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Sibutramine

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581. A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.

A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects. A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects. - 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. A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects. 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

2005 Clinical Trials

582. A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients

A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients - 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. A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients (SCOUT) 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

2005 Clinical Trials

583. Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes

Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes - 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. Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes 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: NCT00433641 Recruitment Status : Completed First Posted : February 12, 2007 Last Update Posted : March 14, 2011 Sponsor: Mayo Clinic Collaborator: National

2007 Clinical Trials

584. A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder

A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder - 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. A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder 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: NCT00402584 Recruitment Status : Completed First Posted : November 22, 2006 Last

2006 Clinical Trials

585. Sibutramine may be associated with memory impairment (Full text)

Sibutramine may be associated with memory impairment 15576742 2004 12 17 2018 11 13 1756-1833 329 7478 2004 Dec 04 BMJ (Clinical research ed.) BMJ Sibutramine may be associated with memory impairment. 1316 Clark David W J DW Intensive Medicines Monitoring Programme (IMMP), New Zealand Pharmacovigilance Centre, Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand. Harrison-Woolrych Mira M eng Case Reports Journal Article Research Support, Non-U.S. Gov't England (...) BMJ 8900488 0959-8138 0 Appetite Depressants 0 Cyclobutanes WV5EC51866 sibutramine AIM IM Adult Appetite Depressants adverse effects Cyclobutanes adverse effects Female Humans Memory Disorders chemically induced 2004 12 4 9 0 2004 12 18 9 0 2004 12 4 9 0 ppublish 15576742 329/7478/1316 10.1136/bmj.329.7478.1316 PMC534840 Ann Pharmacother. 2003 Dec;37(12):1800-3 14632599 Ann Med. 2000 Apr;32(3):210-21 10821328

2004 BMJ : British Medical Journal PubMed abstract

586. The efficacy and safety of sibutramine for weight loss: a systematic review. (Full text)

The efficacy and safety of sibutramine for weight loss: a systematic review. The primary goal of weight loss is to prevent or reduce obesity-associated morbidity and mortality by improving cardiovascular and metabolic risk factors. We conducted a systematic review to assess the efficacy and safety of sibutramine hydrochloride for weight loss.In April 2002, we searched MEDLINE, EMBASE, the Cochrane Library, and 7 other computerized bibliographic search tools using the keywords "sibutramine (...) ," "Meridia," and "Reductil" (in all languages and all available years). The authors and the manufacturer were contacted. We reviewed randomized placebo-controlled trials of sibutramine, 10 to 20 mg/d, in obese adults. Methodological quality was assessed.A total of 29 trials had sufficient data for analysis after including unpublished data from 10 authors. The summary mean differences in weight loss, sibutramine minus placebo, for the 3-month and 1-year trials were -2.78 kg (95% confidence interval, -2.26

2004 Archives of internal medicine PubMed abstract

587. Effect of sibutramine on weight management and metabolic control in type 2 diabetes: a meta-analysis of clinical studies. (Full text)

Effect of sibutramine on weight management and metabolic control in type 2 diabetes: a meta-analysis of clinical studies. The aim of this study was to provide a comprehensive meta-analysis of randomized controlled clinical studies on the effects of sibutramine on weight loss and glycemic control in obese subjects with type 2 diabetes.Controlled clinical trials assessing the effect sizes of sibutramine on weight loss effects on glycemia in obese subjects with type 2 diabetes were identified (...) and reviewed using the Cochrane Library, Medline, EMBASE, and a manual search.Eight placebo-controlled, double-blind, randomized trials of sibutramine were included. After sibutramine treatment, the decrease in body weight and waist circumference was significantly greater than in the placebo group. Fasting blood glucose and HbA(1c) significantly decreased after sibutramine treatment. Treatment benefits were seen in plasma triglycerides and HDL, without significant variations in serum total and LDL

2005 Diabetes Care PubMed abstract

588. Effects of sibutramine plus verapamil sustained release/trandolapril combination on blood pressure and metabolic variables in obese hypertensive patients. (Abstract)

Effects of sibutramine plus verapamil sustained release/trandolapril combination on blood pressure and metabolic variables in obese hypertensive patients. The management of obese hypertensive subjects may require the administration of anti-obesity and antihypertensive drugs. Sibutramine use has raised concerns regarding a potential increase in subjects' blood pressure and heart rate. The primary end-points of this study were an evaluation of the effect of sibutramine together with a verapamil (...) sustained release/trandolapril combination tablet versus verapamil sustained release/trandolapril alone on the blood pressure and heart rate in obese hypertensive patients.Patients received a low-fat low-calorie diet and were randomly allocated to open-label verapamil sustained release/trandolapril 180/2 mg (n = 26) or sibutramine 10 mg together with verapamil sustained release/trandolapril 180/2 mg (n = 28) daily for 6 months.Significant reductions in the subjects' systolic blood pressure and diastolic

2008 Expert opinion on pharmacotherapy Controlled trial quality: uncertain

589. Sibutramine effect on metabolic control of obese patients with type 2 diabetes mellitus treated with pioglitazone. (Abstract)

Sibutramine effect on metabolic control of obese patients with type 2 diabetes mellitus treated with pioglitazone. Thiazolidinediones are supposed to be the pharmacologic agents that more physiologically fight the insulin resistance, but a possible adverse effect may be a weight increase. The aim of the study was to test the efficacy and tolerability of sibutramine on the metabolic effect of pioglitazone in obese patients with type 2 diabetes mellitus. All enrolled patients were required (...) to have been diagnosed as being diabetic for at least 6 months and did not have glycemic control with diet and oral hypoglycemic agents such as sulfonylureas or metformin, both to the maximum tolerated dose. After a run-in period in which the eligible patients took a fixed dose of pioglitazone (30 mg/d), the patients were randomized to receive also sibutramine (10 mg/d) or placebo for 6 months. We assessed body mass index, hemoglobin A(1c) (HbA(1c)), fasting plasma glucose (FPG), postprandial plasma

2008 Metabolism: clinical and experimental Controlled trial quality: uncertain

590. A controlled pharmacogenetic trial of sibutramine on weight loss and body composition in obese or overweight adults. (Full text)

A controlled pharmacogenetic trial of sibutramine on weight loss and body composition in obese or overweight adults. Weight loss in response to sibutramine is highly variable. We assessed the association of specific markers of polymorphisms of candidate alpha2A adrenoreceptor, 5-HT transporter, and GNbeta3 genes and weight loss with sibutramine.We conducted a randomized, double-blind, pharmacogenetic study of behavioral therapy and sibutramine (10 or 15 mg daily) or placebo for 12 weeks in 181 (...) candidate gene, significant treatment effects at 12 weeks were observed (P < .017) for all specific genotype variants (Delta weight loss in the 2 sibutramine doses vs placebo): alpha2A CC (Delta, approximately 5 kg), GNbeta3 TC/TT (Delta, approximately 6 kg), and 5-HTTLPR LS/SS (Delta, approximately 4.5 kg). Gene pairs resulted in significantly greater sibutramine treatment effects on weight (both P < .002): in participants with 5-HTTLPR LS/SS with GNbeta3 TC/TT; Delta, approximately 6 kg and those

2008 Gastroenterology Controlled trial quality: uncertain PubMed abstract

591. Prediction of response to sibutramine therapy in obese non-diabetic and diabetic patients. (Abstract)

Prediction of response to sibutramine therapy in obese non-diabetic and diabetic patients. Early weight loss is generally considered to predict long-term weight outcome in obese patients, and this is reflected in prescribing guidelines for antiobesity drugs. For example, the current prescribing guidelines for the antiobesity drug, sibutramine, indicate that if patients have not lost 2 kg (or 4 lb) in the first 4 weeks of treatment with sibutramine 10 mg, the physician should re-evaluate (...) the therapy, which may result in increasing the dose to 15 mg or discontinuation. This regimen may deny treatment to a large group of patients who might otherwise benefit, particularly patients with type 2 diabetes who often find it more difficult to lose weight than non-diabetic obese individuals.We have re-analysed pooled data from seven randomized, controlled studies of sibutramine-induced weight loss and maintenance in which patients (n = 928; 75% female) had taken sibutramine 10 or 15 mg continuously

2006 obesity & metabolism

592. Orlistat and sibutramine beyond weight loss. (Abstract)

Orlistat and sibutramine beyond weight loss. To investigate, through a meta-analysis of clinical trials, the effect of two weight-reducing drugs, such as orlistat and sibutramine, on serum lipid profiles in overweight and obese subjects, independently of weight loss.A systematic search strategy, incorporating the terms orlistat, sibutramine, fat, cholesterol, lipid profile, cardiovascular risk, was developed to identify randomized trials in MEDLINE from inception to the end of May 2005. Trial (...) selection was limited by language of publication (English) and duration (6-12 months).Fifteen and ten randomized, double-blind, placebo-controlled trials on orlistat and sibutramine respectively, were eligible for inclusion. In the 15 trials with orlistat, mean weight loss showed a significant correlation with mean reduction of total cholesterol (r=0.48; p<0.05), which maintained statistical significance after adjustment for mean weight loss (B=-2.81+/-1.28; p<0.05). Conversely, in the ten trials

2008 Nutrition, metabolism, and cardiovascular diseases : NMCD

593. Sibutramine improves insulin sensitivity without alteration of serum adiponectin in obese subjects with Type 2 diabetes. (Abstract)

Sibutramine improves insulin sensitivity without alteration of serum adiponectin in obese subjects with Type 2 diabetes. To evaluate the effect of sibutramine on weight loss, insulin sensitivity and serum adiponectin levels in obese patients with Type 2 diabetes.This study is a randomized, double-blind, placebo-controlled parallel comparison study of sibutramine 15 mg/day and placebo. Forty-eight eligible obese patients with Type 2 diabetes (age between 30 and 75 years with body mass index (...) > or = 27 kg/m(2)) were randomly assigned to receive either placebo (n = 24) or sibutramine (15 mg/day) (n = 24) for 6 months. Fifteen subjects in each group underwent meal tests and modified insulin suppression tests before and after 6 months' treatment.After 6 months of sibutramine treatment statistically significant changes from baseline were observed for body weight (85.4 +/- 2.5 vs. 82.9 +/- 2.4 kg, P < 0.005) and body mass index (32.0 +/- 0.7 vs. 31.4 +/- 0.6 kg/m(2), P < 0.05) without

2005 Diabetic medicine : a journal of the British Diabetic Association Controlled trial quality: uncertain

594. Use of sibutramine, an inhibitor of the reuptake of serotonin and noradrenaline, in the treatment of binge eating disorder: a placebo-controlled study. (Abstract)

Use of sibutramine, an inhibitor of the reuptake of serotonin and noradrenaline, in the treatment of binge eating disorder: a placebo-controlled study. Binge-eating disorder, which is characterized by repeated episodes of uncontrolled eating, is common in obese patients and is often accompanied by comorbid psychiatric disorders, especially depression. In previous studies, selective serotonin reuptake inhibitors have demonstrated efficacy in reducing the frequency of binge eating and addressing (...) comorbid psychiatric disorders, but they have not shown the ability to promote weight loss. Sibutramine, a new serotonin and norepinephrine reuptake inhibitor, has been shown in short- and long-term studies to be effective in promoting and maintaining weight loss in obese patients who have binge-eating disorder. In this randomized, double-blind, placebo-controlled study, the efficacy, safety, and tolerability of sibutramine were evaluated in the treatment of binge-eating disorder in obese patients

2005 Advances in therapy Controlled trial quality: predicted high

595. [Effects of sibutramine on blood glucose and lipids, body fat mass and insulin resistance in obese patients: a multi-center clinical trial]. (Abstract)

[Effects of sibutramine on blood glucose and lipids, body fat mass and insulin resistance in obese patients: a multi-center clinical trial]. To evaluate the effects of sibutramine on body weight, body fat mass, metabolism of plasma glucose and serum lipids, and insulin resistance (IR) in primary obesity patients.A double-blind, double-placebo, randomized controlled, multi-center clinical trial was conducted. 359 voluntary obese subjects, whose body mass index (BMI) > or = 27 kg/m(2), without (...) hypertension and diabetes, were enrolled. They were randomly divided into group A, B and C respectively. Sibutramine tablets or capsules were administered 10-20 mg/day for 24 weeks to the test groups and placebo to a control group. CT scan was used to measure the intra or subcutaneous-abdominal fat areas (IAFA, SAFA) at L(4)-L(5) level. Dual energy X-ray absorptiometry (DEXA) was used to measure total body fat mass (TBFM).315 subjects continued to be followed for 24 weeks. After opening the blind

2005 Zhonghua nei ke za zhi [Chinese journal of internal medicine] Controlled trial quality: uncertain

596. Long-term maintenance of weight loss with sibutramine in a GP setting following a specialist guided very-low-calorie diet: a double-blind, placebo-controlled, parallel group study. (Full text)

Long-term maintenance of weight loss with sibutramine in a GP setting following a specialist guided very-low-calorie diet: a double-blind, placebo-controlled, parallel group study. Very-low-calorie diets (VLCDs) are used to promote short-term weight loss in obese patients. However, long-term maintenance of weight loss is generally poor. We assessed the efficacy and safety of sibutramine in maintaining weight loss achieved in obese patients by means of a 3-month VLCD.A multicenter double-blind (...) to sibutramine 10 mg/day (n=94) or matching placebo (n=95). All patients received a recommended diet and exercise program. The primary analysis was outcome in terms of achieving 80% weight maintenance of the VLCD period at month 18. Secondary analysis was percentage of initial weight loss maintained at months 6, 12, 18 and end point.At month 18, the odds ratio for achieving successful weight maintenance was 1.76 (95% CI 1.06, 2.93) in favor of sibutramine (P=0.03). In intention-to-treat analysis, more than

2005 European journal of clinical nutrition Controlled trial quality: predicted high PubMed abstract

597. Effects of sibutramine-induced weight loss on cardiovascular system in obese subjects. (Abstract)

Effects of sibutramine-induced weight loss on cardiovascular system in obese subjects. To assess efficacy of sibutramine in obese subjects, and influence on hemodynamics, valve function and left ventricular (LV) geometry and performance.Three-month double-blind, parallel groups, randomized, placebo-controlled of 15 mg o.i.d. sibutramine administration combined with diet. Twenty-five to 65 year-old males or postmenopausal females, were enrolled if their BMI was between 30 and 40 kg/m(2), without (...) evidence of concomitant diseases. Body weight, BMI, blood pressure (BP), echocardiographic LV mass, cardiac output, and diastolic function were measured. Body weight and BMI were better reduced with sibutramine (weight loss of 5% or more in 9 of 11 patients) than placebo group (weight loss of 5% or more in 5 of 9 patients; all p<0.05). Systolic and diastolic BP decreased similarly in both arms. No difference in mean heart rate was detected between treatments. The two groups had slightly different LV

2005 Nutrition, metabolism, and cardiovascular diseases : NMCD Controlled trial quality: uncertain

598. A double-blind, placebo-controlled trial of sibutramine for olanzapine-associated weight gain. (Abstract)

A double-blind, placebo-controlled trial of sibutramine for olanzapine-associated weight gain. Weight gain is commonly observed with olanzapine treatment and can increase the risk for obesity, cardiovascular disease, hypertension, and diabetes mellitus. This study examined the effectiveness of sibutramine, an approved weight loss agent, in overweight and obese subjects taking olanzapine for schizophrenia or schizoaffective disorder.Each subject had a DSM-IV diagnosis of schizophrenia (...) or schizoaffective disorder, had been taking a stable dose of olanzapine for at least 4 months, and had a body mass index of >/=30 kg/m(2) or >/=27 kg/m(2) plus at least one cardiovascular risk factor. In a 12-week double-blind, randomized, placebo-controlled study, 37 subjects received placebo or sibutramine (up to 15 mg/day). For the first 8 weeks all subjects participated in weekly group sessions focused on nutrition and behavioral modification.The sibutramine and placebo groups had no significant baseline

2005 American Journal of Psychiatry Controlled trial quality: uncertain

599. Cost-effectiveness of sibutramine in the LOSE Weight Study: evaluating the role of pharmacologic weight-loss therapy within a weight management program. (Full text)

Cost-effectiveness of sibutramine in the LOSE Weight Study: evaluating the role of pharmacologic weight-loss therapy within a weight management program. the cost-effectiveness of drug therapy when used in conjunction with a weight management program (WMP) for treatment of obesity. The objective was to compare the cost-effectiveness of sibutramine (Meridia) plus a structured WMP versus only a structured WMP in both overweight and obese individuals. The core WMP was a physician-supervised (...) , multidisciplinary program for which each enrollee paid $100 out of pocket.A cost-effectiveness analysis was performed based upon the results of a previously published randomized controlled trial conducted within a managed care organization. The target population for this study was obese or overweight persons. The perspective of the study was that of a managed care organization. The intervention consisted of subjects receiving a WMP with or without sibutramine. The primary outcomes of this study were

2005 Journal of managed care pharmacy : JMCP Controlled trial quality: uncertain PubMed abstract

600. Effects of sibutramine in overweight, poorly controlled Chinese female type 2 diabetic patients: a randomised, double-blind, placebo-controlled study. (Abstract)

Effects of sibutramine in overweight, poorly controlled Chinese female type 2 diabetic patients: a randomised, double-blind, placebo-controlled study. To assess the efficacy of sibutramine 15 mg once daily as weight reduction in overweight and obese (body mass index > 25 kg/m2) Chinese female type 2 diabetic patients and to evaluate the influence of weight loss on diabetic control, a randomised, double-blind, placebo-control, 12-week study was conducted. Chinese female type 2 diabetic patients (...) , poorly controlled glucose levels and HbA(1C) > 8% were randomly assigned to two groups. In addition to their hypoglycaemic agents (maximal doses of sulphonylureas and metformin), one group (n = 30) received a sibutramine 15 mg once daily for 12 weeks, and the other (n = 30) received placebo for the same period. Comparing the changes that occurred after 12 weeks in the sibutramine and placebo groups, the former showed significantly greater reduction in body weight (2.5 vs. 0.1 kg, p < 0.05), fasting

2005 International journal of clinical practice Controlled trial quality: uncertain

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