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Treating Type 2 Diabetes in Obese Patients
with Bariatric Surgery
Highlights of Evidence from Recent Studies
©2016 Ethicon US, LLC. 024421-160815
Executive Summary
• The DSS-II clinical guidelines (published 2016) are endorsed by 45
worldwide societies (including International Diabetes Federation,
American Diabetes Association and American Association of Clinical
Endocrinologists) and are the first to highlight the important role of
surgical intervention for severely obese patients with Type 2 Diabetes.
• Recent RCT evidence supports cohort studies & meta-analyses showing
bariatric/metabolic surgery can lead to improvement or resolution of Type 2
diabetes (T2DM) and weight loss that leads to improvement in CV comorbidities – and reduce medication usage*.
• Risks and complications for bariatric surgery are similar to many other
general surgery procedures‡ and include risk of cholecystitis, cholelithiasis,
dilated pouch, dysphagia, GERD, incisional hernia, malnutrition and vitamain
and mineral deficiency.
• Bariatric surgery should be strongly considered for the treatment of T2DM
with obesity.¶
*Schauer P, Deepak B, Kirwan J, et al. Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 3-Year Outcomes. N Engl J Med 2014; 370:2002-2013.
† Sjöström L, Lindroos AK, Peltonen M. Lifestyle, Diabetes, and Cardiovascular Risk Factors 10 Years after Bariatric Surgery. New Engl J Med. 2004;351(26):2683-93.
‡SRC BOLD report: summary of key statistics prepared for SRC’s strategic alliance partners. March 2010. Data is reported on 80,157 research consented patients who had
surgery entered in BOLD from June 2007 through Sept. 22, 2009. All patients with data in BOLD had their bariatric surgery performed by a surgeon participating in SRC’s
Bariatric Surgery Center of Excellence (BSCOE) program; Washington State Health Care Authority Health Technology Assessment. Bariatric Surgery Draft Key Questions:
Comment & Response. 2014.
§ Handelsman Y, Mechanick JI, Blone L et al. American Diabetes Association. Standards of medical care in diabetes – 2009. Diabetes Care 2009; 32(S1):S13-S61; Paul Poirier,
MD, PhD, FAHA, Chair; Marc-Andre Cornier, MD; Theodore Mazzone, MD, FAHA, et al. Bariatric Surgery and Cardiovascular Risk Factors. Circulation. 2011; 123:1688.
¶ Dixon J, Zimmet P, Alberti KG, Clinical Practice Bariatric surgery: an IDF statement for obese Type 2 diabetes. 2011; Diabet. Med. 28, 628–642.
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Type 2 Diabetes and Bariatric
Surgery Overview
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Type 2 Diabetes Mellitus Overview*
• Diabetes affects 8.3% of the total U.S. population (25.8 million people)
•
•
18.8 million people have been diagnosed
7 million people are unaware they suffer from the disease
• Type 2 diabetes accounts for 95% of the 25.8 million diabetes cases in
the U.S
• Obesity is a major independent risk factor for developing the disease,
and more than 90% of type 2 diabetics are overweight or obese
•
More than one-third (35.7%) of adults are obese; rate nearly tripled
between 1960-2010
• Modest weight loss, as little as 5% of total body weight, can help to
improve type 2 diabetes in patients who are overweight or obese
• Metabolic and bariatric surgery may result in resolution or improvement
of type 2 diabetes independent of weight loss
*American Obesity Association. Fact Sheet. TYPE 2 DIABETES AND OBESITY: TWIN EPIDEMICS. November 2005.
http://asmbs.org/resources/weight-and-type-2-diabetes-after-bariatric-surgery-fact-sheet. Last accessed August 30, 2016.
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T2DM Prevalence in the US*
• The rise in diabetes diagnoses is attributed to increasing childhood
obesity rates, which have tripled since the 1980s, with approximately
17% (or 12.5 million) of children aged 2-19 suffering from obesity12
• African-Americans and the elderly are disproportionately affected by
diabetes13
• 18.7% of all African-Americans over twenty years old have diabetes,
compared to 10.2% of whites
• 26.9% of Americans age 65 and older have diabetes, compared to
11.3% of adults over 20
*American Obesity Association. Fact Sheet. TYPE 2 DIABETES AND OBESITY: TWIN EPIDEMICS. November 2005.
http://asmbs.org/resources/weight-and-type-2-diabetes-after-bariatric-surgery-fact-sheet. Last accessed August 30, 2016.
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Bariatric Surgery
A generic term for any operation performed on the gastrointestinal tract
which is used to help morbidly obese patients lose weight. New
evidence suggests that it may be helpful for the treatment of T2DM as
well, independent of the weight loss.
Most Common Bariatric Surgery Procedures
• Gastric bypass
• Sleeve gastrectomy
• Biliopancreatic Diversion with Duodenal Switch
• Gastric Banding
• Revisional Surgery
Kaplan L, Seeley R, Harris J. Bariatric Surgery: The Road Ahead. Bariatric Times 2012: 9(3): Supplement C.
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Surgical Treatment and Medical Therapy vs.
Medical Therapy Alone – Comparative Studies
• Meta-analysis (796 participants in 11 studies) compared bariatric surgery
to nonsurgical treatment for obesity. Findings were that surgery resulted
in greater weight loss and higher type 2 diabetes remission rates*
• Studies with 6+ months follow up showed surgical patients lost an
average of 57 more pounds than nonsurgical/weight loss program
patients, and were 22 times more likely to see their T2DM abate*
• Head-to-head studies comparing bariatric surgery to medical therapy
found bariatric surgery superior to medical treatment in producing type 2
diabetes remission, even before weight loss†
• Cleveland Clinic study showed within one year, diabetes remission rates
with bariatric surgery were 42% gastric bypass, 37% gastric sleeve
compared to about 12% for patients treated with the best
pharmacotherapy available; patients had BMI between 27 and 43†
*Gloy V.L., Briel M., Bhatt D.L., et. al. Bariatric surgery versus non-surgical treatment for obesity: a systematic review
and meta-analysis of randomised controlled trials. BMJ 2013;347: f5934.
† Schauer P, Kashyap S, Wolski, K, et al. Bariatric surgery vs. intensive medical therapy in obese patients with
diabetes. N Engl J Med 2012; 366:1567-157.
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Surgical Treatment and Medical Therapy vs.
Medical Therapy Alone – Comparative Studies
• Catholic University/New York-Presbyterian/Weill Cornell Medical
Center showed remission rates were about 85% for bariatric surgery
(75% gastric bypass, 95% biliopancreatic diversion) and zero for
medical therapy in patients with BMI greater than 35, after two years*
– In surgical groups, both weight loss and preoperative BMI were not
predictors of diabetes control, suggesting such surgical procedures may be
independent of weight loss
• 73% of gastric band patients with type 2 diabetes experience
remission two years after surgery, a 5 times higher resolution rate
than those receiving convention therapy†
*Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery vs. conventional medical therapy for type 2
diabetes. N Engl J Med 2012; 366:1577-1585.
†Dixon
J, O’Brien P, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes.
JAMA 2008; 299(3):316-323.
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Safety and Risks
•
Agency for Healthcare Research and Quality (AHRQ) and recent clinical studies report
significant improvements in metabolic and bariatric surgery safety *
•
Reasons for improved safety, advancements in surgical techniques including laparoscopy,
†and ASMBS and American College of Surgeons (ACS) accreditation program
•
Overall mortality rate is about 0.1% ‡ — less than gallbladder (0.7%) €€ and hip
replacement (0.93%) surgery§ — and overall likelihood of serious complications is less
than 2%¶.
•
Clinical evidence shows risks of morbid obesity may outweigh risks of bariatric surgery \\, **
•
Individuals with morbid obesity or BMI≥30 have a 50-100% increased risk of premature
death compared to individuals of healthy weight††
•
Studies show that weight loss increases lifespan‡‡, €
Of note, there are risks with any surgery such as adverse reactions to medications, problems with anesthesia,
problems breathing, bleeding, blood clots, inadvertent injury to nearby organs and blood vessels, even death.
Bariatric surgery has it’s own risks, including failure to lose weight, nutritional or vitamin deficiencies, and weight
regain. Patients should consult their physicians to determine if this procedure is appropriate for them.
*Encinosa, W. E., et al. (2009). Recent improvements in bariatric surgery outcomes. Medical Care. 47(5):531-535.
Poirier P, et al. Bariatric surgery and cardiovascular risk factors. Circulation 2011;123:1-19.
‡ Statistical Brief #23. Healthcare Cost and Utilization Project (HCUP). December 2007. Agency for Healthcare Research and Quality, Rockville, MD. www.hcupus.ahrq.gov/reports/statbriefs/sb23.jsp. Last accessed August 31, 2016.
€€Dolan J, et al. National mortality burden and significant factors associated with open and laparoscopic cholecystectomy: 1997–2006. J Gastrointest Surg 2009;13(12):2292-2301.
§ Pedersen A, et al. Short- and long-term mortality following primary total hip replacement for osteoarthritis. J Bone Joint Surg [Br] 2011;93-B(2):172-177.
¶ Flum D, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med 2009;361:445-54
\\ Christou N, et al. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg 2004;240: 416–424.
** Schauer P, et al. Decision modeling to estimate the impact of gastric bypass surgery on life expectancy for the treatment of morbid obesity. Arch Surg. 2010 Jan;145(1):57-62.
†† U.S. Department of Health and Human Services. The Surgeon General’s call to action to prevent and decrease
overweight and obesity. [Rockville, MD]: U.S. Department of Health and Human Services, Public Health Service, Office of the
Surgeon General; [2001]. Available from: U.S. GPO, Washington.
‡‡ Sjöström L., et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med 2007; 357(8):741-752.
€ Adams T, et al. Long-term mortality after gastric bypass surgery. New Engl J Med. 2007;357:753-761.
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Implications for Payers
• Short-term: Bariatric / metabolic surgery is able to achieve improved
glycemic control of Type 2 diabetes in obese patients with BMI>35.
– Benefits for up to 2 years now shown in RCTs and up to 5 years in matched
cohort studies with large groups of patients*
• Long-term: Durability of this effect has yet to be fully characterized &
potential benefits have yet to be definitively proven in routine clinical
practice.
– Exception: Swedish Obesity Subjects study with 15+ years of evidence
suggests CV benefit, T2DM prevention & prolonged glycemic control†
†
Sjostrom L, Peltonen M, Jacobson P et al. Bariatric surgery and long-term cardiovascular events. JAMA 2012;
307(1): 56-65. *Carlsson, L, Peltonen M, Ahlin S et al. Bariatric surgery and prevention of type 2 diabetes in Swedish
obese subjects. N Engl J Med 2012; 367(8): 695-704.
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Implications for Referring Physicians
• Bariatric / metabolic surgery can achieve better control of Type 2
diabetes with much less medication in obese patients with BMI>35*
– Focus on those patients who are at highest risk of a CV event:†
» Younger (under 60)
» Treated less than 10 years
» Difficulty maintaining glycemic control with pharmacological agents.
» Having at least one other CV risk factor in addition to T2DM, e.g.,
elevated insulin, hypertension and/or dyslipidemia.
» Difficulty maintaining acceptable weight (almost all T2DM patients).
– Surgery is a therapeutic for T2DM in the severely obese population.‡
– Mode of action of bariatric surgery is metabolically analogous to many
T2DM medications with positive impact on GLP-1 & insulin sensitivity.
* Sjostrom L, Peltonen M, Jacobson P et al. Bariatric surgery and long-term cardiovascular events. JAMA 2012; 307(1): 56-65.
†Berry J, Dyer A, Cai X et al. Lifetime risks of cardiovascular disease. N Engl J Med 2012; 366(4): 321-29.
‡ Dixon JB, Zimmet P, Alberti KG, et. al. Bariatric Surgery: An IDF Statement for Obese Type 2 Diabetes. Diabetes Medicine
2011 Jun; 28(6): 628–642.
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Guidelines and Recommendations
• The DSS-II guidelines are endorsed by 45 worldwide societies
(30 medical and 15 surgical organisations), including the
International Diabetes Federation, American Diabetes Association
and Diabetes UK and AACE.
• American Diabetes Association recommends bariatric surgery be
considered for adults with type 2 diabetes who have a BMI greater
than 35, in particular if diabetes or associated comorbidities are
difficult to control with lifestyle and pharmacologic therapy*
• 2011 statement from International Diabetes Federation said surgery
was “effective, safe and cost-effective therapy” for patients with
obesity and type 2 diabetes, noting it significantly improves glycemic
control in severely obese patients with the disease†
*American Diabetes Association. Diabetes Management Guidelines. Diabetes Care 2016;39(Suppl. 1):S47–S51.
† Dixon JB, Zimmet P, Alberti KG, et. al. Bariatric Surgery: An IDF Statement for Obese Type 2 Diabetes. Diabetes Medicine
2011 Jun; 28(6): 628–642.
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Costs Associated with Type 2 Diabetes
•
Recent estimates of annual medical costs for treating preventable obesity-related
conditions range from $147 billion to nearly $210 billion (2012 costs) 1
•
Analysts predict that the medical costs for treating preventable obesity-related conditions
will increase by between $48 billion and $66 billion each year over the next 2 decades. 1,2
•
More than 1-in-5 health care dollars in the U.S. are spent on diabetes care with half
directly attributable to treatment 3
•
Obesity-related absenteeism costs the nation’s employers an estimated $8.65 billion per
year 4
- Obesity is associated with an increased incidence of workday absences. Employees affected by
obesity miss approximately 1.1 to 1.7 more days each year than healthy-weight employees
•
Diabetes patients incur avg. medical costs of $7,900/treatment; with total medical
expenses 2.3 times higher than for people without diabetes 5
•
The total monthly costs for patients affected by type 2 diabetes, hypertension, and high
cholesterol were lower for patients who underwent bariatric surgery than for the control
group who did not undergo surgery 6
- Annual health care costs decreased 34.2%/70.5% after two/three years 7
- 72% reduction in average monthly diabetes prescription drug cost 2 years after surgery for patients
who underwent bariatric surgery, compared with control patients(no surgery) 8
for America’s Health and Robert Wood Johnson Foundation. F as in Fat: How Obesity Threatens America’s Future. 2013.
Healthy Americans website. http://stateofobesity.org/files/fasinfat2013.pdf. Accessed April 8, 2016.
2 Finkelstein E. Annual Medical Spending. 2009; 28(5):w822-w831.
3 American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2012. Diabetes Care 2013 Apr; 36(4): 1033-1046.
4 Andreyeva T. State-level Estimates of Obesity. 2014; 56(11):1120-1127. 5 American Diabetes Association. The Cost of Diabetes.
www.Diabetes.org. Last accessed 9/28/2016.
6 Segal J. et al. Effective Health Care Program. 2010; no. 28; Research and Quality website.
https://www.effectivehealthcare.ahrq.gov/ehc/products/214/487/28finalrev.pdf. Accessed April 13, 2016.
7 Makary M. et al. Medication Utilization. 2010; 145(8):726-731.
13
8 Klein S, et al. Obesity. 2011;19(3):581–587
1 Trust
Body of Evidence
High Quality (Level I & II-1,2) Studies on Bariatric / Metabolic Surgery in Diabetic Patients
Investigator
Study Type
# Diabetic
Patients
Primary Endpoint
Study
Duration
Carlsson
Non-randomized,
prospective, controlled
3429 pts, 2 arms
(1658 surgery)
Rate of incident Type 2 diabetes
mellitus
15 years
STAMPEDE
(Schauer)*
RCT, single center
150 pts, 3 arms
HbA1c < 6 with or w/o meds
Year 3 of
5-year study
Mingrone
RCT, single center
60 pts, 3 arms
HbA1c < 6.5 without meds
2 years
Buchwald*
Systematic Review &
Meta-Analysis
135,000 pts, 621
studies, 888 arms
Effect of bariatric surgery on
Type 2 diabetes
N/A
Klein*
Matched Cohort, Claims data
1600 pts, 2 arms
Economic impact & clinical
benefits of bariatric surgery
3 years
AHRQ
(Segal)*
Matched Cohort, Claims data
8400 pts, 2 arms
(2100 surgery)
Impact of surgery to reduce
utilization of CV meds
Year 1 of
3-year study
Bolen*
Matched Cohort, Claims data
14,000 pts, 2 arms
(6300 surgery)
% Obesity-related co-morbidities
between groups
5 years
Cohen
Non-randomized, prospective
66 pts, 1 arm
Safety and % of patients
experiencing diabetes remission
5 years
(median)
* Supported by a grant from Ethicon
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Clinical Evidence
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Clinical Evidence: STAMPEDE
• Surgical treatment and medications
achieved glycemic control in more patients
than medical therapy alone.
• Schauer, Kashyap, Wolski, et al. Bariatric
Surgery versus Intensive Medical Therapy
in Obese Patients with Diabetes. N Engl J
Med 2012; 366: 1567-1576.
• Schauer P, Deepak B, Kirwan J, et al.
Bariatric Surgery versus Intensive Medical
Therapy for Diabetes — 3-Year Outcomes.
N Engl J Med 2014; 370:2002-2013.
• Study supported by a grant from Ethicon
Endo-Surgery.
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STAMPEDE: Study Design
* As defined by ADA guidelines, including lifestyle counseling, weight management,
frequent home glucose monitoring, and the use of newer drug therapies.
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STAMPEDE: Results
Patients at Glycemic Control, 12 months
50%
40%
Significantly More Diabetic
Patients at Glycemic
Control with Bariatric /
Metabolic Surgery
“In obese patients with
uncontrolled Type 2
diabetes, 12 months of
medical therapy plus
bariatric surgery achieved
glycemic control in
significantly more patients
than medical therapy alone.”
42%
37%
30%
20%
10%
0%
*
12%
Medical
Therapy
*
*
Medical
Therapy +
Gastric
Bypass
Medical
Therapy +
Sleeve
Gastrectomy
*p=0.002
**p=0.008
Patients at Glycemic Control, 36 months
50%
40%
38%
30%
25%
20%
10%
0%
5%
Medical Therapy Medical Therapy + Medical Therapy +
Gastric Bypass
Sleeve
p=0.01
Gastrectomy
p=0.17
Glycemic control: HbA1c < 6.0% with or without diabetes medications, 12 mo after
randomization. Figures adapted from study data.
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STAMPEDE: Results
Average levels of HbA1c
were also significantly lower
after Bariatric / Metabolic
Surgery
• “Mean levels of glycated
hemoglobin and fasting
plasma glucose were
significantly lower in each
of the two surgical groups
than in the medical
therapy group”(p<0.001).
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STAMPEDE: Results
Significant Decreases in Diabetic
Medication Usage with Bariatric /
Metabolic Surgery
• The average number of diabetic
medications per patient per day
tended to increase in the
medical therapy group but
decreased significantly in each
surgical group (p<0.001):
• > 50% of patients in each
surgical group used NO
diabetes medications at 12
months.
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Clinical Evidence: Mingrone
Bariatric surgery resulted in
better glucose control than did
medical therapy
• Mingrone et al. Bariatric
Surgery versus Conventional
Medical Therapy for Type 2
Diabetes, N Engl J Med 2012;
366: 1577-1585.
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Mingrone et al. Study Design
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Mingrone Study
Glycated Hemoglobin Levels during 2 Years of Follow-up
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Clinical Evidence: Swedish Obese Subjects (SOS)
• Bariatric surgery appears to be
markedly more efficient than
usual care in the prevention of
Type 2 diabetes in obese
persons.
• Carlsson, Peltonen, Ahlin, et al,
Bariatric Surgery and
Prevention of Type 2 Diabetes
in Swedish Obese Subjects. N
Engl J Med 2012; 367: 695704.
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Carlsson et al. Study Design
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Carlsson et al.: Results
• Significantly lower
incidence of Type 2
diabetes in Bariatric
/ Metabolic Surgery
group
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Sjostrom et al. (2012)
“High insulin may be a better selection criteria for bariatric surgery than
high BMI, as far as CV events are concerned”
Source: Sjostrom L, Peltonen M, Jacobson P et al. Bariatric surgery and long-term
cardiovascular events. JAMA 2012; 307(1): 56-65.
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Clinical Evidence
Bariatric / Metabolic Surgery and
Diabetes Management
Matched Cohort Studies / Administrative Claims Data
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Buchwald: Systematic Review & Meta-Analysis (2009)
T2DM resolved or improved in 87% of patients following bariatric surgery
100%
80%
60%
40%
20%
0%
Total
Gastric
Banding
Resolved
Gastroplasty
Gastric
Bypass
BPD/DS
Resolved or Improved
• Systematic review & meta-analysis reviewing 621 studies including 135,246 patients
• Overall, T2DM 87% resolved or improved (78% resolved) for patients after bariatric surgery
Source: Buchwald H, Estok R, Farbach K, et al. Weight and type 2 diabetes after bariatric surgery:
Systematic review and meta-analysis. Am J Med 2009; 122(3): 248-256.
Figure adapted from source data. Data included includes 621 studies with 888 treatment arms & 135,246
patients; 103 treatment arms with 3188 patients reported on resolution of diabetes.
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Klein: 3-Year Matched Cohort Analysis (2011)
46% fewer T2DM-related claims for patients following bariatric surgery
• 3-year matched cohort analysis comparing claims from 1,616 privately insured patients (808 per cohort)
• At 6 months, 28% of surgery patients reported a diabetes claim vs. 74% of control patients (p<0.001)
• The trend in diabetes claims was sustained to 3 years.
Source: Klein S, Ghosh A, Cremieux P et al. Economic impact of the clinical benefits of bariatric
surgery in diabetes patients with BMI ≥35 kg/m2. Obesity 2011; 19(3): 581-587.
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Bolen: 5-Year Matched Cohort Analysis (2012)
Lower proportion – and likelihood - having T2DM at 5yr following bariatric surgery
• 5-year matched cohort analysis comparing 22,693 obese patients with versus without bariatric surgery
from seven BCBS plans
• The proportion of patients with T2DM at 5 years was 18% lower with bariatric surgery (15% vs. 33%)
• Bariatric surgery patients had a 31% lower likelihood (odds ratio) of having T2DM at 5 years
Source: Bolen S, Chang H, Wiener J et al. Clinical outcomes after bariatric surgery: A five-year
matched cohort analysis in seven US states. Obesity Surgery 2012; 22(5): 749-763.
Figure adapted from source data. Non-concurrent, matched cohort study following 22,693 persons
who underwent bariatric surgery using logistic regression between groups for up to 5 years.
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Clinical Evidence
Bariatric / Metabolic Surgery and
Diabetes Management (BMI 30-35)
Prospective Study
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Cohen: 5-Year Study of Diabetic Patients (2012)
88% of diabetic patients without severe obesity showed diabetes remission
• Study of 66 consecutive diabetic patients with
BMI 30-35 who underwent RYGB
• At median 5 years durable diabetes remission
occurred in 88% of cases and diabetes
improvement in an additional 11%
• There was no recurrence of diabetes following
remission during the six-year follow-up
• Hypertension and dyslipidemia also improved,
yielding 50-84% reductions in predicted 10-year
cardiovascular disease risks of fatal and
nonfatal coronary heart disease and stroke
Source: Cohen R, Pinheiro J, Schiavon C et al. Effects of gastric bypass surgery in
patients with type 2 diabetes and only mild obesity. Diabetes Care 2012; 35: 1420-1428.
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Clinical Evidence
Bariatric / Metabolic Surgery and
Medication Usage
Matched Cohort Studies
Administrative Claims Data
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Segal: AHRQ 1-Year Cohort Study (2010)
76% decline in diabetes medication use at 12 months post-surgery (p≤0.0001)
• 3-year cohort study using BCBS
data from 7 plans, covering 6,235
patients (34% of whom had
T2DM)
• 55% decrease in the mean
number of diabetes medications
within three months
• Patients without surgery had an
increase in mean number of
diabetes medications during the
same period
■ nonsurgical group
◊ surgical group
Source: Segal J, Clark J, Shore A et al. Prompt reduction in use of medications
for comorbid conditions after bariatric surgery. Obes Surg 2009; 19: 1646-1656.
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Segal: AHRQ 1-Year Cohort Study (2010)
Significant declines in cardiovascular medication use at 12 months post-surgery
• Use of medication for
hypertension & hyperlipidemia
declined 51% and 59%
respectively at 12 months postsurgery (p<0.0001)
• Patients without surgery had an
increase in medications for
hypertension and hyperlipidemia
Source: Segal J, Clark J, Shore A et al. Prompt reduction in use of medications for
comorbid conditions after bariatric surgery. Obes Surg 2009; 19: 1646-1656.
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Klein: 3-Year Matched Cohort Analysis (2011)
56% fewer diabetes prescriptions were filled for bariatric surgery patients
• 3-year matched cohort analysis covering 1,616 obese patients with diabetes (808 per cohort)
• Six months post-surgery only 34% of surgery patients had filled a prescription for diabetes
medication in the previous three months compared to 90% of control patients (p<0.001)
• This difference is sustained to the end of the study period (three years)
Source: Klein S, Ghosh A, Cremieux P et al. Economic impact of the clinical benefits of bariatric surgery in diabetes
patients with BMI ≥35 kg/m2. Obesity 2011; 19(3): 581-587. Figure adapted from study data.
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Klein: 3-Year Matched Cohort Analysis (2011)
Significantly lower supply costs in diabetes medication for surgery patients
P < 0.001
• Total diabetes medication costs decreased significantly among surgery patients relative to controls.
• 3 months after bariatric surgery, the average total cost of diabetes medications and supplies for
surgery patients was $33 compared to $123 for control patients (p<0.001)
• Total monthly prescription drug costs for surgery patients were 72% lower at two years.
Source: Klein S, Ghosh A, Cremieux P et al. Economic impact of the clinical benefits of bariatric surgery in diabetes
patients with BMI ≥35 kg/m2. Obesity 2011; 19(3): 581-587. Figure adapted from study data.
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Clinical Evidence
Bariatric Surgery Safety
Matched Cohort Studies /
Administrative Claims Data
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CMS: Inpatient Discharge Data (2010)
Morbidity & mortality rates of gastric bypass are similar to other common
procedures
Procedure
Bariatric
surgeries
Other common
procedures
Complications
Mortality
Gastric Bypass
0.4%
0.2%
Gastric Banding
*
*
Colectomy
2.4%
0.8%
Hysterectomy
0.4%
*
Cholecystectomy
0.9%
0.9%
Hip replacement
1.0%
0.2%
*≤10 cases reported
Source: Direct Research, LLC, Center for Medicare and Medicaid Services, FY 2010
MedPAR, Medicare Fee-for-Service Inpatient Discharges with Selected Procedures
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UHC Database: Surgery Data (2012)
Morbidity & complication rates of laparoscopic bariatric surgery are similar to
other laparoscopic general surgery procedures
Outcomes of laparoscopic procedures in general surgical operations between 2006 and 2009
N
Utilization of
laparoscopy
LOS* (days)
Complications*
Mortality*
Bariatric surgery
54,885
90.0%
2.3 ± 2.8
6.3%
0.06%
Cholecystectomy
54,782
81.4%
3.3 ± 3.8
8.3%
0.18%
Antireflux surgery
8,339
79.3%
2.9 ± 4.3
10.7%
0.02%
Appendectomy
51,077
71.5%
1.6 ± 1.3
3.5%
0.02%
Colectomy
21,761
18.9%
5.6 ± 4.6
21.5%
0.54%
Ventral hernia repair
25,885
8.1%
3.2 ± 3.4
14.0%
0.24%
Rectal resection
2,392
7.4%
6.9 ± 5.1
25.0%
0.57%
Operations
* Outcome of laparoscopic operations; LOS: Length Of Stay
Source: Nguyen N, Nguyen B, Shih A et al. Use of laparoscopy in general surgical
operations at academic centers. Surgery for Obesity and Related Diseases 2013; 9: 1520.
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Conclusions &
Recommended Next Steps
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Conclusions
The evidence has shown that bariatric surgery:
• Helped Type 2 diabetic patients
achieve glycemic control with
surgery and medical therapy more
effectively than intensive medical
therapy alone at 3 years
(STAMPEDE) and at 2
years (MINGRONE)
(STAMPEDE & Mingrone)
• Resolved or improved Type 2
diabetes and other obesity-related
CV comorbidities for up to 5 years
(STAMPEDE, Buchwald, Klein and Bolen)
• Reduced medication use for Type 2
diabetes and other CV comorbidities
for up to 3 years
(STAMPEDE, AHRQ/Segal and Klein)
• Was more efficient than usual care
for the prevention of Type 2 diabetes
in persons with obesity at 15 years
(Carlsson)
• Reduced the risk of cardiovascular
death (myocardial infarction or
stroke) compared to customary
intervention at 15 years (Sjostrom)
• Resulted in morbidity / mortality
rates similar to well-established
general surgery procedures such as
gallbladder surgery and
hysterectomy (CMS)
• Is viewed an acceptable treatment
option for severely obese patients
with T2DM
(medical societies including the ADA, AHA, IDF, AACE
& the Endocrine Society)
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Next Steps – Encourage referring physicians & PCPs …
• To recommend bariatric surgery to selected obese patients (BMI>35)
with Type 2 diabetes to achieve better control of their diabetes with
much less medication:
– Rethink surgery as a treatment for T2DM in the obese population, no just
for severe obesity.
» Mode of action of bariatric surgery is metabolically analogous to many
T2DM medications with positive impact on GLP-1 & insulin sensitivity.
– Focus on those patients who are at highest risk of a CV event:
» Younger (under 60)
» Treated less than 10 years
» Difficulty maintaining glycemic control with metformin
» Having at least one other CV risk factor in addition to T2DM, e.g.
elevated insulin, hypertension and/or dyslipemia.
» Difficulty maintaining acceptable weight (almost all T2DM patients).
Sources: Sjostrom L, Peltonen M, Jacobson P et al. Bariatric surgery and long-term cardiovascular
events. JAMA 2012; 307(1): 56-65.
Berry J, Dyer A, Cai X et al. Lifetime risks of cardiovascular disease. N Engl J Med 2012; 366(4): 321-29.
Dixon JB, Zimmet P, Alberti KG, et. al. Bariatric Surgery: An IDF Statement for Obese Type 2 Diabetes.
Diabetes Medicine 2011 Jun; 28(6): 628–642.
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Discussion….
“What are your thoughts?”
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Bariatric Surgery –
Medical Society Support
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A growing consensus favors bariatric surgery
“Bariatric surgery should be considered for adults with BMI ≥
35 kg/m2 and type 2 diabetes, especially if the diabetes is
difficult to control with lifestyle and pharmacologic therapy.”
– American Diabetes Association (2016)
“When indicated, surgical intervention leads to significant
improvements in decreasing excess weight and comorbidities that can be maintained over time.”
– American Heart Association (2011)
“Bariatric surgery is an appropriate treatment for people with
type 2 diabetes and obesity not achieving recommended
treatment targets with medical therapies”
– International Diabetes Federation (2011)
“The beneficial effect of surgery on reversal of existing DM
and prevention of its development has been confirmed in a
number of studies”
– American Association of Clinical Endocrinologists (2011)
Sources: American Diabetes Association. Obesity management for the
treatment of type 2 diabetes. Sec. 6. In Standards of Medical Care in
Diabetesd2016. Diabetes Care 2016; 39(Suppl. 1):S47–S51.
Poirier P, Cornier M, Mazzone T et al. Bariatric surgery and
cardiovascular risk factors: A scientific statement from the American
Heart Association. Circulation 2011; 123: 1683-1701.
International Diabetes Federation. Bariatric Surgical and procedural
interventions in the treatment of obese patients with type 2 diabetes
2011.
Handelsman Y, Mechanick J, Blonde L et al. American Association of
Clinical Endocrinologists medical guidelines for clinical practice for
developing a diabetes mellitus comprehensive care plan. Endocr
Pract. 2011; 17(Suppl 2): 1-53.
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A growing consensus favors bariatric surgery
“The Endocrine Society recommends that
practitioners consider several factors in
recommending surgery for their obese patients
with type 2 diabetes, including patient’s BMI and
age, the number of years of diabetes and the
assessment of the (patient’s) ability to comply with
the long-term lifestyle changes that are required to
maximize success of surgery and minimize
complications.”
“… remission of diabetes, even if temporary, will
still lead to a reduction in the progression to
secondary complications of diabetes (such as
retinopathy, neuropathy and nephropathy), which
would be an important outcome of … surgery.”
– The Endocrine Society (March 2012)
Source: The Endocrine Society. Evaluating the benefits of treating type 2 diabetes with bariatric surgery, March 29, 2012.
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Discussion….
“What are your thoughts?”
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