Bariatric Times

FEB 2018

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

Issue link: http://bariatrictimes.epubxp.com/i/937206

Contents of this Issue

Navigation

Page 16 of 28

16 Review Bariatric Times • February 2018 glycemic control, and cardiovascular risk factors. LAGB. In an Australian open-label study with 60 patients with obesity (BMI 30–40kg/m 2 ) with recently diagnosed T2DM for LAGB compared to conventional diabetes therapy with focus on weight loss and T2DM remission for a follow-up period of two years. The investigators reported T2DM remission rates of 73 percent in the surgical group versus only 13 percent in the control group. 30 Weight loss after LAGB was nearly 10-fold higher compared to the conventional therapy group (20.7% vs. 1.7%, respectively). In this study, T2DM remission was related to the extent of weight loss and lower baseline HbA1c levels. In another RCT, 50 patients with overweight and T2DM were randomly allocated to intensive diabetes care with or without LAGB. The investigators reported T2DM remission at two years was achieved in 50 percent of LAGB patients and eight percent in the control group. 31 However, in both studies, long-term efficacy and safety data are missing. In contrast with the above data, in another RCT, in patients with obesity and T2DM underwent LAGB or to an intensive medical weight management program. The researchers reported similar HbA1c reductions at three and 12 months in both groups, similar weight loss at three months, and similar changes in blood pressure, serum lipids, cardiovascular risk scores, and patient-reported health outcomes after both interventions, thus questioning the real potential of LAGB to powerfully affect cardiometabolic outcomes in this population. 32 RYGB/BPD/SG. In an Italian, single-center, non-blinded RCT, 60 patients with a BMI greater than 35kg/m 2 and a history of at least five years of poorly controlled T2DM were randomized to either conventional medical treatment or RYGB/BPD. 6 T2DM remission at two years was specified as fasting plasma glucose less than 100mg/ dL and HbA1c less than 6.5 percent without pharmacologic therapy for at least one year. This was achieved by none of the medically treated patients, 75 percent of RYGB-treated patients, and 95 percent of BPD- treated patients. In multivariate regression analysis, age, sex, baseline BMI, T2DM duration, and body weight changes were not significant predictors of T2DM remission at two years or improvement of glycemic control at one and three months. 6 Authors concluded that bariatric surgery resulted in better short- term metabolic control in patients with poorly controlled T2DM than high-standard medical therapy, but baseline adiposity and weight loss could not predict improved metabolic outcomes. In a similarly designed single- center RCT (STAMPEDE) comparing intensive medical treatment (IMT) to medical therapy plus RYGB or SG in 150 patients with severe obesity and poorly controlled T2DM (baseline HbA1c 9%), the percentage of patients with complete T2DM remission (HbA1c <6%) at one-year follow-up was 42 percent in the RYGB and 37 percent in the SG group, compared to only 12 percent in the IMT group. 7 Extended follow-up three years post-surgery (mid-term outcomes) showed T2DM remission rates of only five percent in the IMT group compared to 38 percent in the RYGB and 24 percent in the SG group, and a significantly lower use of glucose-lowering medications in the surgical groups. 33 An important difference in this study was that patients were allowed to stay on oral hypoglycemic agents to allow them to achieve an HbA1c of less than six percent, suggesting that the benefit of surgery can be further enhanced with the use of appropriate medication. RYGB was further compared to IMT in another RCT (Diabetes Surgery Study) in terms of cardiovascular risk factors, including T2DM, hypertension, and hyperlipidemia. 11 This study enrolled 120 participants with obesity, T2DM for at least six months, and poor glycemic control. A composite triple endpoint of HbA1c less than seven percent, LDL-cholesterol less than 100mg/ dL, and systolic blood pressure less than 130mmHg was achieved in significantly more patients in the RYGB group compared to IMT, both at one and two years of follow-up (43–49% vs. 14–19%). Of note, these outcomes were mainly attributable to weight loss and predominantly driven by improved glycemic control, as shown by regression analyses. 11 With regard to T2DM remission, the comparison between RYGB and IMT reveals higher remission rates at one year, approaching 90 percent in some studies, alongside a greater positive impact on quality of life and amelioration of insulin resistance, subclinical inflammation, and cardiovascular comorbidities. 34 Data from the CROSSROADS RCT comparing RYGB and IMT in terms of T2DM remission and diabetes medication requirements are in line with the above. 9 RYGB appears to be significantly more effective than LAGB in terms of weight loss and T2DM remission in short- and mid-term studies. In a three-arm, single-center RCT that included 69 patients with grade I and II obesity and concomitant T2DM, RYGB and LAGB were compared to an intensive lifestyle weight loss intervention (LWLI) at one and three years of follow-up. 12 The gradient for weight loss and complete and partial T2DM remission rates at one and three years of follow-up was RYGB > LAGB > LWLI. 12,13 LONG-TERM OUTCOMES OF BARIATRIC SURGERY IN PATIENTS WITH OBESITY AND T2DM Table 2 summarizes the key TABLE 2. Major studies on the long-term outcomes of bariatric surgery in obese patients with T2DM REFERENCE STUDY POPULATION INTERVENTION DURATION OF FOLLOW-UP MAJOR OUTCOMES KEY RESULTS Sjöström et al, 2004 35 SOS cohort LAGB, VGB, RYGB 10 years CVD risk factors (remission/prevention) Increased recovery from T2DM, dyslipidemia, HTN, and hyperuricemia, decreased incidence of T2DM and lipid disorders after surgery Adams et al, 2007 49 N=9,949 RYGB 7.1 years Total and cause- specific mortality Decreased T2DM-, cancer-, and CHD-related mortality, increased mortality related to accidents and suicide after RYGB Sjöström et al, 2007 48 SOS cohort LAGB, VGB, RYGB 10.9 years Overall mortality Decreased CVD, cancer, and overall mortality after surgery vs. usual conventional care Iaconelli et al, 2011 39 N=110, BMI >35, newly diagnosed decompensated T2DM BPD 10 years Micro- and macrovascular complications, renal function, T2DM remission Increased recovery from microalbuminuria, decreased CHD probability after surgery vs. medical arm Adams et al, 2012 36 N=1,156, BMI >35 RYGB 6 years Weight loss, T2DM remission Superior weight loss maintenance, increased T2DM remission, and decreased T2DM incidence after surgery vs. control group Sjöström et al, 2012 45 SOS cohort LAGB, VGB, RYGB 14.7 years Stroke, myocardial infarction Decreased CVD incidenceand mortality after surgery vs. usual conventional care Arterburn et al, 2013 26 N=4,434, inadequately controlled T2DM RYGB 10 years T2DM remission 68 percent T2DM remission within five years post-RYGB, 35 percent relapse within five years after initial remission, median duration of remission 8.3 years Brethauer et al, 2013 44 N=217 LAGB, RYGB, SG 6 years T2DM remission, cardiometabolic comorbidities 25 percent T2DM remission after surgery, 19 percent T2DM relapse after initial remission, up to 80 percent control of cardiometabolic risk factors Sjöström et al, 2014 40 SOS cohort LAGB, VBG, RYGB 18 years T2DM remission, micro- and macrovascular complications Decreased incidence of micro- and macrovascular T2DM-related complications Arterburn et al, 2015 47 N=2,500, mainly male LAGB, RYGB, SG 14 years Mortality/survival Decreased all-cause mortality after surgery Mingrone et al, 2015 8 N=60, BMI >35, inadequately controlled T2DM for at least five years RYGB, BPD 5 years T2DM remission, CVD risk, medication use, QOL, diabetes-related complications Increased T2DM remission but existing risk of release, decreased lipids, CVD risk, medication use, and major complications after surgery vs. conventional diabetes treatment Schauer et al, 2017 38 N=150, BMI 27–43, poorly controlled T2DM RYGB, SG 5 years HbA1c <6% with or without medication Metabolic endpoint met by 29 percent of RYGB, 23 percent of SG, and five percent of IMT group, superior weight loss, better lipid profile, decreased use of insulin, increased QOL after surgery BMI: body mass index; BPD: biliopancreatic diversion; CHD: coronary heart disease; CVD: cardiovascular disease; HbA1c: glycosylated haemoglobin; HTN: hypertension; IMT: intensive medical treatment; LAGB: laparoscopic adjustable gastric banding; QOL: quality of life; RYGB: Roux-en-Y gastric bypass; SG: sleeve gastrectomy; SOS: Swedish Obese Subjects; T2DM: type 2 diabetes mellitus; VBG: vertical banded gastroplasty

Articles in this issue

Archives of this issue

view archives of Bariatric Times - FEB 2018