OBESITY MANAGEMENT: DIET/EXERCISE, NEW DRUGS AND/OR SURGERY?

Transcription

1 OBESITY MANAGEMENT: DIET/EXERCISE, NEW DRUGS AND/OR SURGERY? ERIC VOLCKMANN, MD DIRECTOR OF BARIATRIC SURGERY OCTOBER 20, 2017

2 OBJECTIVES Define prevalence and health effects of obesity Discuss different therapies for weight loss including diet & lifestyle modification, physical activity, medications, and surgery Compare and contrast commonly performed bariatric surgical procedures Review non-surgical procedures for weight loss

3 WHAT IS OBESITY BMI Calculator BMI (body mass index) Based on a ratio of height and weight Body composition not accounted for Defined as BMI 30 kg/m 2

4 PREVALENCE OF OBESITY IN THE U.S. Obesity [body mass index (BMI) 30] is an epidemic in the United States Obesity rate in Utah in 2015 was 25.4% 2016 Centers for Disease Control and Protection Data and Statistics:

5 EFFECTS OF OBESITY: HEALTH RISKS Increased morbidity Type II diabetes High blood pressure/dyslipidemia Cardiovascular disease and stroke Osteoarthritis Obstructive sleep apnea and respiratory problems Gallbladder disease Endometrial, breast, prostate, and colon cancer Increased complications of pregnancy, menstrual irregularity & PCOS, stress incontinence & depression Increased mortality Obese individuals (BMI 30 kg/m 2 ) have % all cause increase in mortality vs. normal weight individuals (BMI kg/m 2 ) 1998 NIH Clinical Guidelines on the Identification, evaluation, and treatment of Overweight, and Obesity in Adults

6 EFFECTS OF OBESITY: QUALITY OF LIFE Common Patient Complaints Chronic fatigue and joint pain Unable to participate in activities that they enjoy Difficulty with activities of daily living and hygiene Can t fit into seats on airplanes, in movie theaters, and on amusement park rides Social stigma and discrimination Multiple medications for weight-related medical problems

7 EFFECTS OF OBESITY: FINANCIAL COST Obesity is expensive: High lifetime direct medical costs Medical costs rise with increasing BMI Obesity related costs are expected to continue to rise in the next 15 years High cost to employers: lost productivity absenteeism (second only to depression) Bray GA, et al. Lancet. 2016

8 MODERN APPROACH TO OBESITY: Acknowledges multifactorial nature of obesity : Genetic, epigenetic, physiological, behavioral, sociocultural, and environmental factors Factors lead to energy imbalance: Foundation of any weight effort loss includes: Lifestyle change Diet Physical activity Bray GA, et al. Lancet. 2016

9 MODERN APPROACH TO OBESITY For Individuals who struggle with weight loss but would benefit from it: Pharmacologic therapy Approved medications for chronic weight management Medications contributing to weight gain Surgical therapy New non-surgical procedures

10 AACE/ACE OBESITY GUIDELINES- PREVENTION Garvey WT, et al. Endocr Pract. 2016

11 AACE/ACE OBESITY GUIDELINES- LIFESTYLE Important Points: Diet macronutrient composition generally affects weight loss less than adherence rates. Best to provide low energy diets that are likely to be adhered to and provide health benefits. Type of physical activity (e.g. aerobic vs. resistance and intensity level) doesn t appear to affect overall weight loss. Garvey WT, et al. Endocr Pract. 2016

12 AACE/ACE OBESITY GUIDELINES- MANAGEMENT Important Points: AACE/ACE staging emphasizes complications > BMI Pharmacotherapy added with failure of meaningful weight loss (> 5% total body weight) and BMI 27 kg/m 2 with comorbidities or 30 kg/m 2 and higher. Consider surgery at BMI 35 kg/m 2 with comorbidity. Garvey WT, et al. Endocr Pract. 2016

13 AHA/ACC/TOS OBESITY GUIDELINES- MANAGEMENT Recommendation 1 grade A (strong) Use BMI as a screening test for patients who might be at risk for CVD, type 2 DM, and all-cause mortality Use waist circumference as an indicator of risk for CVD, type 2 DM, and all-cause mortality. Recommendation 2 grade A Counsel patients that weight loss (3% 5%) results in improvements in triglycerides, diabetes measures, and prediabetes. Greater amounts will improve blood pressure & cholesterol levels. Recommendation 3 grade A Prescribe a reduced caloric diet as part of a comprehensive lifestyle intervention regardless of macronutrient content of the diet. Recommendation 4 grade A Patients needing weight loss should receive a comprehensive program that is at least 6 months or longer in length including diet, physical activity, and behavior modification. Medications are considered appropriate for those with BMI >30 or >27 with a comorbidity (expert opinion). Recommendation 5 grade A Consider bariatric surgery for patients with BMI >35 plus a comorbidity or >40 Apovian CM, et al. Circulation 2015

14 PHARMACOTHERAPY-GENERAL PRINICIPLES Many medications are associated with weight gain or loss Obese patients should avoid medications that produce weight gain (when possible) and use weight neutral medications or those associated with weight loss 5 medications approved for long-term weight loss in U.S. Orlistat, Lorcaserin, Phentermine/topiramate ER, Naltrexone SR/ bupropion SR, and Liraglutide [Phentermine FDA-approved for short term use only (12 weeks)] Medications should be used in conjunction with lifestyle modification Prescriber and patient should be familiar with complications No medication is effective in every patient (3-4 months for meaningful weight loss) Bray GA, et al. Lancet. 2016

15 PHARMACOTHERAPY-MEDICATIONS THAT AFFECT WEIGHT Bray GA, et al. Lancet. 2016

16 PHARMACOTHERAPY-AVAILABLE MEDICATIONS Bray GA, et al. Lancet Wharton, S, Can J. Diabetes 2016

17 PHARMACOTHERAPY-EFFECTIVENESS 2016 Systematic Review and Meta-analysis of 28 RCTs of FDAapproved medications for long-term obesity treatment Among overweight or obese adults, all approved medications were associated with achieving at least 5% weight loss at 52 weeks Phentermine-topiramate and liraglutide were associated with the highest odds of achieving at least 5% weight loss Khera R, et al. JAMA. 2016

18 SURGICAL TREATMENT OPTIONS Malabsorptive & Restrictive Roux-en-Y Gastric Bypass Biliopancreatic Diversion with Duodenal Switch Purely Restrictive Sleeve Gastrectomy Laparoscopic Adjustable Gastric Banding (e.g. Lap-Band )

19 QUALIFICATION FOR BARIATRIC SURGERY Patients with clinically severe obesity Based on 1991 NIH Consensus Conference Statement on Gastrointestinal Surgery for Obesity BMI 40 (equivalent to being about 100 lbs. overweight) BMI 35 with weight related medical problem Type II Diabetes Hypertension, hyperlipidemia, coronary artery disease Obstructive sleep apnea Osteoarthritis 1998 NIH Clinical Guidelines on the Identification, evaluation, and treatment of Overweight, and Obesity in Adults

20 CANDIDATES FOR BARIATRIC SURGERY Well-informed, well-motivated individuals who: Meet weight and health criteria for surgery Understand and accept operative risks Modify dietary habits and lifestyle Tool for weight loss Commit to long-term follow-up care Lifelong commitment and not a short term fix"

21 PATHWAY TO SURGERY Information session Insurance verification- Covered benefit? Complete intake form, smoking policy, sleep apnea screening form, and 2-day food record Initial appointment with surgeon Evaluations: dietician (evaluation & 3-6 mos. education/medically supervised weight loss), psychologist (psychological testing), medical, endoscopy and/or upper GI series Preoperative visit with surgeon +/- anesthesiologist Scheduled bariatric surgery procedure Insurance pre-authorization VLCD 4 weeks before surgery

22 BENEFITS OF SURGERY: WEIGHT-RELATED MEDICAL PROBLEMS Buchwald H, et al. JAMA 2004

23 BENEFITS OF SURGERY: MORTALITY Diabetic-related causes decreased by 92% Cancer deaths decreased by 60% Coronary causes decreased by 56% All cause mortality decreased by 40% Adams TD, et al. NEJM 2007

24 BENEFITS OF SURGERY: DURABLE WEIGHT LOSS Systematic review of literature and meta-analysis of 22,094 bariatric patients Low failure rate with mean excess body weight loss (EBWL) of 61.2% Retrospective review of 272 gastric bypass patients 67.6% EBWL at mean of 11.4 years 71.9% (morbid obesity) 59.7% (super obesity) Buchwald H, et al. JAMA 2004 Christou, Ann Surg 2006

25 CONTRAINDICATIONS TO SURGERY Age over 70* / adolescents* Smoking, smokeless tobacco, electronic cigarette, Alcohol or drug abuse Non-ambulatory patients* Severe cardiac or pulmonary comorbities* Organ failure or Impending failure* Inability to comply with nutritional requirements Mental illness (untreated) Women should avoid pregnancy for 1-2 years after surgery (2 years preferred) *Relative Contraindications

26 ROUX-EN-Y GASTRIC BYPASS

27 ROUX-EN-Y GASTRIC BYPASS 30 ml pouch ~15-16 mm stoma 150 cm Roux limb Biliopancreatic limb Common channel

28 ROUX-EN-Y GASTRIC BYPASS Gold standard bariatric surgical procedure About 60-80% excess body weight (EBW) loss in months with >75% control of comorbidities Cures GERD Effects on type II diabetes independent of wt. loss Patients typically regain less than 15 percent of their weight after 5-10 years Difficult to reverse 300% increase of alcohol potency Risk of ulcers (NO NSAIDs, steroids, tobacco) Higher risk of vitamin and mineral deficiencies? Dumping Syndrome (+/-?)

29 VERTICAL SLEEVE GASTRECTOMY

30 VERTICAL SLEEVE GASTRECTOMY 2006, Ethicon Endo-Surgery. Inc.

31 SLEEVE GASTRECTOMY No malabsorption with similar follow-up to gastric bypass Excess body weight loss between gastric banding and gastric bypass (50-70% EBWL) Lower risk of ulcers compared to gastric bypass Few long term studies > 5 years May worsen/cause GERD (Barrett s esophagus) Gastric stenosis Not reversible Staple line leaks difficult to manage

32 LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB)

33 LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) Small gastric pouch Adjustable band Port for adjustments

34 ADJUSTABLE GASTRIC BANDING (LAGB) Creates small gastric pouch limiting food consumption Causes feeling of fullness with small amounts of food Patients lose up to 50% of their EBW by 1 ½ -5 years Goal weight loss: 1-2 lbs/week or 4-8 lbs/month Monthly evaluations during 1 st 12 months Resolution of type II diabetes mirrors weight loss Adjustable and reversible May worsen/cause GERD Up to 25% fail to lose 30% of EBW by 5 years

35 OTHER BARIATRIC PROCEDURES Biliopancreatic Diversion with Duodenal Switch Vertical Banded Gastroplasty 150 cm 100 cm

36 PERIOPERATIVE COMPLICATIONS May include: Anesthetic related risks (cardiac, pulmonary) Bleeding Infection (wound infection) Incisional pain: larger laparoscopic incisions Anastomotic/Staple line leaks <<1% - 4% depending on procedure DVT, pulmonary embolism: < 0.5% Mortality: less than 0.2%

37 BARIATRIC SURGERY SAFETY Bariatric Outcomes Longitudinal Database (BOLD) Summary of Key Statistics (Oct 2010)

38 LONG-TERM SURGICAL RISKS Long-term risks may include: Gallstones (when present) Prevent with Actigall (ursodiol) while rapid weight loss (6 mos.) Difficulty adjusting to body image Ulcers/strictures May need endoscopy to dilate No NSAIDS, steroids, or smoking (lifelong) Hernias (including internal) Gastric band slippage, erosion, infection, malfunction Esophageal dilation Vitamin deficiency (B12, iron, calcium, vitamin D, others)

39 ADJUSTABLE GASTRIC BANDING (LAGB) Long-Term Studies High rates of reoperation (40-60%) Band slippage - GERD, dysphagia, band intolerance Band erosion - Failure of/insufficient weight loss Esophageal dilation - Port/tubing malfunction Frequent follow-up (monthly in 1 st yr. best outcomes) Labor intensive for patients and providers

40 MEDICAL VS. SURGICAL THERAPY FOR TYPE II DM STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial 3 year outcomes of bariatric surgery vs. intensive medical therapy Intensive medical therapy vs. medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy 150 patients with uncontrolled type II DM (Hgb A1c > 7.0%) and BMI kg/m 2 Primary outcome measure: Hgb A1c 6.0%. Met by 38% of RYGBP patients, 24% sleeve patients, 5% medical group (91% follow-up at 3 yrs) Mean % weight loss from baseline: RYGBP: 24.5% ± 9.1%; sleeve 21.1% ± 8.9%; medical 4.2% ± 8.3% Bariatric surgery results in glycemic control in significantly more patients than did medical therapy alone Schauer PR, et al. NEJM 2014

41 ESTIMATE OF BARIATRIC SURGERY NUMBERS, Procedure numbers from 2011, 2012, 2013, 2014 and 2015 based on the best estimates from BOLD, ASC/MBSAQIP, and National Inpatient Sample data and outpatient estimations

42 RYGBP VS. SLEEVE GASTRECTOMY IN SUPER OBESITY Retrospective review of the Bariatric Outcomes Longitudinal Database from 2007 to 2012 in super obese (BMI 50 kg/m 2 ) patients 50,987 patients underwent RYGBP (N = 42,119) vs. SG (N = 8868) Similar adjusted overall 30-day complication rate for RYGBP vs. SG (11.5 vs 11.1%) RYGBP had higher adjusted rates of 30-day mortality (0.3 vs. 0.2%, p = 0.042), reoperation (4.0 vs. 2.4%, p <0.001), and readmission (6.9 vs. 5.5%, p < 0.001) vs. SG RYGBP had significantly greater %TWL than SG at 12 months (34.5 vs %, p 0.001) and at 3 and 6 months postoperatively RYGBP also had increased resolution of all measured comorbidities: DM (61.6 vs. 50.8%, p < 0.001), HTN (53.9 vs. 32.5%, p < 0.001), GERD (53.9 vs. 32.5%, p < 0.001), hyperlipidemia (39.7 vs 32.5%, p < 0.001), and obstructive sleep apnea (42.8 vs. 40.6%, p = 0.058) at 12 months compare to SG In the superobese, there was no difference in 30 day complications between RYGBP and SG, but readmissions and reoperations were higher for RYGBP; however, RYGBP was considerably more effective in controlling comorbid conditions. Celio AC, et al. Surg Endosc. 2016

43 RYGBP VS. SLEEVE GASTRECTOMY EUROPEAN DATA Retrospective review of patients from the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) European Chapter Center of Excellence program from 2010 to ,025 patients underwent RYGBP (N = 10,622) vs. SG (N = 6413) Steadily increasing numbers of SG performed from 2010 to 2015 Higher early (<30 day) complication rate for RYGBP vs. SG (3.02 vs. 2.12%, p = ), with the majority related to marginal ulcers, obstruction, and other complications Equivalent 30-day mortality and readmission rates for RYGBP vs. SG (0.009% vs %, NS; 1.94 vs. 1.61%, NS) Reoperation (75.2 vs. 50.5%, p <0.0001) was higher for SG vs. RYGBP, with a significant difference in intraabdominal abscess rate (0.30 vs. 0.09%, p = 0.004) Significantly better % excess weight loss were seen following RYGBP in all postoperative years (60.36 vs %, p = at year 5), and better remission rates were seen for diabetes, hypertension, dyslipidemia, and sleep apnea in the first year (only). OA treatment results better for SG in all years (p < ) Melissas J, et al. Obes Surg. 2016

44 GASTRIC INTERVENTIONS: NEW DEVICES FOR WEIGHT LOSS ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee, Gastrointest Endosc. 2015

45 GASTRIC INTERVENTIONS: IMPORTANT CONSIDERATIONS All interventions are intended to be used in conjunction with lifestyle modification All interventions are currently not covered by insurers and are performed on a self-pay basis Produce less weight loss than surgery and more than lifestyle invention [%EBWL ~ 25-30%/ TBWL 6.81% ± 5.1% (Obalon)] Balloons FDA approved for BMI low as 30 for 6 months of consecutive use. Procedures are less invasive than surgery but still have potential complications and side-effects

46 CONCLUSIONS Obesity is an epidemic with significant adverse effects on health and quality of life Multiple factors contribute to obesity resulting in energy imbalance that causes weight gain Diet and lifestyle modification along with physical activity form the basis of any weight loss effort and remain important when pharmacotherapy or surgery is implemented Bariatric surgery should be considered for patients with a BMI 40 or 35 with a comorbid condition and is safe and effective The cost, efficacy, and side-effect/complication profile of new therapies and procedures help to determine their role in the management of obesity

47 QUESTION: Which of the following is a true statement regarding gastric bypass?: a) Gastric bypass has a lower rate of complications than sleeve gastrectomy b) Excess body weight loss and comorbidity resolution rates for gastric bypass and sleeve gastrectomy are equivalent c) Gastric bypass effectively treats gastroesophageal reflux disease (GERD) d) Gastric bypass is increasing as a percentage of weight loss operations performed annually in the United States

48 QUESTION: Which of the following is a true statement regarding gastric bypass?: Correct Answer: c) Gastric bypass effectively treats gastroesophageal reflux disease (GERD) Rationale: Although the risk of early complications after gastric bypass is very low, it is higher than what is seen for sleeve gastrectomy; however, gastric bypass results in greater weight loss and comorbidity improvement. Gastric bypass effectively treats gastroesophageal reflux symptoms and is the preferred antireflux operation in individuals with clinically severe obesity. Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass. Data from IFSO-European Chapter Center of Excellence Program. Melissas J, et al. Obes Surg Oct 20. Surgery for Gastroesophageal Reflux Disease in the Morbidly Obese Patient. Duke MC, Farrell TM. J Laparoendosc Adv Surg Tech A Nov 18

49 DISCUSSION Additional information: The Obesity Society Resources: American Society of Metabolic and Bariatric Surgery: NHLBI, Obesity Guidelines: