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Sibutramine

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641. Influence of sibutramine on energy expenditure in African American women. Full Text available with Trip Pro

Influence of sibutramine on energy expenditure in African American women. African American women have a high prevalence of obesity, which partially may be explained by their lower rates of resting energy expenditure (REE). The aim of this study was to examine the influence of acute sibutramine administration on REE and post-exercise energy expenditure in African American women.A total of 15 premenopausal, African American women (age, 29 +/- 5 years; body fat, 38 +/- 7%) completed a randomized (...) , double-blind cross-over design with a 30-mg ingestion of sibutramine or a placebo. Each trial was completed a month apart in the follicular phase and included a 30-minute measurement of REE 2.5 hours after sibutramine or placebo administration. This was followed by 40 minutes of cycling at approximately 70% of peak aerobic capacity and a subsequent 2-hour measurement of post-cycling energy expenditure.There was no difference (p > 0.05) in REE (23.70 +/- 2.81 vs. 23.69 +/- 2.95 kcal/30 min), exercise

2001 Obesity research Controlled trial quality: uncertain

642. Randomized, double-blind, placebo-controlled, multicenter study of sibutramine in obese hypertensive patients. (Abstract)

Randomized, double-blind, placebo-controlled, multicenter study of sibutramine in obese hypertensive patients. To compare weight loss efficacy, safety and tolerability of sibutramine and placebo in mildly to moderately obese hypertensive subjects; to assess the effect of weight loss on blood pressure.Randomized, double-blind, parallel-group; 3-week placebo run-in and 12-week treatment phase.Nine hospital outpatient clinics and general practices in the Netherlands.127 men and women, 18-65 years (...) old, with body mass indices (BMI) ranging from 27 to 40 kg/m(2) and stabilized hypertension - mean resting diastolic blood pressure of 90-120 mm Hg - with or without antihypertensive medication.Sibutramine 10 mg once daily; placebo.Body weight, blood pressure, routine laboratory and clinical safety monitoring.Of 113 evaluable patients, 54 received sibutramine and 59 placebo. Weight reduction was significantly greater with sibutramine from week 2 onwards (last observation carried forward): mean

2000 Cardiology Controlled trial quality: uncertain

643. [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

644. Clinical pharmacology of sibutramine hydrochloride (BTS 54524), a new antidepressant, in healthy volunteers. Full Text available with Trip Pro

Clinical pharmacology of sibutramine hydrochloride (BTS 54524), a new antidepressant, in healthy volunteers. The cardiovascular, anticholinergic and central effects of single doses of 30, 45 and 60 mg of sibutramine hydrochloride (BTS 54524), a new potential antidepressant, were compared with amitriptyline (50 mg) and placebo given at weekly intervals in a randomised design to six healthy male volunteers. Sibutramine was associated with increases in both supine heart rate and systolic blood (...) pressure at 1, 2 and 6 h after 60 mg (P less than 0.05). Amitriptyline caused a significant 50-60% decrease in salivation compared with placebo at 2 and 6 h but there were no changes with sibutramine. No significant changes in pupil size were detected with either drug. Visual analogue rating scales (VARS) revealed significant drowsiness with amitriptyline but neither sedative nor stimulant effects with sibutramine. Impairments of simple auditory and visual reaction times, visual two-choice reaction

1988 British journal of clinical pharmacology Controlled trial quality: uncertain

645. 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

646. 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

647. [A randomized, double-blind, placebo-controlled, multicenter study on sibutramine in over-weighted and obese subjects]. (Abstract)

[A randomized, double-blind, placebo-controlled, multicenter study on sibutramine in over-weighted and obese subjects]. To assess weight loss efficacy, safety and tolerability of sibutramine in simple obese subjects.Randomized, double-blind, placebo-controlled clinical trial. Four hospital outpatient clinics in Shanghai, Chongqing, Shandong and Tianjin, respectively.233 men and women, 18-65 years old, with body mass index (BMI) ranging from 27 to 40 kg/m2 were randomly divided (...) into an intervened group and a placebo control group. Sibutramine 10 mg or placebo once a day.Body weight, routine laboratory and clinical safety monitoring.Of 233 eligible patients, 120 received sibutramine and 113 placebo. Weight reduction was significantly greater in the intervented group (6.8 +/- 3.1) kg than the placebo control group (0.48 +/- 2.6) kg from week 4 onwards to week 24 (P < 0.001). Some minor side effects were noticed in the subjects who took sibutramine. But the symptoms were light and short

2001 Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine] Controlled trial quality: predicted high

648. Role of sibutramine in the treatment of obese Type 2 diabetic patients receiving sulphonylurea therapy. (Abstract)

Role of sibutramine in the treatment of obese Type 2 diabetic patients receiving sulphonylurea therapy. To investigate whether the satiety-inducing agent sibutramine affected body weight and associated anthropometry in overweight and obese (body mass index (BMI) > 27) Type 2 diabetic patients on sulphonylurea therapy.A randomized, placebo-controlled trial was undertaken in 134 patients with stable metabolic control on chronic sulphonylurea therapy. Patients were placed on moderate caloric (...) restriction and received treatment with either sibutramine (15 mg/day) or placebo for 6 months.Fifty-three of 69 sibutramine-treated and 57/65 placebo-treated patients completed the study. Both groups showed progressive weight loss. At the end of the trial weight loss was two times greater in the sibutramine group (mean +/- SEM; -4.5 +/- 0.5 kg) than placebo (-1.7 plus minus 0.5 kg, P < 0.001 vs. sibutramine). There was a trend for more patients to lose > 5% of initial body weight in the sibutramine group

2002 Diabetic medicine : a journal of the British Diabetic Association Controlled trial quality: uncertain

649. Evaluation of the safety and efficacy of sibutramine, orlistat and metformin in the treatment of obesity. (Abstract)

Evaluation of the safety and efficacy of sibutramine, orlistat and metformin in the treatment of obesity. Some of our obese patients who were receiving 10 mg/day sibutramine reported feeling hunger at night. To address this, we designed a randomized, prospective clinical trial to study the efficacy and safety of 10 mg sibutramine twice daily (bid), and compare this treatment with 120 mg orlistat three times daily (tid) and 850 mg metformin (bid).A total of 150 female patients with body mass (...) index (b.m.i.) > 30 kg/m(2) were included. The subjects were all out-patients at the Başkent University Endocrinology and Metabolism Clinic. Each individual was assigned randomly to receive 10 mg sibutramine bid (group 1; n = 50; mean age 42.27 +/- 1.40 years), 120 mg orlistat tid (group 2; n = 50; mean age 42.13 +/- 1.32 years) or 850 mg metformin bid (group 3; n = 50; mean age 43.58 +/- 1.40 years). All patients took the medications for 6 months. Two patients from the sibutramine group and two

2002 obesity & metabolism Controlled trial quality: uncertain

650. 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

651. Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors. Full Text available with Trip Pro

Sibutramine is safe and effective for weight loss in obese patients whose hypertension is well controlled with angiotensin-converting enzyme inhibitors. Sibutramine treatment in obesity results in significantly greater weight reduction compared with placebo, although weight loss with sibutramine may be accompanied by small but statistically significant mean increases in blood pressure (BP). This 52-week, placebo-controlled, double-blind, randomised study investigated the effects of sibutramine (...) 20 mg once daily or placebo on body weight in 220 obese (body mass index (BMI) 27-40 kg/m2), hypertensive patients. At randomisation, hypertension was well controlled (< or = 95 mm Hg diastolic blood pressure (DBP)) with an angiotensin-converting enzyme (ACE) inhibitor, with or without concomitant thiazide diuretic therapy. Therapy for hypertension continued for the 52 weeks of the study. Sibutramine 20 mg produced significantly greater weight loss compared with placebo: 4.5 kg with sibutramine

2002 Journal of human hypertension Controlled trial quality: uncertain

652. 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

653. Evaluation of efficacy, reliability, and tolerability of sibutramine in obese patients, with an echocardiographic study. (Abstract)

Evaluation of efficacy, reliability, and tolerability of sibutramine in obese patients, with an echocardiographic study. This is a double-blind, placebo-controlled study of the efficacy, safety, and tolerability of sibutramine in the management of obese patients for a 6-month period.Sixty-one obese patients (BMI >30, <40 kg/m2), aged 18-65 years were evaluated. In the first phase of the study (30 days), the patients were given a placebo. We monitored compliance with a low-calorie diet (1200 (...) kcal/day) and to the placebo. In the next stage, the double-blind phase (6 months), we compared placebo and sibutramine (10 mg/day). The criteria for evaluating efficacy were weight loss, reduction in body mass index (BMI), and abdominal and hip circumferences. Tolerability was assessed based on reported side effects, variation in arterial blood pressure and heart rate, metabolic profile (fasting glucose, total cholesterol and its fractions, and triglycerides), laboratory tests (renal and hepatic

2002 Revista do Hospital das Clínicas Controlled trial quality: uncertain

654. Effects of sibutramine on ventricular dimensions and heart valves in obese patients during weight reduction. (Abstract)

Effects of sibutramine on ventricular dimensions and heart valves in obese patients during weight reduction. Obesity enhances hemodynamic alterations that predispose to a subsequent increase in left ventricular (LV) wall stress leading to LV hypertrophy. In obese subjects, weight reduction regresses LV mass (LVM), regardless of blood pressure. Sibutramine can increase blood pressure and heart rate, which may attenuate the reductions in LVM associated with weight loss.Outpatients (n = 184, age (...) 18-65 y, body mass index > or =30 to <40 kg/m2) were randomly assigned to 6 months of once daily double-blind treatment with sibutramine 10 mg or 20 mg, or placebo. LV dimensions, status and function of the valves, weight loss, blood pressure, heart rate, and electrocardiogram were assessed.For end point data sets, the mean +/- SD LVM index (LVM/height) changes were -3.0 +/- 11.9 g/m for placebo (n = 56), -4.4 +/- 10.7 g/m for sibutramine 10 mg (n = 61), and -4.3 +/- 10.9 g/m for sibutramine 20

2002 American heart journal Controlled trial quality: uncertain

655. Paradoxical effect of sibutramine on autonomic cardiovascular regulation. (Abstract)

Paradoxical effect of sibutramine on autonomic cardiovascular regulation. Sibutramine, a serotonin and norepinephrine transporter blocker, is widely used as an adjunctive obesity treatment. Norepinephrine reuptake inhibition with sibutramine conceivably could exacerbate arterial hypertension and promote cardiovascular disease.In 11 healthy subjects (7 men, age 27+/-2 years, body mass index 23.1+/-0.7 kg/m2), we compared the effect of sibutramine or matching placebo (ingested 26, 14, and 2 hours (...) before testing) on cardiovascular responses to autonomic reflex tests and to a graded head-up tilt test. In addition, we tested sibutramine in combination with metoprolol. Testing was conducted in a double-blind and crossover fashion. Supine systolic blood pressure was 113+/-3 mm Hg with placebo, 121+/-3 mm Hg with sibutramine (P<0.001 versus placebo), and 111+/-2 mm Hg with the combination of sibutramine and metoprolol. Similarly, sibutramine increased upright blood pressure. Sibutramine

2002 Circulation Controlled trial quality: uncertain

656. A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. (Abstract)

A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. To evaluate the effects of sibutramine (15 and 20 mg/day) on weight, metabolic control, and blood pressure in metformin-treated obese subjects with type 2 diabetes.A 12-month randomized prospective placebo-controlled double-blind study was performed. It included 21 primary and secondary care centers in England, Canada, France, and Belgium. A total of 195 subjects (44% male) with type 2 (...) with weight loss, and subjects who lost > or = 10% weight showed significant decreases in both HbA(1c) (1.2 +/- 0.4%, P < 0.0001) and fasting plasma glucose (1.8 mmol/l, P < 0.001). HDL cholesterol increased slightly with the higher dose, whereas plasma triglycerides fell with both doses, especially in subjects with weight loss of > or = 10% (a 29% decrease, P < 0.01). Treatment was generally well tolerated. Sibutramine treatment raised sitting diastolic blood pressure by > or = 5 mmHg in a higher

2003 Diabetes Care Controlled trial quality: uncertain

657. 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

658. [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

659. 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

660. Second phase of a double-blind study clinical trial on Sibutramine for the treatment of patients suffering essential obesity: 6 months after treatment cross-over. Full Text available with Trip Pro

Second phase of a double-blind study clinical trial on Sibutramine for the treatment of patients suffering essential obesity: 6 months after treatment cross-over. To evaluate the weight gain after Sibutramine 10 mg daily discontinuation. To evaluate the effect of Sibutramine 10 mg daily in patients who were on a diet for 6 months.After a double-blind, placebo-controlled, parallel, prospective phase for 6 months, the treatments were crossed over and the patients continued in double-blind (...) observation for another 6-month period.Forty out of 44 patients who were on Sibutramine and 42/44 who were on placebo switched the trial medication. All the patients were obese at the beginning of the trial (body mass index, BMI>30 kg/m(2)). During the first phase, the weight loss in the Sibutramine group was 7.52 kg (95% confidence intervals (95% CI) 6.15; 8.9) and that in the placebo group 3.56 kg (95% CI 2.41; 4.7) (using last observation carried forward (LOCF)).Body weight, BMI, waist, medical history

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

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