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341. Benefit assessment of non-drug treatment strategies in patients with hypertension: weight reduction1

, which were reported in 9 publications, were identified by means of the search described above. Four studies compared orlistat with placebo, 2 studies compared sibutramine with placebo, and one study compared orlistat with sibutramine. With regard to the methodological quality of the studies, one of the orlistat vs. placebo studies showed major deficiencies, whereas the 3 other studies revealed only minor deficiencies. All sibutramine versus placebo studies exhibited major deficiencies. In the only (...) study comparing sibutramine and orlistat, minor deficiencies were found. As none of the studies was designed to investigate the effect of the weight-reducing drugs with regard to the prevention of long-term complications (e.g., total mortality, cardiovascular mortality and morbidity), it remains unclear whether sibutramine or orlistat provide a benefit in this regard for patients with arterial hypertension. In all studies, both sibutramine and orlistat led to a statistically significantly greater

2006 Institute for Quality and Efficiency in Healthcare (IQWiG)

343. Effectiveness of weight management programs in children and adolescents

, with an average BMI between 35 to 38 kg/m 2 . The pharmacological interventions assessed were sibutramine or orlistat and all of the studies also included a behavioural component in both treatment arms. Control groups received a placebo pill. Included studies of surgical interventions were in obese children aged 12 to 18 years, most of whom had failed previous weight management approaches. Surgical interventions assessed were laparoscopic adjustable gastric banding (LAGB) or gastric bypass procedures (...) /m 2 more in participants who received sibutramine and by 0.5 to 0.85 kg/m 2 more in participants who received orlistat in the short term (up to one year after enrolment) compared with the control group. None of the trials assessed outcomes beyond one year. No severe adverse effects were reported, however adolescents taking sibutramine were more likely to develop small increases in heart rate and, in some cases, blood pressure. Nine percent of adolescents taking orlistat reported faecal

2008 DARE.

344. Effect of weight-reducing agents on glycaemic parameters and progression to type 2 diabetes: a review Full Text available with Trip Pro

) and from 40 to 53 years in non-diabetic populations (body mass index range 32 to 38kg/m 2 ). Most studies were in non-diabetic populations; around three-quarters of this population was female. Treatments used included orlistat (120mg three times a day), sibutramine (10 to 20mg once daily) and rimonabant (20mg daily). All trials used a reduced-calorie diet. The authors did not state how many reviewers performed the selection. Assessment of study quality The authors did not formally assess study quality (...) ; only double-blind randomised controlled trials were eligible for inclusion. Data extraction When more than one dose of sibutramine was studied, data for the 20mg dose was used. One reviewer extracted data. Methods of synthesis A narrative synthesis of the data was undertaken. Results were presented by type of population (diabetic or non-diabetic). Results of the review Twenty-three RCTs (n=14,569) were included in the review. Sample sizes ranged from 86 to 3,277 participants. RCTs in non-diabetic

2008 DARE.

345. Effectiveness of weight loss and maintenance interventions in women

completers (86%) averaged a weight loss of 8.9 kg at 6 months and 8.8 kg at 12 months. Weight loss was 7.9 kg after 18 months (2 studies) and 14 kg at 2 years (1 study). Meal replacement: 79% of women completed the study period, with an average weight loss of 5.9 kg after 6 months which remained the same after 12 months. Medication: 2 studies used orlistat or sibutramine together with lifestyle changes. The study completion rate was 85% and weight loss was 11.6 kg at both 6 and 12 months. VLCDs: women

2004 DARE.

346. An integrative review of interventions for adolescent weight loss

groups, at least one of which had received a weight loss intervention, were eligible for inclusion. The interventions reported in the review included exercise programmes, dietary reductions, medication (i.e. metformin and sibutramine), monetary incentives, telephone- and mail-based interventions, and interventions with and without parental participation. The control interventions, where these existed, included placebo, standard care (e.g. basic dietary and exercise advice with behavioural therapy (...) had a significantly reduced BMI (1.3% reduction) compared with those receiving placebo (2.3% increase). In another study, adolescents receiving sibutramine combined with a behavioural, diet and exercise regimen achieved a 4.5% greater reduction in BMI than adolescents just receiving the behavioural, diet and exercise regimen and placebo. Attenders versus non-attenders (1 study). One behavioural intervention study found that increased attendance was not associated with significant changes in weight

2005 DARE.

347. Changes in body weight and serum lipid profile in obese patients treated with orlistat in addition to a hypocaloric diet: a systematic review of randomized clinical trials

. Specific interventions included in the review Studies that assessed orlistat, at a dosage of 3 x 120 mg per day, compared with control were eligible for inclusion. Twenty-six studies compared orlistat with placebo, one study compared orlistat with sibutramine, and one compared orlistat versus sibutramine and metaformin. All of the studies incorporated some form of hypocaloric diet in both treatment groups, in which calories gained from fat were limited to 30% and daily caloric intake was restricted

2004 DARE.

348. Systematic review of the long-term effects and economic consequences of treatments for obesity and implications for health improvement

, Campbell M K, Grant A M CRD summary This review of obesity treatments in adults concluded that there are beneficial effects of orlistat, sibutramine and metformin and low-fat diets, and that exercise and/or behaviour therapy appear to improve weight loss when added to diet. The review was generally well-conducted and the conclusions are likely to be reliable. Authors' objectives To review obesity treatments in adults in order to identify therapies that impact by achieving weight reduction, risk factor (...) . without dietary advice) were excluded, as were comparisons between low-fat and low-calorie diets, comparisons of two variations of the same type of diet, and comparisons between low-sodium and weight-loss diets. The drugs examined in the review were limited to orlistat, sibutramine, metformin, acarbose and selective serotonin re-uptake inhibitors (SSRIs). Participants included in the review Only studies of adult participants were included (mean or median age of 18 years or older). The mean or median

2004 DARE.

349. Cost-utility analysis of rimonabant in the treatment of obesity Full Text available with Trip Pro

(QALYs), which were discounted at an annual rate of 3%. Cost data: The costs categories included drug costs, direct medical costs of dietician visits and physician visits, cost of a myocardial infarction, and cost of diabetes. Drug costs were based on the average wholesale price of orlistat and sibutramine, reduced by 15% to reflect patients' contributions. The unit costs of dietician visits were obtained from the Medical Assistance Administration in the state of Washington, and those of physician (...) . Other available treatments for obesity, such as sibutramine and orlistat, were mentioned, but were not included in the analysis. Effectiveness/benefits: No systematic review of the literature was reported, so it is unclear whether the best available evidence was used to determine the effectiveness estimates. The methodology of the clinical trials and the pooling of data appear to have been robust. The level of reporting of the assumptions was appropriate. The methods used to estimate the utilities

2008 NHS Economic Evaluation Database.

350. Evidence based review of weight loss medicines: a report commissioned by the New Zealand Accident Compensation Corporation (ACC)

of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Smartt P. Evidence based review of weight loss medicines: a report commissioned by the New Zealand Accident Compensation Corporation (ACC) Christchurch: New Zealand Health Technology Assessment (NZHTA) 2004: 130 Authors' objectives The aim of this report was to evaluate weight loss drugs and anti-obesity drug treatment. Authors' conclusions The weight loss drugs sibutramine and orlistat are effective (...) adjuncts to an appropriate clinical program of weight loss for obese Accident Compensation Corporation (ACC) claimants. Short-term treatment of up to six months should be considered for maximum weight loss. Longer-term treatment - i.e., up to two years should be considered if weight loss is to be maintained. Patients with uncontrolled hypertension or cardiovascular disease may not be suitable candidates for sibutramine therapy; in these patients orlistat should be considered. Meal replacement products

2004 Health Technology Assessment (HTA) Database.

351. Pharmacological and surgical treatment of obesity

and surgical treatment of obesity. Rockville: Agency for Healthcare Research and Quality (AHRQ). Evidence Report/Technology Assessment No. 103. 2004 Authors' objectives The aim of this report was to assess the efficacy and safety of the weight loss medications sibutramine, orlistat, fluoxetine, phentermine, and diethylpropion; to assess the evidence for other medications that have been used for weight loss including bupropion, zonisamide, topiramate, and sertraline; and to assess the efficacy and safety (...) of various types of bariatric surgery. Authors' conclusions Sibutramine, orlistat, phentermine, diethylpropion (probably), bupropion, fluoxetine, and topiramate all promote weight loss when given along with recommendations for diet. Sibutramine and orlistat are the two most-studied drugs. The amount of extra weight loss attributable to these medications is modest (less than 5 kg at one year), but this amount still may be clinically significant. No evidence indicates that any particular drug promotes more

2004 Health Technology Assessment (HTA) Database.

352. Systematic review of the long-term effects and economic consequences of treatments for obesity and implications for health improvement

. Authors' conclusions Orlistat, sibutramine and metformin appear beneficial for the treatment of adults with obesity. Exercise and/or behaviour therapy appear to improve weight loss when added to diet. Low-fat diets with exercise, with or without behaviour therapy, are associated with the prevention of type 2 diabetes and hypertension. Long-term weight loss in epidemiological studies was also associated with reduced risk of developing diabetes, and may be beneficial for cardiovascular disease. Low-fat

2004 Health Technology Assessment (HTA) Database.

353. Review: counselling, pharmacotherapy, and surgery help obese adults lose weight Full Text available with Trip Pro

more than controls at 12–54 mo). In the other 5 RCTs, 1 high intensity intervention was better than another. Moderate intensity interventions showed mixed results (2 RCTs), and 2 of 3 low intensity interventions were ineffective. Drug treatments. Sibutramine was moderately effective (7 RCTs, weight loss 2.8–4.2 kg at 8–52 wk) as was orlistat (10 RCTs, mean loss 3.5 kg at 1 to 2 y). 18 additional RCTs were consistent with the systematic review. Sibutramine led to weight loss of 2.8 kg (95% CI 1.6 (...) to 4.0) to 7.8 kg (CI 5.9 to 9.7) more than placebo (6 RCTs). Orlistat (120 mg 3 times/d) led to a weight loss of 2.8 kg (CI 1.8 to 4.5) to 4.5 kg (CI not calculable) more than placebo (6 RCTs). 1 RCT showed a non-significant difference in favour of orlistat. Evidence for metformin was mixed. 1 RCT showed that sibutramine led to greater weight loss (13.4 kg) than orlistat (8 kg) or metformin (9 kg). Long term adverse events were not reported. Surgical approaches. 3 systematic reviews compared

2005 Evidence-Based Medicine

354. Treatment of obesity with bariatric surgery: evidence and implications

, and depression, as well as decreased quality of life. Non-surgical therapy for obesity Therapy for obesity has included dieting, exercise, and medications. However, reduction in caloric intake combined with exercise typically results in 5-10% reduction in weight (roughly 10-15 pounds) over a number of months, which is rarely sustained. There are no truly effective pharmacologic therapies for obesity; the only currently FDA-approved compounds, sibutramine (trade name Meridia), orlistat (trade name Xenical

2007 Clinical Correlations

355. Obesity - problems and interventions</a>

than conventional low energy diets. In studies of VLCD for 1 to 2 years, where the treatment was often periodic, authors note a retained weight loss of a few kilograms more than in treatment using a balanced diet alone (VLCD = Very Low Calorie Diet, based on protein formulas). Pharmacological treatment using orlistat (Xenical®) or sibutramine (Reductil®) yields an average weight loss of 2 to 5 kg beyond that which would be attained through diet and exercise alone. In clinical trials, one fourth

2002 Swedish Council on Technology Assessement

356. Review: several pharmacological therapies promote modest weight loss Full Text available with Trip Pro

in patients with body mass index ⩾27 kg/m 2 and reported ⩾6 month weight outcomes. Study quality was assessed using the 5 point Jadad scale (5 = highest quality) and considered study design, method of random assignment, blinding, and withdrawal. Outcomes: weight loss and side effects. MAIN RESULTS The studies meeting inclusion criteria were 3 existing meta-analyses (39 RCTs) evaluating sibutramine, phentermine, and diethylpropion, and 47 RCTs that evaluated orlistat, bupropion, topiramate, and fluoxetine (...) . All comparisons were with placebo, and most trials had a hypocaloric diet cointervention. Meta-analyses were done using random effects. Most medications led to modest weight loss compared with placebo; side effects varied by drug (table). View this table: Medical therapies v placebo for obesity* CONCLUSION On average, sibutramine, phentermine, orlistat, diethylpropion, bupropion, topiramate, and fluoxetine led to 1–7 kg of weight loss by 6 months in obese adults with body mass index ⩾27 kg/m 2

2006 Evidence-Based Medicine

357. Long-term pharmacotherapy for obesity and overweight. (Abstract)

or compared two or more anti-obesity drugs 3) used an intention-to-treat analysis, and 4) had a minimum follow-up period of one year. Abstracts and pseudo-randomised trials were not included.Two reviewers independently assessed all potentially relevant citations for inclusion and methodological quality. The primary outcome measure was weight loss.Of the eight anti-obesity agents investigated, only orlistat and sibutramine trials met inclusion criteria. Eleven orlistat weight loss studies (four of which (...) reported a second year weight maintenance phase) and five sibutramine studies (three weight loss and two weight maintenance trials) were included. Attrition rates averaged 33% during the weight loss phase of orlistat trials and 43% in sibutramine studies. All patients received lifestyle modification as a co-intervention. Compared to placebo, orlistat-treated patients lost 2.7 kg (95% CI: 2.3 kg to 3.1 kg) or 2.9% (95% CI: 2.3 % to 3.4%) more weight and patients on sibutramine experienced 4.3 kg (95% CI

2003 Cochrane

358. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of orlistat in the management of obesity

were 10, 30, 50, 60, 120 and 240 mg t.d.s.; of these, doses of 60 and 120 mg t.d.s. were the most common. Trials that combined the use of orlistat with other weight reduction or maintenance therapies were eligible for inclusion. While comparisons with placebo interventions, alternative medicines, exercise or behaviour modification were eligible for inclusion, only placebo-controlled trials were located. The review had intended to assess the use of both orlistat and sibutramine, but since the latter (...) of the clinical effectiveness and cost-effectiveness of orlistat in the management of obesity. Health Technology Assessment 2001; 5(18): 1-81 Original Paper URL Other publications of related interest O'Meara S, Riemsma R, Shirran L, Mather L, ter Riet G. The clinical effectiveness and cost-effectiveness of sibutramine in the management of obesity. Health Technol Assess 2000;6(6):1-97. Indexing Status Subject indexing assigned by NLM MeSH Anti-Obesity Agents /therapeutic use; Cost-Benefit Analysis; Drug

2001 DARE.

359. Obesity - problems and interventions

on protein formulas). - Pharmacological treatment using orlistat (Xenical) or sibutramine (Reductil) yields an average weight loss of 2 to 5 kg beyond that which would be attained through diet and exercise alone. In clinical trials, one fourth to one fifth of those who started pharmacological treatment lost at least 10% in weight compared to half as many of those treated with placebo. - The major problem is that weight loss is not usually permanent. Within a few years most who had initially succeeded

2002 Health Technology Assessment (HTA) Database.

360. Pharmacological approaches to weight loss in adults

: Institute for Clinical Systems Improvement (ICSI) 2003 Authors' objectives This review aims to assess the available evidence on the effectiveness of pharmacological approaches to weight loss in adults. Authors' conclusions With regard to pharmacological approaches to weight loss, the ICSI Technology Assessment Committee finds: Sibutramine is safe for most patients. However, due to concerns about hypertension and cardiovascular disease related to sibutramine use, blood pressure and pulse rate should (...) be monitored at regular intervals to identify those patients who experience clinically significant increases in blood pressure or pulse rate during treatment. Orlistat is safe for most patients. Gastrointestinal side effects are common but the frequency and severity decrease over time (typically after 1 week) and can be reduced by careful attention to the dietary fat content. As an adjunct to intensive nutritional and lifestyle changes, both orlistat and sibutramine are associated with greater weight loss

2003 Health Technology Assessment (HTA) Database.

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