM group experienced significant decreases in weight and body mass index (BMI) as compared to participants without MS. Participants with MS in the OLM group and who completed the study lost 9.3+/-7.5 kg (20.5+/-16.5 lb) as compared to participants with MS in the WLC group, who only lost 0.2+/-3.1 kg (0.4+/-6.8 lb). Further, participants with MS in the OLM group who completed the study experienced a 3.1+/-3.9 kg/m2 decrease in BMI whereas participants with MS in the WLC group only experienced a 0.1+/-1.2 kg/m2 decrease in BMI. No changes in other MS risk factors were significant. CONCLUSIONS Patients with MS experienced significant weight loss and decreases in BMI as a result of a lifestyle and pharmacotherapy intervention.
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Orlistat for obesity: benefits beyond weight loss.
Hsieh, CJ, Wang, PW, Liu, RT, Tung, SC, Chien, WY, Chen, JF, Chen, CH, Kuo, MC, Hu, YH
Diabetes research and clinical practice. 2005;(1):78-83
Abstract
Orlistat lowers lipids and improves insulin sensitivity, but its effect on other metabolic syndrome related parameters is not known. To assess its influence on adiponectin, high sensitive C-reactive protein (hs-CRP) and other metabolic syndrome related parameters, this study enrolled 106 participants in a weight-reduction program and categorized them into a group of 51 who had been treated with orlistat 360 mg/day for one year and a group of 55 age and sex and body mass index (BMI) matched controls. The orlistat group had greater changes in BMI, % body fat (% BF), waist circumference, and insulin resistance, hs-CRP, leptin and adiponectin levels after one year on the program than the controls. After adjusting for % BF and waist circumference, change of serum leptin and adiponectin levels remained significantly different. It was found that orlistat could effectively manage obesity related co-morbidities, especially insulin resistance and atherosclerosis risk. It decreases leptin and increases adiponectin independent of % BF and waist circumference. Therefore, orlistat appears to have anti-diabetic and anti-atherogenic properties and may help prevent metabolic syndrome in the overweight people.
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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.