Long-term Weight Loss With Sibutramine

Wirth, Alfred; Krause, J

doi:10.1001/jama.286.11.1331

Cited by 224 publications

(17 citation statements)

References 20 publications

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“…To help put these data in context, placebocontrolled studies of some FDAapproved weight loss pharmacotherapies have reported losses 2.7 to 4.5 kg greater than losses with placebo over 6 to 12 months for patients taking sibutramine [43][44][45][46] or orlistat [47][48][49][50][51] ; or 7.2 kg greater than with placebo at 9 months for patients taking phentermine. 52 There are no data regarding weight loss beyond 6 months' use of ephedrine or ephedra.…”

Section: Commentmentioning

confidence: 99%

Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance

Shekelle¹,

Hardy²,

Morton³

et al. 2003

JAMA

451

198

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ContextEphedra and ephedrine sometimes are used for weight loss or enhanced athletic performance, but the efficacy and safety of these compounds are uncertain.ObjectiveTo assess the efficacy and safety of ephedra and ephedrine used for weight loss and enhanced athletic performance.Data SourcesWe searched 9 databases using the terms ephedra, ephedrine, adverse effect, side effect, efficacy, effective, and toxic. We included unpublished trials and non–English-language documents. Adverse events reported to the US Food and Drug Administration MedWatch program were assessed.Study SelectionEligible studies were controlled trials of ephedra or ephedrine used for weight loss or athletic performance and case reports of adverse events associated with such use. Eligible studies for weight loss were human studies with at least 8 weeks of follow-up; and for athletic performance, those having no minimum follow-up. Eligible case reports documented that ephedra or ephedrine was consumed within 24 hours prior to an adverse event or that ephedrine or an associated product was found in blood or urine, and that other potential causes had been excluded. Of the 530 articles screened, 52 controlled trials and 65 case reports were included in the adverse events analysis. Of more than 18 000 other case reports screened, 284 underwent detailed review.Data ExtractionTwo reviewers independently identified trials of efficacy and safety of ephedra and ephedrine on weight loss or athletic performance; disagreements were resolved by consensus. Case reports were reviewed with explicit and implicit methods.Data SynthesisNo weight loss trials assessed duration of treatment greater than 6 months. Pooled results for trials comparing placebo with ephedrine (n = 5), ephedrine and caffeine (n = 12), ephedra (n = 1), and ephedra and herbs containing caffeine (n = 4) yielded estimates of weight loss (more than placebo) of 0.6 (95% confidence interval, 0.2-1.0), 1.0 (0.7-1.3), 0.8 (0.4-1.2), and 1.0 (0.6-1.3) kg/mo, respectively. Sensitivity analyses did not substantially alter the latter 3 results. No trials of ephedra and athletic performance were found; 7 trials of ephedrine were too heterogeneous to synthesize. Safety data from 50 trials yielded estimates of 2.2- to 3.6-fold increases in odds of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations. Data are insufficient to draw conclusions about adverse events occurring at a rate less than 1.0 per thousand. The majority of case reports are insufficiently documented to allow meaningful assessment.ConclusionsEphedrine and ephedra promote modest short-term weight loss (≈0.9 kg/mo more than placebo) in clinical trials. There are no data regarding long-term weight loss, and evidence to support use of ephedra for athletic performance is insufficient. Use of ephedra or ephedrine and caffeine is associated with increased risk of psychiatric, autonomic, or gastrointestinal symptoms, and heart palpitations.

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Section: Commentmentioning

confidence: 99%

Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance

Shekelle¹,

Hardy²,

Morton³

et al. 2003

JAMA

451

198

View full text Add to dashboard Cite

show abstract

“…The drug administration should be discontinued in patients who do not respond to 3-months’ drug treatment. It has been demonstrated that intermittent treatment with some antiobesity drugs (phentermine, sibutramine) may be as effective as their continuous administration and may diminish both the side effects and costs (66,67). On the other hand, the long-term replacement of antiobesity drugs with placebo is followed by weight regain as demonstrated in the studies with sibutramine, lorcaserin, and rimonabant conducted over a 2-year period (5,37,39).…”

Section: Duration Of Treatment With Antiobesity Drugsmentioning

confidence: 99%

Comparative Efficiency and Safety of Pharmacological Approaches to the Management of Obesity

Hainer

2011

Diabetes Care

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“…As safety issues related to sibutramine therapy are still under investigation, trials conducted using intermittent therapies versus continuous therapy have a special role in obesity management. Intermittent therapy has shown similar efficacy to continuous drug administration [13]. …”

Section: Role Of Sibutraminementioning

confidence: 99%

Pharmacological Approaches for Management of Child and Adolescent Obesity

Kanekar

Sharma

2010

J Clin Med Res

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Overweight and obesity among children and adolescents continue to be a global public health epidemic. Current national data on childhood and adolescent obesity show alarming statistics of overweight and obese children and adolescents. This epidemic runs across various continents and affects various ethnic populations. The current weight management practices involve dietary modification, behavioral change therapies involving exercise, pharmacological therapy and surgical intervention. The purpose of this current review is to focus on pharmacological therapy i.e. role of sibutramine and orlistat in childhood and adolescent weight management. An open search of PUBMED database was made with search 'key words' such as 'orlistat' or 'sibutramine' or "pharmacological approaches" and "child obesity" and "adolescent obesity". This yielded a total of 20 articles. All of these articles have been summarized in the current review. Sibutramine functions by promoting satiety and increases energy expenditure by inhibiting reuptake of noradrenaline and serotonin. Most of the studies, reviews and trials conducted using sibutramine among adolescents and children show limited short-term efficacy. The long-term effects of sibutramine use are not yet studied due to the severity of its side-effects profile. Orlistat was approved by Food and Drug Administration for adolescent weight reduction. Despite its approval, it has a limited role in adolescent and pediatric obesity reduction due to the purported malabsorption of fat soluble vitamins and its side-effect profile. Obesity and adolescent weight management in present times mainly deals with dietary modification with superadded behavioral therapies promoting exercise. There is insufficient evidence as of now if these alone would cause adequate weight reduction and weight maintenance. Pharmacotherapy i.e use of drugs like sibutramine and orlistat has a limited role in the current fight against childhood and adolescent obesity. Extreme side-effects, close monitoring and lack of long-term studies involving these drugs, suggest questionable efficacy in current times. Future research studies involving pharmacological agents need to not only have immense scientific rigor during preliminary analyses but should also translate their efficacy in practical and clinical settings.KeywordsObesity; Overweight; Adolescents; Pharmacological; sibutramine; Orlistat

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Long-term Weight Loss With Sibutramine

Abstract: Sibutramine, administered for 48 weeks to a typically obese population, results in clinically relevant weight loss compared with placebo. Regarding effectiveness, continuous and intermittent sibutramine therapies are equivalent and the safety profiles for both treatments are comparable.

Cited by 224 publications

References 20 publications

Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance

Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance

Comparative Efficiency and Safety of Pharmacological Approaches to the Management of Obesity

Pharmacological Approaches for Management of Child and Adolescent Obesity

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