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Sibutramine

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661. Efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by beta-adrenergic blocking agents: a placebo-controlled, double-blind, randomised trial. Full Text available with Trip Pro

Efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by beta-adrenergic blocking agents: a placebo-controlled, double-blind, randomised trial. Sibutramine is a serotonin-noradrenaline reuptake inhibitor that is effective for long-term weight reduction and maintenance in obese patients when used as an adjunct to dietary and behavioural measures. Because the inhibition of noradrenaline reuptake may be expected to increase systolic and diastolic (...) blood pressure (SBP and DBP) and pulse rate (PR), a 12-week multi-centre, placebo-controlled, double-blind study was designed to evaluate the efficacy and tolerability of sibutramine for weight loss in obese patients whose hypertension was well controlled (DBP < or = 95 mm Hg) by beta-adrenergic blocking agents (beta-blockers), with or without concomitant thiazide diuretics. Of the 61 patients randomised to sibutramine 20 mg once daily or placebo, 55 patients (90%) completed the study. After 12

2002 Journal of human hypertension Controlled trial quality: uncertain

662. Effects of sibutramine on the treatment of obesity in patients with arterial hypertension. (Abstract)

Effects of sibutramine on the treatment of obesity in patients with arterial hypertension. To assess the effects of weight reduction with 10mg of sibutramine or placebo on blood pressure during 24 hours (ambulatory blood pressure monitoring), on left ventricular mass, and on antihypertensive therapy in 86 obese and hypertensive patients for 6 months.The patients underwent echocardiography, ambulatory blood pressure monitoring, and measurement of the levels of hepatic enzymes prior to and after (...) treatment with sibutramine or placebo.The group using sibutramine had a greater weight loss than that using placebo (6.7% versus 2.5%; p<0.001), an increase in heart rate (78.3 +/- 7.3 to 82 +/- 7.9 bpm; p=0.02), and a reduction in the left ventricular mass/height index (105 +/- 29.3 versus 96.6 +/- 28.58 g/m; p=0.002). Both groups showed similar increases in the levels of alkaline phosphatase and comparable adjustments in antihypertensive therapy; blood pressure, however, did not change.The use

2002 Arquivos brasileiros de cardiologia Controlled trial quality: uncertain

663. Pharmacokinetics of sibutramine hydrochloride in Chinese healthy volunteers. (Abstract)

Pharmacokinetics of sibutramine hydrochloride in Chinese healthy volunteers. To evaluate the pharmacokinetic profiles of the pharmacologically active primary amine metabolite of sibutramine, N-di-desmethyl sibutramine (BTS 54505) in Chinese origin.According to a randomized cross-over design, a single oral dose of 20 mg of sibutramine hydrochloride capsule was given to 20 healthy Chinese young volunteers. After dosing, serial blood samples were collected for a period of 72 h. BTS 54505 (...) concentration in plasma was analyzed by high-performance liquid chromatography-electrospray ionization-tandem mass spectrometry.Various pharmacokinetic parameters including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2, Kelm and MRT were determined for both test and reference capsules and found to be in good agreement with literature values.The test and reference sibutramine capsules were bioequivalent.

2003 Yao xue xue bao = Acta pharmaceutica Sinica Controlled trial quality: uncertain

664. A randomized, double-blind, placebo-controlled study of sibutramine in the treatment of binge-eating disorder. Full Text available with Trip Pro

A randomized, double-blind, placebo-controlled study of sibutramine in the treatment of binge-eating disorder. Although antidepressants are the pharmacological agents most often studied in the treatment of binge-eating disorder (BED), preliminary evidence from an open trial suggests that the antiobesity agent sibutramine hydrochloride may be effective. The objective of this study was to evaluate the efficacy and tolerability of sibutramine in obese patients with BED.After a 2-week run-in period (...) , 60 obese outpatients (body mass index [calculated as weight in kilograms divided by the square of height in meters] 30-45), who met DSM-IV criteria for BED were randomly assigned to receive sibutramine hydrochloride (n = 30), 15 mg/d, or placebo (n = 30) in a 12-week double-blind study at 2 centers. The primary outcome measure was binge frequency, expressed as the number of days with binge-eating episodes during the past week. Secondary outcome measures included Binge Eating Scale, Beck

2003 Archives of general psychiatry Controlled trial quality: predicted high

665. Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome. (Abstract)

Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome. 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).Prospective randomized, controlled study.Endocrinology and gynecology clinics.Forty obese women with PCOS.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.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

2003 Fertility and sterility Controlled trial quality: uncertain

666. Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine. (Abstract)

Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine. Very-low-calorie diets are a well established method to achieve substantial short-term weight loss in obese patients, but long-term maintenance of the weight loss is very disappointing. A combined very-low-calorie diet and pharmacologic approach could be an effective means of prolonging its benefits.Eligible patients had a body-mass index greater than (...) 30 kg/m2; those who lost 6 kg or more during a 4-week treatment with a very-low-calorie diet were randomly assigned to 1 year of treatment with sibutramine (10 mg) or identical placebo.In an intention-to-treat analysis, mean (+/-SD) absolute weight change at 1 year (or study endpoint) was -5.2 (+/-7.5) kg in the 81 patients in the sibutramine group and +0.5 (+/-5.7) kg in the 78 patients in the placebo group (P = 0.004). When compared with their weight at study entry (before the very-low-calorie

1999 The American journal of medicine Controlled trial quality: uncertain

667. [Serum leptin and insulin resistance in obesity and effects of sibutramine on them]. (Abstract)

[Serum leptin and insulin resistance in obesity and effects of sibutramine on them]. To assess the relationship between serum leptin and insulin resistance (IR) in obesity, and to investigate the effects of sibutramine on obesity, serum leptin and IR.Seventy obese subjects [body mass index (BMI) > or =25 kg/m2] were randomly divided into 2 groups: group B (sibutramine 10 mg/day) and group C (a placebo tablet/day). Both had been treated for 12 weeks. Another 30 healthy adults served (...) with sibutramine in group B (P < 0.01), but those indexes did not change after the treatment with placebo in group C (P > 0.05). The levels of leptin and FINS were higher (P < 0.01), but ISI was lower (P < 0.01) both in group B and C compared with those in group A at the baseline. The levels of serum leptin and FINS decreased (P < 0.01), and ISI increased significantly (P < 0.05) after the treatment with sibutramine in group B, while those indexes did not change after the treatment with placebo in group C

2003 Hunan yi ke da xue xue bao = Hunan yike daxue xuebao = Bulletin of Hunan Medical University Controlled trial quality: uncertain

668. Effects of sibutramine on body weight and serum lipids: a double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia. Full Text available with Trip Pro

Effects of sibutramine on body weight and serum lipids: a double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia. Cardiovascular risk factors associated with obesity, including dyslipidemia, can be improved by weight loss. The main dyslipidemia associated with obesity is elevated serum triglyceride and decreased serum high-density lipoprotein cholesterol (HDL-C) levels.A total of 322 obese patients (body mass index > or = 27) with serum (...) triglyceride levels > or = 250 mg/dL and < or = 1000 mg/dL and serum HDL-C levels < or = 45 mg/dL (women) and < or = 40 mg/dL (men) were placed on a step I American Heart Association diet and subsequently randomized to sibutramine 20 mg (n = 162) or placebo (n = 160) once daily for 24 weeks.Patients taking sibutramine had significantly greater mean weight loss than those receiving placebo (-4.9 kg vs -0.6 kg, P < or = .05). Forty-two percent of the sibutramine group lost > or = 5% of baseline weight and 12

2001 American heart journal Controlled trial quality: uncertain

669. Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. (Abstract)

Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity. The researchers assessed the long-term weight reduction efficacy, tolerability, and safety of sibutramine used once daily in conjunction with behavior modification to treat mild to moderate obesity.This was a double-blind randomized placebo-controlled parallel-group comparative study of sibutramine 10 mg or 15 mg (or placebo) once daily for 1 year, given with dietary advice.A total of 485 (...) obese men and women with uncomplicated obesity were included (mean age=42 years, mean body mass index=32.7 kg/m2).The outcomes were mean weight loss, percentage losing more than 5% or 10% of their body weight, and adverse drug effects.Among patients completing the study, those taking sibutramine 10 mg or 15 mg had greater mean weight loss compared with placebo at 12-month assessment (P < or = .001). Changes in body weight from baseline to end point were -1.6 kg for those taking placebo, -4.4 kg

2001 Journal of Family Practice Controlled trial quality: predicted high

670. [The effect of sibutramine for the maintenance of weight loss. A randomized controlled clinical trial]. (Abstract)

[The effect of sibutramine for the maintenance of weight loss. A randomized controlled clinical trial]. Sibutramine is a tertiary amine that has been shown to induce dose-dependent weight loss and enhance the effects of a low-calorie diet for up to a year. We did a randomised, double-blind trial to assess the usefulness of sibutramine in maintaining substantial weight loss over 18 months.Eight European centres recruited 605 obese patients (BMI 30-45 kg/m2) for a 6-month period of weight loss (...) with sibutramine (10 mg/day) in combination with an individualised dietary deficit programme of 600 kcal/day based on the measured resting rates of energy expenditure. Of these 605, 467 (77%) patients with more than a 5% weight loss were then randomly assigned to 10 mg/day sibutramine (n = 352) or placebo (n = 115) for a further 18 months. Sibutramine was increased up to 20 mg/day if a weight regain occurred.One hundred and forty-eight (42%) subjects in the sibutramine group and 58 (50%) in the placebo group

2001 Ugeskrift for laeger Controlled trial quality: predicted high

671. Effect of moderate weight loss on health-related quality of life: an analysis of combined data from 4 randomized trials of sibutramine vs placebo. (Abstract)

Effect of moderate weight loss on health-related quality of life: an analysis of combined data from 4 randomized trials of sibutramine vs placebo. To determine whether (1) patients who experience greater weight loss also experience correspondingly greater improvements in health-related quality of life (HRQOL); (2) the improvement in HRQOL is noticeable for patients achieving moderate (5%-10%) weight reduction; and (3) the relationship between weight reduction and HRQOL is similar for patients (...) receiving sibutramine hydrochloride vs placebo.We combined data from 4 double-blind, randomized, controlled trials of administration of sibutramine (20 mg/d) vs placebo.Patients (n = 555) were mildly to moderately obese and had type 2 diabetes mellitus, dyslipidemia, or hypertension that was well controlled with an angiotensin-converting enzyme inhibitor or calcium channel blocker. The HRQOL was operationalized using the Impact of Weight on Quality of Life (IWQOL) and the Medical Outcomes Study 36

2001 The American journal of managed care

672. Effects of sibutramine in obese female subjects with type 2 diabetes and poor blood glucose control. (Abstract)

Effects of sibutramine in obese female subjects with type 2 diabetes and poor blood glucose control. In this study, we evaluated the efficacy of sibutramine in combination with hypoglycemic drugs in obese type 2 diabetic women whose glucose levels were poorly regulated.Female patients with type 2 diabetes, poorly controlled glucose levels, and HbA(1c) >8% were randomly assigned to one of two groups. In addition to their prescribed hypoglycemic agents (maximum doses of sulfonylureas (...) and metformin), one group (n = 30) received a placebo twice daily for 6 months and the other (n = 30) received sibutramine 10 mg b.i.d. for the same period.One patient in the sibutramine group was excluded during the study period because of hypertension; thus, a total of 29 data sets were analyzed for this group. In the placebo group, five patients had to be excluded because of low treatment efficacy, leaving a total of 25 who completed the study. Comparing the changes that occurred over 6 months

2001 Diabetes Care Controlled trial quality: uncertain

673. Paradoxical effect of sibutramine on autonomic cardiovascular regulation in obese hypertensive patients--sibutramine and blood pressure. (Abstract)

Paradoxical effect of sibutramine on autonomic cardiovascular regulation in obese hypertensive patients--sibutramine and blood pressure. Sibutramine, a serotonin and norepinephrine transporter blocker, is a common adjunctive obesity treatment. Acute studies in healthy subjects suggested that an inhibitory central nervous mechanism might attenuate the peripheral stimulatory effect on the sympathetic nervous system. This notion has not been tested in overweight and obese patients.We conducted (...) a randomized, controlled clinical study in hypertensive patients with BMI > or = 27 to < 40 kg/m(2). After 4 week placebo run-in period patients were randomized to four different antihypertensive treatments or placebo. After 4 weeks of antihypertensive therapy, patients were additionally treated with sibutramine 15 mg o. d. for 3 months. Patients underwent cardiovascular autonomic reflex testing and a graded head-up tilt test at the end of each phase.Mean body weight decreased from 98.5+/-4 to 94.7+/-4 kg

2005 Clinical autonomic research : official journal of the Clinical Autonomic Research Society Controlled trial quality: uncertain

674. Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial. (Abstract)

Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial. Uncertainties about the cardiovascular safety of sibutramine led to the SCOUT trial that is investigating sibutramine plus weight management in high-risk, overweight/obese patients. A 6-week lead-in period during which all patients received sibutramine permitted an initial assessment (...) of tolerability. A total of 10,742 patients received sibutramine and 3.1% of these discontinued due to an adverse event; issues affecting more than 10 patients were drug intolerance, headache, insomnia, nausea, dry mouth, and constipation-, tachycardia-, and hypertension-related events. Serious adverse events, most commonly associated with the System Organ Class, Cardiac disorders, were reported by 2.7% of patients; however, the majority was not considered sibutramine-related. Adverse events relating to high

2008 Journal of cardiovascular pharmacology Controlled trial quality: uncertain

675. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance. (Abstract)

Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance. Sibutramine is a tertiary amine that has been shown to induce dose-dependent weight loss and to enhance the effects of a low-calorie diet for up to a year. We did a randomised, double-blind trial to assess the usefulness of sibutramine in maintaining substantial weight loss over 2 years.Eight European centres recruited 605 obese patients (...) (body-mass index 30-45 kg/m2) for a 6-month period of weight loss with sibutramine (10 mg/day) and an individualised 600 kcal/day deficit programme based on measured resting metabolic rates. 467 (77%) patients with more than 5% weight loss were then randomly assigned 10 mg/day sibutramine (n=352) or placebo (n=115) for a further 18 months. Sibutramine was increased up to 20 mg/day if weight regain occurred. The primary outcome measure was the number of patients at year 2 maintaining at least 80

2001 Lancet Controlled trial quality: predicted high

676. Effects of sibutramine plus orlistat in obese women following 1 year of treatment by sibutramine alone: a placebo-controlled trial. (Abstract)

Effects of sibutramine plus orlistat in obese women following 1 year of treatment by sibutramine alone: a placebo-controlled trial. This study assessed whether adding orlistat to sibutramine would induce further weight loss in patients who previously had lost weight while taking sibutramine alone.Patients were 34 women with a mean age of 44.1 +/- 10.4 years, weight of 89.4 +/- 13.8 kg, and body mass index (BMI) of 33.9 +/- 4.9 kg/m2 who had lost an average of 11.6 +/- 9.2% of initial weight (...) during the prior 1 year of treatment by sibutramine combined with lifestyle modification. Patients were randomly assigned, in double-blind fashion, to sibutramine plus orlistat or sibutramine plus placebo. In addition to medication, participants were provided five brief lifestyle modification visits during the 16-week continuation trial.Mean body weight did not change significantly in either treatment condition during the 16 weeks. The addition of orlistat to sibutramine did not induce further weight

2000 Obesity research Controlled trial quality: predicted high

677. Predictors of weight loss and maintenance during 2 years of treatment by sibutramine in obesity. Results from the European multi-centre STORM trial. Sibutramine Trial of Obesity Reduction and Maintenance. (Abstract)

Predictors of weight loss and maintenance during 2 years of treatment by sibutramine in obesity. Results from the European multi-centre STORM trial. Sibutramine Trial of Obesity Reduction and Maintenance. In this report we assess pre-treatment determinants of weight loss and maintenance outcome in The Sibutramine Trial of Obesity Reduction and Maintenance (STORM), a 2 y randomized, double-blind, placebo-controlled, European multicenter study examining the effect of sibutramine (Sib) on inducing

2001 International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity Controlled trial quality: uncertain

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