Therapeutics
Bariatric surgery improved HbA1c more than intensive medical therapy in obese patients with uncontrolled type 2 DM
Schauer PR, Bhatt DL, Kirwan JP, et al; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes— 3-year outcomes. N Engl J Med. 2014;370:2002-13.
Clinical impact ratings: F ★★★★★✩✩ e ★★★★★★✩ Question
Conclusion
In obese patients with uncontrolled type 2 diabetes, what is the relative long-term efficacy of bariatric surgery and medical therapy for glycemic control?
In obese patients with uncontrolled type 2 diabetes, adding gastric bypass or sleeve gastrectomy to intensive medical therapy (IMT) improved glycemic control more than IMT alone at 3 years after surgery.
Methods Design: Randomized controlled trial (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently [STAMPEDE] trial). ClinicalTrials.gov NCT00432809.
*See Glossary. †Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366:1567-76.
Allocation: Unclear allocation concealment.* Blinding: {Unblinded}†.*
Sources of funding: Ethicon, Investigator-Initiated Study Program of LifeScan, and National Institutes of Health.
Follow-up period: 3 years. Setting: 1 clinical center in the USA.
For correspondence: Dr. P.R. Schauer, Cleveland Clinic, Cleveland, OH, USA. E-mail [email protected]. ■
Patients: 150 adults aged 20 to 60 years (mean age 48 y, 68% women, mean hemoglobin [Hb] A1c level 9.3%) who had an HbA1c level > 7.0% and a body mass index of 27 to 43 kg/m2. {Exclusion criteria included previous bariatric surgery, other complex abdominal surgery, or poorly controlled medical or psychiatric conditions}†.
Commentary Before the emergence of bariatric surgery, remission of type 2 diabetes was not a feasible outcome for obese patients. Bariatric surgery increases the chance of remission 5-fold up to 2 years after surgery (relative risk 5.3, 95% CI 1.8 to 15.8) (1). The STAMPEDE trial, with no major threats to its validity, extends this evidence to up to 3 years after surgery.
Intervention: Roux-en-Y gastric bypass (RYGB) plus intensive medical therapy (IMT) {n = 50}†, sleeve gastrectomy plus IMT {n = 50}†, or IMT alone {n = 50}†.
Sleeve gastrectomy has emerged as a less aggressive, but less effective, form of bariatric surgery for diabetes remission compared with RYGB. The complications after RYGB include mortality (0.2%), venous thromboembolism (0.4%), and need for reoperation (3% to 5%) (2). Overall, RYGB has a higher incidence of postoperative complications than sleeve gastrectomy (20% vs 10%, odds ratio 1.96, CI 1.26 to 3.04) (3).
Outcomes: Glycemic control (HbA1c level ≤ 6.0%). Secondary outcomes included change in HbA1c and in weight. Patient follow-up: 91%.
Main results The main results are in the Table. Gastric bypass plus IMT vs sleeve gastrectomy plus IMT vs IMT alone in obese patients with type 2 diabetes‡ Outcomes
HbA1c≤ 6.0%
Change in HbA1c from baseline (%)
Change in body weight from baseline (kg)
Gastric Sleeve IMT bypass gastrectomy alone + IMT + IMT
At 3 y
RBI (95% CI)
NNT (CI)
38%
–
5%
650% (114 to 2718)
4 (3 to 7)
–
24%
5%
390% (34 to 1796)
38%
24%
–
6 (3 to 21)
53% (−16 to 183)
Not significant
Difference in scores
CI
−2.5
–
−0.6
−1.9
−2.8 to −1.0
–
−2.5
−0.6
−1.9
−2.9 to −0.9
−2.5
−2.5
–
−26
–
−4
−22
0.0
−26 to −18
−0.8 to 0.8
–
−21
−4
−17
−21 to −13
−26
−21
–
−4.9
−9.0 to −0.8
‡Hb = hemoglobin; IMT = intensive medical therapy; other abbreviations defined in Glossary. RBI, NNT, and CI calculated from event rates in article.
© 2014 American College of Physicians JC4 Downloaded From: http://annals.org/ by a Tulane University User on 05/13/2015
Bariatric surgery offers important benefits, including diabetes improvement or remission, to patients with medically complicated obesity for whom weight loss programs are ineffective. The challenge is to identify patients with diabetes who are at high risk for difficulty controlling glycemia and for complications (to justify the perioperative risks and postoperative burdens of these surgeries) and to do so soon after diagnosis when there is a better chance of diabetes remission. Where (e.g., high-volume centers with protocolized postoperative care), when, and which form of surgery to select are subjects for careful deliberation between expert clinicians and informed patients. B. Gisella Carranza Leon, MD Victor M. Montori, MD, MSc Mayo Clinic Rochester, Minnesota, USA References 1. Gloy VL, Briel M, Bhatt DL, et al. BMJ. 2013;347:f5934. 2. Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/ TOS Guideline for the Management of Overweight and Obesity in Adults. Circulation. 2014;129:S102-38.. 3. Li JF, Lai DD, Lin ZH, et al. Surg Laparosc Endosc Percutan Tech. 2014;24:1-11. 19 August 2014 | ACP Journal Club | Volume 161 • Number 4
Bariatric surgery improved HbA1c more than intensive medical therapy in obese patients with uncontrolled type 2 DM
Schauer PR, Bhatt DL, Kirwan JP, et al; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes— 3-year outcomes. N Engl J Med. 2014;370:2002-13.
Clinical impact ratings: F ★★★★★✩✩ e ★★★★★★✩ Question
Conclusion
In obese patients with uncontrolled type 2 diabetes, what is the relative long-term efficacy of bariatric surgery and medical therapy for glycemic control?
In obese patients with uncontrolled type 2 diabetes, adding gastric bypass or sleeve gastrectomy to intensive medical therapy (IMT) improved glycemic control more than IMT alone at 3 years after surgery.
Methods Design: Randomized controlled trial (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently [STAMPEDE] trial). ClinicalTrials.gov NCT00432809.
*See Glossary. †Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366:1567-76.
Allocation: Unclear allocation concealment.* Blinding: {Unblinded}†.*
Sources of funding: Ethicon, Investigator-Initiated Study Program of LifeScan, and National Institutes of Health.
Follow-up period: 3 years. Setting: 1 clinical center in the USA.
For correspondence: Dr. P.R. Schauer, Cleveland Clinic, Cleveland, OH, USA. E-mail [email protected]. ■
Patients: 150 adults aged 20 to 60 years (mean age 48 y, 68% women, mean hemoglobin [Hb] A1c level 9.3%) who had an HbA1c level > 7.0% and a body mass index of 27 to 43 kg/m2. {Exclusion criteria included previous bariatric surgery, other complex abdominal surgery, or poorly controlled medical or psychiatric conditions}†.
Commentary Before the emergence of bariatric surgery, remission of type 2 diabetes was not a feasible outcome for obese patients. Bariatric surgery increases the chance of remission 5-fold up to 2 years after surgery (relative risk 5.3, 95% CI 1.8 to 15.8) (1). The STAMPEDE trial, with no major threats to its validity, extends this evidence to up to 3 years after surgery.
Intervention: Roux-en-Y gastric bypass (RYGB) plus intensive medical therapy (IMT) {n = 50}†, sleeve gastrectomy plus IMT {n = 50}†, or IMT alone {n = 50}†.
Sleeve gastrectomy has emerged as a less aggressive, but less effective, form of bariatric surgery for diabetes remission compared with RYGB. The complications after RYGB include mortality (0.2%), venous thromboembolism (0.4%), and need for reoperation (3% to 5%) (2). Overall, RYGB has a higher incidence of postoperative complications than sleeve gastrectomy (20% vs 10%, odds ratio 1.96, CI 1.26 to 3.04) (3).
Outcomes: Glycemic control (HbA1c level ≤ 6.0%). Secondary outcomes included change in HbA1c and in weight. Patient follow-up: 91%.
Main results The main results are in the Table. Gastric bypass plus IMT vs sleeve gastrectomy plus IMT vs IMT alone in obese patients with type 2 diabetes‡ Outcomes
HbA1c≤ 6.0%
Change in HbA1c from baseline (%)
Change in body weight from baseline (kg)
Gastric Sleeve IMT bypass gastrectomy alone + IMT + IMT
At 3 y
RBI (95% CI)
NNT (CI)
38%
–
5%
650% (114 to 2718)
4 (3 to 7)
–
24%
5%
390% (34 to 1796)
38%
24%
–
6 (3 to 21)
53% (−16 to 183)
Not significant
Difference in scores
CI
−2.5
–
−0.6
−1.9
−2.8 to −1.0
–
−2.5
−0.6
−1.9
−2.9 to −0.9
−2.5
−2.5
–
−26
–
−4
−22
0.0
−26 to −18
−0.8 to 0.8
–
−21
−4
−17
−21 to −13
−26
−21
–
−4.9
−9.0 to −0.8
‡Hb = hemoglobin; IMT = intensive medical therapy; other abbreviations defined in Glossary. RBI, NNT, and CI calculated from event rates in article.
© 2014 American College of Physicians JC4 Downloaded From: http://annals.org/ by a Tulane University User on 05/13/2015
Bariatric surgery offers important benefits, including diabetes improvement or remission, to patients with medically complicated obesity for whom weight loss programs are ineffective. The challenge is to identify patients with diabetes who are at high risk for difficulty controlling glycemia and for complications (to justify the perioperative risks and postoperative burdens of these surgeries) and to do so soon after diagnosis when there is a better chance of diabetes remission. Where (e.g., high-volume centers with protocolized postoperative care), when, and which form of surgery to select are subjects for careful deliberation between expert clinicians and informed patients. B. Gisella Carranza Leon, MD Victor M. Montori, MD, MSc Mayo Clinic Rochester, Minnesota, USA References 1. Gloy VL, Briel M, Bhatt DL, et al. BMJ. 2013;347:f5934. 2. Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/ TOS Guideline for the Management of Overweight and Obesity in Adults. Circulation. 2014;129:S102-38.. 3. Li JF, Lai DD, Lin ZH, et al. Surg Laparosc Endosc Percutan Tech. 2014;24:1-11. 19 August 2014 | ACP Journal Club | Volume 161 • Number 4
