Cost-effectiveness of sibutramine in the treatment of obesity.

BACKGROUND: This study reports incremental cost-utility of sibutramine compared to diet and lifestyle advice for the treatment of obesity. METHOD: The model estimates the costs and quality of life benefits associated with weight loss itself and the reduced incidence of coronary heart disease (CHD) and diabetes in the "healthy obese." The key source of effectiveness data is 2 randomized controlled trials over 12 months. Utility gain per kilogram lost is analyzed using Short Form-36 data from sibutramine trials. The impact on CHD is estimated using the Framingham risk equation, which relates age/sex/body mass index to risk of heart disease. The reduced incidence of diabetes due to weight loss is estimated from published literature. A life tables approach was used to calculate the cost per quality-adjusted life year (QALY) of 1 year's treatment with sibutramine compared to diet and lifestyle advice. RESULTS: The incremental cost per QALY of sibutramine is 4,780 UK pounds. Sensitivity analyses show that this result is sensitive to utility associated with weight loss and the frequency of monitoring. CONCLUSIONS: Sibutramine is a cost-effective treatment for obesity when combined with diet and lifestyle advice.     

Management of obesity as a chronic disease: nonpharmacologic,pharmacologic, and surgical options

The successful management of obesity requires a long-term approach that is tailored to an individual's lifestyle and needs. Initial treatment should focus on lifestyle modifications-dietary interventions and increased physical activity-with behavioral modification strategies used adjunctively. Several antiobesity drugs are approved by the Food and Drug Administration for use in obese patients, as well as in overweight individuals with at least one obesity-related comorbidity. Most are approved only for short-term weight loss, but sibutramine and orlistat are approved for long-term weight loss and maintenance. In addition to weight reduction, in clinical trials these drugs provided beneficial actions on several cardiovascular risk factors. Several other drugs currently approved for other uses show promise in their ability to cause weight loss. Surgical options should be reserved for severely obese patients with significant medical comorbidities or physical conditions.     

Effects of sibutramine plus orlistat in obese women following 1 year of treatment by sibutramine alone: a placebo-controlled trial

OBJECTIVE: This study assessed whether adding orlistat to sibutramine would induce further weight loss in patients who previously had lost weight while taking sibutramine alone. RESEARCH METHODS AND PROCEDURES: Patients were 34 women with a mean age of 44.1 +/- 10.4 years, weight of 89.4 +/- 13.8 kg, and body mass index (BMI) of 33.9 +/- 4.9 kg/m2 who had lost an average of 11.6 +/- 9.2% of initial weight during the prior 1 year of treatment by sibutramine combined with lifestyle modification. Patients were randomly assigned, in double-blind fashion, to sibutramine plus orlistat or sibutramine plus placebo. In addition to medication, participants were provided five brief lifestyle modification visits during the 16-week continuation trial. RESULTS: Mean body weight did not change significantly in either treatment condition during the 16 weeks. The addition of orlistat to sibutramine did not induce further weight loss as compared with treatment by sibutramine alone (mean changes = +0.1 +/- 4.1 kg vs. +0.5 +/- 2.1 kg, respectively). DISCUSSION: These results must be interpreted with caution because of the study's small sample size. The findings, however, suggest that the combination of sibutramine and orlistat is unlikely to have additive effects that will yield mean losses > or =15% of initial weight, as desired by many obese individuals.     

Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity.

OBJECTIVE: The researchers assessed the long-term weight reduction efficacy, tolerability, and safety of sibutramine used once daily in conjunction with behavior modification to treat mild to moderate obesity. STUDY DESIGN: This was a double-blind randomized placebo-controlled parallel-group comparative study of sibutramine 10 mg or 15 mg (or placebo) once daily for 1 year, given with dietary advice. POPULATION: A total of 485 obese men and women with uncomplicated obesity were included (mean age=42 years, mean body mass index=32.7 kg/m2). OUTCOMES MEASURED: The outcomes were mean weight loss, percentage losing more than 5% or 10% of their body weight, and adverse drug effects. RESULTS: Among patients completing the study, those taking sibutramine 10 mg or 15 mg had greater mean weight loss compared with placebo at 12-month assessment (P < or = .001). Changes in body weight from baseline to end point were -1.6 kg for those taking placebo, -4.4 kg for those taking sibutramine 10 mg (P < or =.01, last observation carried forward [LOCF]), and -6.4 kg for those taking sibutramine 15 mg (P < or =.001, LOCF). For placebo patients, 20% lost 5% or more of their body weight compared with 39% of patients taking sibutramine 10 mg and 57% taking sibutramine 15 mg. Only 7% of the patients taking placebo lost 10% or more of their body weight, compared with 19% taking sibutramine 10 mg and 34% taking sibutramine 15 mg (P <.001 for both 10 mg and 15 mg vs placebo, and for both > or =5% and > or =10%). CONCLUSIONS: Sibutramine 10 mg or 15 mg once daily given with dietary advice produces and maintains statistically and clinically significantly greater weight loss than dietary advice alone (placebo) throughout a 12-month treatment period, and is safe and well tolerated.     

Use of sibutramine to assist obese women with weight loss can be successful in dietitian-led clinics: another tool in the dietitian's toolbox

Background  This study investigated differences in weight loss outcomes in obese women with Type 2 diabetes (T2D) compared to those without T2D attending a 6-month dietetic led 'Lifestyle' intervention. In those who had failed to reach weight loss goals using the 'Lifestyle' approach, the study further examined the effect on weight loss with the addition of sibutramine (Reductil^®, Abbott Laboratories, USA) over a 6-month period.
Methods  The study comprised a case–control analysis of data from 38 obese female patients (18 with T2D) from the 'Lifestyle' and 'Pharmacotherapy' clinics attending a tertiary hospital in the UK.
Results  In the 'Lifestyle' treatment groups, those with T2D lost significantly less body weight than those without T2D [5.26 kg (4.54%) versus 9.89 kg (9.55%), respectively]. For subjects who had failed to lose weight via the 'Lifestyle' intervention, the addition of sibutramine resulted in a similar weight loss compared to their pair-matched 'Lifestyle' only 'successful' counterparts (9.66% versus 9.55%).
Conclusions  Not all obese women, and those with T2D in particular, will derive benefit from 'Lifestyle' advice and those who are resistant to this treatment approach may be assisted by pharmacotherapy. Dietitians can play a role in identifying those individuals who may benefit from the use of pharmacotherapy.     

Predictors of weight control advice in primary care practices: patient health and psychosocial characteristics

BACKGROUND: Past research has surveyed primary care physicians (PCP) about their attitudes and practices towards obese patients, yet less is known about the patients receiving advice. METHODS: The Primary Care Weight Control Project (PCWC) enrolled 18 PCPs in a randomized clinical trial and asked 255 of their patients who were either overweight or obese at baseline about past weight control advice. RESULTS: At baseline, 66.4% of patients reported that their physician previously told them they were overweight. Body mass index (BMI) was a strong predictor of being identified as obese. While 65.1% received information on the health benefits of weight loss, only 36.6% of patients were ever given specific weight control advice, and 28.2% were advised to increase their physical activity. A history of type 2 diabetes, high cholesterol, or hypertension was associated with physician-delivered weight control advice. Stages of change and number of prior visits with the PCP were also associated with physician advice. CONCLUSIONS: Patients were more likely to receive education about weight loss than specific behavioral advice on how to lose weight. Physicians were more likely to provide weight control advice to their patients who had obesity-related comorbidities than to patients who were overweight or obese and without risk factors.     

Practice guideline for the treatment of morbid obesity

The increasing prevalence of obesity and its related comorbidities represents an increasing burden for the Dutch health care and requires effective therapy. The primary treatment of obesity consists of lifestyle interventions directed at lifestyle change; in morbidly obese subjects only bariatric surgery is cost-effective in the long term, with respect to both weight loss and reduction in comorbidity. There is a new Dutch multidisciplinary practice guideline on the treatment of morbid obesity, in which the following aspects are covered: indications for surgery, pre-operative policy advice, considerations for the type of operation, and the short and long term follow-up after bariatric surgery. Patients between 18 and 65 years old are eligible for bariatric surgery if they have a BMI ≥ 40 kg/m2 or a BMI ≥ 35 kg/m2 in the presence of comorbidity. In adolescents under 18 bariatric surgery should only be performed in a research setting; in patients older than 65 years bariatric surgery can be performed exceptionally, preferably in a centre with large experience.     

Sibutramine treatment in obesity: predictors of weight loss including rorschach personality data

OBJECTIVE: To study personality and clinical factors in weight loss by sibutramine (Meridia and Reductil), an anti-obesity drug enhancing satiety. RESEARCH METHODS AND PROCEDURES: The subjects were 30 obese patients [43 +/- 12 years (mean +/- SD), BMI 40 +/- 4 kg/m(2)]. The treatment comprised 15 mg of sibutramine administered daily and monthly dietary advice. Weight loss after 6 months of treatment was evaluated. For psychological assessment, the Rorschach method (Comprehensive System) and the Beck Depression Inventory were used. RESULTS: A multiple linear regression model including the Rorschach predictors' physical demand states (animal movement, designated as FM) being intrusive or difficult to hold and a dependency orientation (food contents) could explain 47% of 6 months of weight loss. A model including initial weight loss in addition to the Rorschach predictors explained 58% of the 6-month weight loss. DISCUSSION: The personality factors predicted greater weight loss. In particular, patients with difficulties concerning physical demand states, which would include hunger, could have reduced their eating behavior with enhanced satiety, resulting in greater weight loss. Enhanced satiety could also have helped patients with a dependent need for food to limit food intake. Being enrolled in a treatment program could also have provided essential support for patients with dependency needs. Furthermore, initial weight loss was a predictor of greater weight loss in sibutramine treatment, in accordance with prior research.     

Health Care Providers' Advice on Lifestyle Modification for Older Adults

ObjectivesTo describe the pattern of health care providers' advice on lifestyle modification to older adults, and identify correlates of receiving such advice.DesignCross-sectional survey.Setting and participantsData from the National Health and Nutrition Examination Survey study from 2007-2016 on adults ≥65 years (n = 3758) were analyzed.MethodsWe estimated the weighted prevalence and correlates of receiving advice on the following lifestyle modifications: (1) increase physical activity, (2) reduce fat/calories, (3) control/lose weight, and (4) a combination of control/lose weight and physical activity. Data were analyzed according to level of comorbidity (number of chronic conditions including high blood pressure, high blood cholesterol, type 2 diabetes mellitus, coronary heart disease, and arthritis) and body mass index (BMI).ResultsPhysical activity was the most widely prescribed lifestyle modification, reported by 15.7% of older adults free of chronic conditions and 28.9%, 35.4%, and 52.6% of older adults with 1, 2, and ≥3 comorbidities. Advice on reducing fat/calories was reported by 9.2%, 18.5%, 26.3%, and 40.9% of older adults with 0, 1, 2, and ≥3 comorbidities, respectively, and advice on weight loss/control was reported by 6.5%, 19.1%, 20.8%, and 37.5%, respectively. The combination of advice on weight loss/control and physical activity was least commonly reported: 5.1%, 13.5%, 16.6%, and 32.0%, respectively. Overall, lifestyle modifications were more frequently advised to older adults who were overweight, obese, or Hispanic.Conclusions and implicationsIn the United States, lifestyle modifications are not routinely recommended to older adults, particularly those free of chronic conditions, presenting a missed opportunity for chronic disease prevention and management. Among those advised to lose or manage weight, concurrent advice to increase physical activity is not consistently provided.     

What interventions should we add to weight reducing diets in adults with obesity? A systematic review of randomized controlled trials of adding drug therapy,exercise, behaviour therapy or combinations of these interventions

BACKGROUND: Evidence is needed for the effectiveness of interventions given with reducing diets for obese adults: drug therapy, exercise, or behaviour therapy. METHODS: We systematically reviewed randomized controlled trials in any language. We searched 13 databases and handsearched journals. Trials lasted 1 year or more. One investigator extracted data and a second checked data extraction. Trial quality was assessed. RESULTS: Adding orlistat to diet was associated with weight change for up to 24 months (-3.26 kg, 95% CI, -4.15 to -2.37 kg), and statistically significant beneficial changes were found for total and LDL cholesterol, blood pressure and glycaemic control. Adding sibutramine to diet was associated with a 12 month weight change of -4.18 kg (95% CI, -5.14 to -3.21 kg), and statistically significant beneficial effects on high density lipoprotein cholesterol (HDL) and triglycerides (TGs), but an increase in diastolic blood pressure. Adding exercise to diet, or to diet and behaviour therapy, was associated with improved weight loss for up to 36 months and improvements in HDL, TGs and blood pressure. Adding behaviour therapy to diet, or to diet and sibutramine together, was associated with improved weight loss for up to 18 months. Adding drugs, exercise or behaviour therapy to dietary advice was each associated with similar weight change. CONCLUSIONS: Adding orlistat, sibutramine, exercise, or behaviour modification to dietary advice can improve long-term weight loss.     

A cost utility analysis of treatment options for gallstone disease: Methodological issues and results

The techniques of cost utility analysis (CUA) were used to evaluate the treatment of gallstone disease by open and laparoscopic cholecystectomy and by extracorporeal shockwave lithotripsy (ESWL). The application of the techniques in this context raised three methodological questions which are not satisfactorily resolved in the literature. The first is whether an ex ante or ex post perspective is best adopted for the measurement of quality of life (QoL). The second is the method for converting a short term deterioration in QoL followed by full health into QALYs and the reliability of the methods available. The third is the issue of indirect costs which, in the context of a temporary disease state, cannot be easily avoided. The economic evaluation found laparoscopic cholecystectomy to be generally superior than the competitor technologies (entailing lower costs and better outcomes). However, the results were sensitive to assumptions about the perspective for measuring benefits and the inclusion of indirect costs.     

Modelling the lifetime costs and health effects of lifestyle intervention in the prevention and treatment of obesity in Switzerland

Summary Aim: To quantify the lifetime health and economic consequences of preventing and treating obesity with lifestyle intervention in Switzerland. Methods: A Markov model was developed comparing lifestyle intervention and standard care in overweight and obese people. Changes in weight and cardiovascular risk factors over time were modeled from reduction in body mass index, systolic blood pressure, total cholesterol and high density lipoprotein in three-year active treatment period. A probabilistic sensitivity analysis was performed. Three groups of people were followed in the analysis: overweight, borderline and moderate obese. The cost-effectiveness of interventions was compared using incremental cost-effectiveness ratio. Results: Lifestyle intervention resulted in increased survival duration and quality of life over lifetime. Compared with standard care, the average incremental cost of lifestyle intervention was lower in borderline and obese and higher in overweight. Lifestyle intervention dominated standard care in borderline female age 35 to 55 years, borderline male age 25 to 60 years, obese female age 45 years and obese male age 55 years. Conclusion: Our economic analysis suggests that lifestyle intervention is cost-effective in the long-term prevention and treatment of obesity. Submitted: 18 October 2006; Revised: 11 May 2007; Accepted: 22 May 2007     

Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up

OBJECTIVE: To assist health professionals who counsel patients with overweight and obesity, a systematic review was undertaken to determine types of weight-loss interventions that contribute to successful outcomes and to define expected weight-loss outcomes from such interventions. DESIGN: A search was conducted for weight-loss-focused randomized clinical trials with >or=1-year follow-up. Eighty studies were identified and are included in the evidence table. OUTCOMES MEASURES: The primary outcomes were a measure of weight loss at 6, 12, 24, 36, and 48 months. Eight types of weight-loss interventions-diet alone, diet and exercise, exercise alone, meal replacements, very-low-energy diets, weight-loss medications (orlistat and sibutramine), and advice alone-were identified. By using simple pooling across studies, subjects mean amount of weight loss at each time point for each intervention was determined. STATISTICAL ANALYSES PERFORMED: Efficacy outcomes were calculated by meta-analysis and provide support for the pooled data. Hedges' gu was combined across studies to obtain an average effect size (and confidence level). RESULTS: A mean weight loss of 5 to 8.5 kg (5% to 9%) was observed during the first 6 months from interventions involving a reduced-energy diet and/or weight-loss medications with weight plateaus at approximately 6 months. In studies extending to 48 months, a mean 3 to 6 kg (3% to 6%) of weight loss was maintained with none of the groups experiencing weight regain to baseline. In contrast, advice-only and exercise-alone groups experienced minimal weight loss at any time point. CONCLUSIONS: Weight-loss interventions utilizing a reduced-energy diet and exercise are associated with moderate weight loss at 6 months. Although there is some regain of weight, weight loss can be maintained. The addition of weight-loss medications somewhat enhances weight-loss maintenance.     

Prevalence of weight cycling and its relation to health indicators in Finland

OBJECTIVE: This study was performed to identify weight cyclers and to assess the prevalence of weight cycling and its relation to health indicators in Finnish adults. RESEARCH METHODS AND PROCEDURES: Data for the study consisted of 3320 men and 3540 women (25 to 64 years of age). The subjects went through a health examination, and data on intentional weight losses and regains during the last 10 years were collected by a questionnaire. The subjects were divided into five groups: severe weight cyclers (weight loss >/= 5 kg at least three times with regain), mild weight cyclers (weight loss >/= 5 kg one to two times and regain), successful dieters (weight loss >/= 5 kg with no regain), nonobese nondieters, and obese nondieters. RESULTS: Approximately 7% of men and 10% of women were defined as severe weight cyclers, and an additional 11% and 19% were defined as mild weight cyclers, respectively. In men, 20% of severe weight cyclers and 15% of obese nondieters perceived their health as poor, whereas in other groups, these proportions were <10%. In both sexes, severe weight cyclers seemed to have visited a doctor more frequently than nonobese nondieters. Severe weight cyclers were also more likely to use some medication compared with other groups. DISCUSSION: Weight cycling is more common in women than in men, and it seems to be associated with more regular visits to a doctor and poor self-perceived health. However, because of the cross-sectional design of the study, causal conclusions cannot be drawn.     

Impact of Nutrition and Physical Activity Interventions Provided by Nutrition and Exercise Practitioners for the Adult General Population: A Systematic Review and Meta-Analysis

Healthy dietary intake and physical activity reduce the risk of non-communicable diseases. This systematic review and meta-analysis aimed to examine the effect of interventions including both nutrition and physical activity provided by nutrition and exercise practitioners for adults in the general population (those without diagnosed disease). The MEDLINE, CINAHL, Cochrane Central, Cochrane Database of Systematic Reviews and SportDiscus databases were searched for randomized controlled trials (RCTs) published from 2010 until April 2021. Outcomes included physical activity, fruit and vegetable intake, waist circumference, percent weight loss, quality of life (QoL) and adverse events. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods were used to synthesize and grade evidence. Meta-analyses were stratified according to participant health status. The database search identified 11,205 articles, and 31 RCTs were included. Interventions increased physical activity amount [standardized mean difference (SMD) (95% CI): 0.25 (0.08, 0.43)] (low certainty evidence); increased vegetable intake [SMD (95% CI): 0.14 (0.05, 0.23)] (moderate certainty evidence); reduced waist circumference [MD (95% CI): −2.16 cm (−2.96, −1.36)] (high certainty evidence); and increased likelihood of achieving 5% weight loss for adults with overweight and obesity [relative risk (95% CI): 2.37 (1.76, 3.19)] (high certainty evidence). Very low and low certainty evidence described little-to-no effect on QoL or adverse events. Nutrition and exercise practitioners play key roles in facilitating positive lifestyle behaviors to reduce cardiometabolic disease risk in adults.     

The contributions of weight loss and increased physical fitness to improvements in health-related quality of life

The relative contribution of obesity versus poor fitness to adverse health outcomes and diminished quality of life remains an area of controversy. Indeed, some researchers contend that poor cardiorespiratory fitness represents a greater threat to health and health-related quality of life than excess body weight. We addressed this issue by providing 298 obese 50–75 year-old women with a six-month lifestyle intervention that incorporated a low-calorie eating pattern coupled with an aerobic exercise program consisting of 30 min/day of brisk walking. The results showed that weight loss exhibited a significant individual contribution to improvements in seven of the nine domains of quality of life assessed by the Medical Outcomes Study Short Form (SF-36). With the exception of physical functioning, however, physical fitness did not significantly contribute to improvements beyond the effects weight loss. Moreover, weight loss functioned as a full mediator of the association between increases in physical fitness and improvements in general health, vitality, and change in health relative to the previous year. Collectively, these findings suggest that for treatment-seeking obese individuals, weight loss rather than increased fitness contributes significantly to improvements in health-related quality of life.     

Is Quality of Life Related to Cardiorespiratory Fitness in Overweight and Obese Breast Cancer Survivors?

This study assessed changes in quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the relation between these changes. The intervention of this single-arm pre-post study involved supervised, 1-hour weekly, diet sessions and 75-minute bi-weekly PA sessions of moderate-to-high intensity. This 12-week intervention targeted overweight/obese women who had recently completed BC treatment. Pre- and post-CRF and QoL measurements were compared using paired t-tests. Linear regression models, including baseline participants’ characteristics and weight change, were used to assess the association between changes in CRF and QoL. The 37 BC survivors who completed the intervention between May 7, 2012 and July 27, 2012 showed significant increases in CRF and QoL. Peak oxygen uptake (mL/kg/min) increased from 19.0 ± 2.8 to 24.0 ± 4.1 while peak workload (watts/kg) increased from 1.3 ± 0.3 to 1.7 ± 0.3. Although statistical significance was not reached, the increase in workload seemed associated with increases in physical, mental, and general health and with a decrease in fatigue. This lifestyle intervention improved BC survivors’ QoL and CRF and suggested possible relationships between CRF and QoL. More research needs to confirm these associations and promote lifestyle interventions aiming at improving BC survivors’ QoL.     

Obesity and quality of life

The focus of this review is the impact of obesity and weight loss on quality of life. A focus on quality of life broadens the scope of treatment efficacy beyond weight loss and provides a patient-centered perspective. The concept of quality of life is defined, and both general and obesity-specific measures are reviewed. It is clear that obesity confers negative consequences on both the physical and psychosocial aspects of quality of life, especially among the severely obese. The effects of weight loss appear to be favorable, although few studies have examined non-surgical interventions. Future studies would be enhanced by assessing a variety of approaches to weight loss by using both general and obesity-specific measures of quality of life and conducting follow-up studies to assess the effects of weight regain on quality of life.     

Pharmacotherapy for obesity

The current obesity pandemic imposes a major global disease burden. However, sustained weight loss of between 5 and 10% in the obese confers marked health benefits. Currently available pharmacotherapies, orlistat and sibutramine, can induce weight loss of between 5 and 10% over 2 years or more. However, in these trials, drug induced weight loss tends to be only 2-4 kg greater than that produced by placebo control. Despite this, in the XENDOS trial, the modest placebo-subtract weight loss produced by orlistat (2.8 kg) reduced the incidence of diabetes by over a third. Recent data on the potential anti-obesity drug rimonabant are also reviewed.     

High-Protein,Low-Glycaemic Meal Replacement Improves Physical Health-Related Quality of Life in High-Risk Persons for Metabolic Syndrome—A Subanalysis of the Randomised-Controlled ACOORH Trial

While obesity impairs health-related quality of life (HRQOL), lifestyle interventions targeting weight reduction have been effective in improving HRQOL. Therefore, we hypothesised that a meal replacement-based lifestyle intervention, which has been shown to successfully reduce weight, would also improve HRQOL more effectively than a lifestyle intervention alone. In the international, multicenter, randomised-controlled ACOORH-trial (Almased-Concept-against- Overweight-and-Obesity-and-Related-Health-Risk), overweight or obese participants with elevated risk for metabolic syndrome (n = 463) were randomised into two groups. Both groups received telemonitoring devices and nutritional advice. The intervention group additionally used a protein-rich, low-glycaemic meal replacement for 6 months. HRQOL was estimated at baseline, after 3 and 12 months, using the SF-36 questionnaire, and all datasets providing HRQOL data (n = 263) were included in this predefined subanalysis. Stronger improvements in the physical component summary (PCS) were observed in the intervention compared to the control group, peaking after 3 months (estimated treatment difference 2.7 [1.2; 4.2]; p < 0.0001), but also in the long-term. Multiple regression analysis demonstrated that insulin levels and the achieved weight loss were associated with the mental component summary (MCS) after 12 months (p < 0.05). Thus, meal replacement-based lifestyle intervention is not only effective in weight reduction but, concomitantly, in enhancing HRQOL.