XI. STRATEGIES FOR IMPROVING DIABETES CARE D iabetes is a chronic illness that requires continuing medical care and patient self-management education to prevent acute complications and to reduce the risk of long-term complications. Diabetes care is complex and requires that many issues, beyond glycemic control, be addressed. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes. These standards of care are intended to provide clinicians, patients, researchers, payors, and other interested individuals with the components of diabetes care, treatment goals, and tools to evaluate the quality of care. While individual preferences, comorbidities, and other patient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to preclude more extensive evaluation and management of the patient by other specialists as needed. For more detailed information, refer to Bode (Ed.): Medical Management of Type 1 Diabetes (1), Burant (Ed): Medical Management of Type 2 Diabetes (2), and Klingensmith (Ed): Intensive Diabetes Management (3). The recommendations included are diagnostic and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. A grading system (Table 1), developed by the American Diabetes Association (ADA) and modeled after existing methods, was utilized to clarify and codify the evidence that forms the basis for the recommendations. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E.

Standards of Medical Care in Diabetes

Background Glucagon-like peptide-1 receptor agonists (GLP-1RAs) act by increasing insulin secretion, decreasing glucagon secretion, slowing gastric emptying, and increasing satiety. Objective Published evidence directly comparing GLP-1RAs with other approved treatments for type 2 diabetes (T2D) was systematically reviewed. Methods A literature search was performed using MEDLINE and Embase databases to identify papers comparing GLP-1RAs with other classes of glucose-lowering therapy in patients with T2D. Results Of the 1303 papers identified, 57 met the prespecified criteria for a high-quality clinical trial or retrospective study. The efficacy and tolerability of approved GLP-1RAs (exenatide twice daily or once weekly, dulaglutide, liraglutide, lixisenatide, and albiglutide) were compared with insulin products (23 prospective studies + seven retrospective studies), dipeptidyl peptidase-4 inhibitors (11 prospective studies + three retrospective studies), sulfonylureas (nine prospective studies + one retrospective study), thiazolidinediones (five prospective studies), and metformin (two prospective studies). GLP-1RAs are effective as a second-line therapy in improving glycemic parameters in patients with T2D. Reductions in glycated hemoglobin from baseline with GLP-1RAs tended to be greater or similar compared with insulin therapy. GLP-1RAs were consistently more effective in reducing body weight than most oral glucose-lowering drugs and insulin and were associated with lower hypoglycemia risk versus insulin or sulfonylureas. GLP-1RAs improved cardiovascular risk factors, and preliminary data suggest they improve cardiovascular outcomes in patients with T2D compared with oral glucose-lowering drugs. However, results from ongoing studies are awaited to confirm these early findings. Conclusion This systematic review found that GLP-1RAs are an effective class of glucose-lowering drugs for T2D.

/pdf/glucagon-like-peptide-1-receptor-agonists-a-systematic-2hk3y8nv4i.pdf

Glucagon-like peptide-1 receptor agonists: a systematic review of comparative effectiveness research.

Exenatide, administered subcutaneously twice daily (Byetta®), is a synthetic version of the natural peptide exendin-4, which is a glucagon-like peptide-1 (GLP-1) receptor agonist (incretin mimetic). Exenatide binds to the GLP-1 receptor with the same affinity as GLP-1, but has a much longer half-life, since it is not degraded by the enzyme dipeptidyl peptidase-4. Exenatide twice daily enhances glucose-dependent insulin secretion, suppresses inappropriately elevated glucagon secretion, slows gastric emptying and reduces caloric intake. In well-designed clinical trials, adjunctive subcutaneous exenatide 5 or 10 μg twice daily for 16–52 weeks significantly and dose-dependently improved glycaemic control and reduced mean body weight compared with placebo in patients with type 2 diabetes inadequately controlled with oral antihyperglycaemic drugs (OADs) and/or basal insulin. The improvements in glycaemic control and reductions in body weight were stably maintained during long-term therapy (up to 3.5 years). The efficacy of adjunctive exenatide twice daily was generally similar to that of basal, prandial or biphasic insulin, sulfonylureas, rosiglitazone and lixisenatide, and less than that of liraglutide, taspoglutide or exenatide once weekly with respect to reductions in glycated haemoglobin. Exenatide twice daily was generally well tolerated; mild to moderate nausea and vomiting, which decreased with time on therapy, were the most common adverse events. In patients not receiving concomitant sulfonylureas or insulin, the incidence of hypoglycaemia was low; when it did occur, it was generally mild in severity. Thus, adjunctive exenatide twice daily is a valuable option in the treatment of type 2 diabetes inadequately controlled with OADs and/or basal insulin.

Exenatide Twice Daily: A Review of Its Use in the Management of Patients with Type 2 Diabetes Mellitus

AIM: To identify a potential efficacy-effectiveness gap and possible explanations (drivers of effectiveness) for differences between results of randomized controlled trials (RCTs) and observational studies investigating glucose-lowering drugs. METHODS: A systematic literature review was conducted in English language articles published between 1 January, 2000 and 31 January, 2015 describing either RCTs or observational studies comparing glucagon-like peptide-1 analogs (GLP-1) with insulin or comparing dipeptidyl peptidase-4 inhibitors (DPP-4i) with sulfonylurea, all with change in glycated hemoglobin (HbA1c) as outcome. Medline, Embase, Current Content, and Biosis were searched. Information on effect estimates, baseline characteristics of the study population, publication year, study duration, and number of patients, and for observational studies, characteristics related to confounding adjustment and selection- and information bias were extracted. RESULTS: From 312 hits, 11 RCTs and 7 observational studies comparing GLP-1 with insulin, and from 474 hits, 16 RCTs and 4 observational studies comparing DPP-4i with sulfonylurea were finally included. No differences were observed in baseline characteristics of the study populations (age, sex, body mass index, time since diagnosis of type 2 diabetes mellitus, and HbA1c) or effect sizes across study designs. Mean effect sizes ranged from -0.43 to 0.91 and from -0.80 to 1.13 in RCTs and observational studies, respectively, comparing GLP-1 with insulin, and from -0.13 to 2.70 and -0.20 to 0.30 in RCTs and observational studies, respectively, comparing DPP-4i and sulfonylurea. Generally, the identified observational studies held potential flaws with regard to confounding adjustment and selection- and information bias. CONCLUSIONS: Neither potential drivers of effectiveness nor an efficacy-effectiveness gap were identified. However, the limited number of studies and potential problems with confounding adjustment, selection- and information bias in the observational studies, may have hidden a true efficacy-effectiveness gap.

/pdf/a-systematic-literature-review-on-the-efficacy-effectiveness-6l56ad19w5.pdf

A systematic literature review on the efficacy-effectiveness gap : comparison of randomized controlled trials and observational studies of glucose-lowering drugs

BACKGROUND According to the International Diabetes Federation, total global health care expenditures for diabetes tripled between 2003 and 2013 because of increases in the number of people with diabetes as well as in the average expenditures per patient. This study aims to provide accurate and timely information about the economic impacts of type 2 diabetes mellitus (T2DM) in Vietnam. METHOD The cost-of-illness estimates followed a prospective, prevalence-based approach from the societal perspective of T2DM with 392 selected diabetic patients who received treatment from a public hospital in Ho Chi Minh City, Vietnam, during the 2016 fiscal year. RESULTS In this study, the annual cost per patient estimate was US $246.10 (95% CI 228.3, 267.2) for 392 patients, which accounted for about 12% (95% CI 11, 13) of the gross domestic product per capita in 2017. That includes US $127.30, US $34.40 and US $84.40 for direct medical costs, direct nonmedical expenditures, and indirect costs, respectively. The cost of pharmaceuticals accounted for the bulk of total expenditures in our study (27.5% of total costs and 53.2% of direct medical costs). A bootstrap analysis showed that female patients had a higher cost of treatment than men at US $48.90 (95% CI 3.1, 95.0); those who received insulin and oral antidiabetics (OAD) also had a statistically significant higher cost of treatment compared to those receiving OAD, US $445.90 (95% CI 181.2, 690.6). The Gradient Boosting Regression (Ensemble method) and Lasso Regression (Generalized Linear Models) were determined to be the best models to predict the cost of T2DM (R2=65.3, mean square error [MSE]=0.94; and R2=64.75, MSE=0.96, respectively). CONCLUSION The findings of this study serve as a reference for policy decision making in diabetes management as well as adjustment of costs for patients in order to reduce the economic impact of the disease.

https://www.dovepress.com/getfile.php?fileID=38174

Type 2 diabetes in Vietnam: a cross-sectional, prevalence-based cost-of-illness study.

Aim: This observational study evaluated the clinical effectiveness of exenatide BID (exenatide) vs. insulin glargine (glargine) in patients with type 2 diabetes mellitus in ambulatory clinical practice.



Methods: Retrospective analyses were conducted using an electronic medical record (EMR) database among adult patients with type 2 diabetes mellitus initiating exenatide or glargine between 1 November 2006 and 30 April 2009. The cohorts were propensity-score matched to control baseline demographics, clinical measures, health status and medication use. The changes from baseline to a 12-month follow-up period for A1C (primary outcome), weight, body mass index (BMI), blood pressure and lipid levels were compared between the matched cohorts using paired tests.



Results: Propensity-score matching between the exenatide (n = 4494) and glargine (n = 5424) cohorts led to 2683 matched pairs with comparable characteristics, including age, gender and baseline clinical values. The exenatide cohort achieved a greater mean reduction in A1C (−0.6% vs. −0.4%, p < 0.01), weight (−2.6 kg vs. −0.2 kg, p < 0.01), BMI (−0.8 kg/m2 vs. −0.04 kg/m2, p < 0.01) and systolic blood pressure (SBP) (−1.8 mmHg vs. −0.1 mmHg, p < 0.01) in the follow-up period. The changes in diastolic blood pressure and lipid levels were not significantly different between cohorts.



Conclusions: Compared to glargine, exenatide-treated patients experienced significant reductions in A1C, weight, BMI and SBP. Acknowledging the limitations of observational research, exenatide showed greater clinical effectiveness than glargine from a large EMR database in the ambulatory care setting.

Metabolic outcomes of matched patient populations initiating exenatide BID vs. insulin glargine in an ambulatory care setting.

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Metabolic outcomes of matched patient populations initiating exenatide BID vs. insulin glargine in an ambulatory care setting.