ESPEN Congress Florence 2008

Transcription

1 ESPEN Congress Florence 2008 Severe obesity - Session organised in conjunction with ASPEN The SOS study Setting the Scene A. Thorell (Sweden)

2 The SOS study Setting the Scene Anders Thorell MD, PhD Associate Professor of Surgery Karolinska Institutet, CLINTEC, Division of Surgery & Ersta hospital, Stockholm, Sweden ESPEN, Florence 2008

3 SOS Effects of surgically induced weight loss on diabetes, stroke, myocardial infarction and overall mortality

4 SOS Effects of surgically induced weight loss on diabetes, stroke, myocardial infarction and overall mortality Scientific background Study design and aims Weight loss

5 SOS Effects of surgically induced weight loss on diabetes, stroke, myocardial infarction and overall mortality Scientific background Study design and aims Weight loss Effects of surgically induced, intentional weight loss on: Incidence of and recovery from diabetes Incidence of stroke and MI Overall mortality

6 SOS Effects of surgically induced weight loss on diabetes, stroke, myocardial infarction and overall mortality Scientific background Study design and aims Weight loss Effects of surgically induced, intentional weight loss on: Incidence of and recovery from diabetes Incidence of stroke and MI Overall mortality

7 Scientific background Mortality ratio Baseline BMI Lew EA et al. J Chronic Dis 1979; 32:

8 The crucial question Mortality ratio Baseline BMI

9 Most observational epidemiological studies Mortality ratio Baseline BMI

10 Weight loss is associated with increased mortality Lean ME Diabet Med1990;7: Wannamethee G Eur J Clin Nutr 1990;44: Lissner L N Engl J Med 1991;324: Lee IM JAM A 1992;268: Pamuk ER Am J Epidemiol 1992;136: Walker M Int J Epidemiol1995;24: Suadicani P J Cardiovasc Risk 1997;4:25-32 Yaari S Am J Epidemiol 1998;148: Nilsson PM J Intern Med 2002;252:70-78 Gaesser GA Med Sci Sports Exerc 1999:31:1118 Mikkelsen KL Epidemiol 1999;10: Williamsson DF Am J Epidemiol 1999;149: Wannamethee SG Am J Epidemiol 2000;151:

11 Risk factor changes, % Risk factor changes by weight change over two years in 842 obese SOS subjects No No SBP -40 TG DBP INS HDL 25 CHOL URIC GLU Body weight changes, kg 40

12 Body weight loss and risk change Risk Mortality Risk factors Body weight

13 Body weight loss and risk change Mortality Risk Condition Body weight

14 Body weight loss and risk change Mortality Risk Condition? Body weight

15 The SOS intervention study Primary aim Effects of intentional weight loss on total mortality

16 The SOS intervention study Primary aim Effects of intentional weight loss on total mortality Secondary aims Effects of intentional weight loss on incidence of diabetes, MI, stroke and cancer

17 The SOS intervention study Power SOS was powered (80 % power, p<0.05) to detect a 23% reduction in total mortality in the surgery group as compared to a conventionally treated contemporaneously matched control group. This power required 2000 surgically treated subjects and 2000 controls followed for 10 years (40,000 person years).

18 SOS Swedish Obese Subjects Participating sites: 25 surgical departments 480 primary health care centers

19 SOS Swedish Obese Subjects Application forms n=11,953 Obese eligible applicants n=8,966 Registry study n=6,905 Intervention study

20 Postoperative mortality in the 1970ies and 1980ies: 1 5 % Brolin, RE; Gastroenterol Clin North Am 1987;16:317

21 Contemp. Matched SOS Swedish Obese Subjects Application forms n=11,953 Obese eligible applicants n=8,966 Registry study n=6,905 Intervention study Surgical group n=2,010 Non-surgical controls n=2,037

22 SOS recruitment Study Inclusion n Follow up period years SOS ,047 20

23 SOS Swedish Obese Subjects Inclusion and exclusion criteria Inclusion criteria: Exclusion criteria: Age years BMI men 34 women 38 minimal and aimed at ensuring that subjects in the surgery group could tolerate the operation Identical inclusion and exclusion criteria in both study groups.

24 SOS Swedish Obese Subjects Matching variables Sex Age Height Weight Waist Hip Systolic BP S-Cholesterol S-Triglycerides Menopausal status Diabetes Smoking Psychastenia Monotony avoidance Current health Social interaction Attachment Stressful life events SOS: L. Sjöström

25 SOS Swedish Obese Subjects Key variables at registry examination Control group n = 2037 Surgery group n = 2010 Age, yrs Male gender, % Smoker, % Weight, kg Height, cm BMI, kg/m

26 SOS Swedish Obese Subjects Key variables at registry examination Control group n = 2037 Surgery group n = 2010 Syst BP, mm Hg Glucose, mmol/l Insulin, mu/l TG, mmol/l Total Chol, mmol/l HDL Chol, mmol/l

27 SOS examinations Examination at sites with weight, blood pressure, anthropometry, patient and site questionnaires. Examination also includes ECG and a centralized laboratory evaluation yrs n:

28 Participation rates at SOS examinations 2 yr 10 yr 15 yr Surgery 94% 84% 66% Control 83% 75% 87%

29 SOS Intervention study Surgical treatment Vertical Banded Gastroplasty Gastric Banding Gastric bypass Conventional treatment of obese controls According to standard at the primary health care center the patient belonged to

30 SOS Weight change Sjostrom L et al. NEJM 2007;357:

31 Two and ten year diabetes incidence *** Odds-ratio: 95% CI: 8 *** 2-year 1 10-year Odds ratio: % CI: N control N surgery Control Surgery Adapted from L. Sjöström NEJM 2004;351:

32 Two and ten year recovery from diabetes *** *** * year 10-year Odds-ratio: 95% CI: Odds ratio: % CI: Control Surgery Adapted from L. Sjöström NEJM 2004;351:

33 Cumulative incidence, % SOS Myocardial infarction 8 6 Individuals with MI, n Control 87 Surgery % 4 2 HR = % CI: to P= Years of follow up Lars Sjöström, Aug. 2006

34 SOS Myocardial infarction Percent of subjects by gender and diabetic state 12,00 10,00 % 8,00 8 6,00 6 4,00 4 2,00 2 0,00 0 All Males Females Diab Non-Diab Controls Surgery Lars Sjöström, Aug. 2006

35 SOS Mortality HR = % CI: 0.59 to 0.99 P= 0.04 Sjostrom L et al. NEJM 2007;357:

36 SOS Mortality % All Males Females Diab Non-Diab Controls Surgery Lars Sjöström, Aug. 2006

37 SOS Cause of death Cardiovascular Surgery Control n=2010 n=2037 ANY EVENT Cardiac Myocardial infarction Heart failure 2 5 Sudden death Stroke 6 6 Intracerebral hemorrhage 2 4 Infarction 1 2 Subarachnoid bleeding 3 0 Other 2 3 Aortic aneurysm 1 2 Aortic thrombosis 0 1 Diabetic gangrene 1 0 Noncardiovascular Surgery Control n=2010 n=2037 ANY EVENT Tumor Cancer Meningioma 0 1 Infection 12 3 Thromboembolic disease 5 7 Pulmonary embolism 4 7 Vena caval thrombosis 1 0 Other NO. OF DEATHS Sjostrom L et al. NEJM 2007;357:

38 SOS - Conclusions Surgically induced weight loss is associated with: Improved HRQL Improvements in cardiovascular risk factors Recovery from diabetes Reduced incidence in diabetes Reduced risk for myocardial infarction Reduction in overall mortality

39 Future of obesity surgery Metabolic surgery Diabetic surgery Tailored surgery/medication Studies of mechanisms of action!!

40 ERAS

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42 Gastric bypass

43 Laparoscopic gastric bypass

44 High volume of surgical cases Standardized surgical technique (RYGBP) Access to biological material

45 Treatment goals PREVENT AND TREAT DISEASES IMPROVE QUALITY OF LIFE