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CHICAGO – Bariatric surgery crushed intensive medical therapy for the management of hyperglycemia in a randomized trial involving obese patients with poorly controlled type 2 diabetes.
"The lesson of this study is that for those obese patients who also have uncontrolled diabetes, there is now another treatment option that may be very, very effective at getting them in good control," Dr. Philip R. Schauer declared in presenting the 1-year results of the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial.
STAMPEDE was a single-center prospective study involving 150 randomized patients. The primary end point – hemoglobin A1c of 6.0% or less at 1 year – was achieved in 42% of patients in the Roux-en-Y gastric bypass group, 37% in the sleeve gastrectomy group, and 12% of patients assigned to state-of-the-art intensive medical management based upon American Diabetes Association guidelines, including a weight loss program, reported Dr. Schauer, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic.
At enrollment the average HbA1c was 9.2% even though most patients were on three or more diabetes medications, and about half were taking insulin. The average baseline body mass index was 37 kg/m2. More than 60% of subjects had moderate to severe fatty liver disease.
Particularly noteworthy was the finding that all gastric bypass patients with an HbA1c of 6.0% or less at 1 year achieved that target despite having discontinued all diabetes medications, including insulin. So did 13 of 18 patients in the sleeve gastrectomy group who reached the primary end point.
"That’s as close to a definition of remission of diabetes as you can get to," the surgeon commented.
Improvements in secondary study end points related to cardiovascular risk were also far more impressive in the surgery arms.
Three patients in the gastric bypass group and one in the sleeve gastrectomy arm required redo operations. There were other serious complications in the surgical groups as well, but no deaths.
Follow-up of STAMPEDE participants will continue through 4 years. Dr. Schauer predicted that on the basis of the highly positive STAMPEDE findings, future studies will look at bariatric surgery versus intensive medical management in obese type 2 diabetic patients with lesser degrees of uncontrolled type 2 diabetes – say, HbA1cs between 7% and 9%.
Reaction to STAMPEDE was cautious.
"That’s a huge intervention in order to get control of diabetes. I’m just not sure it’s ready for prime time yet," former ACC President Dr. W. Douglas Weaver said in an interview.
"I would like to see some more outcomes data in patients who’ve been managed in this way. You’d like to see that it not only keeps the weight off and the glucose levels lower over the longer term, but that it actually improves outcomes in terms of cardiovascular events and diabetic complications. Then it becomes compelling. Right now, we just have these surrogate improvements," added Dr. Weaver, head of the division of cardiovascular medicine at the Henry Ford Health System, Detroit.
Cleveland Clinic endocrinologist Dr. Sangeeta Kashyap, who headed the STAMPEDE diabetology team, said medical therapy is not to be discounted. It’s titratable, even stoppable if need be. A surgical fix is not.
"Surgery works very well, but once it’s done, it’s done. If you want to eat an extra bite of food, you’re not going to be able to without getting violently ill," she observed in an interview.
"Even though our results strongly support bariatric surgery for diabetes, I don’t think it’s going to be right for everybody. I think more studies need to be done to figure out who the best candidates are, and for which procedures," Dr. Kashyap said.
The durability of surgery’s antidiabetic effect has yet to be established, she added.
Simultaneously with Dr. Schauer’s presentation of STAMPEDE in Chicago, the study was published online by the New England Journal of Medicine (N. Engl. J. Med. 2012 March 26 [10.1056/NEJMoa1200225]).
STAMPEDE was supported by Ethicon Endo-Surgery, the National Institutes of Health, and LifeScan. Dr. Schauer and Dr. Kashyap reported serving as consultants to Ethicon, and Dr. Schauer consults for other companies as well.
The randomized STAMPEDE trial from the Cleveland Clinic comparing the results of bariatric surgery to intensified medical therapy in obese patients with long-standing, poorly controlled type 2 diabetes is a seminal study. In contrast to most studies of bariatric surgery and diabetes, this study prospectively randomized patients to surgical treatments versus intensive medical therapy. The patients entering the study had long-standing diabetes, were poorly controlled on their current medical regimen, and had a high percentage of comorbidities. This is the population that could justify an invasive intervention that might be more effective in improving metabolic control and reducing complications.
The results of the surgical treatments were dramatic and far superior to the results of the intensified medical therapy. Patients undergoing gastric bypass surgery decreased mean HbA1c to 6.4 plus or minus 0.9 % compared with intensive medical therapy, 7.5 plus or minus 1.8 %. Additionally, 42% of those with the gastric bypass achieved an HbA1c below 6 % on no diabetes medications. The gastric bypass patients had greater reductions in triglycerides and high sensitivity C-reactive protein and increases in HDL cholesterol than did the medically treated patients, despite greater reductions in lipid lowering agents. Blood pressure and LDL cholesterol were the same between the surgical and medical patients, but were achieved with a decreased need for medications. The benefits from sleeve gastrectomy were similar to, but not as great as, those with gastric bypass.
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Both surgical procedures resulted in much greater weight loss than the medical therapy. It is not possible to determine how much of the benefit of the surgical procedures was due to the greater weight loss and how much to non–weight loss mechanisms. A key question that is unanswered by the 1-year data, but may be resolved by the 5-year follow-up, is whether the better metabolic control from the surgical procedures will be matched by better improvements in clinical outcomes. Since surgical therapies are associated with significant morbidities, an evaluation of risk versus benefits compared with medical therapies in future long-term trials are necessary. This study is a very good start in beginning such an assessment.
Harold Lebovitz, M.D., is professor of medicine, State University of New York Health Science Center at Brooklyn. He is a consultant to Ethicon Endo-Surgery and serves on advisory boards for Amylin, Merck, Intarcia, and Medicure.
The randomized STAMPEDE trial from the Cleveland Clinic comparing the results of bariatric surgery to intensified medical therapy in obese patients with long-standing, poorly controlled type 2 diabetes is a seminal study. In contrast to most studies of bariatric surgery and diabetes, this study prospectively randomized patients to surgical treatments versus intensive medical therapy. The patients entering the study had long-standing diabetes, were poorly controlled on their current medical regimen, and had a high percentage of comorbidities. This is the population that could justify an invasive intervention that might be more effective in improving metabolic control and reducing complications.
The results of the surgical treatments were dramatic and far superior to the results of the intensified medical therapy. Patients undergoing gastric bypass surgery decreased mean HbA1c to 6.4 plus or minus 0.9 % compared with intensive medical therapy, 7.5 plus or minus 1.8 %. Additionally, 42% of those with the gastric bypass achieved an HbA1c below 6 % on no diabetes medications. The gastric bypass patients had greater reductions in triglycerides and high sensitivity C-reactive protein and increases in HDL cholesterol than did the medically treated patients, despite greater reductions in lipid lowering agents. Blood pressure and LDL cholesterol were the same between the surgical and medical patients, but were achieved with a decreased need for medications. The benefits from sleeve gastrectomy were similar to, but not as great as, those with gastric bypass.
|
Both surgical procedures resulted in much greater weight loss than the medical therapy. It is not possible to determine how much of the benefit of the surgical procedures was due to the greater weight loss and how much to non–weight loss mechanisms. A key question that is unanswered by the 1-year data, but may be resolved by the 5-year follow-up, is whether the better metabolic control from the surgical procedures will be matched by better improvements in clinical outcomes. Since surgical therapies are associated with significant morbidities, an evaluation of risk versus benefits compared with medical therapies in future long-term trials are necessary. This study is a very good start in beginning such an assessment.
Harold Lebovitz, M.D., is professor of medicine, State University of New York Health Science Center at Brooklyn. He is a consultant to Ethicon Endo-Surgery and serves on advisory boards for Amylin, Merck, Intarcia, and Medicure.
The randomized STAMPEDE trial from the Cleveland Clinic comparing the results of bariatric surgery to intensified medical therapy in obese patients with long-standing, poorly controlled type 2 diabetes is a seminal study. In contrast to most studies of bariatric surgery and diabetes, this study prospectively randomized patients to surgical treatments versus intensive medical therapy. The patients entering the study had long-standing diabetes, were poorly controlled on their current medical regimen, and had a high percentage of comorbidities. This is the population that could justify an invasive intervention that might be more effective in improving metabolic control and reducing complications.
The results of the surgical treatments were dramatic and far superior to the results of the intensified medical therapy. Patients undergoing gastric bypass surgery decreased mean HbA1c to 6.4 plus or minus 0.9 % compared with intensive medical therapy, 7.5 plus or minus 1.8 %. Additionally, 42% of those with the gastric bypass achieved an HbA1c below 6 % on no diabetes medications. The gastric bypass patients had greater reductions in triglycerides and high sensitivity C-reactive protein and increases in HDL cholesterol than did the medically treated patients, despite greater reductions in lipid lowering agents. Blood pressure and LDL cholesterol were the same between the surgical and medical patients, but were achieved with a decreased need for medications. The benefits from sleeve gastrectomy were similar to, but not as great as, those with gastric bypass.
|
Both surgical procedures resulted in much greater weight loss than the medical therapy. It is not possible to determine how much of the benefit of the surgical procedures was due to the greater weight loss and how much to non–weight loss mechanisms. A key question that is unanswered by the 1-year data, but may be resolved by the 5-year follow-up, is whether the better metabolic control from the surgical procedures will be matched by better improvements in clinical outcomes. Since surgical therapies are associated with significant morbidities, an evaluation of risk versus benefits compared with medical therapies in future long-term trials are necessary. This study is a very good start in beginning such an assessment.
Harold Lebovitz, M.D., is professor of medicine, State University of New York Health Science Center at Brooklyn. He is a consultant to Ethicon Endo-Surgery and serves on advisory boards for Amylin, Merck, Intarcia, and Medicure.
CHICAGO – Bariatric surgery crushed intensive medical therapy for the management of hyperglycemia in a randomized trial involving obese patients with poorly controlled type 2 diabetes.
"The lesson of this study is that for those obese patients who also have uncontrolled diabetes, there is now another treatment option that may be very, very effective at getting them in good control," Dr. Philip R. Schauer declared in presenting the 1-year results of the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial.
STAMPEDE was a single-center prospective study involving 150 randomized patients. The primary end point – hemoglobin A1c of 6.0% or less at 1 year – was achieved in 42% of patients in the Roux-en-Y gastric bypass group, 37% in the sleeve gastrectomy group, and 12% of patients assigned to state-of-the-art intensive medical management based upon American Diabetes Association guidelines, including a weight loss program, reported Dr. Schauer, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic.
At enrollment the average HbA1c was 9.2% even though most patients were on three or more diabetes medications, and about half were taking insulin. The average baseline body mass index was 37 kg/m2. More than 60% of subjects had moderate to severe fatty liver disease.
Particularly noteworthy was the finding that all gastric bypass patients with an HbA1c of 6.0% or less at 1 year achieved that target despite having discontinued all diabetes medications, including insulin. So did 13 of 18 patients in the sleeve gastrectomy group who reached the primary end point.
"That’s as close to a definition of remission of diabetes as you can get to," the surgeon commented.
Improvements in secondary study end points related to cardiovascular risk were also far more impressive in the surgery arms.
Three patients in the gastric bypass group and one in the sleeve gastrectomy arm required redo operations. There were other serious complications in the surgical groups as well, but no deaths.
Follow-up of STAMPEDE participants will continue through 4 years. Dr. Schauer predicted that on the basis of the highly positive STAMPEDE findings, future studies will look at bariatric surgery versus intensive medical management in obese type 2 diabetic patients with lesser degrees of uncontrolled type 2 diabetes – say, HbA1cs between 7% and 9%.
Reaction to STAMPEDE was cautious.
"That’s a huge intervention in order to get control of diabetes. I’m just not sure it’s ready for prime time yet," former ACC President Dr. W. Douglas Weaver said in an interview.
"I would like to see some more outcomes data in patients who’ve been managed in this way. You’d like to see that it not only keeps the weight off and the glucose levels lower over the longer term, but that it actually improves outcomes in terms of cardiovascular events and diabetic complications. Then it becomes compelling. Right now, we just have these surrogate improvements," added Dr. Weaver, head of the division of cardiovascular medicine at the Henry Ford Health System, Detroit.
Cleveland Clinic endocrinologist Dr. Sangeeta Kashyap, who headed the STAMPEDE diabetology team, said medical therapy is not to be discounted. It’s titratable, even stoppable if need be. A surgical fix is not.
"Surgery works very well, but once it’s done, it’s done. If you want to eat an extra bite of food, you’re not going to be able to without getting violently ill," she observed in an interview.
"Even though our results strongly support bariatric surgery for diabetes, I don’t think it’s going to be right for everybody. I think more studies need to be done to figure out who the best candidates are, and for which procedures," Dr. Kashyap said.
The durability of surgery’s antidiabetic effect has yet to be established, she added.
Simultaneously with Dr. Schauer’s presentation of STAMPEDE in Chicago, the study was published online by the New England Journal of Medicine (N. Engl. J. Med. 2012 March 26 [10.1056/NEJMoa1200225]).
STAMPEDE was supported by Ethicon Endo-Surgery, the National Institutes of Health, and LifeScan. Dr. Schauer and Dr. Kashyap reported serving as consultants to Ethicon, and Dr. Schauer consults for other companies as well.
CHICAGO – Bariatric surgery crushed intensive medical therapy for the management of hyperglycemia in a randomized trial involving obese patients with poorly controlled type 2 diabetes.
"The lesson of this study is that for those obese patients who also have uncontrolled diabetes, there is now another treatment option that may be very, very effective at getting them in good control," Dr. Philip R. Schauer declared in presenting the 1-year results of the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial.
STAMPEDE was a single-center prospective study involving 150 randomized patients. The primary end point – hemoglobin A1c of 6.0% or less at 1 year – was achieved in 42% of patients in the Roux-en-Y gastric bypass group, 37% in the sleeve gastrectomy group, and 12% of patients assigned to state-of-the-art intensive medical management based upon American Diabetes Association guidelines, including a weight loss program, reported Dr. Schauer, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic.
At enrollment the average HbA1c was 9.2% even though most patients were on three or more diabetes medications, and about half were taking insulin. The average baseline body mass index was 37 kg/m2. More than 60% of subjects had moderate to severe fatty liver disease.
Particularly noteworthy was the finding that all gastric bypass patients with an HbA1c of 6.0% or less at 1 year achieved that target despite having discontinued all diabetes medications, including insulin. So did 13 of 18 patients in the sleeve gastrectomy group who reached the primary end point.
"That’s as close to a definition of remission of diabetes as you can get to," the surgeon commented.
Improvements in secondary study end points related to cardiovascular risk were also far more impressive in the surgery arms.
Three patients in the gastric bypass group and one in the sleeve gastrectomy arm required redo operations. There were other serious complications in the surgical groups as well, but no deaths.
Follow-up of STAMPEDE participants will continue through 4 years. Dr. Schauer predicted that on the basis of the highly positive STAMPEDE findings, future studies will look at bariatric surgery versus intensive medical management in obese type 2 diabetic patients with lesser degrees of uncontrolled type 2 diabetes – say, HbA1cs between 7% and 9%.
Reaction to STAMPEDE was cautious.
"That’s a huge intervention in order to get control of diabetes. I’m just not sure it’s ready for prime time yet," former ACC President Dr. W. Douglas Weaver said in an interview.
"I would like to see some more outcomes data in patients who’ve been managed in this way. You’d like to see that it not only keeps the weight off and the glucose levels lower over the longer term, but that it actually improves outcomes in terms of cardiovascular events and diabetic complications. Then it becomes compelling. Right now, we just have these surrogate improvements," added Dr. Weaver, head of the division of cardiovascular medicine at the Henry Ford Health System, Detroit.
Cleveland Clinic endocrinologist Dr. Sangeeta Kashyap, who headed the STAMPEDE diabetology team, said medical therapy is not to be discounted. It’s titratable, even stoppable if need be. A surgical fix is not.
"Surgery works very well, but once it’s done, it’s done. If you want to eat an extra bite of food, you’re not going to be able to without getting violently ill," she observed in an interview.
"Even though our results strongly support bariatric surgery for diabetes, I don’t think it’s going to be right for everybody. I think more studies need to be done to figure out who the best candidates are, and for which procedures," Dr. Kashyap said.
The durability of surgery’s antidiabetic effect has yet to be established, she added.
Simultaneously with Dr. Schauer’s presentation of STAMPEDE in Chicago, the study was published online by the New England Journal of Medicine (N. Engl. J. Med. 2012 March 26 [10.1056/NEJMoa1200225]).
STAMPEDE was supported by Ethicon Endo-Surgery, the National Institutes of Health, and LifeScan. Dr. Schauer and Dr. Kashyap reported serving as consultants to Ethicon, and Dr. Schauer consults for other companies as well.
FROM THE ANNUAL MEETING OF THE AMERICAN COLLEGE OF CARDIOLOGY
Major Finding: In obese patients with poorly controlled type 2 diabetes, 1 year of intensive medical management yielded an HbA1c of 6.0% or lower in 12%, compared with 42% of gastric bypass recipients and 37% of patients undergoing sleeve gastrectomy.
Data Source: A three-armed randomized trial of 150 patients assigned to gastric bypass, sleeve gastrectomy, or intensive medical management and followed quarterly for 1 year.
Disclosures: STAMPEDE was supported by Ethicon Endo-Surgery, the National Institutes of Health, and LifeScan. Dr. Schauer and Dr. Kashyap reported serving as consultants to Ethicon, and Dr. Schauer consults for other companies as well.