Cardiovascular responses to weight management and sibutramine in high-risk subjects: an analysis from the SCOUT trial

Torp‐Pedersen, Christian; Caterson, Ian D.; Coutinho, Walmir; Finer, Nick; Gaal, Luc Van; Maggioni, Aldo P.; Sharma, Arya M.; Brisco, Wygenia; Deaton, Roger; Shepherd, Gillian; James, Philip

doi:10.1093/eurheartj/ehm217

Cited by 122 publications

(91 citation statements)

References 15 publications

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“…This study proved increased cardiovascular risks for patients who were taking sibutramine and had a history of ischemic heart disease or stroke (15). All of these high-risk patients were taking sibutramine for a period of six years.…”

Section: Discussionmentioning

confidence: 60%

The role of sibutramine in weight reduction

Pavlík

Fajfrová²,

Slováček³

et al. 2013

BLL

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Abstract:Background: The effectiveness of pharmacologic support with sibutramine along with the preservation of dietary and regimen measures is shown in a group of long-term treated patients at the Metabolic Clinic of the University Hospital in Hradec Králové. Methods: In ambulatory patients, basic anthropometric parameters as body weight, BMI, waist circumference and the total amount of adipose tissue were compared before substitution with 10 mg sibutramine and after a four-month therapy. This group included 94 patients who were administered the same dose of sibutramine for the whole period of time. This group consisted of 37 men and 57 women. Results: After a four-month therapy with sibutramine there was a mean reduction in weight by 7.9 ± 3.8 kg in the monitored group of patients. Their BMI was reduced by 2.3 ±1.5 kg/height 2 and the waist circumference by 4.4±3.8 cm. The decrease in the percentage of the total body lipid was 2.9 %. Conclusion: Despite a surprising decision of the European Drug Agency to suspend the registration of sibutramine in the whole of Europe since January 2010 we can state that in our patients we have proven a positive effect of sibutramine substitution on their weight reduction (Tab. 1, Ref. 19 Obesity has become the most frequent metabolic disease as a result of life conditions and lifestyle which have resulted in a positive energetic balance. As far as the number of obese people is concerned Czech Republic is one of the leading EU countries in both, the obesity of men and women (1). The prevalence of obesity and overweight reaches almost 70 % in this country. Obesity represents a severe risk factor which plays an important role in the occurrence of a number of metabolic diseases such as diabetes mellitus, dyslipidemia and atherosclerosis which is manifested as acute myocardial infarction, angina pectoris, ischemic heart disease etc. Obesity has posed a problem to mankind since a very long time. However, at the end of the 20th century it reached the dimension of a global epidemic as a result of constantly increasing energy intake without an adequate increase in energy expenditure (2). Abdominal obesity -a waist circumference of more than 88 cm in women and of more than 102 cm in men is considered the most dangerous form of obesity (3).The treatment of obesity is based on the consistent observance of the diet and exercise regimen (4, 5). Without this consistent observance pharmacotherapy should not be initiated. The aim of the modern pharmacotherapy of obesity is to help the patients to reduce their weight and to maintain it on a long-term basis or to treat the metabolic disorders which predispose the individual to develop obesity. In accordance with the recommendations of the Czech Society for Obesity the pharmacotherapy should be initiated in obese patients in the following cases: -in patients with an initial body mass index (BMI) of more than 30 kg/m 2 if the complex non-pharmacological therapy of obesity failed, that is more than 5 % of weight reduction has not been reached durin...

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Section: Discussionmentioning

confidence: 60%

The role of sibutramine in weight reduction

Pavlík

Fajfrová²,

Slováček³

et al. 2013

BLL

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“…23 Data on these patients who received sibutramine 10 mg together with advice for lifestyle show that after 6 weeks treatment, there were small but clinically relevant and statistically significant changes in anthropomorphic variables and vital signs (Figure 3). 24 Body weight was reduced by 2.2 kg, waist circumference by 2 cm, systolic blood pressure by 3 mm Hg, and diastolic blood pressure by 1 mm Hg, although heart rate rose by 1.5 b.p.m.…”

Section: The Scout Lead-in Phasementioning

confidence: 95%

“…The rate and number of serious adverse events was lower than had been predicted, leaving the trial with a larger cohort at the end of the 6-week lead-in phase to go into the randomisation phase. 23 Gender comparisons in the SCOUT lead-in phase…”

Section: The Scout Lead-in Phasementioning

confidence: 99%

The obese older female patient: CV risk and the SCOUT study

Coutinho

2007

Int J Obes

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Cardiovascular disease is a major killer in women yet is frequently considered a male-dominated disease. The risk of cardiovascular disease in women is frequently underestimated and there is also considerable evidence of a treatment bias against women. Women are generally underrepresented in cardiovascular clinical trials yet there is evidence of gender-specific differences in the responses to pharmacotherapy. The Sibutramine Cardiovascular Outcomes (SCOUT) trial has been designed to determine whether weight management with sibutramine together with a diet-and exercise-based lifestyle intervention can prevent cardiovascular morbidity and mortality in high-risk overweight and obese patients. The SCOUT population includes a large number of older women, at high risk for cardiovascular disease. Data from the trial's lead-in phase indicate that treatment with sibutramine and lifestyle management for 6 weeks result in clinically important weight loss and reduction in waist circumference. Despite an initial lower body weight, older women with cardiovascular disease and diabetes mellitus appear to lose as much weight as men. In the overall SCOUT population, treatment with sibutramine is associated with small median decreases in systolic and diastolic blood pressure and small median increases in pulse rate. The side-effect profile of sibutramine in this older, 'at-risk' population was similar to that previously observed in younger patients.

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“…The 5year Sibutramine Cardiovascular OUTcomes (SCOUT) trial was a randomized, doubleblind and pla cebocontrolled study involving 10 742 overweight or obese patients with cardiovascular disease, hypertension or type 2 diabetes [28] . After a 6wk leadin period, patients who received singleblind sibutramine had, on average, a 2.2 kg reduction of body weight, a 2.0 cm reduction of waist circumference, a 3.0 mmHg decrease in systolic blood pressure, a 1.0 mmHg decrease in diastolic blood pressure, and a 1.5 bpm decrease in pulse rate [28] .…”

Section: Sibutraminementioning

confidence: 99%

“…After a 6wk leadin period, patients who received singleblind sibutramine had, on average, a 2.2 kg reduction of body weight, a 2.0 cm reduction of waist circumference, a 3.0 mmHg decrease in systolic blood pressure, a 1.0 mmHg decrease in diastolic blood pressure, and a 1.5 bpm decrease in pulse rate [28] . In ad dition, sibutramine was found to be efficacious, tolerable and safe in this 6wk singleblind period [28] .…”

Section: Sibutraminementioning

confidence: 99%

Rise and fall of anti-obesity drugs

Li¹

2011

WJD

104

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Although it is not generally a life-threatening disease, obesity is becoming a major health problem worldwide. It can be controlled by means of drugs, and, consequently, these are required to be safe as well as effective. In this paper, we summarize the fate of various drugs that have been introduced for clinical use in the treatment of obesity. Fenfluramine and dexfenfluramine were withdrawn because of heart valve damage. Sibutramine suppresses appetite and increases heart rate and blood pressure. In the Sibutramine Cardiovascular OUTcomes trial, an increase in major adverse cardiovascular events prompted its withdrawal in Europe and the United States. Rimonabant is an endocannabinoid receptor antagonist that reduces body weight and ameliorates some cardiovascular risk factors. However, adverse psychiatric side effects led to its withdrawal as well. Orlistat is approved in Europe and the United States for the treatment of obesity, but its use is limited by gastrointestinal side-effects. Ephedrine and caffeine are natural ingredients in foods and supplements that may help the person to lose weight. In the light of several failed attempts, there is a clear need to develop drugs that are effective and safe in the long term in order to successfully combat the phenomenon of obesity .

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Cardiovascular responses to weight management and sibutramine in high-risk subjects: an analysis from the SCOUT trial

Abstract: Six-week treatment with sibutramine appears to be efficacious, tolerable and safe in this high-risk population for whom sibutramine is usually contraindicated.

Cited by 122 publications

References 15 publications

The role of sibutramine in weight reduction

The role of sibutramine in weight reduction

The obese older female patient: CV risk and the SCOUT study

Rise and fall of anti-obesity drugs

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