The effects of orlistat on weight and on serum lipids in obese patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled, multicentre study

Muls, Erik; Kolanowski, Jaroslaw; Scheen, André; Gaal, L. Van

doi:10.1038/sj.ijo.0801814

Cited by 162 publications

(101 citation statements)

References 21 publications

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“…51,55 The remaining 12 studies (2 studies were single-group pre-post designs, 1 study had a more active comparison group, and 9 studies reported outcomes at < 12 mo) were only included in analyses of adverse events. 24,29,57,63,[75][76][77][78][79][80][81]83 High within-group heterogeneity was common; however, the direction of treatment effect was consistent across most studies, and the confidence intervals overlapped. This statistical heterogeneity is likely due to small versus large treatment effects observed across studies.…”

Section: Resultsmentioning

confidence: 99%

Treatment for overweight and obesity in adult populations: a systematic review and meta-analysis

et al. 2014

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Section: Resultsmentioning

confidence: 99%

Treatment for overweight and obesity in adult populations: a systematic review and meta-analysis

et al. 2014

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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

455

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 We included unpublished trials and non–English-language documents.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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“…In adults, orlistat at the standard dose, 120 mg TID, inhibits approximately 30% of triglyceride absorption 15 with few adverse effects 17 . In placebocontrolled studies, adults treated with orlistat for periods as long as 2 years exhibited greater average weight loss, better weight maintenance, lower total and LDL cholesterol, and, in those with type 2 diabetes, improved glycemic control [16][17][18][19][20][21][22][23][24][25][26][27][28] .…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Orlistat as an Adjunct to Behavioral Treatment in Overweight African American and Caucasian Adolescents with Obesity-related Co-morbid Conditions

McDuffie¹,

Calis²,

Uwaifo³

et al. 2004

Journal of Pediatric Endocrinology and Metabolism

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This pilot study compared the efficacy of orlistat as an adjunctive treatment for obesity between African American and Caucasian adolescents. 20 obese adolescents with obesity-related comorbid conditions underwent measurements of body composition, glucose homeostasis by frequently sampled intravenous glucose tolerance test (FSIGT), and fasting lipids before and after 6-months' treatment with orlistat 120mg TID in conjunction with a comprehensive behavioral program.Weight (p< 0.05), BMI (p<0.001), total cholesterol (p<0.001), LDL cholesterol (p<0.001), fasting insulin (p<0.02) and fasting glucose (p<0.003) were lower after treatment. Insulin sensitivity, measured during the FSIGT, improved significantly (p<0.02), as did fasting indices such as the homeostasis model assessment for insulin resistance (p<0.01). African American subjects exhibited significantly less improvement in weight (p<0.05), BMI (p<0.01), waist circumference (p=0.03), and insulin sensitivity (p=0.05). Improvements in cholesterol were not significantly different between African Americans and Caucasians.We conclude that Caucasians lost more weight and had greater improvements in insulin sensitivity than African Americans, but both exhibited improvements in plasma lipids. The true benefit of orlistat treatment over a comprehensive behavioral program remains to be determined in placebocontrolled trials.

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The effects of orlistat on weight and on serum lipids in obese patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled, multicentre study

Cited by 162 publications

References 21 publications

Treatment for overweight and obesity in adult populations: a systematic review and meta-analysis

Treatment for overweight and obesity in adult populations: a systematic review and meta-analysis

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

Efficacy of Orlistat as an Adjunct to Behavioral Treatment in Overweight African American and Caucasian Adolescents with Obesity-related Co-morbid Conditions

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