Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for the Treatment of Obesity.

BACKGROUND AND AIMS: The growing burden of obesity as a chronic disease necessitates a multifaceted approach to management. There has been an increase in the number of available endoscopic therapies for weight management with endoscopic sleeve gastroplasty (ESG) proving to be one of the best options. The long-term efficacy of ESG for management of obesity is not known. This study sought to assess the long-term safety and efficacy of ESG for treatment of obesity. METHODS: This was a prospective cohort study. Participants underwent ESG in a single academic center, and were prospectively enrolled. All procedures were performed by the same therapeutic endoscopist. Patients with a body mass index of >30 kg/m2 (or >27 with comorbidities), who underwent ESG from August 2013 to August 2019 for treatment of obesity were enrolled. Patients were followed for up to 5 years after their procedure. The primary outcome was weight loss at 5 years after the procedure (% total body weight loss, TBWL) RESULTS: 216 patients (68% female) with a mean age of 46±13 years, and mean BMI of 39±6 kg/m2 underwent ESG. Out of 216 patients, 203, 96, and 68 patients were eligible for a 1-, 3-, and 5-year follow up, with complete follow-up rates of 70%, 71%, and 82%, respectively. At 5 years, mean TBWL was 15.9% (95% CI, 11.7-20.5, p < .001) and 90 and 61% of patients maintained 5 and 10% TBWL, respectively. There was an overall rate of 1.3% moderate adverse events (AEs), without any severe or fatal AEs. CONCLUSIONS: Our results suggest that ESG is safe and effective for treatment of obesity, with durable long-term results for at least up to 5 years after the procedure. This procedure should be considered as a reliable option for treatment of obesity.

Trial of restarting and tolerating metformin (TreatMet).

This randomized, double-blind, placebo-controlled, n-of-1 crossover study assessed whether metformin's side effects are reproducible in patients with a history of metformin intolerance. Participants completed up to four cycles of 2 weeks of metformin exposure and 2 weeks of placebo exposure. Participants completed surveys based on the Gastrointestinal Symptom Rating Scale and the Treatment Satisfaction Questionnaire for Medication. The primary hypotheses were that treatment satisfaction would be equal for placebo and metformin and that more than 30% of the study enrollees would be able to adhere to a higher dose of metformin 6 months after participation. Thirteen patients (all women, mean age 52.4 years) enrolled, three of whom were lost to follow-up or were non-adherent to study protocol. Metformin was associated with significantly lower global treatment satisfaction scores compared with placebo (39.58 vs. 53.75, P < .05 ) but participants could not distinguish metformin from placebo and did not report higher rates of gastrointestinal side effects on metformin. Two out of 10 participants adhered to a higher dose of metformin after trial completion. Metformin appears to have barriers to use beyond its classic gastrointestinal side effects.

The impact of food order on postprandial glycaemic excursions in prediabetes.

Data suggest that nutrient order during a meal significantly impacts postprandial glucose and insulin excursions in type 2 diabetes, while its effects in prediabetes have not been reported. Fifteen participants with prediabetes consumed the same meal on 3 days in random order: carbohydrate first, followed 10 minutes later by protein and vegetables (CF); protein and vegetables first, followed 10 minutes later by carbohydrate (PVF); or vegetables first followed by protein and carbohydrate (VF). Blood was sampled for glucose and insulin measurements at 0, 30, 60, 90, 120, 150 and 180 minutes. Incremental glucose peaks were similarly attenuated by >40% in the PVF and VF meal conditions compared with CF. The incremental area under the curve for glucose was 38.8% lower following the PVF meal order, compared with CF, and postprandial insulin excursions were significantly lower in the VF meal condition compared with CF. The CF meal pattern showed marked glycaemic variability whereas glucose levels were stable in the PVF and VF meal conditions. Food order presents a novel, simple behavioural strategy to reduce glycaemic excursions in prediabetes.

Practical Use of Pharmacotherapy for Obesity.

Obesity management requires a multidisciplinary approach, as there are many factors that contribute to the development of obesity, as well as the preservation of excess weight once it has been gained. Diet, exercise, and behavior modification are key components of treatment. In addition to lifestyle changes, weight gain secondary to medications is an important modifiable risk factor. Even after appropriate lifestyle modification, and medication adjustments (where possible) to avoid agents that can contribute to weight gain, many patients are still unable to achieve clinically meaningful weight loss. Pharmacotherapy for obesity management can fill an important role for these patients. This article will review medications that can lead to weight gain and potential alternatives, currently approved anti-obesity medications and best practices to individualize the selection process, and the use of testosterone in men with hypogonadism and obesity.

Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients.

BACKGROUND & AIMS: Endoscopic sleeve gastroplasty (ESG) is an incisionless, minimally invasive bariatric procedure that reduces the length and width of the gastric cavity to facilitate weight loss. We performed a prospective study to evaluate the effects of ESG on total body weight loss and obesity-related comorbidities. METHODS: We collected data from 91 consecutive patients (mean age, 43.86 ± 11.26 years; 68% female) undergoing ESG from August 2013 through March 2016. All patients had a body mass index (BMI) greater than 30 kg/m2 and had failed noninvasive weight-loss measures or had a BMI greater than 40 kg/m2 and were not considered as surgical candidates or refused surgery. All procedures were performed with a cap-based flexible endoscopic suturing system to facilitate a triangular pattern of sutures to imbricate the greater curvature of the stomach. Patients were evaluated after 6 months (n = 73), 12 months (n = 53), and 24 months (n = 12) for anthropometric features (BMI, weight, waist circumference, blood pressure) and underwent serologic (hemoglobin A1c), lipid panel, serum triglycerides, and liver function tests. The primary outcomes were total body weight loss at 6, 12, and 24 months. Secondary outcomes were the effects of ESG on metabolic factors (blood pressure, diabetes, hyperlipidemia, steatohepatitis) and safety. RESULTS: The patients' mean BMI before the procedure was 40.7 ± 7.0 kg/m2. Patients had lost 14.4% of their total body weight at 6 months (80% follow-up rate), 17.6% at 12 months (76% follow-up rate), and 20.9% at 24 months (66% follow-up rate) after ESG. At 12 months after ESG, patients had statistically significant reductions in levels of hemoglobin A1c (P = .01), systolic blood pressure (P = .02), waist circumference (P < .001), alanine aminotransferase (P < .001), and serum triglycerides (P = .02). However, there was no significant change in low-density lipoprotein after vs before ESG (P = .79). There was one serious adverse event (1.1%) (perigastric leak) that occurred that was managed non-operatively. CONCLUSIONS: ESG is a minimally invasive and effective endoscopic weight loss intervention. In addition to sustained total body weight loss up to 24 months, ESG reduced markers of hypertension, diabetes, and hypertriglyceridemia.

Pharmacologic Approaches to Weight Management: Recent Gains and Shortfalls in Combating Obesity.

Obesity is a growing epidemic in the USA with over one third of adults presently classified as obese. Obesity-related comorbidities include many leading causes of preventable death such as heart disease, stroke, type 2 diabetes, and certain types of cancer. Modest weight loss of 5-10 % of body weight is sufficient to produce clinically relevant improvements in cardiovascular disease risk factors among patients with overweight and obesity. Until recently, there were limited pharmacologic options approved by the Food and Drug Administration to treat obesity. Phentermine/topiramate ER and lorcaserin were approved in 2012, and naltrexone SR/bupropion SR and liraglutide 3.0 mg were approved in 2014. This article reviews recent literature in the field of Obesity Medicine and highlights important findings from clinical trials. Future directions in the pharmacologic management of obesity are presented along with new diabetes medications that promote weight loss and reduce cardiovascular mortality.

Cardiometabolic impact of non-statin lipid lowering therapies.

Among the range of lipid modifying medications currently available, statins clearly stand as the primary agent capable of reducing cardiovascular risk. While non-statin lipid-lowering drugs improve lipid parameters, their impact on clinical outcomes is less clear, thus necessitating an even closer look at ancillary effects. Recent studies have reported the potential cardiometabolic effects of statins, yet considerably less information has been published about cardiometabolic changes associated with non-statin lipid-lowering agents. This review describes the cardiometabolic profile of non-statin lipid-lowering agents--fibrates, niacin, omega-3 polyunsaturated fatty acids, ezetimibe, and bile acid sequestrants--and therefore aims to facilitate informed decision-making in the pharmacologic management of lipid abnormalities.

Impact of Adjunctive Pharmacotherapy With Intragastric Balloons for the Treatment of Obesity.

BACKGROUND: We conducted this study to compare the weight loss outcome of intragastric balloons (IGBs) in conjunction with pharmacotherapy vs IGB and intensive lifestyle changes alone. METHODS: This was a multicenter, non-randomized, retrospective study involving 4 academic hospitals. Patients underwent IGB placement with or without concomitant anti-obesity pharmacotherapy. The primary outcome was percent total weight loss (TBWL) after IGB placement at 6 and 12 months. RESULTS: This study included 102 patients, with 23 patients (mean age 46.6 years, 82.6% female) treated with IGB/pharmacotherapy and 79 patients (mean age 46.0 years, 88.6% female) treated with IGB/lifestyle modifications. Patients had a 100% follow-up rate at 6 and 12 months. At 6 months following IGB placement, both groups achieved a similar %TBWL. At 12 months, %TBWL was greater in the IGB/pharmacotherapy group (12.6% ± 1.2 vs 9.7% ± 0.7, P = .04). 65.2% of patients achieved ≥10% TBWL at 12 months in the IGB/pharmacotherapy group, compared to 38.0% in the IGB/lifestyle group (P < .05). The proportion of patients that achieved ≥15% weight loss at 12 months was also significantly different between the IGB/pharmacotherapy and IGB/lifestyle groups (30.4% vs 20.3%, P < .05). DISCUSSION: IGB with concomitant use of pharmacotherapy did not improve weight loss while the IGB was in place compared to IGB and lifestyle changes. However, patients receiving IGB with pharmacotherapy did have greater weight loss and diminished weight regain after balloon removal compared to those receiving just IGB and lifestyle changes.

Advances in medical therapy for weight loss and the weight-centric management of type 2 diabetes mellitus.

Overweight and obesity are now recognized as leading causes of diseases such as type 2 diabetes, hypertension, hyperlipidemia, and ultimately, cardiovascular disease. Despite the serious consequences, roughly two thirds of Americans are presently classified as overweight, and about one third are classified as obese. Weight loss via lifestyle modification and pharmacotherapy can promote improvement in many of these obesity-related conditions. This review addresses recent advances in pharmacotherapy for the management of obesity and obesity-related co-morbidities, with a focus on the management of obesity specifically in individuals with type 2 diabetes. Emphasis is also placed on a proposed paradigm shift from the glucose-centric to the weight-centric management of type 2 diabetes mellitus.

Impact of refitted race-free eGFR formula on obesity pharmacotherapy options.

OBJECTIVE: Recent changes to the Chronic Kidney Disease Epidemiology Collaboration estimated glomerular filtration rate (eGFR) formula (2021 CKD-EPI) removed race from the 2009 formula, increasing the number of Black people classified as having CKD, but these changes may impact eligibility and/or dosing for antiobesity medications. This study estimated the number of people with obesity nationwide who might have pharmacotherapy options impacted by the new formula. METHODS: Using National Health and Nutrition Examination Survey (NHANES) cohort study data, the number of people eligible for antiobesity medication was estimated, and the number who would require a dosage reduction or would no longer be eligible for specific medications based on the new eGFR formula was also estimated. RESULTS: Among 16,412,571 Black and 109,654,751 non-Black people eligible for antiobesity medication, 911,336 (6.1%) Black and 6,925,492 (6.6%) non-Black people had ≥CKD stage 3 by the 2009 CKD-EPI formula. Applying the 2021 CKD-EPI formula, 1,260,969 (8.5%) Black people and 4,989,919 (4.7%) non-Black people had ≥CKD stage 3. For medications requiring renal adjustment, the number of Black people who would require a lower dose or be precluded from using a medication increased by 24.7% to 50.2%. CONCLUSIONS: These findings highlight the importance of measuring-rather than estimating-GFR in Black people with CKD when considering many antiobesity pharmacotherapy options.

Best Practices in the Management of Overweight and Obesity.

Obesity is a chronic disease caused by dysregulated energy homeostasis pathways that encourage the accumulation of adiposity, which in turn results in the development or exacerbation of weight-related comorbidities. Treatment of obesity relies on a foundation of lifestyle modification; weight loss pharmacotherapy, bariatric surgery and devices are additional tools to help patients achieve their health goals. Appropriate management of patients with obesity provides multiple metabolic benefits beyond weight loss.

Metformin-induced weight loss in patients with or without type 2 diabetes/prediabetes: A retrospective cohort study.

It is unknown whether weight loss outcomes differ with metformin monotherapy in patients with obesity with or without type 2 diabetes (T2DM)/prediabetes (PreDM). In this retrospective study, 6- or 12-month weight loss outcomes were compared in 222 patients with or without T2DM/preDM who completed metformin monotherapy. Average weight loss was similar between groups, euglycemic vs. T2DM/preDM (6 months: 6.5 [6.0%] vs. 6.5 [6.1%] p = 0.97; 12 months: 7.4 [6.2%] vs. 7.3 [7.7%], p = 0.92). Categorical weight losses (≥5% and ≥10% of baseline weight) were also similar. Comparable clinically significant weight loss was achieved with metformin monotherapy in patients with obesity with or without T2DM/PreDM.

Surgical and Nonsurgical Weight Loss for Patients with Obstructive Sleep Apnea.

A strong association exists between excess weight and obstructive sleep apnea (OSA), and most patients with OSA have elevated body mass index. Weight loss is an essential part of treatment for patients with OSA and overweight or obesity. Lifestyle interventions are cornerstones of weight management. However, most patients have difficulty achieving and maintaining clinically significant weight loss with lifestyle interventions alone. Health care providers who treat patients with OSA should be familiar with advanced treatment options for overweight and obesity including antiobesity medications, bariatric surgery, and devices. The future of weight management is a customized, multidisciplinary approach for each patient.

Medical Weight-Loss Outcomes in Patients Receiving Concomitant Psychotropic Medication: A Retrospective Cohort Study.

OBJECTIVE: This study aimed to elucidate medical weight-loss outcomes in patients unexposed or exposed to psychotropic medication(s). METHODS: This retrospective cohort study evaluated weight-loss outcomes of completers treated at an academic weight-management center between April 1, 2014, and April 1, 2016. Patients were classified as either unexposed (not prescribed psychotropic medication) or exposed (prescribed psychotropic medication) based on use of antidepressants, mood stabilizers, or antipsychotics during the study. RESULTS: Of 1,932 patients seen during the study period, 885 were eligible for inclusion, of whom 619 (70.0%) were unexposed and 266 (30.0%) were exposed to psychotropic medications. In the unexposed and exposed groups, the mean age, sex distribution, proportion with type 2 diabetes, initial BMI, and number of weight-loss medications prescribed were similar. At 12 months, the unexposed group lost 1.6% more weight on average than the exposed group (9.1% [SD 7.6%] vs. 7.5% [SD 8.1%], respectively; P = 0.02); 71.0% and 41.2% of the unexposed group achieved ≥ 5% and ≥ 10% weight loss at 12 months, respectively, compared with 63.1% and 31.8% in the exposed group at 12 months (P = 0.04 at 5%; P = 0.02 at 10%). CONCLUSIONS: Exposure to psychotropic medications was associated with diminished weight loss in patients with medically managed overweight and obesity.

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.

Obesity: When to consider surgery.

Bariatric surgery is underutilized despite an obesity epidemic. Here, 3 patients pursue a surgical option when they can't reach their target weight and optimal health by nonsurgical means.

Obesity Pharmacotherapy.

Although diet, physical activity, and behavioral modifications are the cornerstones of weight management, weight loss achieved by lifestyle modifications alone is often limited and difficult to maintain. Pharmacotherapy for obesity can be considered if patients have a body mass index (BMI) of 30 kg/m2 or greater or BMI of 27 kg/m2 or greater with weight-related comorbidities. The 6 most commonly used antiobesity medications are phentermine, orlistat, phentermine/topiramate extended release, lorcaserin, naltrexone sustained release (SR)/bupropion SR, and liraglutide 3.0 mg. Successful pharmacotherapy for obesity depends on tailoring treatment to patients' behaviors and comorbidities and monitoring of efficacy, safety, and tolerability.

Devices and Endoscopic Bariatric Therapies for Obesity.

PURPOSE OF REVIEW: In this review, we describe the FDA-approved and investigational devices and endoscopic bariatric therapies for the treatment of obesity. We focus on literature published in the past few years and present mechanisms of action as well as efficacy and safety data. RECENT FINDINGS: Devices and endoscopic procedures are emerging options to fill the significant treatment gap in the management of obesity. Not only are these devices and procedures minimally invasive and reversible, but they are potentially more effective than antiobesity medications, often safer for poor surgical candidates and possibly less expensive than bariatric surgery. As many patients require a variety of management strategies (medications, devices, procedures, and/or surgery) in addition to lifestyle modifications to achieve clinically significant weight loss, the future of obesity treatment involves a multidisciplinary approach. Combinations of advanced treatment strategies can lead to additive or synergistic weight loss. This is an area that requires further investigation.

Obesity: When to consider medication.

These 4 cases illustrate how weight loss drugs--including the 4 newest--can be integrated into a treatment plan that includes diet, exercise, and behavior modification.