The American Diabetes Association and the European Association for the Study of Diabetes have briefly updated their 2018 recommendations on management of hyperglycemia, based on important research findings from large cardiovascular outcomes trials published in 2019. Important changes include: 1) the decision to treat high-risk individuals with a glucagon-like peptide 1 (GLP-1) receptor agonist or sodium-glucose cotransporter 2 (SGLT2) inhibitor to reduce major adverse cardiovascular events (MACE), hospitalization for heart failure (hHF), cardiovascular death, or chronic kidney disease (CKD) progression should be considered independently of baseline HbA1c or individualized HbA1c target; 2) GLP-1 receptor agonists can also be considered in patients with type 2 diabetes without established cardiovascular disease (CVD) but with the presence of specific indicators of high risk; and 3) SGLT2 inhibitors are recommended in patients with type 2 diabetes and heart failure, particularly those with heart failure with reduced ejection fraction, to reduce hHF, MACE, and CVD death, as well as in patients with type 2 diabetes with CKD (estimated glomerular filtration rate 30 to ≤60 mL min-1 [1.73 m]-2 or urinary albumin-to-creatinine ratio >30 mg/g, particularly >300 mg/g) to prevent the progression of CKD, hHF, MACE, and cardiovascular death.

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Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

2013 AHA/ACC/TOS Guideline for the Management of Overweight

The mean (±SD) age of the patients at baseline was 48±8 years, 68% were women, the mean baseline glycated hemoglobin level was 9.3±1.5%, and the mean baseline body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.0±3.5. A total of 91% of the patients completed 36 months of follow-up. At 3 years, the criterion for the primary end point was met by 5% of the patients in the medical-therapy group, as compared with 38% of those in the gastric-bypass group (P<0.001) and 24% of those in the sleeve-gastrectomy group (P = 0.01). The use of glucose-lowering medications, including insulin, was lower in the surgical groups than in the medical-therapy group. Patients in the surgical groups had greater mean percentage reductions in weight from baseline, with reductions of 24.5±9.1% in the gastric-bypass group and 21.1±8.9% in the sleeve-gastrectomy group, as compared with a reduction of 4.2±8.3% in the medical-therapy group (P<0.001 for both comparisons). Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group. There were no major late surgical complications. Conclusions Among obese patients with uncontrolled type 2 diabetes, 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone. Analyses of secondary end points, including body weight, use of glucose-lowering medications, and quality of life, also showed favorable results at 3 years in the surgical groups, as compared with the group receiving medical therapy alone. (Funded by Ethicon and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.)

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Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 3-Year Outcomes

The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the prior position statements, published in 2012 and 2015, on the management of type 2 diabetes in adults. A systematic evaluation of the literature since 2014 informed new recommendations. These include additional focus on lifestyle management and diabetes self-management education and support. For those with obesity, efforts targeting weight loss, including lifestyle, medication and surgical interventions, are recommended. With regards to medication management, for patients with clinical cardiovascular disease, a sodium–glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) receptor agonist with proven cardiovascular benefit is recommended. For patients with chronic kidney disease or clinical heart failure and atherosclerotic cardiovascular disease, an SGLT2 inhibitor with proven benefit is recommended. GLP-1 receptor agonists are generally recommended as the first injectable medication.

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Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

Context Obesity is a risk factor for cardiovascular events. Weight loss might protect against cardiovascular events, but solid evidence is lacking. Objective To study the association between bariatric surgery, weight loss, and cardiovascular events. Design, Setting, and Participants The Swedish Obese Subjects (SOS) study is an ongoing, nonrandomized, prospective, controlled study conducted at 25 public surgical departments and 480 primary health care centers in Sweden of 2010 obese participants who underwent bariatric surgery and 2037 contemporaneously matched obese controls who received usual care. Patients were recruited between September 1, 1987, and January 31, 2001. Date of analysis was December 31, 2009, with median follow-up of 14.7 years (range, 0-20 years). Inclusion criteria were age 37 to 60 years and a body mass index of at least 34 in men and at least 38 in women. Exclusion criteria were identical in surgery and control patients. Surgery patients underwent gastric bypass (13.2%), banding (18.7%), or vertical banded gastroplasty (68.1%), and controls received usual care in the Swedish primary health care system. Physical and biochemical examinations and database cross-checks were undertaken at preplanned intervals. Main Outcome Measures The primary end point of the SOS study (total mortality) was published in 2007. Myocardial infarction and stroke were predefined secondary end points, considered separately and combined. Results Bariatric surgery was associated with a reduced number of cardiovascular deaths (28 events among 2010 patients in the surgery group vs 49 events among 2037 patients in the control group; adjusted hazard ratio [HR], 0.47; 95% CI, 0.29-0.76; P = .002). The number of total first time (fatal or nonfatal) cardiovascular events (myocardial infarction or stroke, whichever came first) was lower in the surgery group (199 events among 2010 patients) than in the control group (234 events among 2037 patients; adjusted HR, 0.67; 95% CI, 0.54-0.83; P  Conclusion Compared with usual care, bariatric surgery was associated with reduced number of cardiovascular deaths and lower incidence of cardiovascular events in obese adults.

Bariatric Surgery and Long-term Cardiovascular Events

Importance Bariatric surgery is beneficial in persons with a body mass index (BMI) of 35 or greater with obesity-related comorbidities. There is interest in using these procedures in persons with lower BMI and diabetes. Objective To assess the association between bariatric surgery vs nonsurgical treatments and weight loss and glycemic control among patients with diabetes or impaired glucose tolerance and BMI of 30 to 35. Evidence Review PubMed, EMBASE, and Cochrane Library databases were searched from January 1985 through September 2012. Of 1291 screened articles, we included 32 surgical studies, 11 systematic reviews on nonsurgical treatments, and 11 large nonsurgical studies published after those reviews. Weight loss, metabolic outcomes, and adverse events were abstracted by 2 independent reviewers. Findings Three randomized clinical trials (RCTs) (N = 290; including 1 trial of 150 patients with type 2 diabetes and mean BMI of 37, 1 trial of 80 patients without diabetes [38% with metabolic syndrome] and BMI of 30 to 35, and 1 trial of 60 patients with diabetes and BMI of 30 to 40 [13 patients with BMI 1c levels) during 1 to 2 years of follow-up than nonsurgical treatment. Indirect comparisons of evidence from observational studies of bariatric procedures (n ≈ 600 patients) and meta-analyses of nonsurgical therapies (containing more than 300 RCTs) support this finding at 1 or 2 years of follow-up. However, there are no robust surgical data beyond 5 years of follow-up on outcomes of diabetes, glucose control, or macrovascular and microvascular outcomes. In contrast, some RCT data of nonsurgical therapies show benefits at 10 years of follow-up or more. Surgeon-reported adverse events were low (eg, hospital deaths of 0.3%-1.0%), but data were from select centers and surgeons. Long-term adverse events are unknown. Conclusions and Relevance Current evidence suggests that, when compared with nonsurgical treatments, bariatric surgical procedures in patients with a BMI of 30 to 35 and diabetes are associated with greater short-term weight loss and better intermediate glucose outcomes. Evidence is insufficient to reach conclusions about the appropriate use of bariatric surgery in this population until more data are available about long-term outcomes and complications of surgery.

Bariatric Surgery for Weight Loss and Glycemic Control in Nonmorbidly Obese Adults with Diabetes: A Systematic Review

Searching This review was an update of a previous report (see Other Publications of Related Interest). PubMed, EMBASE, CINAHL, PsycINFO, DARE and Cochrane Central Register of Controlled Trials (CENTRAL) were searched to May 2011. Search terms were reported. Additional searches included regulatory documents from the US Food and Drug Administration and Health Canada, ClinicalTrials.gov and references from relevant reviews and included papers. Only papers published in English were considered for inclusion.

Off-label use of atypical antipsychotics: an update

Objectives To systematically review the scientific evidence on efficacy, safety, and comparative effectiveness of various types of bariatric surgery for treating adult patients with a body mass index (BMI) of 30.0 to 34.9 kg/m2 and diabetes or impaired glucose tolerance (IGT) and to compare effectiveness of surgery versus nonsurgical interventions in this population. Data sources Systematic reviews, case series, cohort, case control studies and controlled trials, found through searching PubMed®, Embase, CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Abstracts of Reviews of Effects (DARE), and Clinicaltrials.gov through March, 2012. Review methods To be included, studies had to report on laparoscopic adjustable gastric banding (LAGB), Roux-en-Y gastric bypass (RYGB), biliopancreatic diversion with duodenal switch (BPD), sleeve gastrectomy (SG), or nonsurgical treatment, and had to include patients with a BMI of at least 30 kg/m2 but less than 35 kg/m2 with diabetes or IGT. The following studies were excluded: (1) those with no outcomes of efficacy, effectiveness, or safety/adverse events; (2) nonsurgical studies with less than one year followup; (3) nonsurgical studies already included in previous systematic reviews; and (4) studies with a sample size of less than three. Two reviewers, each trained in the critical analysis of scientific literature, independently reviewed and abstracted each study. Results We found only 24 studies reporting bariatric surgery results in this specific target population. Two were trials comparing different procedures, three were trials of surgical versus nonsurgical interventions, and the rest were observational studies. Both weight and blood glucose improved significantly for surgery patients in the trials. In the observational studies, surgery patients showed much greater weight loss at 1 year than reported in systematic reviews and randomized controlled trials (RCTs) on diet, exercise, medication, and other behavioral interventions. While both behavioral interventions and medications lowered HbA1c (glycosylated hemoglobin) levels significantly, the decreases reported in surgery patients were much greater. Improvements in blood glucose measures were reported as early as one month postsurgery. Improvements in hypertension, low-density lipoprotein (LDL) cholesterol, and triglycerides were also reported in some studies. Short-term rates of adverse events associated with bariatric surgery were relatively low. One death, a case of sepsis at 20 months in an LAGB patient, was reported. Short-term complications were minor and tended not to require major intervention. Due to the dearth of long-term studies of bariatric surgery in this particular target population, few data exist about long-term adverse effects, and we found no evidence regarding major clinical endpoints such as all-cause mortality, cardiovascular mortality and morbidity, and peripheral arterial disease. Conclusions According to blood glucose outcomes, there is moderate strength evidence of efficacy for RYGB, LAGB, and SG as treatment for diabetes and IGT in patients with a BMI between 30 kg/m2 and 35 kg/m2 in the short term (up to 2 years). The strength of evidence for BPD is rated low because there are fewer studies, and these have smaller sample sizes. Evidence on comparative effectiveness of surgical procedures is insufficient. Short-term adverse events are relatively minor; strength of evidence is low due to small sample size with low power to detect rare events. Strength of evidence is insufficient regarding adverse events in the long-term (2 years or more postsurgery). Longitudinal studies of bariatric surgery patients are needed to assess overall safety and comparative effectiveness regarding diabetes-related morbidity such as kidney failure and blindness.

Jianhui Hu

Papers

Bariatric Surgery for Weight Loss and Glycemic Control in Nonmorbidly Obese Adults with Diabetes: A Systematic Review

Off-label use of atypical antipsychotics: an update

Bariatric Surgery and Nonsurgical Therapy in Adults With Metabolic Conditions and a Body Mass Index of 30.0 to 34.9 kg/m2

Off-label Use of Atypical Antipsychotics

Bariatric Surgery for Weight Loss and Glycemic Control in Nonmorbidly Obese Adults With Diabetes: A Systematic Review