bariatric surgery vs. intensive medical therapy in obese diabetic patients: 3-year outcome s
DESCRIPTION
Bariatric Surgery vs. Intensive Medical Therapy in Obese Diabetic Patients: 3-Year Outcome s. Philip R Schauer , Deepak L Bhatt, John P Kirwan, Kathy Wolski, Stacy A Brethauer, Sankar D Navaneethan, Ali Aminian, Claire E Pothier, Esther SH Kim, Steve E Nissen, and Sangeeta R Kashyap - PowerPoint PPT PresentationTRANSCRIPT
Bariatric Surgery vs. Intensive Medical Bariatric Surgery vs. Intensive Medical Therapy in Obese Diabetic Patients: Therapy in Obese Diabetic Patients:
3-Year Outcome3-Year Outcomes
Philip R Schauer, Deepak L Bhatt, John P Kirwan, Kathy Wolski, Philip R Schauer, Deepak L Bhatt, John P Kirwan, Kathy Wolski, Stacy A Brethauer, Sankar D Navaneethan, Ali Aminian, Stacy A Brethauer, Sankar D Navaneethan, Ali Aminian,
Claire E Pothier, Esther SH Kim, Steve E Nissen, and Claire E Pothier, Esther SH Kim, Steve E Nissen, and Sangeeta R Sangeeta R KashyapKashyap
STAMPEDE investigatorsSTAMPEDE investigators
Results of the Results of the STAMPEDE TrialSTAMPEDE Trial
Cleveland ClinicCleveland ClinicBariatric and Metabolic InstituteBariatric and Metabolic Institute
Endocrinology, Diabetes and MetabolismEndocrinology, Diabetes and Metabolism
DisclosuresDisclosuresDisclosuresDisclosures
• Research support: Ethicon Endo-Surgery, NIH, American Research support: Ethicon Endo-Surgery, NIH, American Diabetes AssociationDiabetes Association
• Consulting and honoraria: Ethicon Endo-Surgery Consulting and honoraria: Ethicon Endo-Surgery
• STAMPEDE was funded by Ethicon Endo-Surgery, LifeScan STAMPEDE was funded by Ethicon Endo-Surgery, LifeScan Inc, Cleveland Clinic, and NIH-NIDDKInc, Cleveland Clinic, and NIH-NIDDK
BackgroundBackground• T2DM affects over 25 million individuals in the US, but < 50% T2DM affects over 25 million individuals in the US, but < 50%
of patients achieve adequate glycemic control on current of patients achieve adequate glycemic control on current pharmacotherapy. pharmacotherapy.
• Observational studies show improvement in glycemic control Observational studies show improvement in glycemic control and CV risk factors following bariatric surgery. and CV risk factors following bariatric surgery.
• Short-term (1-2 yrs.) RCTs, including the 1 year data of the Short-term (1-2 yrs.) RCTs, including the 1 year data of the STAMPEDE trial demonstrated remission of T2DM following STAMPEDE trial demonstrated remission of T2DM following bariatric surgery*.bariatric surgery*.
• However, no long-term However, no long-term ((>>3 yrs) RCT3 yrs) RCT data exist to compare data exist to compare the durability of bariatric surgery vs medical therapy for T2DM the durability of bariatric surgery vs medical therapy for T2DM control.control.
*Schauer P, Kashyap S, Wolski K. et al, NEJM 2012 366(17):1567-76
ObjectivesObjectives
1)1) Compare the durability of bariatric surgery vs Compare the durability of bariatric surgery vs medical therapy with respect to:medical therapy with respect to:
• Achieving biochemical resolution of T2DMAchieving biochemical resolution of T2DM
2) Compare differences between types of surgery 2) Compare differences between types of surgery
EndpointsEndpoints
Success rate of achieving HbA1c ≤ 6%Success rate of achieving HbA1c ≤ 6%PrimaryPrimary
SecondarySecondary
• Change in fasting plasma glucose (FPG)Change in fasting plasma glucose (FPG)
• Change in lipids, blood pressure, BMI Change in lipids, blood pressure, BMI
• Change in carotid intimal medial thicknessChange in carotid intimal medial thickness
• Change in medicationsChange in medications
• Safety and adverse eventsSafety and adverse events
• Quality of LifeQuality of Life
Intensive Medical TherapyIntensive Medical Therapy
• Weight management with diet and lifestyle Weight management with diet and lifestyle counseling per ADA clinical care guidelines*counseling per ADA clinical care guidelines*
• Insulin sensitizers, GLP-1 agonists, sulfonylureas Insulin sensitizers, GLP-1 agonists, sulfonylureas and multiple insulin injections utilized to target and multiple insulin injections utilized to target HbA1c ≤6%HbA1c ≤6%
• Scheduled visits with nutrition, psychology and Scheduled visits with nutrition, psychology and endocrinology per protocolendocrinology per protocol
• Follow-up visits every 3 months through year 2, and Follow-up visits every 3 months through year 2, and every 6 months for remaining follow upevery 6 months for remaining follow up
*Standards of medical care in diabetes--2011. Diabetes Care;34 Suppl 1:S11-61
Bariatric SurgeryBariatric Surgery
Roux-en-Y Gastric Bypass Sleeve GastrectomyRoux-en-Y Gastric Bypass Sleeve GastrectomyKashyap S, Schauer P, Bhatt D; Diabetes Obesity Metabolism 2010 Sep;12(9):833
218 patients screened
50Intensive medical
therapy alone
50 Medical therapy
plussleeve gastrectomy
Population for 3-Year Analysis 40 48 49
150 randomized
STAMPEDE Trial: Flow of PatientsSTAMPEDE Trial: Flow of Patients
50Medical therapy
plusgastric bypass
1 withdrew consent prior to surgery
8 withdrew consent2 Lost to follow-up
• HbA1c >7.0%HbA1c >7.0%• BMI 27- 43 kg/mBMI 27- 43 kg/m22
• Age 20-60 yearsAge 20-60 years
91% retention
2 Lost to follow-up
Baseline CharacteristicsBaseline CharacteristicsBaseline CharacteristicsBaseline Characteristics
ParameterParameterMedical Medical TherapyTherapy(n=40)(n=40)
Bypass Bypass (n=48)(n=48)
SleeveSleeve (n=49) (n=49)
Age (yrs)Age (yrs) 50.350.3 48.048.0 47.847.8
FemalesFemales 67%67% 58%58% 78%78%
Duration of diabetes (yrs)Duration of diabetes (yrs) 8.88.8 8.08.0 8.38.3
HbA1c (%)HbA1c (%) 9.09.0 9.39.3 9.59.5
Body Mass Index (kg/mBody Mass Index (kg/m22)) 36.436.4 37.137.1 36.136.1
≥ ≥ 3 diabetes medications3 diabetes medications 61%61% 52%52% 46.9%46.9%
Insulin useInsulin use 51.2%51.2% 46%46% 44.9%44.9%
DepressionDepression 32%32% 37%37% 46%46%
Microvascular complicationsMicrovascular complications 20%20% 42%42% 29%29%
Note: Based on analyzed population
Primary and Secondary Endpoints at 36 MonthsPrimary and Secondary Endpoints at 36 MonthsPrimary and Secondary Endpoints at 36 MonthsPrimary and Secondary Endpoints at 36 Months
ParameterParameterMedical Medical Therapy Therapy (n=40)(n=40)
Bypass Bypass (n=48)(n=48)
Sleeve Sleeve (n=49)(n=49)
P P ValueValue11
P P ValueValue22
HbA1c ≤ 6% HbA1c ≤ 6% 5%5% 37.5%37.5% 24.5%24.5% <0.001<0.001 0.0120.012
HbA1c ≤ 6% HbA1c ≤ 6% (without DM meds)(without DM meds) 0%0% 35.4%35.4% 20.4%20.4% <0.001<0.001 0.0020.002
HbA1c ≤ 7% HbA1c ≤ 7% 40% 64.6% 65.3% 0.020.02 0.020.02
Change in FPG (mg/dL)Change in FPG (mg/dL) -6 -85.5 -46 0.0010.001 0.0060.006
Relapse of glycemic Relapse of glycemic controlcontrol 80%80% 23.8%23.8% 50%50% 0.030.03 0.340.34
% % change inchange in HDL HDL +4.6+4.6 +34.7+34.7 +35.0+35.0 <0.001<0.001 <0.001<0.001
% % change inchange in TG TG -21.5-21.5 -45.9-45.9 -31.5-31.5 0.010.01 0.010.01
% % change in change in CIMTCIMT 0.0480.048 0.0130.013 0.0170.017 0.360.36 0.490.49
1 Gastric Bypass vs Medical Therapy; 2 Sleeve vs Medical Therapy
0.0
-0.5
-1.0
-1.5
-2.0
-2.5
-3.0
-3.50 3 6 12 24 36
0.0
-0.5
-1.0
-1.5
-2.0
-2.5
-3.0
-3.50 3 6 12 24 36
Change in HbA1cChange in HbA1c
Change in HbA1c (%)
P<0.001
P<0.001
Value at Visit Baseline Month 6 Month 12 Month 24 Month 36Medical 9.0 (8.5) 7.1 (6.8) 7.5 (6.9) 7.7 (7.3) 8.4 (7.6)Gastric Bypass 9.3 (9.2) 6.3 (6.2) 6.3 (6.1) 6.5 (6.4) 6.7 (6.6)Sleeve 9.5 (8.9) 6.7 (6.4) 6.6 (6.4) 6.8 (6.8) 7.0 (6.6)
Value at Visit Baseline Month 6 Month 12 Month 24 Month 36Medical 9.0 (8.5) 7.1 (6.8) 7.5 (6.9) 7.7 (7.3) 8.4 (7.6)Gastric Bypass 9.3 (9.2) 6.3 (6.2) 6.3 (6.1) 6.5 (6.4) 6.7 (6.6)Sleeve 9.5 (8.9) 6.7 (6.4) 6.6 (6.4) 6.8 (6.8) 7.0 (6.6)
Medical
Sleeve Gastric Bypass
Medical
Sleeve Gastric Bypass
Change in Body Mass IndexChange in Body Mass Index
Changein BMI
(Kg/M2)
-12.0
-10.0
-8.0
-6.0
-4.0
-2.0
0.0
-12.0
-10.0
-8.0
-6.0
-4.0
-2.0
0.0
90 3 6 12 24 360 3 6 12 24 369
P=0.006
P<0.001
P<0.001
Value at Visit Baseline Month 6 Month 12 Month 24 Month 36Medical 36.4 34.6 34.2 35.0 34.8Gastric Bypass 37.1 28.2 26.7 27.3 27.9Sleeve 36.1 28.3 27.1 27.9 29.2
Value at Visit Baseline Month 6 Month 12 Month 24 Month 36Medical 36.4 34.6 34.2 35.0 34.8Gastric Bypass 37.1 28.2 26.7 27.3 27.9Sleeve 36.1 28.3 27.1 27.9 29.2
Medical
Sleeve Gastric Bypass
Medical
Sleeve Gastric Bypass
0
10
20
30
40
50
60
Baseline Month 3 Month 6 Month 12 Month 24 Month 360
10
20
30
40
50
60
Baseline Month 3 Month 6 Month 12 Month 24 Month 36
Percentage of Patients on InsulinPercentage of Patients on Insulin
% Patients% Patients
Medical 52 54 44 40 47 55Gastric Bypass 46 25 10 4 7 6Sleeve 45 16 6 8 9 8
Medical 52 54 44 40 47 55Gastric Bypass 46 25 10 4 7 6Sleeve 45 16 6 8 9 8
Medical
Sleeve Gastric Bypass
Medical
Sleeve Gastric Bypass
Cardiovascular Medications atCardiovascular Medications atBaseline and Month 36Baseline and Month 36
Cardiovascular Medications atCardiovascular Medications atBaseline and Month 36Baseline and Month 36
CV medications – number CV medications – number (%)(%)
Medical TherapyMedical Therapy(n=40)(n=40)
Bypass Bypass (n=48)(n=48)
SleeveSleeve (n=49) (n=49)
Baseline
NoneNone 0 (0)0 (0) 3 (6.3)3 (6.3) 2 (4.1)2 (4.1)
1 - 21 - 2 19 (47.5)19 (47.5) 17 (35.4)17 (35.4) 28 (57.1)28 (57.1)
>> 3 3 21 (52.5) 21 (52.5) 28 (58.3)28 (58.3) 19 (38.8)19 (38.8)
Month 36
NoneNone 1 (2.5)1 (2.5) 33 (68.8) *33 (68.8) * 21 (42.9) *21 (42.9) *
1 - 21 - 2 18 (45)18 (45) 14 (29.2)14 (29.2) 25 (51)25 (51)
>> 3 3 21 (52.5)21 (52.5) 1 (2.1)1 (2.1) 3 (6.1)3 (6.1)
* P value <0.05 with Medical Therapy group as comparator
Change in Quality of Life MeasuresChange in Quality of Life MeasuresRAND-36RAND-36
% C
hang
eCh
ange
Adverse Events through 36 MonthsAdverse Events through 36 MonthsAdverse Events through 36 MonthsAdverse Events through 36 Months
ParameterParameter Medical Therapy Medical Therapy (n=43)(n=43)
Bypass Bypass (n=50)(n=50)
Sleeve Sleeve (n=49)(n=49)
GI complicationsGI complications 2 (5)2 (5) 13 (26)13 (26) 5 (4)5 (4)
Re-opRe-op 00 2(4)2(4) 2(4)2(4)
StrokeStroke 00 00 1 (2)1 (2)
RetinopathyRetinopathy 00 1 (2)1 (2) 2 (4)2 (4)
NephropathyNephropathy 4 (9)4 (9) 7 (14)7 (14) 5 (10)5 (10)
Foot ulcersFoot ulcers 0 0 2 (4)2 (4) 1 (2)1 (2)
Excessive weight gainExcessive weight gain 7 (16)7 (16) 00 00
LimitationsLimitationsLimitationsLimitations
• Single-center trial – multicenter studies needed to Single-center trial – multicenter studies needed to determine if results can be generalized. determine if results can be generalized.
• Larger studies will need to determine potential Larger studies will need to determine potential benefit on cardiovascular events and diabetes benefit on cardiovascular events and diabetes related microvascular complications.related microvascular complications.
• Single-center trial – multicenter studies needed to Single-center trial – multicenter studies needed to determine if results can be generalized. determine if results can be generalized.
• Larger studies will need to determine potential Larger studies will need to determine potential benefit on cardiovascular events and diabetes benefit on cardiovascular events and diabetes related microvascular complications.related microvascular complications.
SummarySummarySummarySummary• Bariatric surgery was more effective than intensive medical Bariatric surgery was more effective than intensive medical
therapy in achieving glycemic control (HbA1c therapy in achieving glycemic control (HbA1c << 6.0%) with 6.0%) with weight loss as the primary determinant of this outcome. weight loss as the primary determinant of this outcome.
• Many surgical patients achieved glycemic control without use Many surgical patients achieved glycemic control without use of any diabetic medications (particularly insulin).of any diabetic medications (particularly insulin).
• Metabolic syndrome components (HDL, triglycerides, Metabolic syndrome components (HDL, triglycerides, glucose, BMI) showed greater improvement after surgery.glucose, BMI) showed greater improvement after surgery.
• Marked improvement in quality of life.Marked improvement in quality of life.
• Bariatric surgery was more effective than intensive medical Bariatric surgery was more effective than intensive medical therapy in achieving glycemic control (HbA1c therapy in achieving glycemic control (HbA1c << 6.0%) with 6.0%) with weight loss as the primary determinant of this outcome. weight loss as the primary determinant of this outcome.
• Many surgical patients achieved glycemic control without use Many surgical patients achieved glycemic control without use of any diabetic medications (particularly insulin).of any diabetic medications (particularly insulin).
• Metabolic syndrome components (HDL, triglycerides, Metabolic syndrome components (HDL, triglycerides, glucose, BMI) showed greater improvement after surgery.glucose, BMI) showed greater improvement after surgery.
• Marked improvement in quality of life.Marked improvement in quality of life.
ConclusionConclusionConclusionConclusion
Bariatric surgery (gastric bypass or sleeve Bariatric surgery (gastric bypass or sleeve gastrectomy) should be considered as a treatment gastrectomy) should be considered as a treatment option for patients with uncontrolled T2DM and option for patients with uncontrolled T2DM and moderate to severe obesity (BMI > 30 Kg/Mmoderate to severe obesity (BMI > 30 Kg/M22) with ) with results durable through 3 years of follow up.results durable through 3 years of follow up.
Bariatric surgery (gastric bypass or sleeve Bariatric surgery (gastric bypass or sleeve gastrectomy) should be considered as a treatment gastrectomy) should be considered as a treatment option for patients with uncontrolled T2DM and option for patients with uncontrolled T2DM and moderate to severe obesity (BMI > 30 Kg/Mmoderate to severe obesity (BMI > 30 Kg/M22) with ) with results durable through 3 years of follow up.results durable through 3 years of follow up.
Renal Outcomes through 36 MonthsRenal Outcomes through 36 MonthsRenal Outcomes through 36 MonthsRenal Outcomes through 36 Months
Change in Quality of Life MeasuresChange in Quality of Life Measures
Physical Functioning
Role Limitations
Physical Health Components
Mental Health Components
****
* <0.05 ** <0.001 (Compared to IMT)**
*
*%
%*
*