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12 Interview Bariatric Times • March 2017 METABOLIC SURGERY IS HERE TO STAY Five-Year Data Released Demonstrating Continued Durability, Superiority of Glycemic Control after Metabolic Surgery Bariatric Times. 2017;14(2):12–14. Dr. Kashyap, thank you for taking the time to discuss STAMPEDE and its final results. Why are five-year results important and what are the trial's key takeaways? Dr. Kashyap: These final results are very important because five years marks the time when we can really conclude if there is durability of the procedures to help control diabetes. Although we did observe relapse in some patients, our results indeed showed continued durability of glycemic control after metabolic surgery as well as persistent weight loss and reductions in diabetes and cardiovascular medications at five years. Both sleeve and gastric bypass had similar metabolic benefits and greater benefits were seen for those with shorter duration of diabetes prior to surgery. Final outcomes also confirmed our previous findings that intensive medical therapy plus bariatric surgery results in better glycemic control than medical therapy alone. The bottom line is that there are limits to intensive medical therapy for diabetes, especially when patients are overweight. For refractory patients, surgery is a superior option. Can you provide more detail regarding patients who experienced T2DM remission relapse? Dr. Kashyap: Throughout the trial, T2DM remission was defined as a glycated hemoglobin level of 6.0% or less. We found that the percentage of patients who hit remission dropped at five years as compared to the first year. In the one-year results, the remission rates were as follows: 12 percent in the medical-therapy group, 37 percent in the sleeve gastrectomy group, and 42 percent in the gastric bypass group. At five years, remission dropped to five percent in the medical- therapy group, 23 percent in the sleeve gastrectomy group, and 29 percent in the gastric-bypass group. This shows that both procedures were equally effective and as effective as each other, though the relapse rate was slightly higher with the sleeve. Also, there was considerably more weight loss in the surgical groups (particularly gastric bypass) as compared to the medical group. What do these results tell us about weight regain and patients' risk for remission relapse after surgery? Dr. Kashyap: We measured weight regain among STAMPEDE patients and are planning to conduct it as an ancillary study. Five-year results tell us that the rates of remission do diminish over time after surgery and it's important to talk to patients about their expectations. We see that the people who relapse typically have longer duration of diabetes (> 8 years) and tend to lose less weight initially than those who don't relapse. So, weight loss has been shown to be the most important modifiable factor in driving diabetes improvement. At Cleveland Clinic, we encourage our patients to keep exercising, eating healthy, and following recommendations long after their procedures. Weight regain is something that we as clinicians have to deal with because weight regain in a RYGB or LSG patient means that they are at risk for diabetes recurrence. How else might you help patients achieve good initial weight loss and prevent weight regain after surgery? How might you help a patient who experienced remission relapse following surgery get back into remission? Dr. Kashyap: During STAMPEDE, all patients received intensive medical therapy. "Intensive medical therapy," included lifestyle counseling, weight management, frequent home glucose monitoring, and the use of newer drug therapies approved by the Food and Drug Administration (FDA). Many of my patients—surgical and nonsurgical—are self-monitoring their weight loss. I find that people who self monitor and show up to their appointments are the patients who are continuously trying, and thus achieving weight loss/HbA1c goals. After surgery, I tell patients, "Listen, you've had surgery. I can still consider you diabetic, but you're diet controlled. As long as you adhere to the program, exercise, and continue to keep the weight off, you may be able to see A n I n t e r v i e w w i t h SANGEETA KASHYAP, MD Professor of Medicine, Cleveland Clinic Lerner College of Medicine; Staff Physician, Department of Endocrinology, Cleveland Clinic, Cleveland, Ohio T he STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial is the largest single center randomized trial with one of the longest follow-ups comparing medical therapy with bariatric surgery. Last month, Philip Schauer, MD, lead author, presented the STAMPEDE trial's final results during the American College of Cardiology's 65th Annual Scientific Session (ACC.16). 1 Recently, final five-year data was published in New England Journal of Medicine. 2 STAMPEDE is a three-arm controlled trial conducted by investigators from Cleveland Clinic, Cleveland, Ohio, that randomized 150 patients with obesity and uncontrolled type 2 diabetes mellitus (T2DM) to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG). The primary end point was a glycated hemoglobin level of 6.0% or less. One- and three-year outcomes 3,4 concluded that among patients with obesity and uncontrolled T2DM, intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone. The final, five-year outcomes report confirms these findings. Bariatric Times interviewed Sangeeta Kashyap, MD, co-author on the trial, for her insight on STAMPEDE, its final results, and what they mean for the field of metabolic surgery.