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42. Clinical Practice Guideline for the Behavioral Treatment of Obesity and Overweight in Children and Adolescents

favoring behavioral interven- tion. Two medications used as adjunctive therapy to behaviorally based interven- tions found small (orlistat) or moderate (sibutramine) improvements in weight status in adolescents who had obesity and only when on active medication. Based on the results of the review, the USPSTF rec- ommended that clinicians screen children aged 6 to 18 years for obesity and offer or refer these children to intensive counseling and behavioral interventions to promote improvements in weight

2018 American Psychological Association

43. Migraine: Drugs for acute migraine

triptans — manufacturer advises waiting at least 24 hours following the use of one triptan before changing to an alternative triptan. Triptans should be used with caution in people taking selective serotonin reuptake inhibitors (SSRIs), selective noradrenaline reuptake inhibitors (SNRIs), lithium, sibutramine, ondansetron or St John's wort (because of the small risk of serotonin syndrome). The maximum dose of rizatriptan in people who are also taking propranolol should be 5 mg due to the risk

2018 NICE Clinical Knowledge Summaries

44. Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutrition

adolescents. Pharmacotherapy: most studies were small and of short duration, the notable exceptions being two large RCTs of sibutramine and orlistat. Sibutramine led to a mean estimated change in BMI from baseline of –3.1 kg/m 2 versus –0.3 kg/m 2 for placebo over 12 months. Orlistat was also beneficial, with a mean change in BMI of –0.55 kg/m 2 versus a change of +0.31 kg/m 2 in the placebo group at 12 months. Bariatric surgery: most papers presented clinical observations and there were no RCTs. Robust

2017 World Health Organisation Guidelines

45. Obesity in Adolescents

agents in the management of obesity in adolescents. Medical therapies are most often employed for adolescents who have not responded to lifestyle changes or for those with medical comorbidities. Only tetrahydrolipstatin is approved by the U.S. Food and Drug Administration for use in adolescents and it is considered the first-line adjunct to behavioral interventions ( ). Sibutramine was voluntarily withdrawn from the market in 2010 because of cardiovascular concerns (82). Tetrahydrolipstatin

2017 American College of Obstetricians and Gynecologists

47. Drug interventions for the treatment of obesity in children and adolescents. Full Text available with Trip Pro

), sibutramine (six trials), orlistat (four trials), and one trial arm investigated the combination of metformin and fluoxetine. The ongoing trials evaluated metformin (four trials), topiramate (two trials) and exenatide (two trials). A total of 2484 people participated in the included trials, 1478 participants were randomised to drug intervention and 904 to comparator groups (91 participants took part in two cross-over trials; 11 participants not specified). Eighteen trials used a placebo in the comparator (...) split by drug type, sibutramine, metformin and orlistat all showed reductions in BMI in favour of the intervention.Intervention versus comparator for change in weight showed a MD of -3.9 kg (95% CI -5.9 to -1.9; P < 0.00001; 11 trials; 1180 participants; low certainty evidence). As with BMI, when the trials were split by drug type, sibutramine, metformin and orlistat all showed reductions in weight in favour of the intervention.Five trials reported serious adverse events: 24/878 (2.7%) participants

2016 Cochrane

48. Naltrexone + bupropion (Mysimba°): too risky for only modest weight loss

. Sibutramine: cardiovascular events Prescrire Int 2010; 19 (107): 125. Obesity: weight loss without drugs Prescrire Int 2007; 16 (90): 162-167. | | | Prescrire Your change of address has been received and will be processed promptly but will not appear instantaneously Prescrire Your message has been sent

2015 Prescrire

49. Outcomes with Intra-gastric Balloon Therapy in BMI &lt; 35 Non-morbid Obesity: 10-Year Follow-Up Study of an RCT. (Abstract)

measurement as early outcomes (up to 2 years) and 10-year follow-up. Primary outcomes were total body weight loss (kg) and BMI. Secondary outcomes were new-onset diabetes mellitus, other new comorbidities, and willingness for further intervention.Initial RCT recruited 99 patients (50 IGB vs 49 sibutramine group). Forty-nine patients (26 IGB vs 23 control group) participated in a 10-year review (follow-up rate of 51.6%). Total body weight loss at 6 (9.75 vs 7.48 kg, p = 0.03), 12 (6.52 vs 4.42 kg, p = 0.05

2020 Obesity Surgery

50. Studying the Effects of Sibutramine on Eating Behavior

Studying the Effects of Sibutramine on Eating Behavior Studying the Effects of Sibutramine on Eating Behavior - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Studying the Effects of Sibutramine on Eating (...) Behavior The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01170364 Recruitment Status : Terminated (Terminated due to sibutramine being withdrawn from the market.) First Posted : July 27, 2010 Results First Posted : July 31, 2017 Last Update Posted : August 30, 2017 Sponsor: New York State Psychiatric

2010 Clinical Trials

51. Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01184560 Recruitment Status : Completed First Posted : August 19, 2010 Last Update Posted : August 19, 2010 Sponsor: Gachon University

2010 Clinical Trials

52. Sibutramine should be excluded from use in obese patients with preexisting cardiovascular disease Full Text available with Trip Pro

Sibutramine should be excluded from use in obese patients with preexisting cardiovascular disease 21977163 2011 11 10 2011 10 06 2069-6116 5 3 2010 Jul Maedica Maedica (Buchar) Sibutramine should be excluded from use in obese patients with preexisting cardiovascular disease. 229-30 Constantinescu Maria Cristina MC Cardiology Department, Emergency University Hospital, Bucharest, Romania. eng Journal Article Romania Maedica (Buchar) 101526930 1841-9038 2011 10 7 6 0 2010 7 1 0 0 2010 7 1 0 1

2010 Mædica

53. The effects of sibutramine on the microstructure of eating behaviour and energy expenditure in obese women. Full Text available with Trip Pro

The effects of sibutramine on the microstructure of eating behaviour and energy expenditure in obese women. Given the suggestion that many potential anti-obesity drugs may enhance within-meal satiation, few studies have directly measured the effects of any drug on the microstructure of human eating behaviour. The effects of 7 days dosing with sibutramine 10 mg and 15 mg a day on appetite and energy balance were determined in 30 obese women (BMI 34.6 +/- 3.3 kg/m2, age 46.0 +/- 12.9 years) using (...) a Universal Eating Monitor (UEM) and indirect calorimetry, in a double-blind, placebo-controlled crossover study. At day 7, sibutramine 10 mg and 15 mg reduced food intake by 16.6% and 22.3%, respectively (p < 0.001), compared with placebo. Sibutramine reduced eating rate compared with placebo rather than meal length (10 mg p < 0.05; 15 mg p < 0.001). In addition, sibutramine 10 mg significantly reduced hunger later in the meal (p < 0.05) and sibutramine 15 mg increased fullness early in the meal (p

2010 Journal of psychopharmacology (Oxford, England) Controlled trial quality: uncertain

54. Cardiac valve evaluation and adipokine levels in obese women treated with sibutramine. Full Text available with Trip Pro

Cardiac valve evaluation and adipokine levels in obese women treated with sibutramine. The aims of present study were 1) to evaluate cardiac valve characteristics, 2) to determine the plasma concentrations of fibrinogen, high sensitivity C-reactive protein (hsCRP), adiponectin, and tumor necrosis factor-alpha (TNF-alpha) in the obese women before and after 19 months sibutramine treatment in the obese women.Sixty obese women were enrolled in this prospective, randomized study. Thirty women (...) received 10 mg once daily dose of sibutramine for 19 months. The rest of the obese women received 15 mg once daily dose of sibutramine for 19 months. All patients were evaluated with echocardiography. Plasma levels of adiponectin and TNF-alpha were measured by enzyme-linked immunosorbent assay (ELISA) and hsCRP by immunoturbimetric assay. Student paired and unpaired t tests were used to compare the 10 mg or 15 mg dose sibutramine effects either in groups or between the groups.There were no signs

2010 Anadolu kardiyoloji dergisi : AKD = the Anatolian journal of cardiology Controlled trial quality: uncertain

55. Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period. (Abstract)

Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period. The Sibutramine Cardiovascular Outcomes (SCOUT) trial protocol defines a patient population predominantly outside current European Union label criteria. This article explores responses to sibutramine during the 6-week, single-blind, lead-in period between patients who conformed to the label requirements ("conformers") and those who did not ("nonconformers"). SCOUT (...) is an ongoing, randomized, double-blind, placebo-controlled outcome trial in overweight/obese patients at high risk of a cardiovascular event. In total, 10,742 patients received sibutramine and weight management during the lead-in period. Initial responses were assessed post hoc in label conformers and nonconformers. Of that 8.1% patients met label criteria; 91.9%, the majority with cardiovascular disease and/or blood pressure >145/90 mm Hg, were nonconformers. Conformers and nonconformers had similar

2010 Obesity Controlled trial quality: predicted high

56. Brain serotonin transporter occupancy by oral sibutramine dosed to steady state: a PET study using (11)C-DASB in healthy humans. Full Text available with Trip Pro

Brain serotonin transporter occupancy by oral sibutramine dosed to steady state: a PET study using (11)C-DASB in healthy humans. Sibutramine is a centrally acting monoamine reuptake inhibitor prescribed as an appetite suppressant in the management of obesity. Its effects are mostly attributable to serotonin and norepinephrine transporter (SERT and NET, respectively) inhibition by its potent metabolites mono-desmethylsibutramine (M1) and di-desmethylsibutramine (M2). However, there is a paucity (...) of in vivo data in humans about mechanisms underlying both clinical efficacy and the dose-independent non-response observed in a minority of patients. Twelve healthy male patients (mean age 41 years) completed a double-blind, placebo-controlled, within-subject crossover investigation of brain SERT occupancy by sibutramine 15 mg daily at steady state. Correlations were measured between occupancy and (i) plasma concentrations of sibutramine, M1 and M2; (ii) appetite suppression. (11)C-DASB PET scans were

2010 Neuropsychopharmacology Controlled trial quality: uncertain

57. No compelling evidence that sibutramine prolongs life in rodents despite providing a dose-dependent reduction in body weight. Full Text available with Trip Pro

No compelling evidence that sibutramine prolongs life in rodents despite providing a dose-dependent reduction in body weight. The health and longevity effects of body weight reduction resulting from exercise and caloric restriction in rodents are well known, but less is known about whether similar effects occur with weight reduction from the use of a pharmaceutical agent such as sibutramine, a serotonin-norepinephrine reuptake inhibitor.Using data from a 2-year toxicology study of sibutramine

2010 International Journal of Obesity

58. Effects of one year treatment of sibutramine on insulin resistance parameters in type 2 diabetic patients. (Abstract)

Effects of one year treatment of sibutramine on insulin resistance parameters in type 2 diabetic patients. Comparison of the effects of one year treatment with sibutramine compared to placebo on insulin resistance parameters, body weight, glycemic control, and lipid profile, in type 2 diabetic patients.Two hundred and forty-six patients with uncontrolled type 2 diabetes mellitus in therapy with different oral hypoglycemic agents or insulin were enrolled in this study and randomised to take (...) sibutramine 10 mg or placebo for one year. We evaluated at baseline, and after 3, 6, 9, and 12 months these parameters: homeostasis model assessment insulin resistance index (HOMA-IR), retinol binding protein-4 (RBP-4), resistin, visfatin, and high sensitivity-C reactive protein (Hs-CRP), body weight, body mass index (BMI), glycated hemoglobin (HbA(₁c)), fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), fasting plasma insulin (FPI), total cholesterol (TC), low density lipoprotein

2010 Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Société canadienne des sciences pharmaceutiques Controlled trial quality: uncertain

59. Distinct modulatory effects of satiety and sibutramine on brain responses to food images in humans: a double dissociation across hypothalamus, amygdala, and ventral striatum. Full Text available with Trip Pro

Distinct modulatory effects of satiety and sibutramine on brain responses to food images in humans: a double dissociation across hypothalamus, amygdala, and ventral striatum. We used functional magnetic resonance imaging to explore brain responses to food images in overweight humans, examining independently the impact of a prescan meal ("satiety") and the anti-obesity drug sibutramine, a serotonin and noradrenaline reuptake inhibitor. We identified significantly different responses (...) to these manipulations in amygdala, hypothalamus, and ventral striatum. Each region was specifically responsive to high-calorie compared to low-calorie food images. However, the ventral striatal response was attenuated by satiety (but unaffected by sibutramine), while the hypothalamic and amygdala responses were attenuated by drug but unaffected by satiety. Direct assessment of regional interactions confirmed the significance of this double dissociation. We explored the regional responses in greater detail

2010 The Journal of neuroscience : the official journal of the Society for Neuroscience Controlled trial quality: uncertain

60. Enhanced weight loss following coadministration of pramlintide with sibutramine or phentermine in a multicenter trial. (Abstract)

Enhanced weight loss following coadministration of pramlintide with sibutramine or phentermine in a multicenter trial. Preclinical evidence suggests that pharmacotherapy for obesity using combinations of agents targeted at distinct regulatory pathways may produce robust additive or synergistic effects on weight loss. This randomized placebo-controlled trial examined the safety and efficacy of the amylin analogue pramlintide alone or in combination with either phentermine or sibutramine. All (...) patients also received lifestyle intervention. Following a 1-week placebo lead-in, 244 obese or overweight, nondiabetic subjects (88% female; 41 +/- 11 years; BMI 37.7 +/- 5.4 kg/m(2); weight 103 +/- 19 kg; mean +/- s.d.) received placebo subcutaneously (sc) t.i.d., pramlintide sc (120 microg t.i.d.), pramlintide sc (120 microg t.i.d.) + oral sibutramine (10 mg q.a.m.), or pramlintide sc (120 microg t.i.d.) + oral phentermine (37.5 mg q.a.m.) for 24 weeks. Treatment was single-blind for subjects

2010 Obesity Controlled trial quality: uncertain

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