Achieving glycosylated hemoglobin targets using the combination of repaglinide and metformin in type 2 diabetes: a reanalysis of earlier data in terms of current targets

BACKGROUND: For patients with type 2 diabetes, the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) currently recommend a glycosylated hemoglobin (HbA(1c) ) target of <7%, and the British Medical Association (BMA) Quality and Outcomes Framework recommends an HbA(1c) target of >or=7.5%. OBJECTIVE: This letter presents a reanalysis of data from a previous study of the effect on glycemic control of adding repaglinide to metformin monotherapy in patients with type 2 diabetes to determine the proportion of patients achieving current ADA/EASD and BMA targets. METHODS: PubMed was searched using the terms repaglinide AND metformin AND HbA(1c) to identify published comparisons of monotherapy and combination therapy with these drugs in patients with type 2 diabetes. RESULTS: In the original analysis, which employed an HbA(1c) target of <7.1%, 59%of patients treated with metformin plus repaglinide achieved their glycemic target, compared with approximately 20% of patients treated with metformin or repaglinide alone. On reanalysis of the data according to the current ADA/EASD HbA(1c) target of <7%, 56% of patients receiving metformin and repaglinide achieved that goal,compared with 19%each in the groups treated with metformin or repaglinide monotherapy. On reanalysis of the data according to the BMA Quality and Outcomes Framework HbA(1c) target of >or=7.5%, 89% of patients receiving metformin and repaglinide achieved that goal, compared with 43%and 42% of patients receiving metformin and repaglinide monotherapy, respectively. CONCLUSION: Based on this reanalysis of earlier data in terms of currently recommended HbA(1c) targets, combination therapy with repaglinide and metformin would appear to be a good treatment option for patients with type 2 diabetes.     

Utilizing current diagnostic criteria and treatment algorithms for managing type 2 diabetes mellitus

Within the past 2 years, the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) and the American Association of Clinical Endocrinologists (AACE)/American College of Endocrinology (ACE) have revised their guidelines for the diagnosis and treatment of type 2 diabetes mellitus (T2DM). Both organizations recommend a diagnostic glycated hemoglobin (HbA1c) of >6.5% (based on a new appreciation of the relationship between glycemia and complications) and fasting plasma glucose levels or an oral glucose tolerance test. Findings from major trials of glucose control in patients with T2DM and the approval of novel medications have prompted revised treatment algorithms from both organizations. While both treatment guidelines recommend starting metformin in most patients on diagnosis of T2DM, they differ in terms of the "trigger" for treatment intensification (HbA1c≥7% and >6.5%, respectively) and which agents are preferred as second-line therapies. The ADA/EASD recommends a tiered approach to treatment, starting with well-validated second-line agents, such as sulfonylureas and basal insulin for patients unable to achieve target glucose levels with metformin. The AACE/ACE recommendations are based on the patient's HbA1c level and include a broader range of first- and second-line therapies and combinations. In addition to metformin, the ACCE/ACE treatment algorithm includes dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, thiazolidinediones, α-glucosidase inhibitors, sulfonylureas, and glinides. Both organizations advocate individualizing therapy to meet patient needs. This review highlights recent changes in the guidelines and uses a case-based format to illustrate how the current guidelines may be tailored to fit individual patient characteristics and circumstances.     

Many Americans Have Pre-Diabetes and Should Be Considered for Metformin Therapy

OBJECTIVE

To determine the proportion of the American population who would merit metformin treatment, according to recent American Diabetes Association (ADA) consensus panel recommendations to prevent or delay the development of diabetes.

RESEARCH DESIGN AND METHODS

Risk factors were evaluated in 1,581 Screening for Impaired Glucose Tolerance (SIGT), 2,014 Third National Health and Nutrition Examination Survey (NHANES III), and 1,111 National Health and Nutrition Examination Survey 2005–2006 (NHANES 2005–2006) subjects, who were non-Hispanic white and black, without known diabetes. Criteria for consideration of metformin included the presence of both impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), with ≥1 additional diabetes risk factor: age <60 years, BMI ≥35 kg/m², family history of diabetes, elevated triglycerides, reduced HDL cholesterol, hypertension, or A1C >6.0%.

RESULTS

Isolated IFG, isolated IGT, and IFG and IGT were found in 18.0, 7.2, and 8.2% of SIGT; 22.3, 6.4, and 9.4% of NHANES III; and 21.8, 5.0, and 9.0% of NHANES 2005–2006 subjects, respectively. In SIGT, NHANES III, and NHANES 2005–2006, criteria for metformin consideration were met in 99, 96, and 96% of those with IFG and IGT; 31, 29, and 28% of all those with IFG; and 53, 57, and 62% of all those with IGT (8.1, 9.1, and 8.7% of all subjects), respectively.

CONCLUSIONS

More than 96% of individuals with both IFG and IGT are likely to meet ADA consensus criteria for consideration of metformin. Because >28% of all those with IFG met the criteria, providers should perform oral glucose tolerance tests to find concomitant IGT in all patients with IFG. To the extent that our findings are representative of the U.S. population, ∼1 in 12 adults has a combination of pre-diabetes and risk factors that may justify consideration of metformin treatment for diabetes prevention.Diabetes is a public health epidemic (1) associated with high morbidity, mortality (1), and cost (2). Currently, an estimated 38 million Americans have the disease, nearly 40% of which is undiagnosed, and another 87 million have pre-diabetes: impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) (3). Diabetes develops insidiously over several years, during which time glucose metabolism progresses slowly from normal to pre-diabetes and then more rapidly to diabetes. Based on observational and prospective studies, ∼25–40% of individuals with pre-diabetes go on to develop diabetes over 3–8 years (4–6), and there is evidence of complications in 50% of patients at the time of diagnosis of diabetes (7).Because progression from pre-diabetes can be prevented or delayed by lifestyle change and/or medication (4–6), the American Diabetes Association (ADA) has issued a consensus statement recommending early identification and preventive treatment in high-risk individuals (8). The panel statement recommends that individuals with both IFG and IGT and one additional risk factor (age <60 years, BMI ≥35 kg/m², family history of diabetes in first-degree relative, elevated triglycerides, reduced HDL cholesterol, or A1C >6.0%) should be considered for treatment with metformin, in addition to lifestyle modification, which includes weight loss and physical activity.To determine what proportion of the American population presenting with either IFG or IGT would merit consideration for metformin treatment in accordance with the recent ADA recommendations, we evaluated healthy volunteers without known diabetes who were screened for diabetes/pre-diabetes by the 75-g oral glucose tolerance test (OGTT).     

Sitagliptin phosphate: a DPP-4 inhibitor for the treatment of type 2 diabetes mellitus

BACKGROUND: Sitagliptin phosphate, the first dipeptidyl peptidase 4 (DPP-4) inhibitor, provides a new treatment option for patients with type 2 diabetes. OBJECTIVE: The purpose of this article is to review the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, adverse effects, and cost of sitagliptin in adults with type 2 diabetes. METHODS: A literature search of MEDLINE (1966-May 10, 2007), Iowa Drug Information Service (1966-May 10, 2007), and International Pharmaceutical Abstracts (1970-May 10, 2007) was performed using the terms sitagliptin and MK-0431. English-language, original research and review articles were reviewed, as were citations from these articles. The 2005 and 2006 American Diabetes Association Scientific Abstracts were searched, and the US Food and Drug Administration review of the new drug application for sitagliptin and select information from the manufacturer were consulted. RESULTS: By inhibiting DPP-4, sitagliptin enhances postprandial levels of active glucagon-like peptide-1 (GLP-1), leading to a rise in insulin release and decrease in glucagon secretion from pancreatic alpha-cells. Sitagliptin is 87% orally bioavailable, undergoes minimal hepatic metabolism, and is primarily excreted unchanged (approximately 79%) in the urine. At doses >or=100 mg QD, DPP-4 activity is inhibited by >80%, with a consequent 2-fold rise in active GLP-1 levels. The reduction in glycosylated hemoglobin (HbA(1c)) observed with 100 mg QD of sitagliptin in Phase III monotherapy trials ranged from approximately 0.5% to 0.6% (P 相似文献   

Treating diabetes to accepted standards of care: a 10-year projection of the estimated economic and health impact in patients with type 1 and type 2 diabetes mellitus in the United States

OBJECTIVE: The aim of this study was to investigate the health-economic impact of maintaining glycosylated hemoglobin (HbA(1c)) values in all US patients with currently uncontrolled type 1 or type 2 diabetes mellitus at the American Diabetes Association (ADA) standard of 7.0% and the American Association of Clinical Endocrinologists (AACE) target of 6.5% compared with maintenance at current population-based values. METHODS: The CORE-Center for Outcomes Research Diabetes Model was used to predict costs and outcomes for patients with uncontrolled type 1 and type 2 diabetes who remain at established population mean HbA(1c) values in comparison with those for patients who maintain the standard value of 7.0% or the target value of 6.5%. The analysis was run from a societal perspective over a 10-year time horizon. The costs of treating complications and medication costs were retrieved from published sources. Costs and clinical outcomes were discounted at 3% per annum. Sensitivity analyses were performed on the discount rate and time horizon. RESULTS: This analysis found that maintaining HbA(1c) at the ADA standard value of 7.0% and the AACE target value of 6.5% in patients with uncontrolled type 1 and type 2 diabetes could achieve total direct medical cost savings of nearly 35 US dollars and 50 billion US dollars , respectively, over 10 years. When indirect cost savings were included, the total savings increased to between nearly 50 billion US dollars and 72 billion US dollars for these respective HbA(1c) targets, corresponding to 4% and 6% of the total annual US health care costs of 1.3 trillion US dollars. Reduced savings were observed with a higher discount rate and shorter time horizon, but savings increased as the time horizon became longer. These cost savings must be weighed against the cost of reaching the HbA(1c) goals and the likelihood of achieving the clinical objectives. CONCLUSIONS: Efficient targeting of financial resources toward the goal of lowering HbA(1c) in line with published guidelines could lead to financial savings in the range from nearly 35 billion US dollars to 72 billion US dollars over the next 10 years.     

HbA1c as a Predictor of Diabetes and as an Outcome in the Diabetes Prevention Program: A Randomized Clinical Trial

OBJECTIVE

Glycated hemoglobin (HbA_1c), a standard measure of chronic glycemia for managing diabetes, has been proposed to diagnose diabetes and identify people at risk. The Diabetes Prevention Program (DPP) was a 3.2-year randomized clinical trial of preventing type 2 diabetes with a 10-year follow-up study, the DPP Outcomes Study (DPPOS). We evaluated baseline HbA_1c as a predictor of diabetes and determined the effects of treatments on diabetes defined by an HbA_1c ≥6.5% (48 mmol/mol).

RESEARCH DESIGN AND METHODS

We randomized 3,234 nondiabetic adults at high risk of diabetes to placebo, metformin, or intensive lifestyle intervention and followed them for the development of diabetes as diagnosed by fasting plasma glucose (FPG) and 2-h postload glucose (2hPG) concentrations (1997 American Diabetes Association [ADA] criteria). HbA_1c was measured but not used for study eligibility or outcomes. We now evaluate treatment effects in the 2,765 participants who did not have diabetes at baseline according to FPG, 2hPG, or HbA_1c (2010 ADA criteria).

RESULTS

Baseline HbA_1c predicted incident diabetes in all treatment groups. Diabetes incidence defined by HbA_1c ≥6.5% was reduced by 44% by metformin and 49% by lifestyle during the DPP and by 38% by metformin and 29% by lifestyle throughout follow-up. Unlike the primary DPP and DPPOS findings based on glucose criteria, metformin and lifestyle were similarly effective in preventing diabetes defined by HbA_1c.

CONCLUSIONS

HbA_1c predicted incident diabetes. In contrast to the superiority of the lifestyle intervention on glucose-defined diabetes, metformin and lifestyle interventions had similar effects in preventing HbA_1c-defined diabetes. The long-term implications for other health outcomes remain to be determined.     

Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association

The American Heart Association (AHA) and the American Diabetes Association (ADA) have each published guidelines for cardiovascular disease prevention: the ADA has issued separate recommendations for each of the cardiovascular risk factors in patients with diabetes, and the AHA has shaped primary and secondary guidelines that extend to patients with diabetes. This statement will attempt to harmonize the recommendations of both organizations where possible but will recognize areas in which AHA and ADA recommendations differ.     

Secondary Failure of Metformin Monotherapy in Clinical Practice

OBJECTIVE

We sought to document the secondary failure rate of metformin monotherapy in a clinical practice setting and to explore factors that predict therapeutic failure.

RESEARCH DESIGN AND METHODS

We studied 1,799 type 2 diabetic patients who, between 2004 and 2006, lowered their A1C to <7% after initiating metformin monotherapy as their first-ever anti-hyperglycemic drug. We examined all A1C values recorded through 31 December 2008 (2–5 years of follow-up), defining secondary failure as a subsequent A1C ≥7.5% or the addition or substitution of another anti-hyperglycemic agent. We used logistic regression to identify factors associated with the probability of secondary failure.

RESULTS

Of the 1,799 patients studied, 42% (n = 748) experienced secondary failure; the mean failure rate was 17% per year. However, patients who initiated metformin within 3 months of diabetes diagnosis failed at an age-and A1C-adjusted rate of 12.2% (10.5–14.4%) per year, and patients who initiated while A1C was <7% failed at an adjusted rate of 12.3% per year. An interaction term between duration of diagnosed diabetes and A1C was not significant. Age, duration, and A1C at initiation were the only factors that predicted secondary failure.

CONCLUSIONS

Although metformin failure may occur more rapidly in clinical practice than in clinical trails, initiating it soon after diabetes diagnosis and while A1C is low might preserve β-cell function, prolong the effectiveness of metformin, reduce lifetime glycemic burden, and prevent diabetes complications. Our findings support the current treatment algorithm for hyperglycemia management that recommends metformin initiation when diabetes is first diagnosed.The Diabetes Prevention Program and other primary prevention studies (1–3) have shown that metformin therapy can slow the deterioration of glycemic control in individuals with impaired glucose tolerance, thus delaying progression to diabetes. This suggests that initiation of metformin as soon as diabetes is diagnosed would also help to slow the trajectory of loss in insulin secretory capacity and glycemic control, delaying the need for subsequent therapy intensification and the substantial periods of chronic hyperglycemia that typically accompany anti-hyperglycemic failure. Therefore, the current American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) guidelines for the medical management of type 2 diabetes recommend the initiation of metformin concurrently with lifestyle intervention at diagnosis (4).Observational studies indicate that initiation of metformin or sulfonylurea pharmacotherapy at lower levels of hyperglycemia appears to improve the effectiveness and durability of the therapy, but in these studies, duration of diabetes (delay in initiation of therapy) did not predict time to therapy failure (5,6). However, these studies were conducted when sulfonylureas were the first-line agent of choice, and they used an A1C cut point of 8% to define initial success and secondary treatment failure. To our knowledge, no studies have examined the potential benefits of immediate versus delayed metformin initiation used with a modern A1C treatment threshold of 7%. Furthermore, although metformin fails at a rate of ∼4% per year in clinical trials (7), the failure rate in the real world of clinical practice has not been reported.We therefore sought to estimate the rate of secondary metformin monotherapy experienced by unselected patients in a nonresearch setting who had a documented history of successfully lowering their A1C to <7% with metformin. We then sought to identify factors associated with slower loss of glycemic control. Our observational analyses were conducted within a managed care plan using electronic medical records with substantial information technology support, including built-in alerts for A1C testing.     

Trends in Receipt of American Diabetes Association Guideline-Recommended Care Among U.S. Adults With Diabetes: NHANES 2005–2018

OBJECTIVETo characterize national trends and characteristics of adults with diabetes receiving American Diabetes Association (ADA) guideline-recommended care.RESEARCH DESIGN AND METHODSWe performed serial cross-sectional analyses of 4,069 adults aged ≥20 years with diabetes who participated in the 2005–2018 National Health and Nutrition Examination Survey (NHANES).RESULTSOverall, the proportion of U.S. adults with diabetes receiving ADA guideline-recommended care meeting all five criteria by self-report in the past year (having a primary doctor for diabetes and one or more visits for this doctor, HbA_1c testing, an eye examination, a foot examination, and cholesterol testing) increased from 25.0% in 2005–2006 to 34.1% in 2017–2018 (P-trend = 0.004). For participants with age ≥65 years, it increased from 29.3% in 2005–2006 to 44.2% in 2017–2018 (P-trend = 0.001), whereas for participants with age 40–64 and 20–39 years, it did not change significantly during the same time period: 25.2% to 25.8% (P-trend = 0.457) and 9.9% to 26.0% (P-trend = 0.401), respectively. Those who were not receiving ADA guideline-recommended care were more likely to be younger, of lower socioeconomic status, uninsured, newly diagnosed with diabetes, not on diabetes medication, and free of hypercholesterolemia.CONCLUSIONSReceipt of ADA guideline-recommended care increased only among adults with diabetes aged ≥65 years in the past decade. In 2017–2018, only one of three U.S. adults with diabetes reported receiving ADA guideline-recommended care, with even a lower receipt of care among those <65 years of age. Efforts are needed to improve health care delivery and equity in diabetes care. Insurance status is an important modifiable determinant of receiving ADA guideline-recommended care.     

Analysis of Guidelines for Screening Diabetes Mellitus in an Ambulatory Population

OBJECTIVES: To compare the case-finding ability of current national guidelines for screening diabetes mellitus and characterize factors that affect testing practices in an ambulatory population.PATIENTS AND METHODS: In this retrospective analysis, we reviewed a database of 46,991 nondiabetic patients aged 20 years and older who were seen at a large Midwestern academic physician practice from January 1, 2005, through December 31, 2007. Patients were included in the sample if they were currently being treated by the physician group according to Wisconsin Collaborative for Healthcare Quality criteria. Pregnant patients, diabetic patients, and patients who died during the study years were excluded. The prevalence of patients who met the American Diabetes Association (ADA) and/or US Preventive Services Task Force (USPSTF) criteria for diabetes screening, percentage of these patients screened, and number of new diabetes diagnoses per guideline were evaluated. Screening rates were assessed by number of high-risk factors, primary care specialty, and insurance status.RESULTS: A total of 33,823 (72.0%) of 46,991 patients met either the ADA or the USPSTF screening criteria, and 28,842 (85.3%) of the eligible patients were tested. More patients met the ADA criteria than the 2008 USPSTF criteria (30,790 [65.5%] vs 12,054 [25.6%]), and the 2008 USPSTF guidelines resulted in 460 fewer diagnoses of diabetes (33.1%). By single high-risk factor, prediabetes (15.8%) and polycystic ovarian syndrome (12.6%) produced the highest rates of diagnosis. The number of ADA high-risk factors predicted diabetes, with 6 (23%) of 26 patients with 6 risk factors diagnosed as having diabetes. Uninsured patients were tested significantly less often than insured patients (54.9% vs 85.4%).CONCLUSION: Compared with the ADA recommendations, the new USPSTF guidelines result in a lower number of patients eligible for screening and decrease case finding significantly. The number and type of risk factors predict diabetes, and lack of health insurance decreases testing.ADA = American Diabetes Association; CI = confidence interval; FPG = fasting plasma glucose; HbA1c = hemoglobin A_1c; ICD-9 = International Classification of Diseases, Ninth Revision; PCOS = polycystic ovarian syndrome; RG = random glucose; USPSTF = US Preventive Services Task Force; WCHQ = Wisconsin Collaborative for Healthcare QualityDiabetes mellitus has reached epidemic proportions in the United States. National Health and Nutrition Examination Survey data from 2005-2006 determined that the prevalence of diabetes in an ambulatory sample aged 20 years and older was 12.9%.¹ An additional 29.5% had either impaired fasting plasma glucose (FPG) levels, impaired glucose tolerance, or both; therefore, 42.4% of the US population aged 20 years or older has some degree of dysglycemia.¹ These numbers represent an increase since 1999-2002, when the National Health and Nutrition Examination Survey reported that the diabetic prevalence was 9.3%.² This trend is expected to continue, with 48.3 million Americans expected to have diabetes by 2050, a 198% increase compared with 2005.³The prevalence of undiagnosed diabetes mellitus is equally alarming, with approximately 40% of the US diabetic population not knowing about their disease.¹ In total, 5.1% of the US population aged 20 years and older has diabetes but is unaware of the diagnosis. These patients are of particular concern because patients without knowledge of their disease obviously cannot be treated and may sustain progressive end-organ compromise. Harris et al⁴ discovered retinopathy in almost 21% of patients with newly diagnosed diabetes, indicating that the disease may have been active for 4 to 7 years before the actual diagnosis. In addition, recent UK Prospective Diabetes Study data confirmed the “legacy effect” in patients with type 2 diabetes, a finding that was originally demonstrated in patients with type 1 diabetes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study.⁵ This phenomenon refers to the finding that a period of untreated hyperglycemia, such as what might be expected in a patient with undiagnosed diabetes, has lasting effects on cardiovascular morbidity and mortality even if blood glucose levels are later appropriately controlled.^6,7 Thus, a more timely diagnosis may reduce these complications by creating an opportunity for early intervention and optimization of glycemic control.Why the prevalence of undiagnosed diabetes remains high is unclear because screening guidelines have been in place for more than a decade. Since 1997, the American Diabetes Association (ADA) has recommended diabetes screening for patients 45 years and older, as well as in younger patients with high-risk factors (Figure 1).^8,9 The US Preventive Services Task Force (USPSTF) has consistently recommended diabetes screening for patients with hypertension and hyperlipidemia since the Guide to Clinical Preventive Services, Third Edition,¹⁰ was published in series beginning in 2000. However, with the USPSTF 2008 update, hyperlipidemia was deleted as a criterion and diabetes screening was advised only for patients with blood pressure greater than 135/80 mm Hg (Figure 1).^10,11 These guidelines are based on evidence-based review of the literature (ADA and USPSTF) and expert opinion (ADA).Open in a separate windowFIGURE 1.Criteria to screen for diabetes mellitus: American Diabetes Association (ADA) and/or US Preventive Services Task Force (USPSTF). BMI = body mass index; GDM = gestational diabetes mellitus; HDL-C = high-density lipoprotein cholesterol; IFG = impaired fasting glucose; IGT = impaired glucose tolerance; PCOS = polycystic ovarian syndrome. Adapted from the ADA⁹ and the USPSTF,^10,11 with permission.The failure of available guidelines to effectively reduce the number of patients with undiagnosed diabetes may be due to factors such as patients not presenting for care or physicians failing to screen. However, whether the guidelines themselves are targeting the correct at-risk population to maximize diabetes case finding is unknown. Despite extensive publication and commentary of the 2 primary guidelines (ADA and USPSTF),¹² it remains unclear how diabetes screening guidelines affect case finding in ambulatory practice. To our knowledge, there have been no systematic comparisons of the testing practices and case-finding ability of the ADA and USPSTF recommendations.The primary objective of this study was to determine the diabetes case-finding ability of the ADA and USPSTF criteria when applied to clinical practice. In addition, we investigated whether patients with more ADA-designated high-risk factors were more likely to be tested, what risk factor was most predictive of a diabetes diagnosis, and whether a screening difference existed on the basis of primary care specialty or presence of health care insurance.     

PS1-35: Impact of an ADA-Accredited Diabetes Education on Healthcare Utilization

Background/Aims Diabetes self-management education delivered by certified diabetes educators (CDE) can improve persons' self-management skills, self-efficacy for managing their diabetes, and clinical outcomes among patients with Type II diabetes. In addition, these education programs have the potential to reduce healthcare utilization, costs, and disabilities associated with the disease. Objective The purpose of this study was to measure the impact of Type 2 Diabetes BASICS education program (obtained from the International Diabetes Center in Minneapolis) on healthcare utilization among Scott & White SeniorCare members. The Diabetes Education site at Scott & White is nationally certified by the American Diabetes Association (ADA). Methods This was a retrospective cohort study of participants who attended the education program at a single program delivery site. Subjects were program participants who attended four BASICS class sessions over a six months period between January 2005 and July 2010 and were also enrolled in a Medicare Cost Contract product. About 349 subjects were included in the analysis. The key outcome variables were number of outpatient visits, number of inpatient hospitalization and length of inpatient stay. Differences in average number of outpatient visits, number of inpatient hospitalization, and length of inpatient stay were compared for the 12-months before participants began the education program and the 12-months after the completion. The unadjusted men differences were calculated using paired t-test. Adjusted mean difference in outpatient utilization was estimated from a linear regression and inpatient utilization by negative binomial regression adjusting for patient's age and gender. Results On average, the number of outpatient visits decreased from 8.38 in the year before participants began the program to 7.70 (p=0.04) in the year after they finished the program. In addition, the unadjusted mean number of inpatient admissions per year was significantly reduced from 0.34 to 0.20(p=0.02). The adjusted mean difference in outpatient visits decreased by 0.72 (p<0.001), however, no significant difference was observed for adjusted inpatient utilization. Discussion Health plan members who participated in the ADA-certified diabetes education class showed significant reductions in both outpatient and inpatient health service utilization in the year following class participation compared to the year before their participation.     

Estimated risk of Chikungunya viremic blood donation during an epidemic on Reunion Island in the Indian Ocean, 2005 to 2007

BACKGROUND: Between 2005 and 2007, Chikungunya virus (CHIKV) caused a massive epidemic on Reunion Island with a major peak in the number of cases in February 2006. Blood donation was interrupted on the island in January 2006. STUDY DESIGN AND METHODS: Estimates of the mean risk of viremic blood donation on Reunion Island were computed for different phases of the epidemic. Calculations used CHIKV incidence estimates derived from sentinel surveillance, duration of viremia, and frequency of asymptomatic infection. Data on these two last parameters were initially based on hypotheses and subsequently obtained from studies carried out during the outbreak. The estimated risk was compared to the results of CHIKV nucleic acid testing (NAT) implemented for platelet (PLT) donations screening. RESULTS: Over the course of the outbreak, the mean risk was estimated at 132 per 100,000 donations. The risk peaked at 1,500 per 100,000 donations at the height of the outbreak in February 2006. In total, 47 blood donations would have been potentially viremic if blood collection had not been interrupted. During this period, an estimated 312,500 of 757,000 inhabitants had been infected by mosquito-borne transmission. From January to May 2006, the estimated mean risk (0.7%) and observed risk on PLT donations (0.4%) were of the same order of magnitude. CONCLUSION: During this large outbreak, the estimated risk of viremic blood donation was high, but low compared to the risk of mosquito-borne CHIKV transmission. The estimated risk was corroborated by the concordant results with the observed risk.     

Diabetes guidelines: a summary and comparison of the recommendations of the American Diabetes Association, Veterans Health Administration, and American Association of Clinical Endocrinologists

OBJECTIVE: This paper summarizes and compares 3 major organizations' guidelines for the management of diabetes mellitus. BACKGROUND: Diabetes mellitus is a chronic disease that affects >16 million Americans. A decrease in adverse events has been demonstrated when hyperglycemia and comorbid conditions such as hypertension and dyslipidemia are controlled in patients with diabetes. Although each patient with diabetes is unique and medical care should be tailored to his or her individual needs, clinical evidence and expert opinion have established a baseline level of care for all patients with diabetes. Guidelines have been created to guide practitioners in selecting appropriate care, but their length and complexity may serve as barriers to their use. METHODS: The diabetes management guidelines of the American Diabetes Association (ADA), Veterans Health Administration (VA), and American Association of Clinical Endocrinologists (AACE) are summarized and compared in both text and tabular form. CONCLUSION: Although the guidelines published by the ADA, VA, and AACE vary slightly, all of them can be used to ensure that patients with diabetes receive appropriate care.     

Identification of patients receiving peritoneal dialysis using health insurance claims data

Objective: The aim of this analysis was to assess alternative methods of identification of patients treated with peritoneal dialysis (PD) in health care claims databases for possible use in future analyses of costs of this treatment modality.Methods: Using a US health insurance claims database spanning January 1, 2004, to December 31, 2006, we identified all patients with renal failure who satisfied a case-finding algorithm for PD anticipated to be highly specific, but not necessarily sensitive—namely, ≥2 claims for PD-related physician services (algorithm 1). All claims from these patients were assessed to identify additional PD-related codes, from which 6 additional algorithms were developed, each of which focused on specific categories of billing codes (eg, diagnostic, procedural/service, equipment). Patient selection was then reimplemented using these alternative algorithms. Concordance between the various algorithms and the extent to which resulting samples were similar in terms of patient characteristics, health care resource utilization, and costs were assessed.Results: We identified a total of 132,274 patients in the database with ≥1 claim for renal failure and valid enrollment data. Among these patients, a total of 2329 satisfied case-selection criteria for algorithm 1, and 4031 patients met criteria for at least 1 of the 7 algorithms for PD. The most sensitive algorithm identified 2859 patients who might have received PD; the least sensitive, 211. Concordance between algorithms was relatively poor. Patients identified using each algorithm were similar, however, with respect to mean age (45–50 years), sex (54%–56% male), and the prevalence of selected comorbidities. Annualized median health care costs were similar across the various algorithms (range, US $80,967-$118,668).Conclusions: Based on the results from this analysis, it seems that health care providers bill insurers for PD-related care using a variety of codes. Investigators using health insurance claims data for analyses of patients treated with PD need to take this into account.     

Guidelines for glycemic control

Glycemic control in diabetes patients continues to evolve as new medications are introduced and clinical trial data become available. The American Diabetes Association (ADA) guidelines for 2004, for the first time, provide targets for both preprandial and postprandial glucose levels. The ADA, however, does not provide guidelines regarding specific medication therapy. This paper provides a detailed treatment algorithm that is easy to follow for nurse practitioners as well as primary care providers. Progress in our understanding of diabetes and new therapeutic agents will dictate modifications of treatment targets and guidelines, with the goal of making euglycemia achievable for all patients with diabetes.     

二甲双胍缓释片联合盐酸罗格列酮治疗2型糖尿病患者的疗效观察

目的探讨二甲双胍缓释片与盐酸罗格列酮联用对2型糖尿病患者的临床疗效。方法选取2006年7月至2009年6月在我院门诊或住院治疗的2型糖尿病患者52例,随机分两组,联合组给予二甲双胍缓释片（盐酸罗格列酮,对照组单独给予二甲双胍缓释片,观察两组空腹血糖（FPG）及饭后2 h血糖（2 hPG）、糖化血红蛋白C（HbA1 c）、体质指数、血脂等指标和治疗期间不良反应,并比较分析。结果与治疗前相比较,两组FPG、2 hPG、HbA1 c及三酰甘油（TG）均明显下降,差异具有统计学意义（P〈0.01,0.05）;与对照组相比较,联合组FPG、2 hPG、HbA1 c改善更优,差异有统计学意义（P〈0.05）。结论二甲双胍缓释片＋盐酸罗格列酮治疗2型糖尿病患者的疗效优于单纯给予二甲双胍缓释片。     

Sitagliptin: a dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes

OBJECTIVE: To review the pharmacology, pharmacokinetics, safety, and efficacy of sitagliptin, a dipeptidyl peptidase IV (DPP-IV) inhibitor in the management of type 2 diabetes mellitus. DATA SOURCES: A MEDLINE search (1966-February 2006) was conducted for English-language articles using the terms dipeptidyl peptidase IV inhibitor, incretin, MK-0431, and sitagliptin. Abstracts from the American Diabetes Association annual meetings in 2004 and 2005 were included as sources of data. STUDY SELECTION AND DATA EXTRACTION: Articles pertaining to the pharmacology of sitagliptin, its pharmacokinetics, safety and efficacy were reviewed. DATA SYNTHESIS: Sitagliptin is a potent, competitive, reversible inhibitor of the DPP-IV enzyme. It is eliminated renally, with a terminal half-life of 11.8-14.4 hours. In Phase II clinical trials, sitagliptin was found to be superior to placebo for the treatment of type 2 diabetes mellitus. Results of a small trial comparing sitagliptin with glipizide indicate that both treatments are comparable. The efficacy of sitagliptin has also been demonstrated when used as adjunctive therapy with metformin. Few adverse effects have been reported. Weight gain and hypoglycemia have not been seen with sitagliptin therapy. CONCLUSIONS: Based on its unique mechanism of action, sitagliptin will provide practitioners with an additional tool in the treatment of diabetes. Review of the literature to date implies sitagliptin may be effective as monotherapy in type 2 diabetes. In addition, existing evidence supports the use of sitagliptin as adjunct therapy to sulfonylureas and metformin. Another advantage of sitagliptin use is that it appears to be free from the adverse effects of weight gain and hypoglycemia that are associated with currently available treatments.     

Adherence to American Diabetes Association standards of care by rural health care providers

OBJECTIVE: To determine whether rural health care providers are compliant with American Diabetes Association (ADA) clinical practice guidelines for glycemic, blood pressure, lipid management, and preventative services. RESEARCH DESIGN AND METHODS: This study was performed using a retrospective chart review of 399 patients 45 years of age and older, with a definitive diagnosis of diabetes seen for primary diabetes care at four rural health facilities in Montana between 1 January 1999 and 1 August 2000. RESULTS: Glycemic testing was adequate (85%), and glycemic control (HbA(1c) 7.43 +/- 1.7%) was above the national average. Comorbid conditions of hypertension and dyslipidemia were not as well managed. Mean systolic blood pressure (SBP) was 139 +/- 18.8 mmHg and LDL was 119 +/- 33 mg/dl. Of 399 patients, 11 were considered as needing no additional treatment based on ADA guidelines of an HbA(1c) level <7%, a BP <130/85 mmHg, and a LDL level <100 mg/dl. Monofilament testing and dilated eye examinations were poorly documented, as were immunizations. There were few referrals for diabetic education. CONCLUSIONS: Rural health care practitioners are not adequately following the ADA standards for comprehensive management of their patients with diabetes. Glycemic testing is being ordered, but HbA(1c) values indicate that patients do not have their diabetes under optimal control. The comorbid conditions of hypertension and dyslipidemia are not optimally managed according to the ADA guidelines.