STAMPEDE: Bariatric Surgery Betters

Meds in Obese Diabetics
Lisa Nainggolan

March 31, 2014

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an endocrinologist." said lead author of the study." said Dr. Senior author Sangeeta Kashyap. who noted that this is the longest follow-up from a randomized clinical trial comparing surgery with intensive medical therapy to date. Philip Schauer. are also a "significant advance over our previous publication. DC (updated) — Three-year results from the STAMPEDE trial indicate that bariatric surgery is better than intensive medical therapy alone when it comes to achieving glycemic control in obese patients with uncontrolled type 2 diabetes. from the Cleveland Clinic. "There is no drug or combination of drugs that comes close to what surgery can do. simply put. Type 2 to My Topic Alert Drug & Reference Information  Obesity  Laparoscopic Lap Band Placement  Laparoscopic Gastric Bypass WASHINGTON. The results "add to some fairly convincing evidence that. MD. in that we now are able to show durability of the effects of surgery. in an interview with Medscape Medical News." he stressed. and that is blood sugar control. surgery is superior to medical treatment for type 2 diabetes in terms of the classic end point of therapy that doctors use around the world. Schauer. which were published simultaneously in the New England Journal of Medicine. a bariatric surgeon. Ohio. . presented the findings today during a late-breaking clinical-trial session at the American College of Cardiology 2014 Scientific Sessions. The new findings. with an intermediate duration of 3 years. also from the Cleveland Clinic.  Gastric Bypass 'Cures' Diabetes in Almost a Third of Patients Topic Alert Receive an email from Medscape whenever new articles on this topic are available. MD.  Add Diabetes.

endocrinologist Harold Lebovitz.5% on drugs and their [body mass index] BMI is 33. it's really surgery and medications vs medical treatment. that this was not really a trial of surgery vs medication. body weight. that's pretty good. Dr.or 15-year follow-up data to determine the role of metabolic surgery in the primary treatment of type 2 diabetes. an HbA1c level of 6. he added. and 90% of surgery patients were able to be weaned off insulin completely. who was not involved in the study." Dr. mean HbA1c of 9. HDL cholesterol. 27 – 43) — were randomized to one of 2 bariatric procedures. Schauer said." And little is known about the effects of metabolic surgery in reducing diabetic complications. with less use of glucose-lowering medications including insulin among the surgery patients.0% or less was achieved in 5% of medical-therapy patients compared with 37. 66% female. from the State University of New York.5% of gastric-bypass ( P < . At 3-year follow-up. Schauer acknowledged. including BMI.Dr. told Medscape Medical News: "The 3-year follow-up data of the STAMPEDE trial reinforces the difficulty in determining the role of metabolic surgery as a primary treatment for type 2 diabetes. Schauer stressed.2% and average BMI 36. "It will require extension of the STAMPEDE trial as well as additional studies utilizing the STAMPEDE protocol and perhaps 10. MD. Health Sciences Center at Brooklyn.7 (range. use of cardiovascular and glucose-lowering medications. and we could be improving the lives of [patients] and preventing disease if we did more bariatric surgery." Asked to comment on the findings. the surgical and nutritional complications as well as the occasional necessity for reoperation are not to be dismissed as minor problems. or to intensive medical therapy (n = 50).001) and 24.012). I'm not saying every patient with type 2 diabetes needs surgery. "There can be little doubt that glycemic control and weight loss are superior in patients undergoing metabolic surgery as compared with our current intensive medical therapy. "If a patient is well controlled. "While some patients may achieve complete remission. gastric bypass surgery (n = 50) or sleeve gastrectomy (n = 50). their HbA1c is 6. . 35% maintained normal blood sugar (HbA1c < 6%) on no medications at 3 years. however. that there are many obese diabetes patients in whom he would not consider bariatric surgery. but it is underutilized. 150 obese patients with uncontrolled type 2 diabetes — average age 49 years. therefore. "It's a misnomer saying it's surgery vs medical treatment." Surgery Plus Medical Therapy vs Medication Alone In STAMPEDE.5% of sleeve- gastrectomy patients (P = . On the other hand. and quality of life also showed favorable results 3 years after surgery compared with intensive medical therapy alone. triglycerides. others experience a marked reduction in need for pharmacological treatment. Of patients who had gastric bypass." Secondary end points.

but lifestyle will never go away.5%. a slow creep of blood sugar. "If you look at our study results at 1 year. so yes. Dr. that good follow-up is key for durability. Lebovitz observed that the weight loss seen in the surgical patients was "remarkable." he noted. what happens with the medical group is even worse." he observed. The medical group dropped by about 1. compared with 4. And so lifestyle interventions are always the key.3 kg." Diabetes "is a progressive disease — everybody gets worse over time.Dr. and she stressed that this needs to continue indefinitely even in the surgery patients.3 kg for intensive medical therapy. who was asked to comment on STAMPEDE during a press conference after the presentation. which is amazing — it went from about 9% to 6%. Slow Creep of Blood Glucose." . years out. it's not uncommon. so Tight Follow-up Needed Everyone stressed." he stressed. and the figure for sleeve gastrectomy was 21. Most of the benefit in terms of improving HbA1c in normalizing blood sugar seems to be retained at 3 years. and these patients need ongoing support. however. even after surgery. very small." A mean weight loss of 26. Schauer acknowledged there is a slow creep up in blood sugar levels over time. MD. Nevertheless. Kashyap explained that lifelong support is required. In fact." After 3 years. "The improvement in glycemic control correlated quite well with the magnitude of weight loss. for the surgery patients to try to maintain weight loss and good glycemic control. from about 9% to 7." he added. "while there has been a slight increase in the average HbA1c in the surgical group. Dr. Cardiologist Amit Khera. patients in the surgical group decreased HbA1c by 3 percentage points.75%. said the results indicate that bariatric surgery "does seem to be quite durable. "Surgery is a tool that initiates the weight loss. Dallas. from the University of Texas Southwestern Medical Center. while there is. All patients during the trial were counseled for lifestyle every 3 months in the first 3 years and then every 6 months during the last year.2 kg at 3 years followed gastric bypass. And metabolic surgical procedures reduced the number of antihypertensive and lipid-lowering agents required per day "but did not significantly lower mean blood pressure or plasma LDL-cholesterol compared with the baseline values. the patients in the medical group — and these are folks who are continuing to receive fairly intense medical treatment including over half on insulin — have deteriorated quite dramatically. to see weight regain [among surgery patients].

" Patients and their doctors need to remember that "diabetes is a silent killer." It is important that patients understand "this is a major operation." she added. the STAMPEDE investigators employed the SF-36 questionnaire and found that the surgical group was happier than the medical group. Kashyap explained. or they absolutely want nothing to do with it. and a lot of it is shaped by fear of having surgery. Dr. as well as intra- abdominal bleeding and dumping syndrome (13 complications in gastric bypass and 5 in sleeve gastrectomy as compared with 2 in patients with intensive medical therapy)." ." she noted." Dr. but it's really far too late by that point. Schauer said it will always remain important to balance the risks of the intervention with the benefits. "Often people have the heart attack or dialysis and then [want to] consider [bariatric surgery]." Dr. and we know that they are obese." she noted. Lebovitz said: "The better improvement in glycemic control by gastric bypass and sleeve gastrectomy was counterbalanced by a significant incidence of surgical complications such as gastrointestinal strictures. surgery is a therapeutic avenue for patients — it's something that physicians need to consider. "They either want it. "While we did have expected complications of surgery in the first year — we had 4 reoperations out of 100 patients. ulcers. but Surgery Improved Quality of Life Counseling of patients prior to surgery is also important to stress all of these issues." he added. Kashyap said. adding that obese diabetic patients who are eligible for surgery tend to be "very opinionated" about the procedure." Dr. And nutritional and metabolic complications "were also greater in the surgically treated patients. And many endocrinologists are uncertain about bariatric surgery too. they are not checking their blood sugar 3 or 4 times a day. Schauer agreed: "The quality of life is substantially better… The patients are not taking as much insulin.Balance Risk/Benefit. Continuing medications without much benefit does not make sense. Dr. but their blood sugar is even better. so a 4% reoperative rate — there were no deaths and there were no complications that resulted in long-term major disability. there could be complications. This "comes from not taking so many agents — insulin is incredibly burdensome. The treatment is weight loss. there was a "marked improvement in quality of life. "But for those who are difficult to manage. and they are on fewer medications. she added. and leaks. Not only that. But for the first time.

" he said. and that's an operation that was 3 times the cost of bariatric surgery.000 cases per year. and the real news here is that surgery offers an opportunity for people who are not well controlled with medical treatment to get in control. "which is not currently a group where bariatric surgery is indicated.000 or 800. and only 18% were in good control with blood sugar. half are not in good control. Khera said that." he commented. that would be valuable information." Dr. Khera said in the press conference that there is still a question mark over the patients with BMI of 30 to 35. And in general." Dr. to his mind. and "when you look those people they enjoy the same type of benefits as those BMI greater than 35. and cholesterol.A significant number of these patients also have comorbid conditions such as osteoarthritis. there can be some complications. "I think we need some more specific data in the 30-35 group.000 surgeries per year: compare that with coronary artery bypass graft [CABG] surgery at its peak. likely due to the weight loss. Bypass Best Despite Trend for Sleeve Gastrectomy Speaking finally to the issue of the benefits of gastric bypass vs the other surgical procedure employed." But Dr. noting that most clinical guidelines and insurance coverage for bariatric surgery limit access to patients with a BMI of 35 kg/m2 or greater." Indeed recent National Health and Nutrition Examination Survey (NHANES) data "suggest that less than 50% of patients in America who have a diagnosis of type 2 diabetes are actually at the appropriate threshold. said Dr." Indeed. "We know that when patients have bariatric surgery there are some dietary changes. Dr. sleeve gastrectomy. "There are about 200. which was 700. We clearly showed that. when you look at that balanced against change in medications and weight loss. "A little more than a third of our patients had a BMI of less than 35. Dr. Schauer said. "This study was mainly designed to look at surgical vs medical therapy. BP. So medical treatment definitely has its shortcomings." he added. the surgical group had "greater confidence in a social setting. Schauer added. bariatric surgery currently "is way underutilized in the US. and that is a really important component. We ." Given that the mean BMI overall in the study was between 36 and 37. Kashyap added. HbA1c of 7%. the quality-of-life data were key. but Question Mark over BMI 30–35 The STAMPEDE results are also some of the first to address use of bariatric surgery in a randomized fashion in patients with a BMI less than 35. but all told. there was a significant improvement in quality of life." she observed. Schauer. and "they gained greater mobility." Bariatric Surgery Way Underused in the United States. both of which are performed laparoscopically. "That tells us that even with current drug therapy.

Dr." he said. Conflicts for coauthors are listed in the article. including Biocon. Dr." Nevertheless. and Sanofi on scientific issues ." However. and they had a greater reduction in medication use and so forth. Schauer has received research grants from Ethicon Endo-Surgery and the National Institutes of Health. and Surgiquest. and in our study weight loss was the primary driver for improvement in glycemic control. and we think it's because people who have the sleeve don't lose as much weight as those who have gastric bypass. For both procedures. but it wasn't really powered enough to really demarcate the differences in that way. Novo Nordisk. and he consults for AstraZeneca. Intracia. the A1c reduction was quite tremendous. and Poxel Pharma. and speaker and from Lilly. and Nestle as a speaker. "But I still think for people with diabetes. honoraria from Ethicon Endo-Surgery as scientific advisory board member. like HbA1c 7% or less. based on what we know now in this trial. Lebovitz is on the advisory board of several companies developing investigational drugs or devices for diabetes. Janssen. particularly more advanced diabetes. consultant. he acknowledged.were able to see some differences between the 2 procedures. Barosense. "We did see greater weight loss with gastric bypass and a higher percentage of patients with bypass achieved good glycemic control. Kashyap told Medscape Medical News: "The sleeve did very well in our study. The only thing we saw with the sleeve was that there was greater relapse. "There is an international trend of increasing popularity of sleeve gastrectomy. He has been a consultant/advisory board member for RemedyMD. educational grants from Stryker Endoscopy. Metacure." Dr. that gastric bypass is the better option in terms of efficacy.