1.
Effect of hypocaloric diet plus sibutramine treatment on hormonal and metabolic features in overweight and obese women with polycystic ovary syndrome: a randomized, 24-week study.
Florakis, D, Diamanti-Kandarakis, E, Katsikis, I, Nassis, GP, Karkanaki, A, Georgopoulos, N, Panidis, D
International journal of obesity (2005). 2008;(4):692-9
Abstract
OBJECTIVE To examine the effect of hypocaloric diet plus sibutramine on body composition, hormonal and metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS). DESIGN Open-label, randomized study at an outpatient clinic. PATIENTS A total of 59 overweight and obese (18-39 years old) women with PCOS. MEASUREMENTS All patients were placed in a hypocaloric diet plus sibutramine (10 mg per day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg per day, group S) or hypocaloric diet only (group D) for the subsequent 6 months. Body composition, hormonal and metabolic features and insulin sensitivity (oral glucose tolerance test, OGTT) were evaluated at baseline and at 3 and 6 months of treatment. RESULTS Body weight reduced in both groups but the reduction was greater with sibutramine (-15.4+/-1.1 vs -11.1+/-1.9% in groups S and D, respectively, P<0.05). At 6 months, a greater percent of patients lost more than 10% of initial body weight in group S than D (81 vs 52.9%). In both groups, all women with abnormal OGTT at baseline presented normal glucose tolerance after 6 months. Free androgen index (FAI), glucose area under the curve and fasting triglyceride (TG) concentration were reduced after 6 months in group S only (P<0.05). No changes in cardiovascular risk factors, prolactin and hepatic enzymes levels were observed in both groups. CONCLUSION A hypocaloric diet and a diet plus sibutramine both result in significant weight loss in overweight and obese women with PCOS. Patients who received sibutramine showed a greater weight loss and improvement in hyperandrogenemia and insulin sensitivity after 6 months of treatment. The amelioration of insulin resistance in this group could not be totally explained by weight loss. Total testosterone, FAI and TG levels reduction could be a possible mechanism. Finally, sibutramine increased compliance to diet and it was well tolerated from these patients.
2.
Impact of weight loss on the metabolic syndrome.
Phelan, S, Wadden, TA, Berkowitz, RI, Sarwer, DB, Womble, LG, Cato, RK, Rothman, R
International journal of obesity (2005). 2007;(9):1442-8
Abstract
OBJECTIVE To evaluate the effects of weight loss on the risk of having metabolic syndrome after 1 year of treatment with lifestyle modification alone, pharmacotherapy alone (sibutramine) or the combination of the two. DESIGN Randomized, controlled, 1-year clinical trial. PATIENTS One hundred and eighty women and 44 men, 18-65 years of age, with a body mass index of 30-45 kg/m(2), free of uncontrolled hypertension or type 1 or 2 diabetes. INTERVENTION Fifteen milligrams of sibutramine per day alone, lifestyle modification counseling alone, sibutramine plus lifestyle modification counseling or sibutramine plus brief lifestyle modification counseling. MEASUREMENTS The metabolic syndrome, as defined by the Adult Treatment Panel III. RESULTS Before treatment, 34.8% of the participants had the metabolic syndrome. Metabolic syndrome was more prevalent in Caucasians than African Americans (42.5 vs 20.3%; P<0.03), in males than females (65.1 vs 34.9%; P<0.002) and in older (>44 years) than younger (≤44 years) participants (47.5 vs 20.8%; P<0.0001). After 1 year of treatment, a moderate decrease in weight (8.0+/-8.7 kg) resulted in significant reductions in the prevalence of metabolic syndrome from 34.8 to 27.2% of all participants (P<0.02). Logistic regression analyses indicated that for each 1 kg of weight lost, the odds of metabolic syndrome were reduced by 8% (CI=0.89-0.97; P<0.003). Lifestyle modification either alone (P<0.04), or in combination with sibutramine (P<0.05), significantly reduced the prevalence of metabolic syndrome compared with sibutramine alone. The group effect was removed after controlling for weight loss. CONCLUSIONS The metabolic syndrome was prevalent in over one-third of obese individuals who sought weight loss treatment, and the prevalence differed by age, sex and ethnicity. Moderate weight loss markedly reduced the odds of metabolic syndrome in this sample.
3.
Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome.
Sabuncu, T, Harma, M, Harma, M, Nazligul, Y, Kilic, F
Fertility and sterility. 2003;(5):1199-204
Abstract
OBJECTIVE To evaluate the effectiveness of sibutramine therapy alone and in combination with ethinyl estradiol-cyproterone acetate (EE-CPA) on the clinical and metabolic parameters of obese women with polycystic ovary syndrome (PCOS). DESIGN Prospective randomized, controlled study. SETTING Endocrinology and gynecology clinics. PATIENT(S): Forty obese women with PCOS. INTERVENTION(S): Group 1 was treated with oral EE-CPA (35 microg-2 mg/day), group 2 with oral sibutramine (10 mg/day), and group 3 with a combination of EE-CPA plus sibutramine for 6 months. All groups were advised to consume a diet of 1200 kcal/day. MAIN OUTCOME MEASUREMENT(S): Measurements were performed before and 6 months after treatment of body mass index, waist-to-hip ratio, systolic and diastolic blood pressure, Ferriman-Gallwey hirsutism score, total testosterone, free testosterone, sex hormone-binding globulin, dihydroepiandrosterone sulfate (DHEAS), total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride, glucose and insulin during oral glucose tolerance test, and insulin sensitivity index; area under the curve for glucose and insulin were obtained from OGTT. RESULT(S): Body mass index, Ferriman-Gallwey hirsutism score, serum total testosterone, free testosterone, and DHEAS levels were significantly decreased and SHBG was significantly increased in all groups at the end of the study. WHR, diastolic blood pressure, and serum triglyceride level were significantly reduced only in the sibutramine group. CONCLUSION(S): Sibutramine might have a positive effect on hyperandrogenemia, and clinical and metabolic risk factors for cardiovascular disease in obese women with PCOS.