Pharmaceutical Cost Savings of Treating Obesity with Weight Loss Medications

GREENWAY, FRANK L., DONNA H. RYAN, GEORGE A. BRAY, JENNIFER C. ROOD, ELIZABETH W. TUCKER, AND STEVEN R. SMITH. Pharmaceutical cost savings of treating obesity with weight loss medications. Obes Res. Objective: To evaluate, in compliant patients, the pharmaceutical costs of treating obesity with fenfluraminel/mazindol, fenfluramine/phentermine, caffeine/ephedrine, or mazindol relative to the pharmaceutical costs of treating obesity-related comorbid conditions and reducing cardiovascular risk. Methods and Procedures: Subjects were between 18 and 60 years of age with a BMI of >30 kg/m². Pharmaceutical costs were evaluated in 73 of 220 subjects taking medications for diabetes, hyperlipidemia, or hypertension before and after treatment using fenfluramine with mazindol or phentermine. The pharmaceutical cost of weight loss, cardiac risk reduction, and low-density lipoprotein (LDL) cholesterol reduction was calculated for fenfluramine with mazindol or phentermine, caffeine with ephedrine, or mazindol alone, and compared to approved lipid-lowering medications. Results: Losses of 6% to 10% of initial body weight reduced pharmacy costs $122. 64/month for insulin treated diabetes, $42. 92/month for sulfonylurea-treated diabetes, $61. O7/month for hyperlipidemia treated with medication, and $0. 20/month for hypertension treated with medication. Blood pressure and laboratory evidence of insulin resistance improved in all medication groups. Caffeine/ephedrine was most cost-effective of the three treatments in reducing weight, cardiac risk, and LDL cholesterol. Discussion: Obesity medications produced a substantial weight loss in compliant patients and resulted in a net pharmaceutical cost savings compared to treating obesity related comorbid conditions.     

Combining Behavioral and Pharmacological Treatments for Obesity

Weight‐loss medications are currently recommended for use only as an adjunct to diet, exercise, and behavior modification. Little, however, is known about the benefits of combining behavioral and pharmacological therapies or about the mechanisms that would make these combined approaches more effective than either used alone. This article reviews the effects of adding pharmacotherapy (i.e., principally sibutramine and orlistat) to a modest program of lifestyle modification. Studies revealed that the addition of medication typically improved short‐ and long‐term weight loss compared with lifestyle modification alone. The best results, however, were obtained when medications were combined with an intensive, group program of lifestyle modification. The two approaches may have additive effects; behavioral treatment seems to help obese individuals control the external (i.e., food‐related) environment, whereas pharmacotherapy may control the internal environment by reducing hunger, cravings, or nutrient absorption. The article examines possible methods of sequencing behavioral and pharmacological therapies and offers suggestions for future research.     

Overweight and Obesity: Knowledge,Attitudes, and Practices of General Practitioners in France

Objective: To describe the current knowledge, attitudes, and practices of French general practitioners (GPs) in the field of adult overweight and obesity management. Research Methods and Procedures: A cross‐sectional telephone survey interviewed a sample of 600 GPs, representative of the private GPs in southeastern France. A four‐part questionnaire assessed personal and professional characteristics, attitudes and opinions about overweight and obesity, relevant knowledge and training, and practices (diagnostic methods, clinical assessments, weight loss objectives, types of counseling). Results: Most GPs knew that weight problems are health‐threatening, and 79% agreed that managing these problems is part of their role. Nevertheless, 58% did not feel they perform this role effectively, and one‐third did not find it professionally gratifying. Approximately 30% had negative attitudes toward overweight and obese patients; 57% were pessimistic about patients’ ability to lose weight; 64% often set weight loss objectives more demanding than guidelines call for; and neither food diaries nor nutritional education were used systematically. GPs’ feelings of effectiveness and attitudes toward obese patients were associated with some professional (training) and personal (BMI, personal diet experience) characteristics. Discussion: GPs’ feelings of ineffectiveness may stem from an underlying conflict between practitioners’ and patients’ representations of weight problems and the relationship problems this causes. Inadequate practices and health care system organization may also play a role.     

New Tools for Weight-Loss Therapy Enable a More Robust Medical Model for Obesity Treatment: Rationale for a Complications-Centric Approach

ObjectiveRecent advances in lifestyle intervention programs, pharmacotherapy, and bariatric surgery have enabled the development of medical models for the treatment of obesity. Regarding pharmacotherapy, in 2012 the U.S. Food and Drug Administration approved two new effective and safe weight-loss medications, phentermine/ topiramate extended release and lorcaserin, which has greatly augmented options for medically assisted weight loss.MethodsThe rationale for advantages of a complications-centric medical model over current body mass index (BMI)-centric indications for therapy is examined.ResultsCurrently, the baseline BMI level is the principle determinant of indications for obesity treatment using medication and surgery. However, the BMI-centric approach fails to target therapy to those obese patients who will benefit most from weight loss. In contrast, a complications-centric medical model is proposed that will earmark the modality and intensity of the therapeutic intervention based on the presence and severity of complications that can be ameliorated by weight loss.ConclusionThe complications-centric approach to “medicalizing” obesity care employs weight loss primarily as a tool to treat obesity-related complications and promotes the optimization of health outcomes, the benefit/risk ratio, and the cost-effectiveness of therapy. (Endocr Pract. 2013;19:864-874)     

Economic evaluation of weight loss interventions in overweight and obese women

Objective: To conduct a clinical and economic evaluation of outpatient weight loss strategies in overweight and obese adult U.S. women. Research Methods and Procedures: This study was a lifetime cost‐use analysis from a societal perspective, using a first‐order Monte Carlo simulation. Strategies included routine primary care and varying combinations of diet, exercise, behavior modification, and/or pharmacotherapy. Primary data were collected to assess program costs and obesity‐related quality of life. Other data were obtained from clinical trials, population‐based surveys, and other published literature. This was a simulated cohort of healthy 35‐year‐old overweight and obese women in the United States. Results: For overweight and obese women, a three‐component intervention of diet, exercise, and behavior modification cost $12,600 per quality‐adjusted life year gained compared with routine care. All other strategies were either less effective and more costly or less effective and less cost‐effective compared with the next best alternative. Results were most influenced by obesity‐related effects on quality of life and the probabilities of weight loss maintenance. Discussion: A multidisciplinary weight loss program consisting of diet, exercise, and behavior modification provides good value for money, but more research is required to confirm the impacts of such programs on quality of life and the likelihood of long‐term weight loss maintenance.     

The Relationship of Health Outcomes to Improvement in BMI in Children and Adolescents

Objective: To evaluate the clinical outcomes of patients participating in an outpatient program for managing childhood and adolescent obesity. Research Methods and Procedures: Based on a retrospective chart review, 394 physician‐referred obese youth (BMI > 95th percentile), 5 to 19 years of age, were treated in an interdisciplinary, family‐centered, behavioral weight management program in a hospital‐based outpatient setting. Treatment included group exercise, parent education, and behavioral intervention therapies to improve diet and physical activity. Results: A total of 177 (45%) completed the initial phase of treatment (mean duration = 5.6 months). For the completion group, there were significant improvements (all p < 0.001) in weight (?2.0 ± 4.9 kg), BMI (?1.7 ± 1.9 kg/m²), and BMI z score (?0.15 ± 0.15), without interfering with growth (height, 2.2 ± 1.3 cm; p < 0.001). Significant improvement was also found for blood pressure, total cholesterol, low‐density lipoprotein (LDL)‐cholesterol, triglycerides, insulin, and aerobic fitness. At onset of treatment, 134 (84%) patients had abnormal fasting insulin concentration, 88 (50%) had abnormal total cholesterol, 14 (8%) had abnormal diastolic blood pressure, and 69 (40%) had abnormal LDL‐cholesterol. At the end of treatment, a significant proportion of patients with baseline abnormal blood pressure, total cholesterol, and LDL‐cholesterol had normal values (p < 0.001). A decrease in BMI z score was associated with significant improvements in insulin and lipid values (all p < 0.05). Discussion: We have demonstrated that a modest decrease in BMI in an ongoing clinical pediatric weight management program is accompanied by significant improvements in related health measures. These results may be helpful in counseling families with overweight children and adolescents.     

Relationship between Body Mass Index and the Use of Healthcare Services in Australia

Objective: To examine the relationship between body mass index (BMI) and the use of medical and preventive health services. Research Methods and Procedures: This study involved secondary analysis of weighted data from the Australian 1995 National Health Survey. The study was a population survey designed to obtain national benchmark information about a range of health‐related issues. Data were available from 17,033 men and 17,174 women, ≥20 years or age. BMI, based on self‐reported weight and height, was analyzed in relation to the use of medical services and preventive health services. Results: A positive relationship was found between BMI and medical service use, such as medication use, visits to hospital accident and emergency departments (for women only); doctor visits, visits to a hospital outpatient clinics; and visits to other health professionals (for women only). A negative relationship was found in women between BMI and preventive health services. Underweight women were found to be significantly less likely to have Papanicolaou smear tests, breast examinations, and mammograms. Discussion: This research shows that people who fall outside the healthy weight range are more likely to use a range of medical services. Given that the BMI of industrialized populations appears to be increasing, this has important ramifications for health service planning and reinforces the need for obesity prevention strategies at a population level.     

Lifestyle Modification in the Pharmacologic Treatment of Obesity: A Pilot Investigation of a Potential Primary Care Approach

This study examined a new method of providing brief, individual lifestyle modification to obese individuals treated by pharmacotherapy. Twenty-six women with a mean (±SD) age of 47.0 ± 7.2 years, weight of 97.6 ± 13.0 kg, and body mass index of 36.5 ± 5.0 kg/m² were prescribed 60 mg/d of fenfluramine and 15 mg/d of phentermine for one year. In addition, half of the women were randomly assigned to traditional group behavior modification, conducted by a nutritionist, which included 32 75-minute sessions during the year. The other half were provided lifestyle modification by a physician during 10 15–20 minute structured visits. All participants received identical treatment manuals and comparable assignments for behavior change. At the end of one year, patients in the physician group achieved the same highly successful weight losses as those treated by group behavior modification (13.9 ± 9.6 kg vs. 15.4 ± 7.9 kg, respectively). Treatment was associated with highly significant improvements in lipids and lipoproteins, as well as in mood and several measures of appetite. Weight loss the first four weeks, as well as patient completion of daily food records during the first 18 weeks, correlated positively with weight loss at weeks 18, 26, and 52. Results of this study await replication using larger samples but strongly suggest that effective lifestyle modification can be provided during brief, structured physician visits. The findings are discussed in terms of their implications for the treatment of obesity in primary care practice.     

Diabetes in Urban African Americans. XII. Anthropometry for Assessing Municipal Hospital Outpatients Recently Diagnosed with Type 2 Diabetes

Objective : Abdominal obesity is associated with insulin resistance and cardiovascular risk factors, but there has been little information published to advance the use of abdominal anthropometry in the care of diabetic patients. Research Methods and Procedures : A cross-sectional survey of municipal hospital outpatients recently diagnosed with type 2 diabetes (73 men and 142 women of whom 89% were African Americans). Age-adjusted linear regression was used to compare the supine sagittal abdominal diameter (SAD), supine waist circumference, four anthropometric ratios, and the body mass index (kg/m²) for their ability to predict serum fasting C-peptide and lipid levels. Results : The best predictor of log-transformed C-peptide was SAD/height (p<0.0001 for men; p = 0.0003 for women). SAD/thigh circumference was the best predictor of log-transformed triglycerides for men (p = 0.002) and of total cholesterol/HDL cholesterol for women (p = 0.043). The body mass index was less able to predict C-peptide, HDL cholesterol and total cholesterol/HDL cholesterol than was SAD/height or SAD/thigh circumference or waist circumference/height. Discussion : Anthropometric indices of abdominal obesity appear to be correlated with insulin production and lipid risk factors among municipal-hospital, type 2 diabetic patients much as they are in other studied populations. Since anthropometric data are inexpensively obtained and immediately available to the practitioner, their utility for preliminary clinical assessment deserves to be tested in prospective outcome studies.     

The Fen-Phen Finale: A Study of Weight Loss and Valvular Heart Disease

Objective : To assess weight loss, as well as the prevalence of valvular heart disease, in 21 obese women who completed 2 years of treatment by fenfluramine and phentermine (fen-phen) in June 1997. Research Methods and Procedures : Patients were 21 of 22 women who had completed a 1-year, open-label trial of fen-phen combined with lifestyle modification. This study describes the results of a second year of treatment. The presence of valvular heart disease, defined as aortic regurgitation of mild or greater severity and/or mitral regurgitation of moderate or greater severity, was assessed using two-dimensional, color Doppler and pulsed- and continuouswave Doppler examinations. Results : At 2 years, the 21 patients had a mean reduction in initial weight of 13.9 ±10.1%, which was significantly (p<<0.001) smaller than their 1-year loss of 17.1 ±8.7%. Nine of 21 patients reported that they took fen-phen irregularly during the last 4 months of the study because of fears of developing health complications. These nine patients had a 2-year weight loss of 8.7 ± 7.5%, compared with a significantly (p<0.04) larger loss of 17.6 ± 10.5% for participants who reported taking medication regularly. Six of 20 (30%) patients met criteria for valvular heart disease. None of the six had signs or symptoms of this condition. Discussion : Fenfluramine was withdrawn from the market on September 15, 1997 because of concerns that it was associated with valvular heart disease. The present findings are discussed in terms of the potentially favorable long-term benefits of combining lifestyle modification with weight loss medications that are both safe and effective.     

Provider Practice Habits And Barriers To Care In Obesity Management In A Large Multicenter Health System

Objective: To identify provider recommendations and barriers in obesity management in a multicenter academic health system with extensive weight-loss management resources.Methods: A 26-question online survey was sent to attending physicians, trainees, and advanced practice providers in primary care specialties (internal medicine, family medicine, women's health) and endocrinology.Results: The survey response rate was 26% (111/430). Of respondents, 50% were internal medicine, 24% family medicine, 16% women's health, and 9% endocrinology. The majority were attending physicians (54%) and residents (40%). About 50% of respondents advised weight loss for a body mass index (BMI) >30 kg/m² in >50% of clinic visits. Limited time (82%) was the most common reason for not discussing weight loss, followed by the perception that discussion would not change patient behavior, insufficient knowledge, and discomfort broaching the subject. Common barriers to prescribing anti-obesity medications included limited experience (57%) and concern for adverse reactions (26%). Only 44% offered bariatric surgery to >50% of their patients who met criteria. Primary reasons for not referring included concerns of high surgical risk from comorbidities (57%) and potential adverse events (32%). Endocrinology had the highest referral to surgery. Attending physicians and fellows were more likely than residents to advise weight loss at lower BMI, offer medications, and refer to bariatric surgery.Conclusion: Our study reveals reluctance and lack of primary care confidence in managing obesity with pharmacotherapy and bariatric surgery, especially in the earlier stages of obesity. Barriers to care include lack of clinic time, limited experience, and concerns about treatment risks.Abbreviations: BMI = body mass index; HbA1c = hemoglobin A1c; IRB = Institutional Review Board     

Prevalence of Pre‐obesity and Obesity in Urban Adult Mexicans in Comparison with Other Large Surveys

Objective: 1. To estimate the prevalence of pre‐obesity and obesity in a 1992 to 1993 national survey of the Mexican urban adult population. 2. To compare our findings with other national surveys and with data for Mexican Americans. Research Methods and Procedures: The national representative sample of the Mexican urban adult population included 8462 women and 5929 men aged 20 to 69 years from 417 towns of >2500 people. Body mass index (BMI), calculated from measured weight and height, was classified using the World Health Organization categories of underweight (BMI < 18.5 kg/m²), normal weight (BMI 18.5 to 24.9 kg/m²), pre‐obesity (PreOB = BMI 25 to 29.9 kg/m²) and obesity (OB = BMI 30+ kg/m²). Estimates for Mexican Americans were calculated from U.S. survey data. Results: Overall, 38% of the Mexican urban adult population were classified as pre‐obese and 21% as obese. Men had a higher prevalence of pre‐obesity than women did at all ages, but women had higher values of obesity. Both pre‐obesity and obesity increased with age up to the age range brackets of 40 to 49 or 50 to 59 years for both men and women. Both pre‐obesity and obesity prevalence estimates were remarkably similar to data for Mexican Americans from 1982 through 1984. Comparison with other large surveys showed that countries differed more in the prevalence of obesity than of pre‐obesity, leading to differences in the PreOB/OB ratio, and that countries also differed in the gender ratio (female/male) for both pre‐obesity and obesity. Discussion: Pre‐obesity and obesity were high in our population and increased with age. Our approach of characterizing large surveys by PreOB/OB and gender ratios appeared promising.     

Diabetes Disease Stage Predicts Weight Loss Outcomes with Long‐Term Appetite Suppressants

Objectives: Characterize degree of weight loss with stage of diabetes and describe its effect on cardiovascular disease risk factors in obese patients with and without diabetes. Research Methods and Procedures: Retrospective cohort analysis from patients participating in a long‐term weight management protocol using diet, exercise, behavioral modification, and appetite‐suppressant therapy. Patient groups, with (n = 19) and without diabetes (n = 19) were matched for age, gender, and weight before weight loss therapy. The effect of 12 months of therapy on weight, blood pressure, glycemic control, lipid profile, and medication requirements were tested. Additionally, patients were grouped or staged based upon therapy required for control of diabetes at the beginning of weight loss intervention. Analysis of covariance described relationships between diabetes disease stage and weight loss at 12 months. Results: Nondiabetic patients had greater mean reduction in BMI than the diabetic group (7.98 kg/m² vs. 4.77 kg/m², p < 0.01). A significant linear trend (p < 0.001) for decreasing weight loss with stage of diabetes was observed. Blood pressure, lipid profile, and glycemia improved significantly. The average daily glyburide‐equivalent dose decreased from 9.4 to 3.0 mg (p < 0.01). Discussion: Patients with diabetes lost less weight than similarly obese patients without diabetes. Regardless of differential weight loss between groups, cardiovascular disease risk factors improved. Hypoglycemic medication requirements decreased with weight loss therapy. A predictive relationship may exist between diabetes disease stage before weight loss therapy and future weight loss potential.     

A longitudinal study of medication exposure and xerostomia among older people

Objective: To describe the incidence of xerostomia among a population of older people over a 6‐year period, with particular attention to medications as risk factors. Background: Understanding the natural history of xerostomia requires longitudinal epidemiological research, but only one study has examined changes in xerostomia over time. While medication is a recognised risk factor for dry mouth, the role of particular medication categories continues to be controversial. Materials and methods: Older South Australians (aged 60+) underwent an interview and dental examination at baseline, and these assessments were repeated 2, 5 and 11 years afterward. Medication data were collected at baseline, 5 and 11 years. Xerostomia data were collected at 5 and 11 years using the Xerostomia Inventory (XI) and a standard question. Results: Of the 1205 dentate participants assessed at baseline, 669 remained after 5 years, and 246 were assessed at 11 years. Medication prevalence increased over the observation period, such that 94.8% of the cohort were taking at least one medication by 11 years. The prevalence of xerostomia increased from 21.4% to 24.8% between 5 and 11 years (p > 0.05), and the mean XI score increased from 20.0 (SD, 6.7) to 21.5 (SD, 7.9; p < 0.001). Some 14.7% of participants were incident cases of xerostomia, while 11.4% were remitted cases; 10.1% were cases at both 5 and 11 years. After controlling for gender and ‘baseline’ xerostomia severity (represented by the XI score at 5 years), participants who commenced taking daily aspirin after 5 years had over four times the odds of becoming incident cases, while those who commenced taking a diuretic after 5 years had nearly six times the odds of doing so. Conclusions: While the overall prevalence of xerostomia increased during the observation period, there was considerable instability, with one‐quarter of the cohort changing their status. Medication exposure was strongly associated with the incidence of the condition, with recent exposure to diuretics or daily aspirin strongly predicting it.     

The Canadian Obesity Epidemic: An Historical Perspective

Objective: To examine temporal trends in stature, body mass, body mass index (BMI), and the prevalence of overweight and obesity in Canada. Research Methods and Procedures: Data for adults 20 to 64 years of age were compared across eight Canadian surveys conducted between 1953 and 1998. Temporal trends in stature and body mass were examined using regression, and changes in weight‐for‐height were expressed as changes from 1953. BMI data were available from 1970 to 1972 to examine changes in overweight and obesity. Qualitative changes in the BMI distribution were examined using Tukey mean‐difference plots. Results: Significant temporal trends in stature and body mass have occurred since 1953 in Canada. Median stature increased 1.4 cm/decade in men and 1.1 cm/decade in women, whereas median body mass increased 1.9 kg/decade in men and 0.8 kg/decade in women. Increases in the 75th percentile of body mass were larger than the median. The average weight‐for‐height increased 5.1% in men and 4.9% in women from 1953. Furthermore, the prevalences of overweight and obesity have increased from 40.0% and 9.7% in 1970–1972 to 50.7% and 14.9% in 1998, respectively. The entire BMI distribution has shifted to the right since 1970–1972 and has become more skewed to the right for men than for women. Discussion: There have been significant increases in stature and body mass in Canada over the last 45 years. Body mass has increased more than stature, particularly in the upper percentiles, which has resulted in the currently observed high prevalences of overweight and obesity.