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Sibutramine

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621. Thermogenic effects of sibutramine in humans. Full Text available with Trip Pro

Thermogenic effects of sibutramine in humans. Sibutramine is an effective compound for the treatment of obesity, acting both on serotonergic and noradrenergic pathways. Animal studies have shown that sibutramine exerts its effect by enhancing satiety as well as by increasing thermogenesis.We tried to compare the acute thermogenic effect of a single 30-mg dose of sibutramine with placebo on basal energy expenditure (EE) and diet-induced thermogenesis.The study was randomized, double-blind (...) , and placebo controlled. Eleven healthy, normal-weight men underwent 4 distinct treatment regimens separated by washout periods of 6-10 d. EE was measured by indirect calorimetry before and for 5.5 h after sibutramine or placebo administration with or without a 2.1-MJ breakfast. Visual analogue scales for assessment of appetite were completed hourly.Sibutramine caused a significant increase in EE above that for placebo (over 5.5 h) during both the fed (34%, 0.15 kJ/min) and fasted (183%, 0.20 kJ/min

1998 The American journal of clinical nutrition Controlled trial quality: uncertain

622. Sibutramine produces dose-related weight loss. (Abstract)

Sibutramine produces dose-related weight loss. Sibutramine is a weight control drug that inhibits the reuptake of both serotonin and norepinephrine. In animals, it reduces food intake and increases thermogenesis and preliminary data in human beings showed weight loss. This paper reports a 24-week dose-ranging study to determine the effect of sibutramine on body weight of patients with obesity.Seven clinical centers screened 1463 patients with obesity and randomized 1047 to 24 weeks of treatment (...) with 1 of 6 doses of sibutramine (1, 5, 10, 15, 20, or 30 mg) or placebo once daily. Six hundred eighty-three patients completed the study. A two-week placebo run-in period was used to initiate a standardized program of diet, physical activity, and lifestyle changes.Weight loss was dose-related and statistically significant vs. placebo (p<0.05) across all time-points for a 5 mg/day to 30 mg/day dosage of sibutramine. At week 24, percent weight loss from baseline for completers was: placebo, 1.2%; 1

1999 Obesity research Controlled trial quality: uncertain

623. 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

624. A double-blind randomized placebo-controlled trial of sibutramine. (Abstract)

A double-blind randomized placebo-controlled trial of sibutramine. Sibutramine is a beta-phenethylamine which blocks reuptake of norepinephrine and serotonin. In this clinical study, a group of 173 patients were randomized to treatment with sibutramine at doses of 1, 5, 10, 15, 20 or 30 mg/d and were compared with placebo in a 24-week double-blind trial. There was a dose-dependent reduction in body weight, with doses of 10, 15, 20 and 30 mg being significantly greater than placebo. Weight loss (...) was still continuing in the highest three doses at the end of the study. When drugs were discontinued patients regained weight, as expected. Side effects were generally mild and were most evident in the group treated with the highest dose. These studies suggest that sibutramine may be a valuable new drug for treatment of obesity.

1996 Obesity research Controlled trial quality: uncertain

625. The effect of sibutramine on resting energy expenditure and adrenaline-induced thermogenesis in obese females. (Abstract)

The effect of sibutramine on resting energy expenditure and adrenaline-induced thermogenesis in obese females. Sibutramine, an inhibitor of serotonin and noradrenaline uptake, reduces appetite to cause weight loss. This study tested the hypothesis that an increase in energy expenditure also contributes to this weight loss. In addition, the effects of sibutramine on adrenaline induced changes in heart rate and cardiac output were determinedNineteen obese females randomly received either (...) sibutramine 15 mg daily or placebo for 12 weeks along with dietary advice. Resting energy expenditure (REE) was measured and then energy expenditure was measured during a 30 min infusion of adrenaline (25 ng/min/kg IBW). Cardiac output and heart rate, measured by Duplex Colour Doppler ultrasonography, were similarly measured in the basal state and post adrenaline. All measurements were recorded at baseline and then after 12 weeks.Ten patients who received sibutramine reduced their weight by 8.1+/-3.8

1999 International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity Controlled trial quality: uncertain

626. The effect of sibutramine on energy expenditure and appetite during chronic treatment without dietary restriction. (Abstract)

The effect of sibutramine on energy expenditure and appetite during chronic treatment without dietary restriction. To assess the contribution of a thermogenic effect to weight loss induced by eight weeks treatment with sibutramine (15mg/d) vs placebo in obese subjects.Randomised, placebo controlled, double blind study.Thirty-two (7 male, 25 female) healthy obese body mass index (BMI) 33.9+/-0.5 kg/m2 subjects completed the trial.Energy expenditure (EE) was measured by indirect calorimetry (...) during a 32 h stay in a respiration chamber before and after 8 weeks treatment. Visual analogue scales were completed for assessment of appetite sensation. No dietary restriction was given.Sibutramine caused a significant weight loss compared with placebo (-2.4 kg vs+0.3 kg, P<0.001). Despite the larger weight loss after 8 weeks, 24-h EE did not decrease more in the sibutramine than in the placebo group (-2. 6% vs -2.5%, P=ns). When the changes in 24-h EE were adjusted for changes in body weight, 24

1999 International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity Controlled trial quality: uncertain

627. Effects of sibutramine alone and with alcohol on cognitive function in healthy volunteers. Full Text available with Trip Pro

Effects of sibutramine alone and with alcohol on cognitive function in healthy volunteers. To investigate the effects of sibutramine in combination with alcohol in a double-blind, randomised, placebo-controlled, four-way crossover study in 20 healthy volunteers.On each study day each volunteer received either: sibutramine 20 mg+0.5 g kg-1 alcohol; sibutramine 20 mg+placebo alcohol; placebo capsules+0.5 g kg-1 alcohol; or placebo capsules+placebo alcohol. Alcohol was administered 2 h following (...) memory (maximum impairment to speed of word recognition=74 ms). Alcohol also increased body sway (maximum increase 17.4 units) and lowered self rated alertness (maximum decrease 13.6 mm). These effects were produced by an inferred blood alcohol level of 53.2 mg dl-1. Sibutramine was not found to potentiate any of the effects of alcohol. There was a small, yet statistically significant, interaction effect observed on the sensitivity index of the picture recognition task. In this test, the combined

2000 British journal of clinical pharmacology Controlled trial quality: uncertain

628. Abuse liability assessment of sibutramine, a novel weight control agent. (Abstract)

Abuse liability assessment of sibutramine, a novel weight control agent. Sibutramine (Meridia) is a serotonin and norepinephrine reuptake inhibitor marketed for weight control. Previous studies demonstrated low abuse potential for 20 and 30 mg sibutramine (doses near the therapeutic range); however, no data existed on supratherapeutic doses. This study, therefore, examined 25 and 75 mg sibutramine in humans compared to d-amphetamine (20 mg) as a positive control and placebo as a negative (...) control.The study examined the acute subjective, reinforcing, and physiological effects of sibutramine to assess its abuse liability.Twelve polydrug abusers with no history of drug dependence participated in this double-blind, inpatient/outpatient study. Volunteers participated in four drug sessions, in which they completed subjective effects scales including the Profile of Mood States (POMS), Visual Analog Scales (VAS), and the Addiction Research Center Inventory (ARCI). The Multiple Choice Procedure

2000 Psychopharmacology Controlled trial quality: uncertain

629. Absence of cardiac valve dysfunction in obese patients treated with sibutramine. (Abstract)

Absence of cardiac valve dysfunction in obese patients treated with sibutramine. Serotonin-releasing agents prescribed as weight-loss medications have been implicated as a cause of acquired aortic and mitral valve abnormalities. Sibutramine hydrochloride (MERIDIA) is a serotonin and norepinephrine reuptake inhibitor with proven efficacy of weight reduction. The purpose of this study was to determine the incidence of cardiac valve disease in sibutraminetreated patients.Obese patients with type 2 (...) diabetes mellitus enrolled in an ongoing double-blind, placebo-controlled, parallel-arm, 12-month study of sibutramine (followed by a 12-month open label extension) underwent transthoracic echocardiographic imaging and color Doppler interrogation for assessment of cardiac valve anatomy and function.A total of 210 patients were evaluated. Of these, 133 were receiving sibutramine (72 in the double-blind period), and 77 were receiving placebo. The mean+/-Standard Deviation age was 54+/-9 years

1999 Obesity research Controlled trial quality: uncertain

630. A clinical trial of the use of sibutramine for the treatment of patients suffering essential obesity. (Abstract)

A clinical trial of the use of sibutramine for the treatment of patients suffering essential obesity. To evaluate the safety and efficacy of Sibutramine 10 mg per os, once a day in obese patients over a period of 6 months.A monocenter, double-blind, placebo-controlled, parallel, prospective clinical trial.109 male and female obese patients (BMI>30 kg/m2) from 16 to 65 y entered the trial.Body weight, body mass index (BMI), waist and waist/hip ratio, medical history, assessment of hunger (...) , satiety and diet compliance, standard laboratory assessments, blood pressure, heart rate and ECG.40 out of 55 patients in the Sibutramine group and 44 out of 54 patients in the placebo group completed the trial. Using the method of last observation carried forward (LOCF), 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 was 3.56 kg (95% CI 2.41; 4.7). The BMI loss was 3.14 kg/m2 (95% CI 2.58; 3.69) in the Sibutramine group

2000 International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity Controlled trial quality: predicted high

631. Sibutramine reduces food intake in non-dieting women with obesity. (Abstract)

Sibutramine reduces food intake in non-dieting women with obesity. Sibutramine (SIB), an inhibitor of serotonin and noradrenaline reuptake, has been shown in clinical trials to be associated with a dose-related decrease in bodyweight. This double-blind, placebo-controlled, Latin square crossover study examined whether the effect on bodyweight could be due in part to a reduction in daily food intake. Twelve non-dieting, women with obesity (body mass index of 30.5 to 41.9) received three

1998 Obesity research Controlled trial quality: uncertain

632. A comparison of sibutramine and dexfenfluramine in the treatment of obesity. (Abstract)

A comparison of sibutramine and dexfenfluramine in the treatment of obesity. Because long-term weight reduction is often unsuccessful with dietary restriction alone, pharmacological agents have been used to promote weight loss. We have compared the novel (multiple monoamine neurotransmitter reuptake inhibitor) antiobesity drug sibutramine (10 mg once daily) with the extensively studied serotonin-releasing antiobesity agent dexfenfluramine (15 mg twice daily).226 healthy outpatients (aged 18 (...) to 65 years; body mass index > or =27 kg/m2) were included in a 12-week, randomized, double-blind, parallel group study. The main outcome measures were changes in weight, body mass index, waist and hip circumference and ratio, and safety profiles.Mean (+/-SEM) absolute weight loss was 4.5 +/- 0.4 kg in the sibutramine group (n = 112) and 3.2 +/- 0.3 kg in the dexfenfluramine group (n = 112) (endpoint analysis); 4.7 +/- 0.4 kg in the sibutramine group (n = 101); and 3.6 +/- 0.3 kg

1998 Obesity research Controlled trial quality: uncertain

633. Sibutramine: a new weight loss agent without evidence of the abuse potential associated with amphetamines. (Abstract)

Sibutramine: a new weight loss agent without evidence of the abuse potential associated with amphetamines. Sibutramine is a serotonin and norepinephrine reuptake inhibitor that has shown efficacy as a weight loss and weight maintenance agent. Because of the abuse liability and physical dependence potential of amphetamines and related antiobesity agents, this study evaluated the abuse potential of sibutramine and compared it with that of dextroamphetamine and placebo in recreational stimulant (...) users. Thirty-one male recreational stimulant users participated in this single-site, Latin square crossover study that compared the effects of two doses of sibutramine (20 mg and 30 mg) to dextroamphetamine (20 mg and 30 mg) and placebo, using a series of validated subjective scales or questionnaires. For scales measuring stimulation and euphoria, there was a greater mean response for dextroamphetamine 30 mg versus 20 mg, with both doses having a significantly greater stimulant and euphoric effect

1998 Journal of Clinical Psychopharmacology Controlled trial quality: uncertain

634. Efficacy and tolerability of sibutramine in obese patients: a dose-ranging study. (Abstract)

Efficacy and tolerability of sibutramine in obese patients: a dose-ranging study. To assess the weight-reducing effects and tolerability of 5 mg, 10 mg and 15 mg daily doses of sibutramine, a novel serotonin and noradrenaline reuptake inhibitor (SNRI).Multicentre, double-blind, and placebo-controlled study. After a one week run-in period, patients were randomized to receive placebo or sibutramine over a 12-week period. Advice on diet and behaviour modification was provided. One follow-up (...) +/- 0.5 kg for 5 mg sibutramine (n = 56), 5.1 +/- 0.5 kg for 10 mg sibutramine (n = 59) and 4.9 +/- 0.5 kg (n = 62) for 15 mg sibutramine. The difference observed between the placebo and the 10 mg and 15 mg groups was statistically significant from week 2 onwards (P < 0.01), but there was no significant difference between these sibutramine groups. The percentage of patients losing > 5% of initial bodyweight was significantly greater for 15 mg sibutramine (55%) and 10 mg sibutramine (49%) than

1998 International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity Controlled trial quality: uncertain

635. Effects of sibutramine on resting metabolic rate and weight loss in overweight women. (Abstract)

Effects of sibutramine on resting metabolic rate and weight loss in overweight women. Sibutramine, a monoamine re-uptake inhibitor, has recently been approved by the Food and Drug Administration as a weight loss agent. Sibutramine lowers bodyweight in rodents by reducing energy intake and increasing energy expenditure. Sibutramine facilitates weight loss in human subjects, but it is not clear whether it acts on energy intake, energy expenditure, or both. The present study was a randomized (...) clinical trial designed to assess the effects of sibutramine (at 10 or 30 mg/day) on body weight and resting metabolic rate (RMR). Forty-four overweight women were randomized to 1) placebo (n=15); 2) sibutramine at 10 mg/day (n=15) or, 3) sibutramine at 30 mg/day (n=14). All subjects were instructed to consume a 1200 kcal/day diet for 8 weeks while receiving drug or placebo. RMR was assessed by indirect calorimetry at baseline, at 3 hours after the first dose of drug (or placebo), and at the end

1998 Obesity research Controlled trial quality: uncertain

636. Efficacy and safety of sibutramine in obese white and African American patients with hypertension: a 1-year, double-blind, placebo-controlled, multicenter trial. (Abstract)

Efficacy and safety of sibutramine in obese white and African American patients with hypertension: a 1-year, double-blind, placebo-controlled, multicenter trial. Obesity is a highly prevalent medical condition and is commonly accompanied by hypertension. This study assessed the efficacy and safety of treatment with sibutramine hydrochloride for promoting and maintaining weight loss in obese patients with controlled hypertension, including a subset analysis of African American patients.Obese (...) patients with a body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) between 27 and 40 and a history of hypertension controlled with a calcium channel blocker (with or without concomitant thiazide diuretic treatment) were randomized to receive sibutramine (n = 150) or placebo (n = 74) with minimal behavioral intervention for 52 weeks. African Americans constituted 36% of enrolled patients. Efficacy assessments were body weight and related parameters (BMI

2000 Archives of internal medicine Controlled trial quality: uncertain

637. Modalities of the food intake-reducing effect of sibutramine in humans. (Abstract)

Modalities of the food intake-reducing effect of sibutramine in humans. Sibutramine is a serotonin and noradrenaline reuptake inhibitor exerting a weight reducing effect partly via its anorectic properties. We investigated the effects of 15 mg sibutramine on objective (intake) and subjective (sensations) parameters of eating behavior in 24 young male subjects. At 0830 h subjects took either placebo or sibutramine in a counterbalanced order, followed by a fixed amount of breakfast. Intake (...) was covertly recorded in the laboratory until the dinner meal, and then until the next morning using diary reports. Sibutramine induced a highly significant reduction in energy (1304 kJ, p < 0.001), protein (294 kJ, p < 0.001), fat (414 kJ, p < 0.01), and carbohydrate (CHO, 594 kJ, p < 0.001) intakes compared to placebo. This reduction was further enhanced when 24-h intake was analyzed (1601 kJ, p < 0.001). The effect of sibutramine occurred mainly at lunch (637 kJ, p = 0.005). Throughout the test day

2000 Physiology & behavior Controlled trial quality: uncertain

638. Six-month treatment of obesity with sibutramine 15 mg; a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population. Full Text available with Trip Pro

Six-month treatment of obesity with sibutramine 15 mg; a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population. To evaluate the safety and efficacy of sibutramine 15 mg by mouth once per day in obese patients over a period of 6 months.A monocenter, double-blind, placebo controlled, parallel, prospective clinical trial was carried out. Sixty-nine male and female obese patients (body mass index [BMI] > 30 kg/m2) aged 16 to 65 years entered the trial.22 of 35 patients (...) in the sibutramine group and 9 of 34 patients in the placebo group completed the trial. The high dropout rate in the sibutramine group was due to adverse events in 3 cases, lack of efficacy (as judged by patients) in 7, loss to follow-up in 2, and an orthopedic device being worn in 1; in the placebo group the dropouts were ascribed to lack of efficacy (as judged by patients) in 17 cases and to loss to follow-up in 8 cases. Using the method of last observation carried forward, the weight loss in the sibutramine

2000 Obesity research Controlled trial quality: predicted high

639. Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomised, double-blind, placebo-controlled study. (Abstract)

Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: a randomised, double-blind, placebo-controlled study. To assess the efficacy and tolerability of sibutramine 15 mg once daily as a weight reduction agent in overweight and obese patients (body mass index (b.m.i.) > 26 kg/m2) with type 2 diabetes when given with a customised, reduced-calorie diet, and to evaluate the influence of weight loss on diabetic control.Randomised, placebo-controlled, double (...) -blind, parallel-group, 12-week study conducted at two hospital-based obesity/diabetes clinics. Patients were men and women aged 30-65 years, with b.m.i. > 26 kg/m2 and < or = 35 kg/m2 and treated or untreated type 2 diabetes diagnosed > or = 6 months previously. Each patient was given sibutramine 15 mg or placebo once daily and advised to follow a customised diet of 500 kcal/day less than the individual's energy needs. The principal measure of efficacy was change in body weight (b.w.). Additional

2000 obesity & metabolism Controlled trial quality: predicted high

640. Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. (Abstract)

Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. To determine the efficacy and tolerability of sibutramine hydrochloride in obese patients whose type 2 diabetes was poorly controlled on diet alone or with an oral antidiabetic agent.This study was a 24-week, double-blind, multicentre trial following a 5-week placebo run-in period. One hundred and seventy-five obese (body mass index (b.m.i.) > or =27 kg/m2 (...) ) patients with poorly controlled type 2 diabetes mellitus were randomized either to sibutramine (n = 89; mean age 53.5 years; mean weight 99.3 kg) or placebo (n = 86; mean age 55 years; mean weight 98.2 kg) at 16 participating centres. To achieve moderate calorie restriction (deficit > or = 250-500 kcal/day), individual dietary counselling was accompanied by either placebo or sibutramine (initial dosage of 5 mg/day titrated up by 5 mg biweekly through week 6, and maintained at 20 mg through week 24

2000 obesity & metabolism Controlled trial quality: uncertain

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