Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial.

BACKGROUND: The multicentre, international ADDITION-Europe study investigated the effect of promoting intensive treatment of multiple risk factors among people with screen-detected type 2 diabetes over 5 years. Here we report the results of a post-hoc 10-year follow-up analysis of ADDITION-Europe to establish whether differences in treatment and cardiovascular risk factors have been maintained and to assess effects on cardiovascular outcomes. METHODS: As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands) were randomly assigned by computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment. Population-based stepwise screening programmes among people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes. Allocation was concealed from patients. Following the 5-year follow-up, no attempts were made to maintain differences in treatment between study groups. In this report, we did a post-hoc analysis of cardiovascular and renal outcomes over 10 years following randomisation, including a 5 years post-intervention follow-up. As in the original trial, the primary endpoint was a composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation, up to Dec 31, 2014. Analyses were based on the intention-to-treat principle. ADDITION-Europe is registered with ClinicalTrials.gov, NCT00237549. FINDINGS: 343 general practices were randomly assigned to routine diabetes care (n=176) or intensive multifactorial treatment (n=167). 317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006. Of the 3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis. Mean duration of follow-up was 9·61 years (SD 2·99). Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA1c, blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up. By 10 years, 443 participants had a first cardiovascular event and 465 died. There was no significant difference between groups in the incidence of the primary composite outcome (16·1 per 1000 person-years in the routine care group vs 14·3 per 1000 person-years in the intensive treatment group; hazard ratio [HR] 0·87, 95% CI 0·73-1·04; p=0·14) or all-cause mortality (15·6 vs 14·3 per 1000 person-years; HR 0·90, 0·76-1·07). INTERPRETATION: Sustained reductions in glycaemia and related cardiovascular risk factors over 10 years among people with screen-detected diabetes managed in primary care are achievable. The differences in prescribed treatment and cardiovascular risk factors in the 5 years following diagnosis were not maintained at 10 years, and the difference in cardiovascular events and mortality remained non-significant. FUNDING: National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Novo Nordisk, Novo Nordisk Foundation, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Wellcome Trust, UK Medical Research Council, UK National Institute for Health Research, UK National Health Service, Merck, Julius Center for Health Sciences and Primary Care, UK Department of Health, and Nuts-OHRA.

10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2019.

The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

Spanish Diabetes Society (SED) recommendations for the pharmacologic treatment of hyperglycemia in type 2 diabetes: 2018 Update. / Recomendaciones de la Sociedad Española de Diabetes (SED) para el tratamiento farmacológico de la hiperglucemia en la diabetes tipo 2: Actualización 2018.

Type 2 diabetes mellitus (DM2) has become a problem of global dimensions by their high and growing prevalence worldwide and the personal and economic costs associated with it. Correct treatment can reduce mortality and associated complications. New concepts have recently been included in routine clinical practice and have changed the algorithm of DM2 pharmacological therapy. Therefore, the Spanish Society of Diabetes (SED) entrusted to the Working Group of Consensus and Clinical Guidelines an update of the 2010 document Recommendations for Pharmacological Treatment of Hyperglycemia in Diabetes type2. Novel aspects include nine characteristics to describe each drug group: efficiency, the risk of hypoglycemia, effects on body weight, the demonstrated effect in cardiovascular risk, nephroprotection, limitation of use in renal insufficiency, the rate of secondary effects, complexity and costs. Additionally, the document details combination options, and develop the start and adjustment of available injectable therapies.

Rates of myocardial infarction and stroke in patients initiating treatment with SGLT2-inhibitors versus other glucose-lowering agents in real-world clinical practice: Results from the CVD-REAL study.

The multinational, observational CVD-REAL study recently showed that initiation of sodium-glucose co-transporter-2 inhibitors (SGLT-2i) was associated with significantly lower rates of death and heart failure vs other glucose-lowering drugs (oGLDs). This sub-analysis of the CVD-REAL study sought to determine the association between initiation of SGLT-2i vs oGLDs and rates of myocardial infarction (MI) and stroke. Medical records, claims and national registers from the USA, Sweden, Norway and Denmark were used to identify patients with T2D who newly initiated treatment with SGLT-2i (canagliflozin, dapagliflozin or empagliflozin) or oGLDs. A non-parsimonious propensity score was developed within each country to predict initiation of SGLT-2i, and patients were matched 1:1 in the treatment groups. Pooled hazard ratios (HRs) and 95% CIs were generated using Cox regression models. Overall, 205 160 patients were included. In the intent-to-treat analysis, over 188 551 and 188 678 person-years of follow-up (MI and stroke, respectively), there were 1077 MI and 968 stroke events. Initiation of SGLT-2i vs oGLD was associated with a modestly lower risk of MI and stroke (MI: HR, 0.85; 95%CI, 0.72-1.00; P = .05; Stroke: HR, 0.83; 95% CI, 0.71-0.97; P = .02). These findings complement the results of the cardiovascular outcomes trials, and offer additional reassurance with regard to the cardiovascular effects of SGLT-2i, specifically as it relates to ischaemic events.

Cost-effectiveness of exenatide twice daily vs insulin glargine as add-on therapy to oral antidiabetic agents in patients with type 2 diabetes in China.

AIMS: To estimate the long-term cost-effectiveness of exenatide twice daily vs insulin glargine once daily as add-on therapy to oral antidiabetic agents (OADs) for Chinese patients with type 2 diabetes (T2DM). METHODS: The Cardiff Diabetes Model was used to simulate disease progression and estimate the long-term effects of exenatide twice daily vs insulin glargine once daily. Patient profiles and treatment effects required for the model were obtained from literature reviews (English and Chinese databases) and from a meta-analysis of 8 randomized controlled trials comparing exenatide twice daily with insulin glargine once daily add-on to OADs for T2DM in China. Medical expenditure data were collected from 639 patients with T2DM (aged ≥18 years) with and without complications incurred between January 1, 2014 and December 31, 2015 from claims databases in Shandong, China. Costs (2014 Chinese Yuan [¥]) and benefits were estimated, from the payers' perspective, over 40 years at a discount rate of 3%. A series of sensitivity analyses were performed. RESULTS: Patients on exenatide twice daily + OAD had a lower predicted incidence of most cardiovascular and hypoglycaemic events and lower total costs compared with those on insulin glargine once daily + OAD. A greater number of quality-adjusted life years (QALYs; 1.94) at a cost saving of ¥117 706 gained was associated with exenatide twice daily vs insulin glargine once daily. (i.e. cost saving of ¥60 764/QALY) per patient. CONCLUSIONS: In Chinese patients with T2DM inadequately controlled by OADs, exenatide twice daily is a cost-effective add-on therapy alternative to insulin glargine once daily, and may address the problem of an excess of medical needs resulting from weight gain and hypoglycaemia in T2DM treatment.

Five-year cost-effectiveness of the Patient Empowerment Programme (PEP) for type 2 diabetes mellitus in primary care.

This study evaluated the short-term cost-effectiveness of the Patient Empowerment Programme (PEP) for diabetes mellitus (DM) in Hong Kong. Propensity score matching was used to select a matched group of PEP and non-PEP subjects. A societal perspective was adopted to estimate the cost of PEP. Outcome measures were the cumulative incidence of all-cause mortality and diabetic complication over a 5-year follow-up period and the number needed to treat (NNT) to avoid 1 event. The incremental cost-effectiveness ratio (ICER) of cost per event avoided was calculated using the PEP cost per subject multiplied by the NNT. The PEP cost per subject from the societal perspective was US$247. There was a significantly lower cumulative incidence of all-cause mortality (2.9% vs 4.6%, P < .001), any DM complication (9.5% vs 10.8%, P = .001) and CVD events (6.8% vs 7.6%, P = .018), in the PEP group. The costs per death from any cause, DM complication or case of CVD avoided were US$14 465, US$19 617 and US$30 796, respectively. The extra amount allocated to managing PEP was small and it appears cost-effective in the short-term as an addition to RAMP.

No increased risk of cardiovascular events in older adults initiating dipeptidyl peptidase-4 inhibitors vs therapeutic alternatives.

AIM: To compare the cardiovascular (CV) risk associated with dipeptidyl peptidase-4 (DPP-4) inhibitors relative to sulphonylureas (SUs) and thiazolidinediones (TZDs). METHODS: During 2007 to 2013, using Medicare data for beneficiaries aged >65 years, we identified the following 2 cohorts of new-users, who had not been exposed to the drugs being compared in the 6 months before initiation: (1) DPP-4 inhibitor vs SU initiators and (2) DPP-4 inhibitor vs TZD initiators. Using propensity-score-adjusted Cox models accounting for competing risk by death, we estimated the hazard ratios (HRs), risk differences and 95% confidence intervals (CIs) for myocardial infarction (MI), stroke, hospitalization for heart failure (HF), and a combined outcome (MI, stroke, all-cause mortality). RESULTS: In the DPP-4 inhibitor vs SU comparison, there were 30 130 DPP-4 inhibitor initiators and 68 382 SU initiators. Their mean age was 75 years, 41% were men and 55% had a baseline CV condition. The HR for the composite outcome was 0.75 (95% CI 0.72-0.79) over a median treatment duration of 1 year, but the 1-year risks of MI were 1.00 (95% CI 0.89-1.12) and 1.47 (95% CI 1.38-1.56) per 100 patients for DPP-4 inhibitors and SUs, respectively, and the corresponding stroke risks were 0.98 (95% CI 0.87-1.10) and 1.09 (95% CI 1.01-1.17). For the DPP-4 inhibitor vs TZD comparison, there were 20 596 DPP-4 inhibitor initiators and 13 526 TZD initiators without previous HF. Their mean age was 74 years, 42% were men and 30% had a baseline CV event. The composite outcome HR was 0.94 (95% CI 0.86-1.02) over a median treatment duration of 1 year. The 1-year risk for MI was ~0.90 and for stroke it was ~0.80 per 100 patients in both DPP-4 inhibitor and TZD initiators. CONCLUSION: Although limited by the short treatment period, the present study suggests there is no increased short-term risk of MI, stroke or HF with DPP-4 inhibitors vs SUs/TZDs.

[Assessment of control of cardiovascular risk factors in obese posmenopausal women after monitoring a structured dietary education and exercise program. (SÍSIFO Program)]. / Valoración del control de los factores de riesgo cardiovascular en mujeres menopáusicas obesas tras el seguimiento de un programa estructurado de educación dietética y ejercicio físico. (Programa SÍSIFO).

OBJECTIVE: Evaluate the influence of a specific program of physical exercise on cardiovascular risk, quality of life and eating habits of menopausal women. METHOD: Prospective, intervention study previous-after without control group for three months. 66 menopausal women were included. The intervention consisted of a structured diet and exercise program. Biochemical, anthropometric, dietary and life quality parameters were determined before and three months after surgery. RESULTS: After the intervention a decrease in weight (4.4±2,3kg) and BMI (1.83±0.84kg/m(2)) (p<.05) occurs. A decrease in SBP (p<.05) was also observed. The fasting glucose went down 13.75±11.11mg/dl and HbA1c fell by 0.19±0,12%, both with p<.05. The lipid profile follows a similar behavior, highlighting a decline of 8± 6.2mg/dl in LDL cholesterol values (p<.05). The score on the measured cardiovascular risk by the Framingham tables decreases by 3% postoperatively (p<.05). Regarding the quality of life, it is significantly improved in all analyzed areas. CONCLUSIONS: The application of a structured exercise and diet program improves close monitoring parameters associated with cardiovascular risk of the women studied. It also improves the quality of life and dietary habits.

Risk of new-onset heart failure in patients using sitagliptin: a population-based cohort study.

AIMS: To examine whether patients using sitagliptin at the time of an acute coronary syndrome event are at increased risk of incident heart failure compared with those not exposed. METHODS: Using US claims data, people with diabetes without a history of heart failure in the 3 years before hospitalization for acute coronary syndrome were identified for the period 2004 to 2010. We used a nested case-control design, whereby cases were patients who developed incident heart failure <30 days after admission to hospital for acute coronary syndrome and were matched by age and sex with up to 10 controls with no heart failure. Subjects exposed or not exposed to sitagliptin in the 90 days before acute coronary syndrome admission were compared using conditional logistic regression after adjustment for clinical and laboratory data, healthcare utilization and propensity scores. RESULTS: In total, 457 cases of heart failure developing de novo after diagnosis of acute coronary syndrome were matched to 4570 controls. The average age of the subjects was 55 years and 65% were male. Overall, 11 of 147 (7%) people exposed to sitagliptin developed heart failure compared with 446 of the 4880 people not exposed (9%, adjusted odds ratio 0.75, 95% CI 0.38-1.46; P=0.40). Sitagliptin exposure before acute coronary syndrome was not associated with an increased risk of death or heart failure combined (7% vs 9%, adjusted odds ratio 0.66, 95% CI 0.34-1.28). CONCLUSIONS: In our sample of patients who are at high risk of heart failure after acute coronary syndrome, sitagliptin exposure was not associated with an increased risk of de novo heart failure.

Early specialist care for diabetes: who benefits most? A propensity score-matched cohort study.

AIMS: To examine whether early endocrinologist care reduces the risk of cardiovascular complications among newly diagnosed patients with diabetes of differing complexity. METHODS: We conducted a population-based propensity score-matched cohort study using provincial health data from Ontario, Canada. Adults (≥ 30 years) diagnosed with diabetes between 1 April 1998 and 31 March 2006 who received endocrinologist care in the first year of diagnosis were matched to a comparison group receiving primary care alone (N = 79 020) based on propensity scores and medical complexity (assigned using information on chronic conditions). Individuals were followed for 3- and 5-year outcomes, including non-fatal acute myocardial infarction or coronary heart disease death (primary endpoint), major cardiovascular events (acute myocardial infarction, stroke) or all-cause death, amputation and end-stage renal disease. RESULTS: Among medically complex patients, early endocrinologist care was associated with a lower 3-year incidence of the primary endpoint (hazard ratio 0.89, 95% CI 0.78-1.01) and major cardiovascular events or all-cause death (hazard ratio 0.91, 95% CI 0.85-0.97). These effects persisted after accounting for a higher incidence of end-stage renal disease on follow-up and were greatest in those with ≥ 3 visits to an endocrinologist (primary endpoint: hazard ratio 0.69, 95% CI 0.56-0.86 and 0.61, 95% CI 0.45-0.82, for unadjusted and end-stage renal disease adjusted analyses, respectively). In contrast, no benefit was observed in the non-medically complex subgroup. Overall effects were similar at 5 years. CONCLUSIONS: Early endocrinologist care is associated with a lower incidence of cardiovascular events and death among newly diagnosed patients with diabetes who have comorbid medical conditions.

Comparison of basal insulin therapies with regard to the risk of acute myocardial infarction in patients with type 2 diabetes: an observational cohort study.

AIMS: To assess the risk of acute myocardial infarction (AMI) in patients with type 2 diabetes mellitus treated with long-acting insulin analogues in comparison with other basal insulin therapy. METHODS: We used German insurance claims data from the years 2004-2009 to conduct a study in a retrospective cohort of patients with type 2 diabetes. Naïve insulin users were defined as patients who had an insulin-free history before the first prescription of long-acting analogue insulin, human NPH insulin or premixed insulin and who were pretreated with oral antidiabetic drugs. Adjusted hazard ratios (HRs) of AMI and corresponding 95% confidence intervals (CIs) were calculated using sex-stratified Cox models. Propensity-score-matched analyses were conducted as sensitivity analyses. RESULTS: We identified 21,501 new insulin users. Patients treated with premixed insulin were older than patients treated with analogue or NPH insulin (mean age 70.7 vs. 64.1 and 61.6 years, respectively) and had more comorbidities. Regarding the risk of AMI, adjusted HRs showed no statistically significant difference between NPH and analogue insulin (HR 0.94, 95% CI 0.74-1.19), but a higher risk for premixed than for analogue insulin (HR 1.27, 95% CI 1.02-1.58). Contrary to the primary analysis, the propensity-score-matched analysis did not show an increased risk for premixed insulin. CONCLUSIONS: In contrast to a former database study, no difference was observed for the risk of AMI between long-acting analogue and NPH insulin in this study. Neither long-acting analogue insulin nor premixed insulin appears to be associated with AMI in patients with type 2 diabetes.

Impact of socio-economic position on health and quality of care in adults with Type 2 diabetes in France: the Entred 2007 study.

AIM: To describe the association between socio-economic position, health status and quality of diabetes care in people with Type 2 diabetes in France, where people may receive full healthcare coverage for chronic disease. METHODS: Data from a national cross-sectional survey performed in people pharmacologically treated for diabetes were used. They combined data from medical claims, hospital discharge, questionnaires for patients (n = 3894 with Type 2 diabetes) and their physicians (n = 2485). Socio-economic position was assessed using educational level (low, intermediate, high) and ability to make ends meet (financial difficulties vs. financially comfortable). RESULTS: People with diabetes reporting financial difficulties were more likely to be smokers (adjusted odds ratio 1.4; 95% CI 1.1-1.6) and obese (adjusted odds ratio 1.3; 95% CI 1.2-1.6) and to have poorer glycaemic control (HbA1c > 64 mmol/mol (8%); adjusted odds ratio 1.4; 95% CI 1.1-1.8), than those who were financially comfortable. They were more likely to have their diabetes diagnosed because of complications (adjusted odds ratio 1.6; 95% CI 1.3-2.0). They were also more likely to have coronary and podiatric complications (adjusted odds ratios 1.3; 95% CI 1.1-1.6 and 1.7; 95% CI 1.4-2.2, respectively). They benefited more often from full coverage (adjusted odds ratio 1.3; 95% CI 1.1-1.6), visited general practitioners more often (ratio of estimated marginal means 1.2; 95% CI 1.1-1.2) but specialists less often (adjusted odds ratio 0.7; 95% CI 0.6-0.8 for a visit to private ophthalmologist). They also felt less well informed about their condition. CONCLUSIONS: Despite frequent access to full healthcare coverage, socio-economic position has an impact on the diagnosis of diabetes, health status and quality of diabetes care in France.

Cost-effectiveness analysis of adding pharmacists to primary care teams to reduce cardiovascular risk in patients with Type 2 diabetes: results from a randomized controlled trial.

BACKGROUND: Adding pharmacists to primary care teams significantly improved blood pressure control and reduced predicted 10-year cardiovascular risk in patients with Type 2 diabetes. This pre-specified sub-study evaluated the economic implications of this cardiovascular risk reduction strategy. METHODS: One-year outcomes and healthcare utilization data from the trial were used to determine cost-effectiveness from the public payer perspective. Costs were expressed in 2014 Canadian dollars and effectiveness was based on annualized risk of cardiovascular events derived from the UKPDS Risk Engine. RESULTS: The 123 evaluable trial patients included in this analysis had a mean age of 62 ( ± 11) years, 38% were men, and mean diabetes duration was 6 ( ± 7) years. Pharmacists provided 3.0 ( ± 1.9) hours of additional service to each intervention patient, which cost $226 ( ± $1143) per patient. The overall one-year per-patient costs for healthcare utilization were $190 lower in the intervention group compared with usual care [95% confidence interval (CI): -$1040, $668). Intervention patients had a significant 0.3% greater reduction in the annualized risk of a cardiovascular event (95% CI: 0.08%, 0.6%) compared with usual care. In the cost-effectiveness analysis, the intervention dominated usual care in 66% of 10,000 bootstrap replications. At a societal willingness-to-pay of $4000 per 1% reduction in annual cardiovascular risk, the probability that the intervention was cost-effective compared with usual care reached 95%. A sensitivity analysis using multiple imputation to replace missing data produced similar results. CONCLUSIONS: Within a randomized trial, adding pharmacists to primary care teams was a cost-effective strategy for reducing cardiovascular risk in patients with Type 2 diabetes. In most circumstances, this intervention may also be cost saving.

Comparative cardiovascular safety of insulin secretagogues following hospitalization for ischemic heart disease among type 2 diabetes patients: a cohort study.

AIM: To evaluate the association between insulin secretagogues and adverse cardiovascular sequelae in type 2 diabetes patients hospitalized for ischemic heart disease (IHD). METHODS: Administrative health records from Alberta, Canada between 1998 and 2010 were used to identify 2,254 gliclazide, 3,289 glyburide and 740 repaglinide users prior to an IHD-related hospitalization. Multivariable Cox regression models were used to compare the 30-day risk of a composite outcome of all-cause mortality or new onset of atrial fibrillation, stroke, heart failure or myocardial infarction according to insulin secretagogue use. RESULTS: Mean (SD) age was 76.1 (6.9) years, and 60.7% were men. The composite outcome occurred in 322 (30.2%) gliclazide users, 455 (28.1%) glyburide users and 81 (23.4%) repaglinide users within 30 days of IHD hospitalization. There were no differences in risk for glyburide use (adjusted hazard ratio [aHR] 0.91; 95% confidence interval [CI] 0.78-1.05) or repaglinide use (aHR 0.80; 95% CI 0.63-1.03) compared to gliclazide. Similar results were observed in analyses for each element of the composite outcome. CONCLUSIONS: In older patients with type 2 diabetes hospitalized for IHD, prior use of gliclazide, glyburide, or repaglinide appears to be associated with a similar risk of adverse cardiovascular sequelae.

Application of a theoretical framework to foster a cardiac-diabetes self-management programme.

AIM: This paper analyses and illustrates the application of Bandura's self-efficacy construct to an innovative self-management programme for patients with both type 2 diabetes and coronary heart disease. BACKGROUND: Using theory as a framework for any health intervention provides a solid and valid foundation for aspects of planning and delivering such an intervention; however, it is reported that many health behaviour intervention programmes are not based upon theory and are consequently limited in their applicability to different populations. The cardiac-diabetes self-management programme has been specifically developed for patients with dual conditions with the strategies for delivering the programme based upon Bandura's self-efficacy theory. This patient group is at greater risk of negative health outcomes than that with a single chronic condition and therefore requires appropriate intervention programmes with solid theoretical foundations that can address the complexity of care required. SOURCES OF EVIDENCE: The cardiac-diabetes self-management programme has been developed incorporating theory, evidence and practical strategies. DISCUSSION: This paper provides explicit knowledge of the theoretical basis and components of a cardiac-diabetes self-management programme. Such detail enhances the ability to replicate or adopt the intervention in similar or differing populations and/or cultural contexts as it provides in-depth understanding of each element within the intervention. CONCLUSION: Knowledge of the concepts alone is not sufficient to deliver a successful health programme. Supporting patients to master skills of self-care is essential in order for patients to successfully manage two complex, chronic illnesses. IMPLICATIONS FOR NURSING PRACTICE OR HEALTH POLICY: Valuable information has been provided to close the theory-practice gap for more consistent health outcomes, engaging with patients for promoting holistic care within organizational and cultural contexts.

Racial disparities in cardiovascular risk factor control in an underinsured population with Type 2 diabetes.

AIM: To investigate the race-specific trend in attainment of the American Diabetes Association cardiovascular risk factor control goals (HbA1c <53 mmol/mol (7.0%), blood pressure <130/80 mmHg and LDL cholesterol <2.6mmol/l) by patients with Type 2 diabetes. METHODS: The study sample included 14 946 African-American and 12 758 white patients who were newly diagnosed with Type 2 diabetes between 2001 and 2009 in the Louisiana State University Hospital system. The race-specific percentages of patients' attainment of American Diabetes Association goals were calculated using the baseline and follow-up measurements of HbA1c , blood pressure, and LDL cholesterol levels. Logistic regression was used to test the difference between African-American and white patients. RESULTS: The percentage of patients who met all three American Diabetes Association goals increased from 8.2% in 2001 to 10.2% in 2009 (increased by 24.4%) in this cohort. Compared with African-American patients, white patients had better attainment of the following American Diabetes Association goals: HbA1c (61.4 vs. 55.1%), blood pressure (25.8 vs. 20.4%), LDL cholesterol (40.1 vs. 37.7%) and all three goals (7.3 vs. 5.1%). African-American and white patients generally had a better cardiovascular disease risk factor profile during follow-up when we assessed attainment of the American Diabetes Association goals by means of HbA1c , blood pressure and LDL cholesterol. CONCLUSIONS: During 2001-2009, the present low-income cohort of people with Type 2 diabetes generally experienced improved control of cardiovascular disease risk factors. White patients had better attainment of the American Diabetes Association cardiovascular risk factor control goals than their African-American counterparts.

Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial.

AIMS: The cost implications of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial were evaluated using a prespecified analysis plan. METHODS: Purchasing power parity-adjusted country-specific costs were applied to consumed healthcare resources by participants from each country. Subgroup analyses were conducted on subgroups based on baseline metabolic status and diabetes duration. RESULTS: The total undiscounted cost per participant in the insulin glargine arm was $13,491 ($13,080 to $14,254) versus $11,189 ($10,568 to $12,147) for standard care, an increase of $2303 ($1370 to $3235; p < 0.0001); the discounted increase was $2099 ($1276 to $2923; P < 0.0001). The greater number of mainly generic oral anti-diabetic agents in the standard group partially offset the higher cost of basal insulin glargine. As the trial progressed and the standard group required more anti-diabetic medications, the annual cost difference decreased, reaching $68 (-$160 to $295) in the last year. The subgroup whose baseline diabetes duration was ≥ 6 years achieved cost-savings during the trial. CONCLUSIONS: From a global perspective basal insulin glargine use in ORIGIN incurred greater costs than standard care using older generic drugs. Nevertheless, the cost difference fell with time such that the intervention was cost-neutral by the last year.

Fasting and post-prandial glucose and diabetic complication. A meta-analysis.

BACKGROUND: The reduction of hemoglobin A1c (HbA1c) levels is recognized as a useful means of preventing diabetic complications. HbA1c results from both fasting and post-prandial glycemia, and therefore FPG and PPG could provide different, and independent, contributions to long-term outcomes. Aim of the present meta-analysis is the assessment of the effects of reduction of FPG and PPG on cardiovascular outcomes in randomized controlled trials. METHODS: An extensive search of Medline was performed for all randomized trials with a duration of at least 52 weeks and performed on glucose-lowering agents. Differences in the incidence of cardiovascular events, and all-cause and cardiovascular mortality were assessed in trials comparing different treatments with a between-group difference in FPG or PPG at endpoint greater than 1 mmol/l. RESULTS: The Mantel-Haenszel Odds Ratio (MH-OR) for cardiovascular events and all-cause and cardiovascular mortality in patients on more intensive treatments, in trials with a between-group difference of PPG greater than 1 mmol/l, was not significantly different from controls (MH-OR [95%CI] 0.90 [0.51-1.58] for MACE); on the contrary, more intensive treatment of FPG produced a significantly lower all-cause (MH-OR 0.90 [0.81-0.99], p = 0.03) and cardiovascular (MH-OR 0.86 [0.76-0.97], p = 0.012) mortality, with no significant effect on the incidence of major cardiovascular events. CONCLUSIONS: In conclusion, reduction of FPG is associated with reduced cardiovascular mortality. Data on PPG are still scarce, but they point in the same direction.

Effect of a 36-month pharmaceutical care program on the coronary heart disease risk in elderly diabetic and hypertensive patients.

PURPOSE: To examine the effect of a pharmaceutical care program on the coronary heart disease risk in elderly diabetic and hypertensive patients. METHODS: A total of 200 elderly (> 60 years) diabetic and/or hypertensive patients were recruited into a randomized, controlled, prospective clinical trial with a 36-month follow-up, developed in a public primary health care unit in a municipality in the Brazilian State of Sao Paulo. A range of clinical measurements were evaluated at the baseline and up to 36 months afterwards. The intervention group patients received pharmaceutical care from a clinical pharmacist, whereas the control group patients received their usual care from the medical and nursing staff. The Framingham scoring method was used to estimate changes in the 10-year coronary heart disease risk scores of all the patients. RESULTS: A total of 194 patients completed the study. Significant reductions (p < 0.05) in the mean values (baseline vs. 36 months) for the systolic blood pressure [156.7 mmHg vs 133.7 mmHg; P < 0.001), diastolic blood pressure (106.6 mmHg vs. 91.6 mmHg; P < 0.001),fasting glucose (135.1 mg/dL vs. 107.9 mg/dL; P < 0.001), hemoglobin A1C (7.7% vs. 7.0%; P <0.001), triglycerides (206.0 mg/dL vs. 152.5 mg/dL; P < 0.001), low-density lipoprotein (LDL)cholesterol (112.4 mg/dL vs. 102.0 mg/dL; P < 0.001), high-density lipoprotein cholesterol (55.5 mg/dL vs. 65.5 mg/dL; P < 0.001), total cholesterol (202.5 mg/dL vs. 185.9 mg/dL; P < 0.001), body mass index (26.2 kg/m2 vs. 26.1 kg/m2; P < 0.001), and abdominal circumference (103.2 cm vs. 102.5 cm; P= 0.001) were observed in the intervention group, whereas no significant changes were verified in the control group. The mean Framingham risk prediction score in the intervention group was 6.8% at baseline and decreased to 4.5%; P < 0.001) after 36 months, but remained unchanged in the control group. CONCLUSION: The pharmaceutical care program resulted in better clinical measurements and reduced the cardiovascular risk scores in elderly diabetic and hypertensive patients over a 36-month period.