EPIDEMIC 23 USA adults and 13 childrenadolescents overweight or obese Increasing BMI above 30kgm 2 correlates with increasing morbiditymortality Adults with BMI gt 40 increased 70 between 2000 and 2010 ID: 1010098
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1. OBESITY: AN “Expanding” EPIDEMIC 2/3 USA adults and 1/3 children/adolescents overweight or obeseIncreasing BMI above 30kg/m2 correlates with increasing morbidity/mortalityAdults with BMI > 40 increased 70% between 2000 and 2010Estimated annual costs for treatment of obesity and attributable diseases $150-210 billion (21% of US health expenditures)
2. IS WEIGHT LOSS THAT IMPORTANT?Weight loss improves obesity-related morbidity/mortality with a positive correlation between amount of weight loss and improvement of obesity related diseasesObesity increases risk of:DiabetesHeart diseaseStrokeHyperlipidemiaHypertensionCoronary artery diseaseAsthmaSleep apneaDegenerative joint diseaseCertain cancers
3. Obesity Facts20% of obese population have type 2 diabetes 33% have hypertensionAmericans spend over $60 billion annually on weight loss products and non-surgical treatmentsWeight loss programs typically result in 10% loss at one year, 1/3 of loss gained back within one year, and almost all back within five years (failure rate 95%)NIH guidelines: surgical interventions for BMI > 40 or BMI > 35 with significant co-morbidities
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5. Excessive Weight gain, obesity, and cancerRecent review of over 1,000 studies linked weight gain, overweight, and obesity with 13 cancers:EsophagusGastric cardiaColonRectumLiverGallbladderPancreasCorpus uteriOvary KidneyThyroidPost menopausal breast cancerMeningiomaMultiple myeloma
6. OBESITY AND CANCER (CONT’d) Cancer associated with overweight and obesity comprised 55% of all cancers among women and 24% among menNearly half of all cancers in those 65 years or younger associated with excessive weight gain and obesityCancer among younger people increasingly related to overweight and obesity
7. WHAT WEAPONS DO WE HAVE TO FIGHT THIS EPIDEMIC? LIFESTYLE INTERVENTIONS (5-10% total body weight loss at one year)DietExerciseBehavior modificationsPHARMACOLOGY (5-10% loss)BARIATRIC SURGERY (33-75% loss)TraditionalEndoluminal
8. WHAT ELSE CAN WE DO?Example: cigarette smoking at an all time low due to: Surgeon General’s 1964 report on consequences of smokingPhysician counseling to avoid tobacco/methods to quitComprehensive public health policies Similar approaches needed against excessive weight gain in all age groups Intense, multicomponent, behavioral intervention programs Routine BMI assessments (less than 50% of primary care physicians regularly conform)Encourage weight management discussions in multiple health care settingsIncrease medical school/residency training in prevention/management of obesity or appropriate referrals
9. WHAT ELSE CAN WE DO? (con’t)Use other health care professionals (nurses, pharmacists, psychologists, and dieticians) to assist with counseling and appropriate referrals Link community obesity prevention, weight management, and physical activity programs with clinical services available (see Cerner)Utilize more widely Medicare covered behavior counseling
10. MEDICATIONS FOR OBESITYORLISTAT (GLAXOSMITHKLINE)BELVIQ (ARENA)QSYMIA (VIVUS)CONTRAVE (TAKEDA)SAXENDRA (NOVONORDISK)WEIGHT LOSS MEDICATIONS COMBINED WITH MODERATELY INTENSE LIFESTYLE INTERVENTION YIELD 5-11% TOTAL BODY WEIGHT LOSSGENERALLY WELL TOLERATED ALTHOUGH SIDE EFFECTS DO OCCUR
11. ORLISTATXenical (Roche)Prescription drug in most countriesAlli (GlaxoSmithKline)OTC in USA and UKDecreases fat absorption (lipase inhibitor)Modest effect (4.4-6.6 pounds loss at one year)Major side effect is steatorrhea (decreases with time and low fat diet)
12. BelviQ (Arena)Activates serotonin receptor 5-HT2C in the hypothalamus to produce satiety5% average weight loss of baseline weightSchedule IV drug for hallucinogenic properties and ?psychiatric dependencyside effects: headache (17%), dizziness (9%), fatigue (7%), nausea (8%)Potential side effects: serotonin syndrome, cognitive impairment, hypoglycemia (with type 2 diabetes treatments), bradycardiaIndications: BMI >30 or >27 with comorbidity (HBP, BS)
13. QSYMIA (vivus)Combination phentermine/topiramate (synergistic)Phentermine a sympathetic amine acting as a simulant for appetite suppressionTopiramate an anticonvulsant with weight loss side effects10-11% weight lossside effects (greater than 5%): parasthesias, dizziness, dysgeusia, insomnia, constipation, dry mouthWARNINGS: tachycardia, suicidal ideation, mood/sleep disorders, creatinine elevation, metabolic acidosis
14. ConTrave (Takeda)Bupropion/naltrexone combination (synergistic)Bupropion has complex actions affecting the hypothalamus Naltrexone is a prime opioid antagonist augmenting bupropion’s effect on hypothalamus5% body weight loss FDA boxed warning: seizure history, bulimia/anorexia, concurrent opioid therapy, pregnancy, MAOI therapy
15. Saxenda (NovoNordisk)Livaglitide: a glucagon-like peptide (GLP-1) agonist affecting hormones involved in weight regulation (insulin, leptin, and glucagon)Reduces glucagon levels and insulin resistance, slows gastric motility, and reduces leptin levelsAverage total body weight loss 18.5 pounds (versus 6 pounds placebo)Daily subcutaneous injections
16. WHICH DRUG IS BEST?Metanalysis of 28 clinical trails (28,091 participants)5% body weight loss achieved in:75% Qsymia68% Saxenda55% Contrave40% Belviq44% Alli (OTC)
17. Average weight loss (lbs)Qsymia-20Saxenda-11.5Contrave-11Belviq-7Orlitstate-5.5Belviq and Alli had fewest adverse effects, Saxenda and Contrave the most, and Qsymia in the middle.
18. Verdict: Obesity Pharmacotherapy“Too little, too late”
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20. Bariatric Surgeries/one year excess weight loss Roux-en-Y gastric bypass/62-74%Lap band/33-34%Sleeve gastrectomy/51-72%Frequency:Sleeve gastrectomy 50%Gastric bypass 44%Lap Band 6%Sleeve gastrectomy rising 5-fold from 2010-2013
21. Bariatric SurgeryBariatric surgery consistently superior over lifestyle changes for obesity and obesity related co-morbiditiesBariatric surgery has low pre and post-operative mortality rates (0.08 and 0.31% respectively) BUT: adverse events rate 10-17% and reoperation rates 6-7%Other factors against bariatric surgery include:Cost ($40,000 for Roux-en-Y)AccessAcceptance by primary care physiciansReversibility 180,000 bariatric surgeries each year for 78.6 million obese adults
22. Verdict: Bariatric SurgeryHighly effective (Roux-en-Y, gastric sleeve)CostlyNot reversibleHigh reoperation ratesLimited access
23. Endoluminal bariatric therapyA new paradigm for obesity therapy?Principles similar to surgery: weight loss and comorbidities resolution throughmalabsorptionvolume restrictionmetabolic/hormonal/neurologic modulationbehavior modificationa combination of the above
24. WHAT DO WE HAVE AVAILABLE?Three intragastric balloonsOne aspiration deviceOne endoscopic suturing device with:FDA approval for tissue apposition in the GI tractBeing used for endoscopic sleeve gastroplasty NONE ARE COVERED BY INSURERS
25. Malabsorption Barrier devices Functions as intestinal bypass similar to Roux-en-Y Mechanism of action:delayed mixing of chyme in with pancreaticobiliary secretions increased satiety levels inducing agents as GLP-1 and peptide YYdelivery of undigested nutrients to distal small bowel improves insulin resistance by modulating gut hormones and signals that affect gastric emptying
26. EndoBarrier (GI Dynamics)Impermeable teflon shield anchored to duodenum (nitinol hooks) extended to proximal jejunumNon FDA approved because of increased incidence of hepatic abscesses (3.5%)12% to 19% EWL at 3 months (2%-7% placebo)Sustained improvement in type 2 diabetesAdverse effects: abdominal pain, bowel obstruction, migration, perforation, GI bleeding, hepatic abscess
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28. ValenTx (ValenTx)Not FDA approvedImplantable, removable, replaceable with transoral, non-surgical procedureAverage 40% EWL at three months, 54% after one yearAdverse Effects: MigrationIntolerance Improves:HypertensionDMHyperlipidemia
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31. Intragastric balloonsProduce feelings of satiety and lead to decreased food intake May cause delayed gastric emptying and behavior modificationMay cause transitory changes of gut hormones in gastric mucosa regulating appetite and energy metabolism (ghrelin and leptin)Endoscopically placed or swallowedAir or fluid filledSingle or doubleSilicone or polymers resistant to gastric secretionsVary in size from 400-800cc volumeTwelve deaths since 2016 (Orbera) US mortality 0.036% (4 deaths per 10,000 patients)
32. Intragastric balloons (con’t)Placement temporary because rupture a concern after six monthsMethylene blue may be added to identify the rupture (changes urine color)Weight regain post removal a concernMay serve as bridge for bariatric surgery or for unrelated surgery with associated comorbiditiesContraindications:Prior bariatric surgeryUGI tract surgeryIBDDaily aspirin use Side effects:Nausea/vomitingAbdominal discomfort Rare pancreatitis
33. Orbera (Apollo endosurgerY)Saline filled balloon (400-700ml) implanted for up to six monthsRequires endoscopic placement/removalAverage 34% EWL at six monthsImproves T2 DM and HBP in 1/3 of patients one year after removalDecreased incidence of metabolic syndrome277,000 placed in non-USA
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35. Reshape integrated balloon system(reshape medical)Dual balloon design (750-900ml)Saline filledRequires endoscopic placement/removal25% EWL at 24 weeksImproves cholesterol, BP, DMAdverse Effects:Weight gain post removalNausea, vomitingGastric ulcerationIntolerance
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37. OBALON Gastric Balloon (Obalon Therapeutics)First and only swallowed balloon deviceCapsule attached to a very thin catheterUnder fluoroscopy, capsule dissolves, relaxing balloon Inflated with 250ml air and catheter removedMay use up to three balloons (at one setting or over six months)Endoscopically removed after six monthsTotal body weight loss 6.9% at six monthsFewer accommodative symptoms vs saline filled balloons
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39. Other Experimental Non-Surgical ApproachesALLURION BALLOON (Allurion Technologies)Saline solution-filled balloon swallowedAfter 4 months it spontaneously deflates and passesIn European trialGELESISIngestible hydrogel that swells on contact with waterGelesis 100 for weight lossGelesis 200 for Type 2 DiabetesIn FDA trial
40. Aspire Assist
41. Full Sense Device (BFKW) Modified gastrointestinal stent provides expansion of gastric cardia and induces a sense of satietyIn European study
42. ReVita duodenal mucosal resurfacing procedure (Fractyl)Hydrothermal ablation of duodenal mucosa6 month reduction of glycemic indicesModest weight loss effectsIn European trials
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44. Baronova Transpyloric Shuttle Device designed to intermittently obstruct the pylorus Endoscopically placed and removedU.S. End Obesity Trial is in progress
45. Spatz Balloon Saline-solution filled adjustable balloon Endoscopy needed for placement, adjustment, and removalFDA-approved trial underway
46. Gi Windows DEVICE
47. Verdict: endoscopic bariatric therapyCan achieve greater than 10% total body weight loss in most patientsExcellent safety and lower cost vs bariatric surgeryAnatomy preserving, reversible, and repeatableCan compliment lifestyle, behavioral modifications, and pharmacotherapy
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49. EnDO-TAGSS Endoscopic Weight Loss System