Development of the simulation-based German albuminuria screening model (S-GASM) for estimating the cost-effectiveness of albuminuria screening in Germany.

BACKGROUND: Chronic kidney disease is often asymptomatic in its early stages but constitutes a severe burden for patients and causes major healthcare systems costs worldwide. While models for assessing the cost-effectiveness of screening were proposed in the past, they often presented only a limited view. This study aimed to develop a simulation-based German Albuminuria Screening Model (S-GASM) and present some initial applications. METHODS: The model consists of an individual-based simulation of disease progression, considering age, gender, body mass index, systolic blood pressure, diabetes, albuminuria, glomerular filtration rate, and quality of life, furthermore, costs of testing, therapy, and renal replacement therapy with parameters based on published evidence. Selected screening scenarios were compared in a cost-effectiveness analysis. RESULTS: Compared to no testing, a simulation of 10 million individuals with a current age distribution of the adult German population and a follow-up until death or the age of 90 shows that a testing of all individuals with diabetes every two years leads to a reduction of the lifetime prevalence of renal replacement therapy from 2.5% to 2.3%. The undiscounted costs of this intervention would be 1164.10 € / QALY (quality-adjusted life year). Considering saved costs for renal replacement therapy, the overall undiscounted costs would be-12581.95 € / QALY. Testing all individuals with diabetes or hypertension and screening the general population reduced the lifetime prevalence even further (to 2.2% and 1.8%, respectively). Both scenarios were cost-saving (undiscounted, - 7127.10 €/QALY and-5439.23 €/QALY). CONCLUSIONS: The S-GASM can be used for the comparison of various albuminuria testing strategies. The exemplary analysis demonstrates cost savings through albuminuria testing for individuals with diabetes, diabetes or hypertension, and for population-wide screening.

A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study.

AIMS/HYPOTHESIS: Long-term follow-up of the Steno-2 study demonstrated that intensified multifactorial intervention increased median lifespan by 7.9 years and delayed incident cardiovascular disease by a median of 8.1 years compared with conventional multifactorial intervention during 21.2 years of follow-up. In this post hoc analysis of data from the Steno-2 study, we aimed to study the difference in direct medical costs associated with conventional vs intensified treatment. METHODS: In 1993, 160 Danish individuals with type 2 diabetes and microalbuminuria were randomised to conventional or intensified multifactorial target-driven intervention for 7.8 years. Information on direct healthcare costs was retrieved from health registries, and the costs in the two groups of participants were compared by bootstrap t test analysis. RESULTS: Over 21.2 years of follow-up, there was no difference in total direct medical costs between the intensified treatment group, €12,126,900, and the conventional treatment group, €11,181,700 (p = 0.48). The mean cost per person-year during 1996-2014 was significantly lower in the intensified treatment group (€8725 in the intensive group and €10,091 in the conventional group, p = 0.045). The main driver of this difference was reduced costs associated with inpatient admissions related to cardiovascular disease (p = 0.0024). CONCLUSIONS/INTERPRETATION: Over a follow-up period of 21.2 years, we found no difference in total costs and reduced cost per person-year associated with intensified multifactorial treatment for 7.8 years compared with conventional multifactorial treatment. Considering the substantial gain in life-years and health benefits achieved with intensified treatment, we conclude that intensified multifaceted intervention in high-risk individuals with type 2 diabetes seems to be highly feasible when balancing healthcare costs and treatment benefits in a Danish healthcare setting.

Screening for chronic kidney disease in Canadian indigenous peoples is cost-effective.

Canadian indigenous (First Nations) have rates of kidney failure that are 2- to 4-fold higher than the non-indigenous general Canadian population. As such, a strategy of targeted screening and treatment for CKD may be cost-effective in this population. Our objective was to assess the cost utility of screening and subsequent treatment for CKD in rural Canadian indigenous adults by both estimated glomerular filtration rate and the urine albumin-to-creatinine ratio. A decision analytic Markov model was constructed comparing the screening and treatment strategy to usual care. Primary outcomes were presented as incremental cost-effectiveness ratios (ICERs) presented as a cost per quality-adjusted life-year (QALY). Screening for CKD was associated with an ICER of $23,700/QALY in comparison to usual care. Restricting the model to screening in communities accessed only by air travel (CKD prevalence 34.4%), this ratio fell to $7,790/QALY. In road accessible communities (CKD prevalence 17.6%) the ICER was $52,480/QALY. The model was robust to changes in influential variables when tested in univariate sensitivity analyses. Probabilistic sensitivity analysis found 72% of simulations to be cost-effective at a $50,000/QALY threshold and 93% of simulations to be cost-effective at a $100,000/QALY threshold. Thus, targeted screening and treatment for CKD using point-of-care testing equipment in rural Canadian indigenous populations is cost-effective, particularly in remote air access-only communities with the highest risk of CKD and kidney failure. Evaluation of targeted screening initiatives with cluster randomized controlled trials and integration of screening into routine clinical visits in communities with the highest risk is recommended.

Strategies and cost-effectiveness evaluation of persistent albuminuria screening among high-risk population of chronic kidney disease.

BACKGROUND: Screening for persistent albuminuria among the high-risk population is important for early detection of CKD while studies regarding screening protocol and related cost-effectiveness analysis are limited. This study explored a feasible and cost-efficient screening strategy for detecting persistent albuminuria among the high-risk population. METHODS: A cohort study including 157 clinically stable outpatients with a risk factor of CKD and whose laboratory tests revealed an albumin-creatinine-ratio (ACR) between 30 and 300 mg/g of creatinine during the previous 12 months was conducted to assess the validity of alternative screening strategies. Each participant collected three first morning urine samples in three consecutive months. These samples were labeled as DAY-1, MONTH-2 and MONTH-3. In the first month, a random spot sample in the afternoon of the first day and another morning sample on the second day were collected and labeled as Random and DAY-2. Persistent albuminuria was defined by abnormal ACR (≥30 mg/g creatinine) for DAY-1, MONTH-2 and MONTH-3. Alternative strategies were DAY-1; Random; DAY-1 + Random; DAY-1 + DAY-2; and DAY-1 + Random + DAY-2. To evaluate the economic performance of those alternative strategies, a hybrid decision tree/Markov model was developed based on the cohort study to simulate both clinical and cost-effectiveness outcomes. Sensitivity analyses were conducted to investigate assumptions of the model and to examine the model's robustness. RESULTS: Altogether, 82 patients exhibited persistent albuminuria. All of the five strategies had sensitivity higher than 90%. Of these strategies, Random had the lowest specificity (46.7%), and DAY-1 + Random + DAY-2 had the highest specificity (81.3%). Estimated cost for each quality adjusted life year (QALYs) gained were ¥112,335.88 for DAY-1 + Random, ¥8134.69 for Random and ¥10,327.99 for DAY-1 + Random + DAY-2. When compared with DAY-1 strategy, the sensitivity and specificity of which were 100.0 and 69.3%, respectively. DAY-1 + Random + DAY-2 had the highest effectiveness and incremental effectiveness of 11.87 and 0.73 QALYs. At a willingness-to-pay threshold of ¥100,000 per QALY, DAY-1 + Random + DAY-2 had the highest acceptability of 91.0%. Sensitivity analyses demonstrated the robustness of the results. CONCLUSIONS: In order to make a quick diagnosis of persistent albuminuria among high-risk population, the strategy of combining two first morning urine samples and one randomized spot urine sample in two consecutive days is accurate, saves time, and is cost-effective.

The cost-effectiveness of using chronic kidney disease risk scores to screen for early-stage chronic kidney disease.

BACKGROUND: Better treatment during early stages of chronic kidney disease (CKD) may slow progression to end-stage renal disease and decrease associated complications and medical costs. Achieving early treatment of CKD is challenging, however, because a large fraction of persons with CKD are unaware of having this disease. Screening for CKD is one important method for increasing awareness. We examined the cost-effectiveness of identifying persons for early-stage CKD screening (i.e., screening for moderate albuminuria) using published CKD risk scores. METHODS: We used the CKD Health Policy Model, a micro-simulation model, to simulate the cost-effectiveness of using CKD two published risk scores by Bang et al. and Kshirsagar et al. to identify persons in the US for CKD screening with testing for albuminuria. Alternative risk score thresholds were tested (0.20, 0.15, 0.10, 0.05, and 0.02) above which persons were assigned to receive screening at alternative intervals (1-, 2-, and 5-year) for follow-up screening if the first screening was negative. We examined incremental cost-effectiveness ratios (ICERs), incremental lifetime costs divided by incremental lifetime QALYs, relative to the next higher screening threshold to assess cost-effectiveness. Cost-effective scenarios were determined as those with ICERs less than $50,000 per QALY. Among the cost-effective scenarios, the optimal scenario was determined as the one that resulted in the highest lifetime QALYs. RESULTS: ICERs ranged from $8,823 per QALY to $124,626 per QALY for the Bang et al. risk score and $6,342 per QALY to $405,861 per QALY for the Kshirsagar et al. risk score. The Bang et al. risk score with a threshold of 0.02 and 2-year follow-up screening was found to be optimal because it had an ICER less than $50,000 per QALY and resulted in the highest lifetime QALYs. CONCLUSIONS: This study indicates that using these CKD risk scores may allow clinicians to cost-effectively identify a broader population for CKD screening with testing for albuminuria and potentially detect people with CKD at earlier stages of the disease than current approaches of screening only persons with diabetes or hypertension.

Development and validation of a cost-utility model for Type 1 diabetes mellitus.

AIMS: To develop a health economic model to evaluate the cost-effectiveness of new interventions for Type 1 diabetes mellitus by their effects on long-term complications (measured through mean HbA1c ) while capturing the impact of treatment on hypoglycaemic events. METHODS: Through a systematic review, we identified complications associated with Type 1 diabetes mellitus and data describing the long-term incidence of these complications. An individual patient simulation model was developed and included the following complications: cardiovascular disease, peripheral neuropathy, microalbuminuria, end-stage renal disease, proliferative retinopathy, ketoacidosis, cataract, hypoglycemia and adverse birth outcomes. Risk equations were developed from published cumulative incidence data and hazard ratios for the effect of HbA1c , age and duration of diabetes. We validated the model by comparing model predictions with observed outcomes from studies used to build the model (internal validation) and from other published data (external validation). We performed illustrative analyses for typical patient cohorts and a hypothetical intervention. RESULTS: Model predictions were within 2% of expected values in the internal validation and within 8% of observed values in the external validation (percentages represent absolute differences in the cumulative incidence). CONCLUSIONS: The model utilized high-quality, recent data specific to people with Type 1 diabetes mellitus. In the model validation, results deviated less than 8% from expected values.

Cost-effectiveness of screening for microalbuminuria among African Americans.

Compared with other racial groups, African Americans have a similar prevalence of CKD but are much more likely to progress to ESRD, suggesting that the cost-effectiveness of screening strategies requires dedicated study in this population. Here, we calibrated the CKD Health Policy Model so that it accurately forecasts the higher rates for ESRD observed for African Americans. We then used the calibrated model to estimate the cost-effectiveness of screening for microalbuminuria followed by treatment with angiotensin-converting enzyme inhibitors or angiotensin II-receptor blockers. Incorporating racial differences in risk factors did not fully explain the much higher lifetime incidence of ESRD among African Americans. Thus, to calibrate the model, we applied a 20% increase in the rate of GFR decline at stage 3 and a 60% increase in the rate of GFR decline at stage 4, which resulted in a model that closely reflects lifetime ESRD incidence among African Americans. Compared with usual care, screening African Americans for microalbuminuria at 10-, 5-, 2-, and 1-year intervals had incremental cost-effectiveness ratios of $9000, $11,000, $19,000, and $35,000 per quality-adjusted life year, respectively. Incremental cost-effectiveness ratios for the same screening intervals were higher for non-African Americans: $17,000, $23,000, $44,000, and $81,000 per quality-adjusted life year, respectively. In summary, these models suggest that screening African Americans for microalbuminuria at either 5- or 10-year intervals is highly cost-effective.

Health economic modelling of the cost-effectiveness of microalbuminuria screening in Switzerland.

PRINCIPLES: Current evidence indicates that chronic kidney disease (CKD) can be detected by simple laboratory tests. This study aimed to evaluate the cost-effectiveness of microalbuminuria screening and subsequent treatment in different populations. METHODS: Cost-effectiveness of microalbuminuria screening in a cohort of simulated subjects aged ≥50 years was assessed using a validated microsimulation model. Microalbuminuria screening was simulated for 1-, 2-, 5- or 10-year intervals and for 3 groups: diabetes (DM), hypertension but no diabetes (HTN), and no diabetes or hypertension. Positive microalbuminuria screening was followed by treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). The model outcomes evaluate costs from a health care system perspective. RESULTS: Screening of risk groups is cost-effective at a 2-year interval for the DM group with an incremental cost-effectiveness ratio (ICER) of 54,000 CHF/ Quality-Adjusted-Life-Years (QALY) and at a 5-year interval for the HTN group with an ICER of 33,000 CHF/QALY. Screening of the remaining population is cost-effective at a 10-year interval with an ICER of 34,000 CHF/QALY. The ICER improves with longer screening intervals for all groups. A probabilistic sensitivity analysis (PSA) confirmed 2-year, 5-year and 10-year intervals as the most cost-effective for the DM group, the HTN group and the remaining population respectively. CONCLUSIONS: Microalbuminuria screening can be considered cost-effective starting at the age of 50 years at bi-annual intervals for subjects with diabetes, at 5-year intervals for subjects with hypertension and at 10-year intervals for the remaining population. Our results indicate that early detection and treatment of CKD might lead to optimised patient care, and offer guidance for future implementation of CKD screening programmes.

Albuminuria: is it time to screen the general population?

Albuminuria has been associated with increased risk of multiple adverse outcomes, including ESRD, acute kidney injury, cardiovascular disease, and death. Some clinicians advocate for population-based screening of this condition, as a means of identifying individuals at high risk for morbidity and mortality. Several factors influence the potential implementation of screening for albuminuria in the general population, including the type of test used, the threshold for albuminuria, the validity and prognostic value of testing, frequency of follow-up testing, and associated costs of screening. This review discusses the available literature addressing these issues, and suggests an approach to screening patients for albuminuria.

Screen-and-treat strategies for albuminuria to prevent cardiovascular and renal disease: cost-effectiveness of nationwide and targeted interventions based on analysis of cohort data from the Netherlands.

BACKGROUND: Albuminuria is a marker for renal and cardiovascular (CV) risk, allowing early diagnosis of subjects with elevated renal and CV risk. OBJECTIVE: This study aimed to estimate the cost-effectiveness and budget impact of various population-based screen-and-treat scenarios for elevated albuminuria levels (ie, microalbuminuria) in the Netherlands. METHODS: A multistate transition Markov model was developed to simulate the natural course of albuminuria-based disease progression to dialysis and occurrence of CV events. Several population-based strategies directed at screening for elevated albuminuria were evaluated. These strategies depended on urinary albumin concentration (UAC), urinary albumin excretion (UAE), and age. Transition probabilities were derived from the observational community-based Prevention of Renal and Vascular End Stage Disease (PREVEND) cohort study. Health care costs (in year-2008 euros) and life-years gained were calculated over an 8-year period. In the base-case analysis, we analyzed screening for and treatment of microalbuminuria. Screening for microalbuminuria involved prescreening for UAC >or=20 mg/L, followed by a confirmation test for UAE >or=30 mg/d. Other options based on combinations of albuminuria for UAC prescreening (no prescreening, and >or=10, >or=20, >or=100, and >or=200 mg/L) and UAE confirmation test (>or=15, >or=30, and >or=300 mg/d) for treatment were investigated in scenario analyses. Furthermore, these various strategies based on UAC and UAE values were analyzed in different subgroups based on age (all ages, aged >or=50 years, and aged >or=60 years). RESULTS: The PREVEND study included 8592 Dutch residents aged 28 to 75 years at the time of initial screening. Among a hypothetical cohort of 1000 subjects identified and treated in the base-case analysis, it was estimated (based on PREVEND follow-up data) that, in the screening/treatment and no-screening scenarios, 76 versus 124 CV events occurred, 16 versus 27 CV deaths, and 3 versus 5 dialysis cases, respectively. The per-person difference in net costs for screening was calculated at euro926 (euro2003 vs euro1077), and prevention of CV deaths was estimated to gain 0.0421 discounted life-year per person. Correspondingly, the cost-effectiveness was estimated at euro22,000 per life-year gained. In the base-case analysis, probabilistic sensitivity analysis indicated that the likelihood of cost-effectiveness of a screen-and-treat strategy was 54%, 90%, and 95% for a maximum acceptable cost-effectiveness threshold of euro20,000, euro50,000, and euro80,000 per life-year gained, respectively. Higher albuminuria thresholds for screening and start of treatment further improved the cost-effectiveness but reduced the overall health gains achieved. Limiting screening to those subjects aged >or=50 and >or=60 years resulted in more favorable cost-effectiveness compared with population-based screening without age restriction. CONCLUSIONS: Our analyses suggest the potentially favorable cost-effectiveness of population-based screening for albuminuria in the general Dutch population. The results offer health care decision-makers new tools for considering actual implementation of such screening.

A health policy model of CKD: 2. The cost-effectiveness of microalbuminuria screening.

BACKGROUND: Microalbuminuria screening may detect chronic kidney disease in its early stages, allowing for treatment that delays or prevents disease progression. The cost-effectiveness of microalbuminuria screening has not been determined. STUDY DESIGN: A cost-effectiveness model simulating disease progression and costs. SETTING & POPULATION: US patients. MODEL, PERSPECTIVE, AND TIMEFRAME: The microsimulation model follows up disease progression and costs in a cohort of simulated patients from age 50 to 90 years or death. Costs are evaluated from the health care system perspective. INTERVENTION: Microalbuminuria screening at 1-, 2-, 5-, or 10-year intervals followed by treatment with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers. We considered universal screening, as well as screening targeted at persons with diabetes, persons with hypertension but no diabetes, and persons with neither diabetes nor hypertension. OUTCOMES: Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. RESULTS: For the full model population, universal screening increases costs and increases QALYs. Universal annual screening starting at age 50 years has a cost-effectiveness ratio of $73,000/QALY relative to no screening and $145,000/QALY relative to usual care. Cost-effectiveness ratios improved with longer screening intervals. Relative to no screening, targeted annual screening has cost-effectiveness ratios of $21,000/QALY, $55,000/QALY, and $155,000/QALY for persons with diabetes, those with hypertension, and those with neither current diabetes nor current hypertension, respectively. LIMITATIONS: Results necessarily are based on a microsimulation model because of the long time horizon appropriate for chronic kidney disease. The model includes only health care costs. CONCLUSIONS: Microalbuminuria screening is cost-effective for patients with diabetes or hypertension, but is not cost-effective for patients with neither diabetes nor hypertension unless screening is conducted at longer intervals or as part of existing physician visits.

Cost-effectiveness of aliskiren in type 2 diabetes, hypertension, and albuminuria.

The Aliskiren in the Evaluation of Proteinuria in Diabetes (AVOID) trial demonstrated that adding aliskiren, an oral direct renin inhibitor, at a dosage of 300 mg/d to the highest approved dosage of losartan and optimal antihypertensive therapy reduces albuminuria over 6 mo among patients with type 2 diabetes, hypertension, and albuminuria. The cost-effectiveness of this therapy, however, is unknown. Here, we used a Markov model to project progression to ESRD, life years, quality-adjusted life years, and lifetime costs for aliskiren plus losartan versus losartan. We used data from the AVOID study and the Irbesartan in Diabetic Nephropathy Trial (IDNT) to estimate probabilities of progression of renal disease. We estimated probabilities of mortality for ESRD and other comorbidities using data from the US Renal Data System, US Vital Statistics, and published studies. We based pharmacy costs on wholesale acquisition costs and based costs of ESRD and transplantation on data from the US Renal Data System. We found that adding aliskiren to losartan increased time free of ESRD, life expectancy, and quality-adjusted life expectancy by 0.1772, 0.1021, and 0.0967 yr, respectively. Total expected lifetime health care costs increased by $2952, reflecting the higher pharmacy costs of aliskiren and losartan ($7769), which were partially offset by savings in costs of ESRD ($4860). We estimated the cost-effectiveness of aliskiren to be $30,500 per quality-adjusted life year gained. In conclusion, adding aliskiren to losartan and optimal therapy in patients with type 2 diabetes, hypertension, and albuminuria may be cost-effective from a US health care system perspective.

Development of an affordable dye-stained microalbuminuria screening test.

BACKGROUND: A simple spot test was developed, which allows quantification of microalbuminuria. Evaluation was carried out according to the ISO 15189 guidelines. METHODS: Urine was spotted on cellulose acetate strips and stained using different sensitive protein binding dyes (nigrosin, Coomassie Blue R-250, amido black). The colour intensity of the stained spots was quantified using a Kodak Image 450 station. RESULTS: Analytical sensitivity of the Coomassie Blue based method (18 mg/L) was better than that for nigrosin (50 mg/ L) or amido black (100 mg/L) based methods. Within-run coefficient of variation (CV) and between-run CV of the Coomassie blue assay were, respectively, 8.4% and 9.7% (50 mg/L), and 3% and 4.5% (400 mg/L). For nigrosin, these data were, respectively, 8.4 and 9.4 (50 mg/L), and 3.4 and 6.4% (400 mg/L). Coomassie Blue showed a preferential binding selectivity towards albumin. The method was found to be linear between 20 and 600 mg/L. A good correlation (r2 = 0.89) was obtained between Coomassie Blue based and immunonephelometric measurements. Immuno-unreactive albumin (prepared by protease treatment) could be detected by the spot test, which offers an advantage of the method versus immunochemical tests. Ammonium sulphate precipitation could further increase the specificity of the assay by eliminating effects of free light chains. CONCLUSION: The described method is very simple and extremely cheap, which makes it potentially suited for screening programmes, particularly in third world countries.

Pharmacoeconomic analysis of angiotensin-converting enzyme inhibitors in type 2 diabetes: a Markov model.

BACKGROUND: Prevention of cardiovascular disease (CVD) events by initiating an angiotensin-converting enzyme (ACE) inhibitor on diagnosis of type 2 diabetes may increase survival and decrease costs. OBJECTIVE: To determine the incremental cost-effectiveness ratios of ACE inhibitor initiation in normoalbuminuric, microalbuminuric, and macroalbuminuric patients with newly diagnosed type 2 diabetes. METHODS: A cohort of patients with newly diagnosed type 2 diabetes was followed for 8 years in a Markov model. Clinical outcomes included CVD events, dialysis, all-cause mortality, and the composite endpoints of the 3 events. Probabilities and costs were obtained from the literature. One-way and two-way sensitivity analyses were conducted to test the robustness of the model. RESULTS: Implementation of ACE inhibitor therapy on diagnosis of type 2 diabetes in normoalbuminuric and microalbuminuric patients is a dominant strategy (ie, more effective and less costly) across all outcomes. In macroalbuminuric patients, an additional $4.10 and $4.58 saves one life and avoids one composite endpoint, respectively; however, in these patients, not giving an ACE inhibitor is dominant for prevention of CVD events and dialysis. This is due to a 28.62% higher mortality rate in patients not receiving an ACE inhibitor. Thus, analysis of the composite endpoint shows that not giving an ACE inhibitor does not remain dominant. A limitation of our study is the inability to determine causality. CONCLUSIONS: If every newly diagnosed patient with type 2 diabetes in the US was prescribed an ACE inhibitor, our model shows that 68,314 CVD events would be averted, 46,410 lives would be saved, and 48 people would be prevented from needing dialysis over 8 years. These findings suggest that ACE inhibitors prevent numerous events in patients with type 2 diabetes who are normoalbuminuric at diagnosis, in addition to those already identified as being at risk for CVD events.

Cost-effectiveness of screening for albuminuria with subsequent fosinopril treatment to prevent cardiovascular events: A pharmacoeconomic analysis linked to the prevention of renal and vascular endstage disease (PREVEND) study and the prevention of renal and vascular endstage disease intervention trial (PREVEND IT).

OBJECTIVE: This study estimated the cost-effectiveness,from the Dutch health care perspective, of screening for albuminuria in the general Dutch population to prevent cardiovascular events (CVEs) with subsequent angiotensin-converting enzyme inhibitor treatment, using data from the Prevention of REnal and Vascular ENdstage Disease Intervention Trial (PREVEND IT). METHODS: PREVEND IT was a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design within the larger observational Prevention of REnal and Vascular ENdstage Disease (PREVEND) study. The PREVEND IT study was conducted to assess the effects of fosinopril 20 mg and pravastatin 40 mg on CVEs in subjects with specific inclusion criteria: urinary albumin excretion (UAE) rate in the range from 15 to 300 mg/d, blood pressure <160/100 mm Hg, and plasma cholesterol level <8.0 mmol/L. Cost-effectiveness estimates for the Dutch population were expressed in euros (2002; 1 euro = US 1.01 dollars) as net costs per life-year gained (LYG) in the baseline and sensitivity (stochastic) analyses. RESULTS: Data were assessed for 864 subjects, with a mean (SD) follow-up of 46 (7) months. CVEs occurred in 45 (5.2%) subjects. Subjects who received fosinopril had a 40% lower incidence of CVEs than subjects in the placebo group (3.9% vs 6.5%, respectively; P = NS). The cost-effectiveness of screening for albumnuria was determined to be euro 16,700/LYG for the study population. Stochastic analysis indicated that the probability of the cost-effectiveness being below the suggested Dutch threshold of euro 20,000/LYG was 59% in the baseline analysis. The probability of cost-effectiveness below euro 20,000/LYG would increase to 91% if only subjects with UAE >50 mg/d were treated with fosinopril. Limiting the screening to subjects aged >50 years and >60 years also improved cost-effectiveness. CONCLUSIONS: The results of our study suggest that screening the general Dutch population for albuminuria and subsequently treating those found positive with fosinopril may be cost-effective compared with no screening and adopting the Dutch health care perspective. However, confirmation from larger multicenter trials is needed.

Health economic implications of irbesartan plus conventional antihypertensive medications versus conventional blood pressure control alone in patients with type 2 diabetes, hypertension, and renal disease in Switzerland.

OBJECTIVES: The aim of this health economic modelling study was to investigate the effect of irbesartan combined with conventional antihypertensive medications compared to conventional antihypertensive therapy alone on the progression of nephropathy in patients with hypertension, type 2 diabetes and microalbuminuria in a Swiss setting. METHODS: In simulated patients with hypertension and type 2 diabetes, treatment of microalbuminuria with irbesartan 300 mg daily plus conventional antihypertensive medications was compared to a control regimen (conventional medications excluding angiotensin converting enzyme inhibitors, other angiotensin-2-receptor antagonist and dihydropyridine calcium channel blockers). Progression from microalbuminuria to nephropathy, doubling of serum creatinine, ESRD, and all-cause mortality was simulated over a 25-year time horizon using a published Markov model adapted to a Swiss setting. Transition probabilities were based on the Irbesartan in Reduction of Microalbuminuria-2 Study, Irbesartan in Diabetic Nephropathy Trial and other sources. Costs and clinical outcomes were discounted at 5% annually according to Swiss guidelines, and a third party payer perspective was taken. RESULTS: Treatment with irbesartan was projected to improve mean life expectancy by 0.57 years compared to conventional antihypertension treatment (undiscounted 1.22 years). Irbesartan treatment was associated with cost savings of CHF 21,488 per patient over the 25-year time horizon. Sensitivity analysis showed that irbesartan therapy remained dominant to conventional antihypertension treatment over a range of plausible assumptions. CONCLUSIONS: Addition of irbesartan to conventional antihypertension therapy was projected to improve life expectancy and reduce costs in hypertensive patients with type 2 diabetes and microalbuminuria in a Swiss setting.

Impact of target organ damage assessment in the evaluation of global risk in patients with essential hypertension.

Accurate assessment of cardiovascular risk is a key step toward optimizing the treatment of hypertensive patients. We analyzed the impact and cost-effectiveness of routine, thorough assessment of target organ damage (TOD) in evaluating risk profile in hypertension. A total of 380 never-treated patients with essential hypertension underwent routine work-up plus evaluation of albuminuria and ultrasonography of cardiac and vascular structures. The impact of these tests on risk stratification, as indicated by European Society of Hypertension-European Society of Cardiology guidelines, was assessed in light of their cost and sensitivity. The combined use of all of these tests greatly improved the detection of TOD, therefore leading to the identification of a higher percentage of patients who were at high/very high risk, as compared with those who were detected by routine clinical work-up (73% instead of 42%; P < 0.0001). Different signs of TOD only partly cluster within the same subgroup of patients; thus, all three tests should be performed to maximize the sensitivity of the evaluation process. The diagnostic algorithm yielding the lowest cost per detected case of TOD is the search for microalbuminuria, followed by echocardiography and then carotid ultrasonography. Adopting lower cut-off values to define microalbuminuria allows us to optimize further the cost-effectiveness of diagnostic algorithms. In conclusion, because of its low cost and widespread availability, measuring albuminuria is an attractive and cost-effective screening test that is especially suitable as the first step in the large-scale diagnostic work-up of hypertensive patients.

Irbesartan is projected to be cost and life saving in a Spanish setting for treatment of patients with type 2 diabetes, hypertension, and microalbuminuria.

OBJECTIVES: The purpose of this study was to project the cumulative incidence of end-stage renal disease (ESRD), life expectancy, and costs in a Spanish setting of treating patients with diabetes, hypertension, and microalbuminuria with either standard hypertension treatment alone or standard hypertension treatment plus irbesartan 300 mg daily. METHODS: A peer-reviewed, published Markov model that simulated progression from microalbuminuria to nephropathy, doubling of serum creatinine, ESRD, and all-cause mortality in patients with hypertension, type 2 diabetes, and microalbuminuria was adapted to a Spanish setting. Two strategies were compared: (1) irbesartan versus (2) standard hypertension care with comparable blood pressure control; both began in diabetic hypertensive subjects with microalbuminuria. Cumulative incidence of ESRD, costs, and life expectancy were projected for a hypothetical cohort of 1000 subjects. Future costs and life expectancy were discounted at 3% yearly. A 25-year time horizon and third party payer perspective were used. RESULTS: When compared to standard blood pressure control, irbesartan was projected to reduce the cumulative incidence of ESRD from (mean +/- standard deviation) 24 +/- 1% to 9 +/- 2%, save 11,082 +/- 2,996 euro, and add 1.40 +/- 0.27 life years per treated patient. The superiority of irbesartan over standard care was robust under a wide range of plausible assumptions. CONCLUSION: Treating patients with hypertension, microalbuminuria, and type 2 diabetes with irbesartan was projected to reduce the incidence of ESRD, extend life, and reduce costs.