Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.

In the SELECT cardiovascular outcomes trial, semaglutide showed a 20% reduction in major adverse cardiovascular events in 17,604 adults with preexisting cardiovascular disease, overweight or obesity, without diabetes. Here in this prespecified analysis, we examined effects of semaglutide on weight and anthropometric outcomes, safety and tolerability by baseline body mass index (BMI). In patients treated with semaglutide, weight loss continued over 65 weeks and was sustained for up to 4 years. At 208 weeks, semaglutide was associated with mean reduction in weight (-10.2%), waist circumference (-7.7 cm) and waist-to-height ratio (-6.9%) versus placebo (-1.5%, -1.3 cm and -1.0%, respectively; P < 0.0001 for all comparisons versus placebo). Clinically meaningful weight loss occurred in both sexes and all races, body sizes and regions. Semaglutide was associated with fewer serious adverse events. For each BMI category (<30, 30 to <35, 35 to <40 and ≥40 kg m-2) there were lower rates (events per 100 years of observation) of serious adverse events with semaglutide (43.23, 43.54, 51.07 and 47.06 for semaglutide and 50.48, 49.66, 52.73 and 60.85 for placebo). Semaglutide was associated with increased rates of trial product discontinuation. Discontinuations increased as BMI class decreased. In SELECT, at 208 weeks, semaglutide produced clinically significant weight loss and improvements in anthropometric measurements versus placebo. Weight loss was sustained over 4 years. ClinicalTrials.gov identifier: NCT03574597 .

Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial.

Importance: The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown. Objective: To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction. Design, Setting, and Participants: This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes. Interventions: Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks. Main Outcomes and Measures: The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period. Results: Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was -5.5% with tirzepatide vs 14.0% with placebo (difference, -19.4% [95% CI, -21.2% to -17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo. Conclusions and Relevance: In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction. Trial Registration: ClinicalTrials.gov Identifier: NCT04660643.

Obesity medicine as a subspecialty and United States certification - A review.

Background: Certification of obesity medicine for physicians in the United States occurs mainly via the American Board of Obesity Medicine (ABOM). Obesity medicine is not recognized as a subspecialty by the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA). This review examines the value of specialization, status of current ABOM Diplomates, governing bodies involved in ABMS/AOA Board Certification, and the advantages and disadvantages of an ABMS/AOA recognized obesity medicine subspecialty. Methods: Data for this review were derived from PubMed and appliable websites. Content was driven by the expertise, insights, and perspectives of the authors. Results: The existing ABOM obesity medicine certification process has resulted in a dramatic increase in the number of Obesity Medicine Diplomates. If ABMS/AOA were to recognize obesity medicine as a subspecialty under an existing ABMS Member Board, then Obesity Medicine would achieve a status like other ABMS recognized subspecialities. However, the transition of ABOM Diplomates to ABMS recognized subspecialists may affect the kinds and the number of physicians having an acknowledged focus on obesity medicine care. Among transition issues to consider include: (1) How many ABMS Member Boards would oversee Obesity Medicine as a subspecialty and which physicians would be eligible? (2) Would current ABOM Diplomates be required to complete an Obesity Medicine Fellowship? If not, then what would be the process for a current ABOM Diplomate to transition to an ABMS-recognized Obesity Medicine subspecialist (i.e., "grandfathering criteria")? and (3) According to the ABMS, do enough Obesity Medicine Fellowship programs exist to recognize Obesity Medicine as a subspecialty? Conclusions: Decisions regarding a transition to an ABMS recognized Obesity Medicine Subspecialty versus retention of the current ABOM Diplomate Certification should consider which best facilitates medical access and care to patients with obesity, and which best helps obesity medicine clinicians be recognized for their expertise.

A model-based approach to predict individual weight loss with semaglutide in people with overweight or obesity.

AIMS: To determine the relationship between exposure and weight-loss trajectories for the glucagon-like peptide-1 analogue semaglutide for weight management. MATERIALS AND METHODS: Data from one 52-week, phase 2, dose-ranging trial (once-daily subcutaneous semaglutide 0.05-0.4 mg) and two 68-week phase 3 trials (once-weekly subcutaneous semaglutide 2.4 mg) for weight management in people with overweight or obesity with or without type 2 diabetes were used to develop a population pharmacokinetic (PK) model describing semaglutide exposure. An exposure-response model describing weight change was then developed using baseline demographics, glycated haemoglobin and PK data during treatment. The ability of the exposure-response model to predict 1-year weight loss based on weight data collected at baseline and after up to 28 weeks of treatment, was assessed using three independent phase 3 trials. RESULTS: Based on population PK, exposure levels over time consistently explained the weight-loss trajectories across trials and dosing regimens. The exposure-response model had high precision and limited bias for predicting body weight loss at 1 year in independent datasets, with increased precision when data from later time points were included in the prediction. CONCLUSION: An exposure-response model has been established that quantitatively describes the relationship between systemic semaglutide exposure and weight loss and predicts weight-loss trajectories for people with overweight or obesity who are receiving semaglutide doses up to 2.4 mg once weekly.

What is clinically relevant weight loss for your patients and how can it be achieved? A narrative review.

Obesity is a chronic disease with increasing prevalence. It affects quality of life and renders those affected at increased risk of mortality. For people living with obesity, weight loss is one of the most important strategies to improve health outcomes and prevent or reverse obesity-related complications. In line with newly released clinical practice guidelines, weight loss targets for people living with obesity should be defined individually based on their clinical profile, and progress measured in the context of improvements in health outcomes, rather than weight loss alone. We outline current treatment options for clinically meaningful weight loss and briefly discuss pharmacological agents and devices under development. Numerous studies have shown that weight loss of ≥5% results in significant improvements in cardiometabolic risk factors associated with obesity; this degree of weight loss is also required for the approval of novel anti-obesity medications by the US Food and Drug Administration. However, some obesity-related comorbidities and complications, such as non-alcoholic steatohepatitis, obstructive sleep apnea, gastroesophageal reflux disease and remission of type 2 diabetes, require a greater magnitude of weight loss to achieve clinically meaningful improvements. In this review, we assessed the available literature describing the effect of categorical weight losses of ≥5%, ≥10%, and ≥15% on obesity-related comorbidities and complications, and challenge the concept of clinically meaningful weight loss to go beyond percentage change in total body weight. We discuss weight-loss interventions including lifestyle interventions and therapeutic options including devices, and pharmacological and surgical approaches as assessed from the available literature.

Engagement between patients with obesity and osteoarthritis and primary care physicians: a cross-sectional survey.

PURPOSE OF THE STUDY: Obesity is a major risk factor for development and worsening of osteoarthritis (OA). Managing obesity with effective weight loss strategies can improve patients' OA symptoms, functionality, and quality of life. However, little is known about the clinical journey of patients with both OA and obesity. This study aimed to map the medical journey of patients with OA and obesity by characterizing the roles of health care providers, influential factors, and how treatment decisions are made. STUDY DESIGN: A cross-sectional study was completed with 304 patients diagnosed with OA and a body mass index (BMI) of ≥30 kg/m2 and 101 primary care physicians (PCPs) treating patients who have OA and obesity. RESULTS: Patients with OA and obesity self-manage their OA for an average of five years before seeking care from a healthcare provider, typically a PCP. Upon diagnosis, OA treatments were discussed; many (61%) patients reported also discussing weight/weight management. Despite most (74%) patients being at least somewhat interested in anti-obesity medication, few (13%) discussed this with their PCP. Few (12%) physicians think their patients are motivated to lose weight, but almost all (90%) patients have/are currently trying to lose weight. Another barrier to effective obesity management in patients with OA is the low utilization of clinical guidelines for OA and obesity management by PCPs. CONCLUSIONS: As the care coordinator of patients with OA and obesity, PCPs have a key role in supporting their patients in the treatment journey; obesity management guidelines can be valuable resources.

PLAIN LANGUAGE SUMMARYOsteoarthritis (OA) is a disease where the soft tissue between joints wears out causing pain and swelling. Obesity, having unhealthy extra body weight, increases the chances of a person getting OA and can make their OA worse.We wanted to learn more about what patients with OA and obesity experience as they try to manage their OA, including the doctors they talked to, the treatments they used, and if their weight was discussed. To better understand this journey, 304 people with OA and obesity and 101 primary care doctors who treat people with OA and obesity took an online survey.We found that people with OA and obesity tried to manage their OA symptoms on their own for an average of five years before going to a doctor for help. Many (54%) talked with their primary care doctor first. When people with obesity were told by doctors that they had OA, most people (61%) said that they talked about weight and weight loss. Most people (72%) also talked with their doctors about OA treatments.Few doctors (12%) thought their patients were serious about losing weight but almost all patients (90%) said they had tried or were still trying to lose weight. About half of doctors followed guidelines for taking care of people with OA (51%) and obesity (61%).Primary care doctors play a key role in helping patients with OA and obesity. Doctors can follow guidelines and provide treatment options including referrals to other specialists to support weight loss efforts.

Diagnosing Obesity as a First Step to Weight Loss: An Observational Study.

OBJECTIVE: This study aimed to explore the relationship between an obesity diagnosis and weight loss as a percentage of total body weight loss over 9 to 15 months, using electronic health record data. METHODS: An observational study of 688,878 adult patients at 15 health systems with BMI ≥ 30 kg/m2 examined the relationship between weight loss and documentation of obesity diagnosis. Multivariable logistic regression models were created using a stepwise backwards elimination procedure to identify potential predictors of weight loss. RESULTS: Of patients with BMI ≥ 30, 44.9% had an obesity diagnosis on a claim or electronic health record problem list; 16.9% and 5.9% lost ≥ 5% and ≥ 10% of their body weight, respectively. Multivariable logistic regression models revealed a diagnosis of obesity on the same day as the initial weight (odds ratio [OR] = 1.3; CI: 1.2-1.3; P < 0.001) as a predictor of ≥ 5% total body weight loss in 9 to 15 months. Other significant predictors included an antiobesity medication prescription, female sex, diagnosis of type 2 diabetes, Medicare/Medicaid insurance, and number of ambulatory visits. CONCLUSIONS: While controlling for potentially confounding factors, documentation of an obesity diagnosis remained independently predictive of at least 5% weight loss. This suggests that documenting a diagnosis of obesity may be an important step toward engaging patients to lose weight.

Development of Obesity Competencies for Medical Education: A Report from the Obesity Medicine Education Collaborative.

OBJECTIVE: Obesity Medicine Education Collaborative (OMEC) was formed to develop obesity-focused competencies and benchmarks that can be used by undergraduate and graduate medical education program directors. This article describes the developmental process used to create the competencies. METHODS: Fifteen professional organizations with an interest in obesity collaborated to form OMEC. Using the six Core Competencies of the Accreditation Council for Graduate Medical Education as domains and as a guiding framework, a total of 36 group members collaborated by in-person meetings, email exchange, and conference calls. An iterative process was used by each working subgroup to develop the competencies and assessment benchmarks. The initial work was subsequently externally reviewed by 19 professional organizations. RESULTS: Thirty-two competencies were developed across the six domains. Each competency contains five descriptive measurement benchmarks for evaluator rating. CONCLUSIONS: This set of OMEC obesity-focused competencies is the first evaluation tool developed to be used within undergraduate and graduate medical training programs for both formative and summative assessments. Routine and more robust assessment is expected to increase the competence of health care providers to assess, prevent, and treat obesity. In addition to dissemination, the competencies and benchmarks will need to undergo evaluation for further validity and practicality.

Lipids and bariatric procedures Part 2 of 2: scientific statement from the American Society for Metabolic and Bariatric Surgery (ASMBS), the National Lipid Association (NLA), and Obesity Medicine Association (OMA).

Bariatric procedures generally improve dyslipidemia, sometimes substantially so. Bariatric procedures also improve other major cardiovascular risk factors. This 2-part Scientific Statement examines the lipid effects of bariatric procedures and reflects contributions from authors representing the American Society for Metabolic and Bariatric Surgery (ASMBS), the National Lipid Association (NLA), and the Obesity Medicine Association (OMA). Part 1 was published in the Journal of Clinical Lipidology, and reviewed the impact of bariatric procedures upon adipose tissue endocrine and immune factors, adipose tissue lipid metabolism, as well as the lipid effects of bariatric procedures relative to bile acids and intestinal microbiota. This Part 2 reviews: (1) the importance of nutrients (fats, carbohydrates, and proteins) and their absorption on lipid levels; (2) the effects of bariatric procedures on gut hormones and lipid levels; (3) the effects of bariatric procedures on nonlipid cardiovascular disease (CVD) risk factors; (4) the effects of bariatric procedures on lipid levels; (5) effects of bariatric procedures on CVD; and finally, (6) the potential lipid effects of vitamin, mineral, and trace element deficiencies, that may occur after bariatric procedures.

Lipids and bariatric procedures part 1 of 2: Scientific statement from the National Lipid Association, American Society for Metabolic and Bariatric Surgery, and Obesity Medicine Association: EXECUTIVE SUMMARY.

Bariatric procedures often improve lipid levels in patients with obesity. This 2-part scientific statement examines the potential lipid benefits of bariatric procedures and represents contributions from authors representing the National Lipid Association, American Society for Metabolic and Bariatric Surgery, and the Obesity Medicine Association. The foundation for this scientific statement was based on data published through June 2015. Part 1 of this 2-part scientific statement provides an overview of: (1) adipose tissue, cholesterol metabolism, and lipids; (2) bariatric procedures, cholesterol metabolism, and lipids; (3) endocrine factors relevant to lipid influx, synthesis, metabolism, and efflux; (4) immune factors relevant to lipid influx, synthesis, metabolism, and efflux; (5) bariatric procedures, bile acid metabolism, and lipids; and (6) bariatric procedures, intestinal microbiota, and lipids, with specific emphasis on how the alterations in the microbiome by bariatric procedures influence obesity, bile acids, and inflammation, which in turn, may all affect lipid levels. Included in part 2 of this comprehensive scientific statement will be a review of: (1) the importance of nutrients (fats, carbohydrates, and proteins) and their absorption on lipid levels; (2) the effects of bariatric procedures on gut hormones and lipid levels; (3) the effects of bariatric procedures on nonlipid cardiovascular disease risk factors; (4) the effects of bariatric procedures on lipid levels; (5) effects of bariatric procedures on cardiovascular disease; and finally (6) the potential lipid effects of vitamin, mineral, and trace element deficiencies that may occur after bariatric procedures. This document represents the executive summary of part 1.

Lipids and bariatric procedures part 1 of 2: Scientific statement from the National Lipid Association, American Society for Metabolic and Bariatric Surgery, and Obesity Medicine Association: FULL REPORT.

Bariatric procedures often improve lipid levels in patients with obesity. This 2 part scientific statement examines the potential lipid benefits of bariatric procedures and represents the contributions from authors representing the National Lipid Association, American Society for Metabolic and Bariatric Surgery, and the Obesity Medicine Association. The foundation for this scientific statement was based on published data through June 2015. Part 1 of this 2 part scientific statement provides an overview of: (1) adipose tissue, cholesterol metabolism, and lipids; (2) bariatric procedures, cholesterol metabolism, and lipids; (3) endocrine factors relevant to lipid influx, synthesis, metabolism, and efflux; (4) immune factors relevant to lipid influx, synthesis, metabolism, and efflux; (5) bariatric procedures, bile acid metabolism, and lipids; and (6) bariatric procedures, intestinal microbiota, and lipids, with specific emphasis on how the alterations in the microbiome by bariatric procedures influence obesity, bile acids, and inflammation, which in turn, may all affect lipid levels. Included in part 2 of this comprehensive scientific statement will be a review of (1) the importance of nutrients (fats, carbohydrates, and proteins) and their absorption on lipid levels; (2) the effects of bariatric procedures on gut hormones and lipid levels; (3) the effects of bariatric procedures on nonlipid cardiovascular disease (CVD) risk factors; (4) the effects of bariatric procedures on lipid levels; (5) effects of bariatric procedures on CVD; and finally, (6) the potential lipid effects of vitamin, mineral, and trace element deficiencies that may occur after bariatric procedures. This document represents the full report of part 1.

Predictors of physical activity in the transition after high school among young women.

PURPOSE: The purpose of this study was to identify factors associated with physical activity (PA) in women during the first year following high school. METHODS: Females from 22 high schools (n = 915) completed the 3-Day Physical Activity Recall in 12th grade and reported if they were sports participants. After graduation, 305 women (18.9 +/- 0.6 years) completed the International Physical Activity Questionnaire. They reported time spent per day in moderate-to-vigorous PA (MVPA) and vigorous PA (VPA) for the previous week. Multiple logistic regression was used to predict postgraduate PA. RESULTS: The odds of being in the high-active group were greater in women who were sports participants (OR = 1.93) in 12th grade. The odds of being in the high-active group were greater among white women (OR = 2.09) and greater among currently employed women compared with unemployed women (OR = 5.57). MVPA had borderline significance in the regression model. CONCLUSION: Sports participation and being currently employed predicted physical activity at postgraduation.