Effects of Sibutramine Treatment in Obese Adolescents

Berkowitz, Robert I.; Fujioka, Ken; Daniels, Stephen R.; Hoppin, Alison G.; Owen, Stanford; Perry, Arlette C.; Sothern, Melinda; Renz, Cheryl L.; Pirner, Mark; Walch, Julia K.; Jasinsky, Olga; Hewkin, Ann C.; Blakesley, Vicky A.

doi:10.7326/0003-4819-145-2-200607180-00005

Cited by 196 publications

(116 citation statements)

References 26 publications

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“…Presently, the Food and Drug Administration approves six drugs specifically for obesity treatment, 118 only two of which, sibutramine and orlistat, have been approved for limited use among pediatric patients. [119][120][121] Other drugs are prescribed in obese adolescents with MS in order to treat insulin resistance (that is, metformin), [122][123][124][125][126] hypertension or dyslipidemia (statins, antihypertensives). [127][128][129] Table 3 compared main characteristics of drug treatment along with PA. We described the changes in anthropometric, biochemical and metabolic parameters that are influenced by drug treatment and PA.…”

Section: Pa As a Drug: Its Use Effects And Limitsmentioning

confidence: 99%

Physical activity as the main therapeutic tool for metabolic syndrome in childhood

Brambilla¹,

Pozzobon

Pietrobelli

2010

Int J Obes

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Physical activity (PA) and diet directly influence obesity and metabolic syndrome (MS) as important determinants of body composition. Understanding how PA relates to MS in youth is of great importance, and could offer a common strategy for clinical and public health approaches to control this condition. The underlying disorder of MS is a condition of insulin resistance, and a strong relationship between PA level and insulin sensitivity is clearly ascertained. The type, duration, frequency and intensity of PA affect fuel metabolism, in particular carbohydrate and lipid oxidation. The possible modulation of metabolism because of increased fat oxidation by PA is the basis for both prevention and restoration of insulin resistance and MS in obese children. In daily clinical practice, diet followed by pharmacologic treatment are usually the approaches taken, whereas PA is often considered just a suggestion. Although diet and PA have different effects on body composition, with both contributing to fat loss, only PA increases muscle mass and thus has a direct effect on metabolic function, expressed by changes in cardiovascular risk factors. Therefore, it is important to remember their complementary but different targets in daily clinical practice, such as body weight control for diet and metabolic health for PA. In this review, we have summarized the literature on the relationship between PA and MS in pediatrics. Then, we have analyzed the possibility of using PA for MS treatment, as an alternative to drugs, by discussing the results of intervention studies, reasons for low compliance to PA, related benefits, adherence difficulties and costs. Finally, we have tried to suggest recommendations for a multiple-step PA strategy in children and adolescents at risk for MS, by considering PA as the 'key' player in treatment.

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Section: Pa As a Drug: Its Use Effects And Limitsmentioning

confidence: 99%

Physical activity as the main therapeutic tool for metabolic syndrome in childhood

Brambilla¹,

Pozzobon

Pietrobelli

2010

Int J Obes

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“…Similarly for sibutramine, published studies report that this drug is generally well tolerated in adolescents [21][22][23]. The largest trial, a randomized placebo-controlled trial in 498 obese adolescents over 12 months, reported that 76% of those in the sibutramine arm continued the drug for the full 12-month trial period, with only 6% of subjects withdrawing because of adverse events [22].…”

Section: Comparison With the Literaturementioning

confidence: 99%

“…The largest trial, a randomized placebo-controlled trial in 498 obese adolescents over 12 months, reported that 76% of those in the sibutramine arm continued the drug for the full 12-month trial period, with only 6% of subjects withdrawing because of adverse events [22]. In a smaller randomized controlled trial of 60 obese adolescents over 6 months, 93% completed the 6-month trial and no subjects withdrew due to sibutramine side-effects [23].…”

Section: Comparison With the Literaturementioning

confidence: 99%

“…Although we have no data on reasons for discontinuation in our study, our data suggest that both orlistat and sibutramine are more poorly tolerated and more rapidly discontinued in use in the general population than in highly selected, motivated and supported clinical trial populations. These differences may reflect the routine weight management support programmes that were integral parts of many of the clinical trials of orlistat and sibutramine [17,18,22,23].…”

Section: Comparison With the Literaturementioning

confidence: 99%

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Rise in antiobesity drug prescribing for children and adolescents in the UK: a population‐based study

Viner

Hsia

Neubert

et al. 2009

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The antiobesity drugs sibutramine and orlistat are not licensed for use in children and adolescents in the UK or USA.• Clinical trials suggest antiobesity drugs are effective and well‐tolerated in obese adolescents. WHAT THIS STUDY ADDS • Prescribing of unlicensed antiobesity drugs in children and adolescents has increased significantly in the past 8 years.• Most prescribed antiobesity drugs in children and adolescents are rapidly discontinued before patients can see clinical benefit, suggesting they are poorly tolerated or poorly efficacious.AIMS The international childhood obesity epidemic has driven increased use of unlicensed antiobesity drugs, whose efficacy and safety are poorly studied in children and adolescents. We investigated the use of unlicensed antiobesity drugs (orlistat, sibutramine and rimonabant) in children and adolescents (0–18 years) in the UK.METHODS Population‐based prescribing data from the UK General Practice Research Database between 1 January 1999 and 31 December 2006.RESULTS A total of 452 subjects received 1334 prescriptions during the study period. The annual prevalence of antiobesity drug prescriptions rose significantly from 0.006 per 1000 [95% confidence interval (CI) 0.0007, 0.0113] in 1999 to 0.091 per 1000 (95% CI 0.07, 0.11) in 2006, a 15‐fold increase, with similar increases seen in both genders. The majority of prescriptions were made to those ≥14 years old, although 25 prescriptions were made for children <12 years old. Orlistat accounted for 78.4% of all prescriptions; only one patient was prescribed rimonabant. However, approximately 45% of the patients ceased orlistat and 25% ceased sibutramine after only 1 month. The estimated mean treatment durations for orlistat and sibutramine were 3 and 4 months, respectively.CONCLUSIONS Prescribing of unlicensed antiobesity drugs in children and adolescents has dramatically increased in the past 8 years. The majority are rapidly discontinued before patients can see weight benefit, suggesting they are poorly tolerated or poorly efficacious when used in the general population. Further research into the effectiveness and safety of antiobesity drugs in clinical populations of children and adolescents is needed.

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“…In the past, sibutramine was approved from FDA to treat pediatric obesity due to its capacity to promote satiety and stimulate the energy expenditure [14]. It was regarded as an effective drug and extensively used, demonstrating significant decreases of BMI up to 4 kg/m 2 and improvement of metabolic risk factors when compared to placebo groups [15]. However, issues regarding cardiovascular safety led to sibutramine's withdraw in 2010 [16].…”

mentioning

confidence: 99%

Management of Pediatric Obesity

Marques¹

2015

JDMDC

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pediatric obesity [9]. Some randomized trials were conducted in order to clarify metformin role in nondiabetic overweight/obese pediatric patients, and the majority of them suggest metformin beneficial in terms of weight loss and insulin resistance improvement; metformin has also been well-tolerated and safe, with no severe side effects or fatal events described so far [9,[11][12][13]. Thus, metformin is seen as a promising agent to treat obese pediatric patients with impaired glucose tolerance, although its use remains controversial due to the lack of data, especially at long term basis as there are no trials conducted for more than 12 months [11,12].The increasing incidence of obesity in the pediatric setting, has led to additional investigation on alternative pharmacological therapies to manage this condition. In the past, sibutramine was approved from FDA to treat pediatric obesity due to its capacity to promote satiety and stimulate the energy expenditure [14]. It was regarded as an effective drug and extensively used, demonstrating significant decreases of BMI up to 4 kg/m 2 and improvement of metabolic risk factors when compared to placebo groups [15]. However, issues regarding cardiovascular safety led to sibutramine's withdraw in 2010 [16]. Other experimental drugs have been studied in childhood obesity, such as octreotide, topiramate, growth hormone, leptin but conclusive data or significant trials are not available, therefore those cannot be recommended [5].Ultimately, selected cases of severe pediatric obesity may be considered for bariatric surgery. This approach, highly effective to treat adult obesity, has several potential complications in the pediatric setting. Bariatric surgery may be considered only if the children has BMI>50 kg/m 2 or BMI>40kg/m 2 with comorbidities, if lifestyle modification with or without pharmacological intervention fails and if a pubertal Tanner 4/5 status and final/ near-final adult height was already achieved [5,17].Summarizing, the increasing incidence of pediatric obesity and its cardiometabolic impact, the disappointing effectiveness of lifestyle intervention and the lack of pharmacological EditorialThe prevalence of childhood and adolescent obesity is increasing worldwide and constitutes a major public health concern [1]. Pediatric obesity is defined as body mass index (BMI) equal to or greater than 95 th percentiles adjusted for age and sex; the children or adolescents are considered overweight for BMIs between 85 th to 95 th percentiles [2]. Weight excess in childhood has increased the prevalence of some conditions practically only found in adulthood some years ago, such as impaired glucose tolerance and type 2 diabetes mellitus (T2DM), dyslipidemia, hypertension and liver steatosis [3]. The early development of these conditions is associated with cardiometabolic mordibity and premature death [4]. Intervention may prevent those complications or avoid further deterioration of cardiovascular and metabolic status.The mainstay approach of pediatric obesity is lifest...

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Effects of Sibutramine Treatment in Obese Adolescents

Abstract: Sibutramine added to a behavior therapy program reduced BMI and body weight more than placebo and improved the profile of several metabolic risk factors in obese adolescents.

Cited by 196 publications

References 26 publications

Physical activity as the main therapeutic tool for metabolic syndrome in childhood

Physical activity as the main therapeutic tool for metabolic syndrome in childhood

Rise in antiobesity drug prescribing for children and adolescents in the UK: a population‐based study

Management of Pediatric Obesity

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