Utility Decrements Associated With Diabetes and Related Complications: Estimates From a Population-Based Study in Germany.

OBJECTIVES: Health utility decrement estimates for diabetes and complications are needed for parametrization of simulation models that aim to assess the cost-utility of diabetes prevention and care strategies. This study estimates health utility decrements associated with diabetes and cardiovascular and microvascular complications from a population-based German study. METHODS: Data were obtained from the population based cross-sectional KORA (Cooperative Health Research in the Augsburg Region) health questionnaire 2016 and comprised n = 1072 individuals with type 2 diabetes and n = 7879 individuals without diabetes. Health utility was assessed through the EQ-5D-5L. We used linear regression models with interaction terms between type 2 diabetes and different cardiovascular and microvascular complications while adjusting for demographic and socio-economic factors and other comorbidities. RESULTS: Type 2 diabetes (ß = -0.028, standard error [SE] = 0.014), stroke (ß = -0.070, SE = 0.010), cardiac arrhythmia (ß = -0.031, SE = 0.006), heart failure (ß = -0.073, SE = 0.009), coronary heart disease (ß = -0.028, SE = 0.010), myocardial infarction (ß = -0.020, SE = 0.011, estimates of main effect), and neuropathy (ß = -0.067, SE = 0.020), diabetic foot (ß = -0.042, SE = 0.030), nephropathy (ß = -0.032, SE = 0.025), and blindness (ß = -0.094, SE = 0.056, estimates of interaction terms) were negatively associated with health utility. The interaction term for diabetes x stroke (ß = -0.052, SE = 0.021) showed that the utility decrement for stroke is significantly larger in people with type 2 diabetes than in people without diabetes. CONCLUSIONS: Diabetes, cardiovascular, and microvascular conditions are associated with significant health utility decrements. Utility decrements for some conditions differ between people with and without type 2 diabetes. These results are of high relevance for the parametrization of decision analytic simulation models and applied health economic evaluations in the field of prevention and management of type 2 diabetes in Germany.

Association Between Systolic Blood Pressure and Cardiovascular Inpatient Cost Moderated by Peer-Support Intervention Among Adult Patients With Type 2 Diabetes: A 2-Cohort Study.

OBJECTIVES: People with type 2 diabetes and increased systolic blood pressure (SBP) are at high risk of cardiovascular disease (CVD). In this study, we aimed to investigate the association between CVD-related hospital payments and SBP and tested whether this association is influenced by diabetes peer support. METHODS: Two cohorts comprising people with type 2 diabetes were included in the study. The first cohort comprised 4,704 patients with type 2 diabetes assessed between 2008 and 2009 from 18 general practices in Cambridgeshire and followed up to 2009-2011. The second cohort comprised 1,121 patients with type 2 diabetes from post-trial follow-up data, recruited between 2011 and 2012 and followed up to 2015. SBP was measured at baseline. Inpatient payments for CVD hospitalization within 2 years since baseline was the main outcome. The impact of 1:1, group or combined diabetes peer support and usual care were investigated in the second cohort. Adjusted mean CVD inpatient payments per person were estimated using a 2-part model after adjusting for baseline characteristics. RESULTS: A "hockey-stick" relationship between baseline SBP and estimated CVD inpatient payment was identified in both cohorts, with a threshold at 133 to 141 mmHg, suggesting increased payments for patients with SBP below and above the threshold. The combined peer-support intervention altered the aforementioned association, with no increased payment with SBP above the threshold, and payment slightly decreased with SBP beyond the threshold. CONCLUSIONS: SBP maintained between 133 and 141 mmHg is associated with the lowest CVD disease management costs for patients with type 2 diabetes. Combined peer-support intervention could significantly decrease CVD-related hospital payments.

Health Care Costs Associated With Macrovascular, Microvascular, and Metabolic Complications of Type 2 Diabetes Across Time: Estimates From a Population-Based Cohort of More Than 0.8 Million Individuals With Up to 15 Years of Follow-up.

OBJECTIVE: Developing country-specific unit-cost catalogs is a key area for advancing economic research to improve medical and policy decisions. However, little is known about how health care costs vary by type 2 diabetes (T2D) complications across time in Asian countries. We sought to quantify the economic burden of various T2D complications in Taiwan. RESEARCH DESIGN AND METHODS: A nationwide, population-based, longitudinal study was conducted to analyze 802,429 adults with newly diagnosed T2D identified during 1999-2010 and followed up until death or 31 December 2013. Annual health care costs associated with T2D complications were estimated, with multivariable generalized estimating equation models adjusted for individual characteristics. RESULTS: The mean annual health care cost was $281 and $298 (2017 U.S. dollars) for a male and female, respectively, diagnosed with T2D at age <50 years, with diabetes duration of <5 years, and without comorbidities, antidiabetic treatments, and complications. Depression was the costliest comorbidity, increasing costs by 64-82%. Antidiabetic treatments increased costs by 72-126%. For nonfatal complications, costs increased from 36% (retinopathy) to 202% (stroke) in the event year and from 13% (retinopathy or neuropathy) to 49% (heart failure) in subsequent years. Costs for the five leading costly nonfatal subtype complications increased by 201-599% (end-stage renal disease with dialysis), 37-376% (hemorrhagic/ischemic stroke), and 13-279% (upper-/lower-extremity amputation). For fatal complications, costs increased by 1,784-2,001% and 1,285-1,584% for cardiovascular and other-cause deaths, respectively. CONCLUSIONS: The cost estimates from this study are crucial for parameterizing diabetes economic simulation models to quantify the economic impact of clinical outcomes and determine cost-effective interventions.

Cost of macrovascular complications in people with diabetes from a public healthcare perspective: a retrospective database study in Brazil.

Aims: To evaluate costs in patients with diabetes who experienced a macrovascular complication from a Brazilian public healthcare system perspective.Materials and methods: A retrospective, observational study that utilized the database of the Brazilian Unified Health System (DATASUS). Data for direct medical costs (hospitalization and outpatient) were extracted for patients with diabetes and a macrovascular complication (1 January 2012-31 December 2018) and converted to US Dollars (2019 USD). Mixed-effects logistic regression explored associations between demographic and clinical characteristics with the incurrence of high direct medical costs.Results: In total, 1,668 (0.2%) patients with diabetes met study inclusion criteria and experienced a macrovascular complication, either alone (N = 1,193) or together with a microvascular complication (N = 475). Median [95% CI] annual costs (USD/patient) were 130.5 [90.7; 264.2] at baseline, increasing to 334.0 [182.2; 923.5] in the first year after the complication. The odds of incurring high costs were significantly elevated in the first and second year (vs. baseline), and in patients who experienced a macrovascular and microvascular complication (vs. macrovascular alone) (all p < 0.001).Limitations: The DATASUS database does not cover primary care (it covers secondary and tertiary care), adding a selection bias to the sample. Additionally, our findings may not be representative of the entire Brazilian population given that approximately 75% of the population of Brazil depend exclusively on the SUS, while the remaining 25% have some access to private healthcare.Conclusions: This study has demonstrated higher medical costs from the perspective of the Brazilian public healthcare system in patients with diabetes after experiencing a macrovascular complication, either alone or in conjunction with a microvascular complication, in comparison with costs before the complication(s). In addition to providing up-to-date cost estimates, our findings highlight the need to implement strategies to reduce the cardiovascular risk in Brazilian patients with diabetes and drive cost savings.

Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).

OBJECTIVE: To compare medical resource use, costs, and health utilities for 14,752 patients with type 2 diabetes who were randomized to once-weekly exenatide (EQW) or placebo in addition to usual diabetes care in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). RESEARCH DESIGN AND METHODS: Medical resource use data and responses to the EuroQol 5-Dimension (EQ-5D) instrument were collected at baseline and throughout the trial. Medical resources and medications were assigned values by using U.S. Medicare payments and wholesale acquisition costs, respectively. Secondary analyses used English costs. RESULTS: Patients were followed for an average of 3.3 years, during which time those randomized to EQW experienced 0.41 fewer inpatient days (7.05 vs. 7.46 days; relative rate ratio 0.91; P = 0.05). Rates of outpatient medical visits were similar, as were total inpatient and outpatient costs. Mean costs for nonstudy diabetes medications over the study period were ∼$1,600 lower with EQW than with placebo (P = 0.01). Total within-study costs, excluding study medication, were lower in the EQW arm than in the placebo arm ($28,907 vs. $30,914; P ≤ 0.01). When including the estimated cost of EQW, total mean costs were significantly higher in the EQW group than in the placebo group ($42,697 vs. $30,914; P < 0.01). With English costs applied, mean total costs, including exenatide costs, were £1,670 higher in the EQW group than the placebo group (£10,874 vs. £9,204; P < 0.01). There were no significant differences in EQ-5D health utilities between arms over time. CONCLUSIONS: Medical costs were lower in the EQW arm than the placebo arm, but total costs were significantly higher once the cost of branded exenatide was incorporated.

Combined effects of diabetes and low household income on mortality: a 12-year follow-up study of 505 677 Korean adults.

AIM: To examine the effects of diabetes, low income and their combination on mortality in the Korean population. METHODS: We analysed a total of 505 677 people (53.9% male) aged 40-79 years old from the National Health Insurance Service-National Health Screening (NHIS-HEALS) cohort. Ten levels of household income were used as indicators of economic status. Diabetes was defined as elevated fasting blood glucose (≥ 6.9 mmol/l) and/or use of glucose-lowering drugs or insulin. Covariates of age, sex, BMI, smoking and Charlson Comorbidity Index were determined at baseline. Outcomes were total and cause-specific mortality over 12 years. Cox's proportional hazard regression models were used to estimate hazard ratios (HRs) for mortality according to the presence of diabetes, household income and their combination. RESULTS: Lower household income was associated with higher mortality from all causes, cardiovascular disease, cancer and non-cancer non-cardiovascular causes. Excessive mortality due to low incomes was observed in both people with and without diabetes. In men, the adjusted HR [95% confidence interval (CI)] of mortality was 1.38 (1.34 to 1.42) for low-income only, 1.48 (1.42 to 1.55) for diabetes only and 1.95 (1.86 to 2.05) for diabetes and low-income combined, relative to the normal glucose and high income group. Corresponding HR (95% CI) in women were 1.19 (1.14 to 1.24), 1.54 (1.44 to 1.64) and 1.87 (1.75 to 2.01), respectively. CONCLUSION: Both low household income and the presence of diabetes independently increase the risk of mortality, but their combined effects on mortality may be different between men and women.

Cost-utility of empagliflozin in patients with type 2 diabetes at high cardiovascular risk.

AIMS: In the Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes (EMPA-REG) trial, empagliflozin reduced cardiovascular and all-cause mortality in type 2 diabetes (T2D) patients at high cardiovascular risk. We sought to estimate the cost-effectiveness of empagliflozin versus standard treatment for the prevention of cardiovascular morbidity and mortality in patients with T2D. METHODS: A Markov model was developed to assess the cost-effectiveness of empagliflozin (versus standard treatment) for the prevention of cardiovascular morbidity and mortality in patients with T2D using a 3-month cycle length and a lifetime horizon. Data sources included the EMPA-REG randomized clinical trial and other published epidemiological studies. Outcomes included treatment costs (in 2016 US$), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Probabilistic sensitivity analysis (PSA) was performed to test the robustness of conclusions. RESULTS: Empagliflozin use resulted in higher total lifetime treatment costs ($371,450 versus $272,966) but yielded greater QALYs (10.712 vs. 9.419) compared to standard treatment. This corresponded to an ICER of $76,167 per QALY gained. PSA suggested empagliflozin would be cost-effective in 96% of 10,000 iterations assuming a willingness-to-pay threshold of $100,000 per QALY gained. CONCLUSION: Empagliflozin may be cost-effective compared to standard treatment in T2D patients at high cardiovascular risk.

Annual direct medical costs associated with diabetes-related complications in the event year and in subsequent years in Hong Kong.

AIM: To develop models to estimate the direct medical costs associated with diabetes-related complications in the event year and in subsequent years. METHODS: The public direct medical costs associated with 13 diabetes-related complications were estimated among a cohort of 128 353 people with diabetes over 5 years. Private direct medical costs were estimated from a cross-sectional survey among 1825 people with diabetes. We used panel data regression with fixed effects to investigate the impact of each complication on direct medical costs in the event year and subsequent years, adjusting for age and co-existing complications. RESULTS: The expected annual public direct medical cost for the baseline case was US$1,521 (95% CI 1,518 to 1,525) or a 65-year-old person with diabetes without complications. A new lower limb ulcer was associated with the biggest increase, with a multiplier of 9.38 (95% CI 8.49 to 10.37). New end-stage renal disease and stroke increased the annual medical cost by 5.23 (95% CI 4.70 to 5.82) and 5.94 (95% CI 5.79 to 6.10) times, respectively. History of acute myocardial infarction, congestive heart failure, stroke, end-stage renal disease and lower limb ulcer increased the cost by 2-3 times. The expected annual private direct medical cost of the baseline case was US$187 (95% CI 135 to 258) for a 65-year-old man without complications. Heart disease, stroke, sight-threatening diabetic retinopathy and end-stage renal disease increased the private medical costs by 1.5 to 2.5 times. CONCLUSIONS: Wide variations in direct medical cost in event year and subsequent years across different major complications were observed. Input of these data would be essential for economic evaluations of diabetes management programmes.

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.

Hospitalization costs and clinical outcomes in CABG patients treated with intensive insulin therapy.

BACKGROUND: The financial impact of intensive (blood glucose [BG] 100-140mg/dl [5.5-7.8mM] vs. conservative (141-180mg/dl (7.9-10.0mM) glucose control in the ICU in patients, with and without diabetes, undergoing coronary artery bypass graft (CABG) surgery is not known. METHODS: This post-hoc cost analysis determined differences in hospitalization costs, resource utilization and perioperative complications in 288 CABG patients with diabetes (n=143) and without diabetes (n=145), randomized to intensive (n=143) and conservative (n=145) glucose control. RESULTS: Intensive glucose control resulted in lower BG (131.4±14mg/dl-(7.2±0.8mM) vs. 151.6±17mg/dl (8.4±0.8mM, p<0.001), a nonsignificant reduction in the median length of stay (LOS, 7.9 vs. 8.5days, p=0.17) and in a composite of perioperative complications including wound infection, bacteremia, acute renal and respiratory failure, major cardiovascular events (42% vs 52%, p=0.10) compared to conservative control. Median hospitalization costs were lower in the intensive group ($39,366 vs. $42,141, p=0.040), with a total cost savings of $3654 (95% CI: $1780-$3723), than conservative control. Resource utilization for radiology (p=0.008), laboratory (p=0.014), consultation service (p=0.013), and ICU utilization (p=0.007) were also lower in the intensive group. Compared to patients without perioperative complications, those with complications had longer hospital length of stay (10.7days vs. 6.7days, p<0.001), higher total hospitalization cost ($48,299 vs. $32,675, p<0.001), and higher resource utilization units (2745 vs. 1710, p<0.001). CONCLUSION: Intensive glycemic control [BG 100-140mg/dl (5.5-7.8mM)] in patients undergoing CABG resulted in significant reductions in hospitalization costs and resource utilization compared to patients treated with conservative [BG 141-180mg/dl (7.9-10.0mM)] glucose control.

A model to estimate cost-savings in diabetic foot ulcer prevention efforts.

BACKGROUND: Sustained efforts at preventing diabetic foot ulcers (DFUs) and subsequent leg amputations are sporadic in most health care systems despite the high costs associated with such complications. We sought to estimate effectiveness targets at which cost-savings (i.e. improved health outcomes at decreased total costs) might occur. METHODS: A Markov model with probabilistic sensitivity analyses was used to simulate the five-year survival, incidence of foot complications, and total health care costs in a hypothetical population of 100,000 people with diabetes. Clinical event and cost estimates were obtained from previously-published trials and studies. A population without previous DFU but with 17% neuropathy and 11% peripheral artery disease (PAD) prevalence was assumed. Primary prevention (PP) was defined as reducing initial DFU incidence. RESULTS: PP was more than 90% likely to provide cost-savings when annual prevention costs are less than $50/person and/or annual DFU incidence is reduced by at least 25%. Efforts directed at patients with diabetes who were at moderate or high risk for DFUs were very likely to provide cost-savings if DFU incidence was decreased by at least 10% and/or the cost was less than $150 per person per year. CONCLUSIONS: Low-cost DFU primary prevention efforts producing even small decreases in DFU incidence may provide the best opportunity for cost-savings, especially if focused on patients with neuropathy and/or PAD. Mobile phone-based reminders, self-identification of risk factors (ex. Ipswich touch test), and written brochures may be among such low-cost interventions that should be investigated for cost-savings potential.

Cost-Effectiveness Analysis of the Use of a Prophylactic Antibiotic for Patients Undergoing Lower Limb Amputation due to Diabetes or Vascular Illness in Colombia.

BACKGROUND: The use of a prophylactic antibiotic in an amputation surgery is a key element for the successful recovery of the patient. We aim to determine, from the perspective of the Colombian health system, the cost-effectiveness of administering a prophylactic antibiotic among patients undergoing lower limb amputation due to diabetes or vascular illness in Colombia. METHODS: A decision tree was constructed to compare the use and nonuse of a prophylactic antibiotic. The probabilities of transition were obtained from studies identified from a systematic review of the clinical literature. The chosen health outcome was reduction in mortality due to prevention of infection. The costs were measured by expert consensus using the standard case methodology, and the resource valuation was carried out using national-level pricing manuals. Deterministic sensitivity, scenarios, and probabilistic analyses were conducted. RESULTS: In the base case, the use of a prophylactic antibiotic compared with nonuse was a dominant strategy. This result was consistent when considering different types of medications and when modifying most of the variables in the model. The use of a prophylactic antibiotic ceases to be dominant when the probability of infection is greater than 48%. CONCLUSIONS: The administration of a prophylactic antibiotic was a dominant strategy, which is a conclusion that holds in most cases examined; therefore, it is unlikely that the uncertainty around the estimation of costs and benefits change the results. We recommend creating policies oriented toward promoting the use of a prophylactic antibiotic during amputation surgery in Colombia.

Possible consequences of regionally based bundled payments for diabetic amputations for safety net hospitals in Texas.

OBJECTIVE: Ongoing health reform in the United States encourages quality-based reimbursement methods such as bundled payments for surgery. The effect of such changes on high-risk procedures is unknown, especially at safety net hospitals. This study quantified the burden of diabetes-related amputation and the potential financial effect of bundled payments at safety net hospitals in Texas. METHODS: We performed a cross-sectional analysis of diabetic amputation burden and charges using publically available data from Centers for Medicare and Medicaid and the Texas Department of Health from 2008 to 2012. Using hospital referral region (HRR)-level analysis, we categorized the proportion of safety net hospitals within each region as very low (0%-9%), low (10%-20%), average (20%-33%), and high (>33%) and compared amputation rates across regions using nonparametric tests of trend. We then used charge data to create reimbursement rates based on HRR to estimate financial losses. RESULTS: We identified 51 adult hospitals as safety nets in Texas. Regions varied in the proportion of safety net hospitals from 0% in Victoria to 65% in Harlingen. Among beneficiaries aged >65, amputation rates correlated to the proportion of safety net hospitals in each region; for example, patients in the lowest quartile of safety net had a yearly rate of 300 amputations per 100,000 beneficiaries, whereas those in the highest quartile had a yearly rate of 472 per 100,000 (P = .007). Charges for diabetic amputation-related admissions varied almost 200-fold, from $5000 to $1.4 million. Using reimbursement based on HRR to estimate a bundled payment, we noted net losses would be higher at safety net vs nonsafety net hospitals ($180 million vs $163 million), representing a per-hospital loss of $1.6 million at safety nets vs $700,000 at nonsafety nets (P < .001). CONCLUSIONS: Regions with a high proportion of safety net hospitals perform almost half of the diabetic amputations in Texas. Changes to traditional payment models should account for the disproportionate burden of high-risk procedures performed by these hospitals.

Cost-effectiveness of medical primary prevention strategies to reduce absolute risk of cardiovascular disease in Tanzania: a Markov modelling study.

BACKGROUND: Cardiovascular disease (CVD) is a growing cause of mortality and morbidity in Tanzania, but contextualized evidence on cost-effective medical strategies to prevent it is scarce. We aim to perform a cost-effectiveness analysis of medical interventions for primary prevention of CVD using the World Health Organization's (WHO) absolute risk approach for four risk levels. METHODS: The cost-effectiveness analysis was performed from a societal perspective using two Markov decision models: CVD risk without diabetes and CVD risk with diabetes. Primary provider and patient costs were estimated using the ingredients approach and step-down methodologies. Epidemiological data and efficacy inputs were derived from systematic reviews and meta-analyses. We used disability- adjusted life years (DALYs) averted as the outcome measure. Sensitivity analyses were conducted to evaluate the robustness of the model results. RESULTS: For CVD low-risk patients without diabetes, medical management is not cost-effective unless willingness to pay (WTP) is higher than US$1327 per DALY averted. For moderate-risk patients, WTP must exceed US$164 per DALY before a combination of angiotensin converting enzyme inhibitor (ACEI) and diuretic (Diu) becomes cost-effective, while for high-risk and very high-risk patients the thresholds are US$349 (ACEI, calcium channel blocker (CCB) and Diu) and US$498 per DALY (ACEI, CCB, Diu and Aspirin (ASA)) respectively. For patients with CVD risk with diabetes, a combination of sulfonylureas (Sulf), ACEI and CCB for low and moderate risk (incremental cost-effectiveness ratio (ICER) US$608 and US$115 per DALY respectively), is the most cost-effective, while adding biguanide (Big) to this combination yielded the most favourable ICERs of US$309 and US$350 per DALY for high and very high risk respectively. For the latter, ASA is also part of the combination. CONCLUSIONS: Medical preventive cardiology is very cost-effective for all risk levels except low CVD risk. Budget impact analyses and distributional concerns should be considered further to assess governments' ability and to whom these benefits will accrue.

Resource use and costs in high-risk symptomatic peripheral artery disease patients with diabetes and prior acute coronary syndrome: a retrospective analysis.

OBJECTIVES: As the prevalence of peripheral artery disease (PAD) increases there is growing concern about the associated healthcare burden. This burden has not been well-characterized in high-risk patients with concurrent diabetes and/or acute coronary syndrome (ACS). The objective of this analysis was to assess comorbidities, medication use, outcomes, services and costs for 3 high-risk symptomatic PAD groups. METHODS: This retrospective longitudinal analysis used the MarketScan Commercial Claims and Encounters Database (2005-2013). The 3 high-risk symptomatic PAD groups were (1) symptomatic PAD with/without diabetes, (2) symptomatic PAD with/without prior ACS, and (3) symptomatic PAD with/without diabetes and prior ACS. The study time frame was a period of 1-year before the earliest date of a symptomatic PAD record and 3 years post. RESULTS: In all, 16,663 symptomatic PAD patients were identified across the three risk groups. Mean age ranged from 66.4-67.4 years; the majority (55.0%-63.3%) were men. At 3 years post index, patients with symptomatic PAD and a risk factor had significantly higher use of beta-blockers, ACE inhibitors and statins (P<0.0007), and higher rates of all-cause and symptomatic PAD-related medical services, diagnoses and procedures (P<0.05). Clopidogrel and statins were used by ≤ 41.2% and ≤ 66.7% of symptomatic PAD patients without risk, respectively, and ≤ 68.9% and ≤ 80.2% of patients with risks. All cause and symptomatic PAD-related treatment costs (P<0.0001) were higher for symptomatic PAD patients with risks versus patients without risks where annualized all-cause cost differences ranged from $7,482 to $13,504 and annualized PAD-related cost differences ranged from $605 to $1,997. CONCLUSIONS: Symptomatic PAD patients with diabetes and/or prior ACS have significantly higher medical resource use and costs compared to symptomatic PAD patients without these risk factors. The utilization rate of secondary prevention therapies is suboptimal; therefore, greater effort must be made to increase utilization and optimize treatment to minimize the impact of symptomatic PAD.

HeLP-Diabetes: randomised controlled trial protocol.

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) is common, affecting nearly 400 million people worldwide. Achieving good health for people with T2DM requires active self-management; however, uptake of self-management education is poor, and there is an urgent need to find better, more acceptable, cost-effective methods of providing self-management support. Web-based self-management support has many potential benefits for patients and health services. The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for people with T2DM. METHODS: This will be a multi-centre individually randomised controlled trial in primary care, recruiting adults with T2DM who are registered with participating general practices in England. Participants will be randomised to receive either an evidence-based, theoretically informed, web-based self-management programme for people with T2DM which addresses medical, emotional, and role management, called Healthy Living for People with type 2 Diabetes (HeLP-Diabetes) or a simple information website. The joint primary outcomes are glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas In Diabetes (PAID) questionnaire. Secondary outcomes include cardiovascular risk factors, depression and anxiety, and self-efficacy for self-management of diabetes. Health economic data include health service use, costs due to the intervention, and EQ-5D for calculation of Quality Adjusted Life Years (QALYS). Data will be collected at baseline, 3 months and 12 months, with the primary endpoint at 12 months. Practice nurses, blinded to patient allocation, collect clinical data; patients complete online questionnaires for patient reported measures. A sample size of 350 recruited participants allows for attrition of up to 15 % and will provide 90 % power of detecting at a 5 % significance level a true average difference in the PAID score of 4.0 and 0.25 % change in HbA1c (both small effect sizes). The analysis will follow a pre-specified analysis plan, based on comparing the groups as randomised (intention-to-treat). DISCUSSION: The findings of this trial are likely to be of interest to policy makers, clinicians, and commissioners, all of whom are actively seeking additional forms of self-management support for people with T2DM. TRIAL REGISTRATION: The Trial Registration number is ISRCTN 02123133 ; date of registration 14.2.13.

Optimal approaches to diabetic patients with multivessel disease.

The pathophysiology of diabetes and systemic insulin resistance contributes to the nature of diffuse atherosclerosis and a high prevalence of multivessel coronary artery disease (CAD) in diabetic patients. The optimal approach to this patient population remains a subject of an ongoing discussion. In this review, we give an overview of the unique pathophysiology of CAD in patients with diabetes, summarize the current state of therapies available, and compare modalities of revascularization that have been investigated in recent clinical trials. We conclude by highlighting the importance of a comprehensive heart team approach to every patient while accommodating both patient preference and quality-of-life decisions.