nephropathy

Abstract: BACKGROUND: The Irbesartan in Reduction of Microalbuminuria trial and the Irbesartan in Diabetic Nephropathy Trial found that irbesartan is renoprotective in patients having hypertension with type 2 diabetes. OBJECTIVE: The objective of this study was to assess whether treatment with irbesartan is cost-effective in Canada relative to conventional care in this patient population and whether it is more cost-effective to treat patients early rather than later in the development of renal disease from the perspective of the Canadian health and social care system. METHODS: The analysis compared 3 alternative strategies for the management of hypertension in patients with type 2 diabetes and early renal disease: (1) conventional hypertensive treatment excluding the use of angiotensin II receptor antagonists (AIIRAs); (2) the early addition of irbesartan (an AIIRA) to conventional treatment; and (3) the late addition of irbesartan to conventional treatment. A Markov model was used to simulate the progression of renal disease (microalbuminuria to death) in hypertensive patients with type 2 diabetes over a 25-year time horizon. Transition probabilities were derived from the 2 randomized controlled trials. A cost-effectiveness analysis was conducted with outcome measured in life-years gained (LYGs). RESULTS: The early addition of irbesartan during microalbuminuria was cost-saving and more effective than both delaying irbesartan treatment until advanced overt nephropathy (AON) (0.45 LYG, Can $54,100 saved) and conventional antihypertensive use (0.62 LYG, $68,400 saved). This was due to the increased drug costs associated with the use of irbesartan being offset by savings arising from delays in the development of overt nephropathy and the subsequent delay to end-stage renal disease (ESRD). Sensitivity analyses confirmed the robustness of the study results. CONCLUSIONS: The early use of irbesartan for patients with hypertension and type 2 diabetes who have yet to develop overt nephropathy is both more effective and less costly than delaying irbesartan treatment until AON and conventional antihypertensive use. Analysis suggests that the earlier irbesartan is added to conventional antihypertensive treatment, the greater the delays in the onset of ESRD and the overall savings in health care resource utilization from the perspective of the Canadian health and social care system.

 prevention;  diabetes;  arb;  nephropathy;  MICROALBUMINURIA;  irbesartan;  economic evaluation;  IDNT;  IRMA;  

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Abstract: OBJECTIVE: To implement a controlled clinical trial (PRODIACOR) in a primary care setting designed 1) to improve type 2 diabetes care and 2) to collect cost data in order to be able to measure cost-effectiveness of three system interventions (checkbook of indicated procedures, patient/provider feedback and complete coverage of medications and supplies) and physician and/or patient education to improve psychological, clinical, metabolic and therapeutic indicators. All three Argentinean health subsectors (public health, social security and the private, prepaid system) are participants in the study. Patients of participating physicians were randomly selected and assigned to one of four groups: control, provider education, patient education, and provider/patient education; the system interventions were provided to all four groups. BASELINE RESULTS: Mean BMI was 29.8 kg/m(2); most subjects had blood pressure, fasting glucose and total cholesterol above targets recommended by international standards. Only 1\% had had microalbuminuria measured, 57\% performed glucose self-monitoring, 37\% had had an eye examination and 31\% a foot examination in the preceding year. Ten percent, 26\% and 73\% of people with hyperglycemia, hypertension and dyslipidemia, respectively, were not on medications. Most patients treated with either insulin or oral antidiabetic agents were on monotherapy as were those treated for hypertension and dyslipidemia. WHO-5 questionnaire scores indicated that 13\% of the subjects needed psychological intervention. CONCLUSIONS: Baseline data show multiple deficiencies in the process and outcomes of care that could be targeted and improved by PRODIACOR intervention.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

Abstract: BACKGROUND: The goals of diabetes management have evolved over the past decade to become the attainment of near-normal glucose and cardiovascular risk factor levels. Improved metabolic control is achieved through optimized medication regimens, but costs specifically associated with such optimization have not been examined. OBJECTIVE: To estimate the incremental medication cost of providing optimal therapy to reach recommended goals versus actual therapy in patients with type 2 diabetes. METHODS: We randomly selected the charts of 601 type 2 diabetes patients receiving care from the outpatient clinics of Massachusetts General Hospital March 1, 1996-August 31, 1997 and abstracted clinical and medication data. We applied treatment algorithms based on 2004 clinical practice guidelines for hyperglycemia, hyperlipidemia, and hypertension to patients current medication therapy to determine how current medication regimens could be improved to attain recommended treatment goals. Four clinicians and three pharmacists independently applied the algorithms and reached consensus on recommended therapies. Mean incremental medication costs, the cost differences between current and recommended therapies, per patient (expressed in 2004 dollars) were calculated with 95\% bootstrap confidence intervals (CIs). RESULTS: Mean patient age was 65 years old, mean duration of diabetes was 7.7 years, 32\% had ideal glucose control, 25\% had ideal systolic blood pressure, and 24\% had ideal low-density lipoprotein cholesterol. Care for these diabetes patients was similar to that observed in recent national studies. If treatment algorithm recommendations were applied, the average annual medication cost/patient would increase from 1525 to 2164 dollars. Annual incremental costs/patient increased by 168 dollars (95\% CI 133-206 dollars) for antihyperglycemic medications, 75 dollars (57-93 dollars) for antihypertensive medications, 392 dollars (354-434 dollars) for antihyperlipidemic medications, and 3 dollars (3-4 dollars) for aspirin prophylaxis. Yearly incremental cost of recommended laboratory testing ranged from 77-189 dollars/patient. LIMITATIONS: Although baseline data come from the clinics of a single academic institution, collected in 1997, the care of these diabetes patients was remarkably similar to care recently observed nationally. In addition, the data are dependent on the medical record and may not accurately reflect patients actual experiences. CONCLUSION: Average yearly incremental cost of optimizing drug regimens to achieve recommended treatment goals for type 2 diabetes was approximately 600 dollars/patient. These results provide valuable input for assessing the cost-effectiveness of improving comprehensive diabetes care.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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Abstract: A systematic review of the literature was conducted to give an overview of economic evaluations of preventive interventions in type 2 diabetes mellitus. The interventions were sorted by type of preventive intervention (primary, secondary or tertiary) and by category (e.g. education, medication for hypertension). Several databases were searched for studies published between January 1990 and May 2004 on the three types of preventive intervention. For each study selected, inclusion of specific components from a standardised list of items, including quality, was recorded in a database. Summary tables were generated based on the database.A number of conclusions were drawn from this review. The most important was that strict blood pressure control was a more cost-effective intervention than less strict control, as shown by six studies reporting cost savings to very low costs per life-year gained. Primary and secondary prevention of type 2 diabetes were also highly cost effective, but these results were based on very few studies. Medications to reduce weight and hyperglycaemia together were cost effective compared with conventional interventions. Finally, the separate results regarding medications to reduce weight, hyperglycaemia and hypercholesterolaemia varied enormously, thus no conclusion could be drawn and further economic analysis is required.

 prevention;  diabetes;  ACEI;  nephropathy;  economic review;  

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Abstract: Microalbuminuria is an early sign of progressive cardiovascular and renal disease in individuals with and without diabetes. Despite compelling data, at present only a minority of patients with diabetes and rarely individuals without diabetes are screened for albuminuria in a systematic way. All of the criteria to implement systematic albuminuria screening are fulfilled in diabetes, and most are nearly fulfilled for microalbuminuria screening in individuals without diabetes. Because of the growing evidence that treatment of microalbuminuria in individuals without diabetes may offer a cost-effective benefit to prevent cardiovascular disease, nephrologists and other health care providers should pay more attention to the early detection and subsequent treatment of individuals with microalbuminuria.

 prevention;  diabetes;  nephropathy;  screening;  MICROALBUMINURIA;  review;  

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Abstract: Diabetes is one of the most common noncommunicable diseases (NCD) globally and a leading cause of death in many countries; the global epidemic of type 2 diabetes will most affect the developing world. The burden of diabetes is related to its chronic complications, both the specific microvascular and the nonspecific macrovascular (atherosclerosis), making diabetes one of the leading causes of death in some countries and an enormous financial burden. The costs of diabetes care, both direct and indirect, are high. Single and multiple risk-factor intervention studies have provided evidence that targeting hyperglycemia and other nonglycemic risk factors reduces the risk of chronic complications; most national guidelines recommend intensified, multitargeted intervention of known modifiable risk factors. The aim in management is optimal control, both glycemic and non-glycemic (blood pressure, lipid and weight control). Management strategies for hyperglycemia include standard methods and individualized options. Given the complexities of the therapeutic choices (classes/agents) and regimens and on the basis of proven benefit, long familiarity, known side-effects, and reduced cost of sulfonylureas, biguanides, and insulin, one should start with standard methods. Despite the evidence for benefit of glycemic control, wide therapeutic choices and regimens and clearer targets for control, glycemic control is far from ideal. The cost-effectiveness of interventions to reduce the burden of diabetes-related complications compares favorably with that of other accepted uses of healthcare resources and provides convincing economic rationale for improving standards of care for patients with type 2 diabetes.

 prevention;  diabetes;  ACEI;  nephropathy;  economic review;  

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Abstract: AIM: Forty percent of hypertensive type 2 diabetes patients develop nephropathy (microalbuminuria/overt nephropathy), indicating end organ damage, increased risk of cardiovascular disease (CVD), and death. In France, screening rates and nephropathy treatment are suboptimal. We assessed the health economic impact of nephropathy screening in hypertensive patients with type 2 diabetes followed by optimal antihypertensive/nephroprotective therapy in those who have nephropathy in France. METHODS: A Markov/Monte Carlo model simulated lifetime impacts of screening for albuminuria (microalbuminuria/overt nephropathy) using semi-quantitative urine dipsticks in a primary care setting, and subsequent addition of irbesartan 300 mg to conventional therapy in hypertensive type 2 diabetes patients identified as having nephropathy. Progression from no renal disease to end-stage renal disease (ESRD) was simulated. Probabilities, utilities and costs of CVD events, medications and ESRD treatment came from published sources. Cumulative incidence of ESRD, life expectancy, quality-adjusted life years (QALYs) and direct costs were projected. Second-order Monte Carlo simulation accounted for uncertainty in multiple parameters. Costs and QALYs were discounted at 3% annually. RESULTS: Screening and optimized treatment led to a 42% reduction in the cumulative incidence of ESRD from 10.1 +/- 9.9% without screening to 5.8 +/- 5.7%, improvements in life expectancy of 0.38 +/- 0.59 years, improvements of 0.29 +/- 0.32 QALYs, and decreased costs of Euro 4,812 +/- 7,882/patient over 25 years. Sensitivity analysis showed that the results were robust. Screening was most beneficial when performed in younger patients. CONCLUSION: In hypertensive patients with type 2 diabetes, screening for albuminuria followed by optimal antihypertensive/nephroprotective treatment improves patient outcomes and leads to cost savings in France.

 prevention;  diabetes;  arb;  nephropathy;  screening;  MICROALBUMINURIA;  irbesartan;  economic evaluation;  IDNT;  IRMA;  BENEDICT;  

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Abstract: INTRODUCTION: The RENAAL (Reduction of Endpoints in Non-insulin dependent diabetes with the Angiotensin II Antagonist Losartan) study demonstrated that, in hypertensive patients with type 2 diabetes mellitus and nephropathy, treatment with losartan plus conventional antihypertensive therapy (CT) reduced the relative risk of end-stage renal disease (ESRD) by 29% versus placebo over the time span of the study (mean patient follow-up of 3.4 years). The objective of this study was to project the effect of losartan compared with placebo on the lifetime incidence of ESRD and associated costs (from a US healthcare system perspective). METHODS: To estimate lifetime incidence of ESRD, we used a competing risks method to account for the risk of death without ESRD. We estimated the cost (US dollars, year 2002 values) associated with ESRD by combining the cumulative incidence of ESRD with the lifetime cost associated with ESRD. Total cost was estimated as the sum of the cost associated with ESRD, the cost of losartan study therapy and other costs (non-ESRD/non-losartan) expected for patients with type 2 diabetes. Survival was estimated by weighting the life expectancies with and without ESRD by the cumulative risk of ESRD. Costs and outcomes were discounted by 3% per annum. RESULTS: We projected a lower lifetime incidence of ESRD for losartan patients (66%) compared with placebo patients (83%). This reduction in ESRD resulted in a decrease in cost associated with ESRD of US dollars 31,803 per patient and a gain of 0.99 life-years per patient (0.70 discounted). After accounting for the cost of losartan and the additional cost associated with greater survival, we projected that treatment with losartan would result in a lifetime net saving of US dollars 24,632 per patient. CONCLUSION: Treatment with losartan plus CT in patients with type 2 diabetes and nephropathy reduced the within-trial incidence of ESRD and is projected to result in lifetime reductions in ESRD and associated costs, and increased survival, versus placebo.

 prevention;  diabetes;  arb;  nephropathy;  RENAAL;  losartan;  economic evaluation;  

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Abstract: There is a rising incidence and prevalence of ESRD as a result of diabetes, with poor outcome and growing costs. Recently, two large trials, the Irbesartan Diabetic Nephropathy Trial (IDNT) and Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL), showed that angiotensin receptor blockers (ARB) are more effective than traditional antihypertensive therapies at reducing progression toward ESRD in hypertensive patients with type 2 diabetes and overt nephropathy, regardless of changes in BP. The results of these two trials were used to compare the costs of ARB with those of renal replacement therapy (dialysis and renal transplantation) in an effort to establish whether ARB are cost-saving because they delay ESRD. Two different pharmacoeconomic approaches were used. With regard to the RENAAL trial, the number of ESRD days on losartan therapy as compared with the number of ESRD days on standard antihypertensive therapy was calculated, and the difference between the two was combined with the costs of ESRD. In the IDNT trial, Markov models were applied to assess the economic impact of irbesartan and to extrapolate future clinical and cost outcomes. Several economic analyses were performed in the United States and in European countries. Applying pharmacoeconomic models showed that treatment with ARB was associated with a greater improvement in life expectancy and lower total costs compared with amlodipine and standard antihypertensive therapy. Therefore, treating patients with type 2 diabetes, nephropathy, and hypertension with ARB is life- and cost-saving compared with traditional antihypertensive therapy.

 prevention;  diabetes;  arb;  nephropathy;  RENAAL;  losartan;  irbesartan;  IDNT;  economic review;  

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Abstract: Diabetic nephropathy (DN) is the leading cause of end-stage renal failure in Western countries and carries an increased risk for cardiovascular mortality. Studies have identified a number of factors that play a part in the development of DN. Among them, hypertension and proteinuria are the most important. In the early stages of DN, when albumin is present in the urine in very low quantities (microalbuminuria) and an increase is seen in BP, there is no loss of filtrate and patients respond well to prophylactic measures. Microalbuminuria is considered an early marker of DN. Prevention of the onset of microalbuminuria, therefore, could be considered as the primary means of preventing DN. The Bergamo Nephrologic Diabetes Complication Trial (BENEDICT) was a prospective, randomized, double-blind, parallel-group study that was organized in two phases. Phase A included 1204 patients and was aimed at assessing the efficacy of the angiotensin-converting enzyme (ACE) inhibitor trandolapril, the non-dihydropyridine calcium channel blocker verapamil, and the trandolapril plus verapamil combination as compared with placebo in prevention of microalbuminuria in hypertensive patients with type 2 diabetes and normal urinary albumin excretion rate. Phase B was aimed at assessing the efficacy of the combination as compared with trandolapril alone in prevention of macroalbuminuria in patients with microalbuminuria. The BENEDICT Phase A study showed that DN can be prevented by ACE inhibitor therapy. The beneficial effect of ACE inhibition is not enhanced by combined non-dihydropyridine calcium channel blocker therapy. The apparent advantage of ACE inhibitors over other agents includes a protective effect on the kidney against the development of microalbuminuria, which is a major risk factor for cardiovascular events and death in this population.

 diabetes;  nephropathy;  MICROALBUMINURIA;  Verapamil;  clinical trial;  BENEDICT;  trandolapril;  

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Abstract: BACKGROUND AND OBJECTIVE: It was the aim of this study to project the long-term clinical and cost outcomes of irbesartan treatment, based on data from the irbesartan in Reduction of Microalbuminuria-2 (IRMA-2) study and the irbesartan in Diabetic Nephropathy Trial (IDNT), in hypertensive patients with type 2 diabetes and renal disease in Germany. PATIENTS AND METHODS: A Markov model adapted to the German setting simulated progression of renal disease and associated changes in mortality in patients with hypertension, type 2 diabetes and microalbuminuria. Early irbesartan 300 mg daily (initiated at microalbuminuria) and late irbesartan (initiated at overt nephropathy) were compared to a control scheme of antihypertensive standard medications with comparable blood pressure control, initiated at microalbuminuria. Cumulative incidence of ESRD, time to onset of ESRD, life expectancy (LE), quality-adjusted life years (QALY) and costs were projected over 25 years for 1,000 simulated patients, from a third party payer perspective. Clinical and cost outcomes were discounted at 5% per annum. RESULTS: When compared to standard blood pressure control, both early and late treatment with irbesartan were projected to reduce the cumulative incidence of ESRD fromm23.80.3% to 9.10.6% and 19.83%, increase discounted LE by 0.670.04 and 0.030.00 years, and improve QALY by 0.750.04 and 0.070.01 years per treated patient, respectively. Early irbesartan treatment was associated with a cost savings of i 12,658825 per patient while late irbesartan treatment was associated with a cost savings of i 4,116575 per patient compared to control over the 25-year time horizon. CONCLUSIONS: Early irbesartan treatment was projected to improve LE and QALY, and reduce the onset of ESRD, with cost savings, in hypertensive patients with type 2 diabetes and microalbuminuria in Germany. Later use of irbesartan in overt nephropathy is also superior to standard care. These findings suggest that irbesartan should be started earlier and continued long-term.

 diabetes;  nephropathy;  MICROALBUMINURIA;  irbesartan;  economic evaluation;  IDNT;  IRMA;   arb;  

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Abstract: Study question. The objective of the study was to assess the cost-effectiveness of losartan, an antihypertensive used for the prevention of ESRD in patients with DM-2 and nephropathy, in comparison with conventional antihypertensive treatment. Conventional antihypertensive treatment included calcium-channel blockers, diuretics, alpha-blockers, beta-blockers and centrally acting agents, but not angiotensin-converting enzyme inhibitors or angiotensin II antagonists. The current analysis used the results from the published Reduction of Endpoints in Non-Insulin-Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan (RENAAL) study, details of which were given elsewhere (Brenner et al. 2001, see 'Other Publications of Related Interest' below for bibliographic details), to carry out an economic evaluation beyond the trial duration (3.4 years) using a long-term time horizon. The analysis was conducted from the perspective of the National Health Service (NHS). Authors' conclusions. A losartan-based regimen in patients with Type 2 diabetes mellitus (DM-2) and nephropathy was cost-saving from the perspective of the National Health Service (NHS) in the UK because it reduced the incidence of end-stage renal disease (ESRD) in comparison with a non angiotensin-converting enzyme inhibitor or non angiotensin II antagonist antihypertensive regimen.

 prevention;  diabetes;  arb;  nephropathy;  RENAAL;  losartan;  economic evaluation;  

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Abstract: AIMS/HYPOTHESIS: This study estimated the economic efficiency (1) of intensive blood glucose control and tight blood pressure control in patients with type 2 diabetes who also had hypertension, and (2) of metformin therapy in type 2 diabetic patients who were overweight. METHODS: We conducted cost-utility analysis based on patient-level data from a randomised clinical controlled trial involving 4,209 patients with newly diagnosed type 2 diabetes conducted in 23 hospital-based clinics in England, Scotland and Northern Ireland as part of the UK Prospective Diabetes Study (UKPDS). Three different policies were evaluated: intensive blood glucose control with sulphonylurea/insulin; intensive blood glucose control with metformin for overweight patients; and tight blood pressure control of hypertensive patients. Incremental cost : effectiveness ratios were calculated based on the net cost of healthcare resources associated with these policies and on effectiveness in terms of quality-adjusted life years gained, estimated over a lifetime from within-trial effects using the UKPDS Outcomes Model. RESULTS: The incremental cost per quality-adjusted life years gained (in year 2004 UK prices) for intensive blood glucose control was 6,028 UK pounds, and for blood pressure control was 369 UK pounds. Metformin therapy was cost-saving and increased quality-adjusted life expectancy. CONCLUSIONS/INTERPRETATION: Each of the three policies evaluated has a lower cost per quality-adjusted life year gained than that of many other accepted uses of healthcare resources. The results provide an economic rationale for ensuring that care of patients with type 2 diabetes corresponds at least to the levels of these interventions.

 prevention;  diabetes;  nephropathy;  glycemic control;  Insulin;  economic evaluation;  metformin;  UKPDS;  

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Abstract: In the primary prevention of coronary heart disease (CHD), the effect of aspirin and statins is well documented in several controlled randomized trials. For aspirin the results can be transferred into clinical practice due to its low price; for the more expensive statins, however, serious economic problems exist. In contrast to secondary prevention these drugs do not reach cost-efficiency in primary prevention; due to their high prices for the criteria of the randomized controlled studies values >60 000 or >100 000 [US dollars/YLS] are gained. Data from England and Scotland indicate that according to the inclusion criteria of the WOSCOPS- and AFCAPS/TexCAPS studies almost 20 and 60\%, respectively, of the adult population had to be treated with a statin. Results of newer studies may even increase these numbers. These costs cannot be covered by any health care system. Primary prevention of CHD with statins reveals paradigmatically that for financial reasons evidence-based medicine can no longer be transferred into clinical practice. The limited resources of all health care systems make rationing with treatment allocation only to the high risk groups necessary. The American, European and German guidelines propose a > or =2\% annual risk of CHD as the limit, for financial reasons the Britisch recommendations favor a limit of 3\%; in order to save >50\% of the costs. Despite the financial restraints of the German health care system, the limit of > or =2\% annual risk of CHD as proposed by the German Cardiac Society may be realistic when the different preventive measures are applied following a step-by-step plan based on the costs. According to the Procam algorithms, persons without diabetes mellitus or familiar disposition, who in case of nicotine abuse have given up smoking and if hypertensive have blood pressure values within the therapeutic range, statins are only to be given under the following conditions: LDL-cholesterol > or =175 or > or =190 mg/dl, for a HDL-cholesterol or =200 or > or =175 mg/dl, respectively. Diabetics without CHD have the same risk as non-diabetics with CHD. Therefore, in diabetics the same measures should be taken for primary prevention as in non-diabetics for secondary prevention. Evaluation of cost-efficiency indicates that intensive blood sugar control as well as intensive antihypertensive treatment and application of statins are all cost-effective in primary prevention of diabetics.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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Abstract: BACKGROUND: Type II diabetes mellitus is associated with an increasing prevalence and incidence, and with a heavy economic burden in Western countries. As a consequence, health authorities consider that avoidance or delay of occurrence of diabetes-related micro- and macro-angiopathic complications is a public health priority, leading to the definition of treatment guidelines. The aim of the study was to assess the budgetary impact of the application of the French guidelines. METHODS: Etiologic cost ratios. RESULTS: Our results conclude that 10\% decrease in body mass index (BMI) among overweight patients, smoking cessation, initiation to undertake a preventive treatment with low-dose aspirin, initiation to undertake or intensify blood pressure control, initiation to undertake or intensify lipidic control, and shift to biguanides among overweight patients are factors associated with significant benefits (avoided costs) which compensate for the increase in treatment costs. The main beneficial strategies are, in decreasing order, initiation to undertake a preventive treatment with low-dose aspirin, smoking cessation, and control of BMI. CONCLUSION: Our results support interest in reinforcing the application of current treatment guidelines for type II diabetes mellitus.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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Abstract: THE ISSUE: Diabetes has become the main cause of end-stage renal disease. The costs for the treatment of diabetic patients with end-stage renal disease have increased in the last years and have become a relevant economic topic of the health service. The first unspecific predictor of a diabetic nephropathy is an albuminuria. The screening for diabetic nephropathy uses microalbuminuria as a proof. OBJECTIVES: - What significance does the determination of albuminuria have on the precaution and course-control of the diabetic nephropathy? a) in type 1 diabetic patients b) in type 2 diabetic patients ? - Which is an appropriate time to determine the albuminuria for the purpose of precaution and course-control of the diabetic nephropathy? a) in type 1 diabetic patients b) in type 2 diabetic patients ? Which method of testing is most effective concerning economic and medical aspects? METHODS: Published literature from 1998 up to 2004 was identified by searching in the most important databases. Most of the guidelines were found by hand searching in the internet. RESULTS: Of 2,792 citation titles and abstracts examined, 274 articles were retrieved for full-text review. Five metaanalyses and reviews, one review about clearing of guidelines (regarding 18 international guidelines) and four guidelines met the inclusion criteria for screening for microalbuminuria and type 1 diabetes. Seven metaanalyses, one HTA report, one review about clearing of guidelines (regarding 17 international guidelines), and seven guidelines met the inclusion criteria for screening for microalbuminuria and type 2 diabetes. At the moment, the determination of albuminuria still has a great significance because it is recommended in most published literature and guidelines. The time to determine the albuminuria depends on the age of the patients and their type of diabetes. Type 2 diabetic patients should start the determination when the diabetes is diagnosed whereas the determination is recommended five years later when type 1 diabetic patients are concerned. Most guidelines recommend a screening for microalbuminuria every year.DISCUSSION AND CONCLUSION: All guidelines an d most of the literature recommend this screening. However, these recommendations are only based on expert consensus. The specificity of this screening is rather low. False positive tests in type 2 diabetic patients will cause psychological problems. A positive test leads to the recommendation to achieve “normal blood pressure” and “normoglycaemia” – but this applies to each diabetic patient. Based on these facts, the screening for albuminuria in type 1 or type 2 diabetes patients cannot be recommended as long as benefit has not been demonstrated by large, clinical, controlled trials. Without an evidence of the benefit, this screening cannot be economic.

 prevention;  diabetes;  nephropathy;  screening;  MICROALBUMINURIA;  economic review;  

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Abstract: BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors slow renal disease progression and reduce cardiac morbidity and mortality in patients with diabetes. Patients out-of-pocket costs pose a barrier to using this effective therapy. OBJECTIVE: To estimate the cost-effectiveness to Medicare of first-dollar coverage (no cost sharing) of ACE inhibitors for beneficiaries with diabetes. DESIGN: Markov model with costs and benefits discounted at 3\%. DATA SOURCES: Published literature and Medicare claims data. TARGET POPULATION: 65-year-old Medicare beneficiary with diabetes. TIME HORIZON: Lifetime. PERSPECTIVE: Medicare and societal. INTERVENTIONS: We evaluated Medicare first-dollar coverage of ACE inhibitors compared with current practice (no coverage) and the new Medicare drug benefit. OUTCOME MEASURES: Costs (2003 U.S. dollars), quality-adjusted life-years (QALYs), life-years, and incremental cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: Compared with current practice, first-dollar coverage of ACE inhibitors saved both lives and money (0.23 QALYs gained and 1606 USD saved per Medicare beneficiary). Compared with the new Medicare drug benefit, first-dollar coverage remained a dominant strategy (0.15 QALYs gained, 922 USD saved). RESULTS OF SENSITIVITY ANALYSIS: Results were most sensitive to our estimate of increase in ACE inhibitor use; however, if ACE inhibitor use increased by only 7.2\% (from 40\% to 47.2\%), first-dollar coverage would remain life-saving at no net cost to Medicare. In analyses conducted from the societal perspective, benefits were similar and cost savings were larger. LIMITATIONS: Results depend on accuracy of the underlying data and assumptions. The effect of more generous drug coverage on medication adherence is uncertain. CONCLUSIONS: Medicare first-dollar coverage of ACE inhibitors for beneficiaries with diabetes appears to extend life and reduce Medicare program costs. A reduction in program costs may result in more money to spend on other health care needs of the elderly.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  DM2;  HOPE;  

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Abstract: The objective of the study was to assess, from a health service perspective, whether a systematic program to modify kidney and cardiovascular disease reduced the costs of treating end-stage kidney failure. The participants in the study were 1,800 aboriginal adults with hypertension, diabetes with microalbuminuria or overt albuminuria, and overt albuminuria, living on two islands in the Northern Territory of Australia during 1995 to 2000. Perindopril was the primary treatment agent, and other medications were also used to control blood pressure. Control of glucose and lipid levels were attempted, and health education was offered. Evaluation of program resource use and costs for follow-up periods was done at 3 and 4.7 years. On an intention-to-treat basis, the number of dialysis starts and dialysis-years avoided were estimated by comparing the fate of the treatment group with that of historical control subjects, matched for disease severity, who were followed in the before the treatment program began. For the first three years, an estimated 11.6 person-years of dialysis were avoided, and over 4.7 years, 27.7 person-years of dialysis were avoided. The net cost of the program was 1,210 dollars more per person per year than status quo care, and dialyses avoided gave net savings of 1.0 million dollars at 3 years and 3.4 million dollars at 4.6 years. The treatment program provided significant health benefit and impressive cost savings in dialysis avoided.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  perindopril;  

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Abstract: Objective: To evaluate losartan and conventional antihypertensive therapy (CT) compared with CT alone on the cost associated with end-stage renal disease (ESRD) in Hong Kong, Japan, Korea, Malaysia, Singapore and Taiwan. Methods: Reduction of end-points in non-insulin-dependent diabetes mellitus with the angiotensin II antagonist losartan (RENAAL) was a multinational, double-blind, randomized, placebo-controlled trial to evaluate the renal protective effects of losartan on a background of CT in patients with type 2 diabetes and nephropathy. The primary composite end-point was a doubling of serum creatinine, ESRD or death. Data on the duration of ESRD for the Asian subgroup of patients enrolled in RENAAL were used to estimate the economic benefits of slowing the progression of nephropathy. The cost associated with ESRD was estimated by combining the number of days each patient experienced ESRD with the average daily cost of dialysis from the third-party payer perspective in Hong Kong, Japan, Korea, Malaysia, Singapore and Taiwan. Total cost, converted to US dollars, was the sum of ESRD and losartan costs. Results: Losartan plus CT reduced the number of days with ESRD by 37.9 per patient over 3.5 years compared with CT alone. This reduction in ESRD days resulted in a decrease in the cost associated with ESRD, which ranges from $910 to $4346 per patient over 3.5 years across the six countries or regions. After accounting for the cost of losartan, the reduction in ESRD days resulted in net savings in each of the six countries or regions, ranging from $55 to $515 per patient. Conclusion: Treatment with losartan in patients with type 2 diabetic nephropathy not only reduced the incidence of ESRD among Asian patients, but resulted in direct medical cost savings in countries or regions representing Asia.

 prevention;  diabetes;  arb;  nephropathy;  RENAAL;  losartan;  economic evaluation;  

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Abstract: BACKGROUND: The prevalence and incidence of diabetic nephropathy with endstage renal disease (ESRD) have increased globally over recent decades. Diabetic nephropathy with ESRD for type 2 diabetes mellitus (DM) now has to be recognized as a growing public health problem. Several studies have found that angiotensin-II receptor antagonists have a renoprotective effect in type 2 diabetics with diabetic nephropathy, independently of their antihypertensive effects. These studies have shown a prevention of the progression of nephropathy to ESRD, or a slowing of that progression. The RENAAL study demonstrated the clinical benefits of losartan in patients with DM type 2 and advanced diabetic nephropathy. AIM: The aim of this cost-effectiveness analysis of the RENAAL study was to evaluate the effect of losartan compared to a placebo from a Swiss third party payer perspective. METHODS: Using a decision analytic model, we evaluated the cost-effectiveness for losartan on the basis of the RENAAL study. A follow-up period of 3.5 years was used. Effectiveness was defined as the number of ESRD days saved. We valued haemodialysis, peritoneal dialysis and kidney transplantation. A weighted mean value was calculated for the daily costs of an ESRD (CHF 215.05). In the case of renal transplantation follow-on costs, resource utilization was determined through a telephone-based interview with 5 of the 6 Swiss transplantation centres. Expert consensus methodology was used to determine the proportion of health care resource utilization in type 2 diabetics. The percentage of patients receiving each of the 3 treatment alternatives was derived from a cross-sectional national study conceived for this purpose. The daily costs for haemodialysis and peritoneal dialysis were derived from figures provided by insurers. The costs of treatment with losartan were calculated on the basis of an average daily dose of losartan over a period of 3.5 years. RESULTS: Over a period of 3.5 years, losartan significantly reduced the number of ESRD days of type 2 diabetics with nephropathy by an average of 33.6 days (95% CI: 10.9, 56.3) compared to the placebo. This reduction in the number of ESRD days resulted in ESRD-associated cost savings of CHF 7,226 per patient over a period of 3.5 years (the ESRD-associated costs savings increased to CHF 10,086 per patient after 4 years). If the average costs per patient for treatment with losartan for the same period (CHF 3,142) are subtracted from the CHF 7,226 then the reduction in ESRD days yields net cost savings of CHF 4,084 per patient over 3.5 years. The univariate sensitivity analyses for the variables ESRD daily costs and percentage distribution of the 3 treatment modalities always yielded net cost savings. DISCUSSION: This evaluation revealed net cost savings of CHF 4,084 (F 2,687) for patients with diabetic nephropathy and type 2 diabetes when given 50 to 100 mg losartan once daily over a period of 3.5 years compared to placebo. The net cost savings that administration of losartan yielded are of considerable importance given that the annual costs of diabetic nephropathy with ESRD in type 2 diabetics in Switzerland are approximately CHF 46 million. On the basis of the scientific evidence currently available, the use of losartan to prevent the advance of diabetic nephropathy is worthwhile from both a clinical and economic perspective.

 prevention;  diabetes;  arb;  nephropathy;  RENAAL;  losartan;  economic evaluation;  

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Abstract: BACKGROUND: The multicenter double-blind, randomized Bergamo Nephrologic Diabetes Complications Trial (BENEDICT) was designed to assess whether angiotensin-converting-enzyme inhibitors and non-dihydropyridine calcium-channel blockers, alone or in combination, prevent microalbuminuria in subjects with hypertension, type 2 diabetes mellitus, and normal urinary albumin excretion. METHODS: We studied 1204 subjects, who were randomly assigned to receive at least three years of treatment with trandolapril (at a dose of 2 mg per day) plus verapamil (sustained-release formulation, 180 mg per day), trandolapril alone (2 mg per day), verapamil alone (sustained-release formulation, 240 mg per day), or placebo. The target blood pressure was 120/80 mm Hg. The primary end point was the development of persistent microalbuminuria (overnight albumin excretion, > or =20 microg per minute at two consecutive visits). RESULTS: The primary outcome was reached in 5.7 percent of the subjects receiving trandolapril plus verapamil, 6.0 percent of the subjects receiving trandolapril, 11.9 percent of the subjects receiving verapamil, and 10.0 percent of control subjects receiving placebo. The estimated acceleration factor (which quantifies the effect of one treatment relative to another in accelerating or slowing disease progression) adjusted for predefined baseline characteristics was 0.39 for the comparison between verapamil plus trandolapril and placebo (P=0.01), 0.47 for the comparison between trandolapril and placebo (P=0.01), and 0.83 for the comparison between verapamil and placebo (P=0.54). Trandolapril plus verapamil and trandolapril alone delayed the onset of microalbuminuria by factors of 2.6 and 2.1, respectively. Serious adverse events were similar in all treatment groups. CONCLUSIONS: In subjects with type 2 diabetes and hypertension but with normoalbuminuria, the use of trandolapril plus verapamil and trandolapril alone decreased the incidence of microalbuminuria to a similar extent. The effect of verapamil alone was similar to that of placebo.

 prevention;  diabetes;  ACEI;  nephropathy;  Verapamil;  clinical trial;  BENEDICT;  trandolapril;  

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Abstract: BACKGROUND: In the Irbesartan Diabetic Nephropathy Trial (IDNT), treatment with irbesartan demonstrated 23% and 20% reductions in the combined endpoint of doubling of serum creatinine (DSC), end-stage renal disease (ESRD) or death in patients with hypertension, type 2 diabetes and overt nephropathy compared to amlodipine and control respectively. A simulation model was developed to project long-term cost consequences of the IDNT in the Spanish setting. METHODS: A Markov model simulated progression from nephropathy to DSC, ESRD and death in patients with hypertension, type 2 diabetes and overt nephropathy. Treatment-specific probabilities were derived from IDNT. Country-specific ESRD-related data were retrieved from published sources. Delay in onset of ESRD, life expectancy and mean lifetime costs were calculated for patients with baseline age 59 years. Future costs were discounted at 6% per annum, and clinical benefits were discounted at 0% and 6% per annum. Extensive sensitivity analyses were performed. RESULTS: Onset of ESRD was delayed with irbesartan by 1.41 and 1.35 years versus amlodipine and control respectively. When a 25-year (lifetime) horizon was considered, delay in ESRD onset led to anticipated improvements in life expectancy (discounted at 6% shown in brackets) of 0.46 (0.21) years versus amlodipine and 0.75 (0.37) years versus control. Irbesartan was associated with cost savings of 13,673 Euro and 7,632 Euro patient versus amlodipine and control respectively. The results were robust under a wide range of plausible assumptions. CONCLUSIONS: Treating patients with hypertension, type 2 diabetes and overt nephropathy using irbesartan was both cost- and life-saving compared to amlodipine and control in the Spanish setting.

 prevention;  diabetes;  arb;  nephropathy;  irbesartan;  economic evaluation;  IDNT;  temp;  

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Abstract: BACKGROUND AND OBJECTIVE: Calcium antagonists (CAs) from two classes - dihydropyridine and non-dihydropyridine (DCAs and NDCAs, respectively) - are important add-on agents in goal blood pressure (BP) attainment. This study compared drug regimens to which DCAs or NDCAs had been added; for each class, BP reduction and healthcare costs were evaluated in a diabetic hypertensive population. DESIGN, SETTING AND PATIENTS: This was a retrospective observational study using administrative claims data within two US health plans. Patients with diabetes mellitus (DM) and hypertension initiated on CA therapy between 1 January 2000 through 30 June 2002 were identified; the date the first CA prescription (CA-Rx) was filled in this period was labelled the index date. Inclusion required plan enrolment for 6 months pre- and 1 year post-index, no CA-Rx 6 months pre-index, and medication possession ratio >50\% for 1 year post-index. Patients fell into either dihydropyridine or non-dihydropyridine study groups. MAIN OUTCOME MEASURES AND RESULTS: For each group, costs (amounts allowed by plans, in US dollars; actual costs for 2000-2002) were calculated for resources attributable to DM/hypertension. A total of 5551 patients met eligibility criteria (NDCA = 1515; DCA = 4036). Most had been taking other antihypertensive medications: 86\% and 76\% in the DCA and NDCA groups, respectively. The NDCA group had lower annual attributable costs than the DCA group ($US1637 [95\% CI $US1479, $US1813] vs $US1989 [95\% CI $US1823, $US2170]; p < 0.004). A total of 313 medical charts were reviewed (DCA = 242, NDCA = 71). Both groups had similar pre-and post-index BP values; mean changes in systolic and diastolic BP were not statistically significant between groups. Only 22\% of all patients attained the recommended systolic/diastolic BP goal of <130/80mm Hg, and <45\% of patients were tested for proteinuria during the study period. CONCLUSIONS: Patients initiated on an NDCA attained similar BP reductions compared with DCA at lower total healthcare costs. Opportunities exist for more aggressive management of BP and testing for proteinuria in DM patients with hypertension.

 prevention;  diabetes;  nephropathy;  economic evaluation;  blood pressure control;  

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Abstract: Two studies comparing the cost-effectiveness of irbesartan to similar blood pressure control with standard antihypertensive medications (excluding angiotensin-converting enzyme inhibitors and other angiotensin receptor blockers) in treatment of patients with hypertension, type 2 diabetes, and microalbuminuria have been published to date; one in a United States setting, the other in a Spanish setting. Both studies were based on a Markov-based Monte Carlo simulation model, with the effects of irbesartan or standard blood pressure control taken from the Irbesartan Reduction of Microalbuminuria-2 (IRMA-2) and the Irbesartan in Diabetic Nephropathy Trial (IDNT) clinical trials. In both Spanish and U.S. settings, irbesartan was projected to delay the onset of end-stage renal disease (ESRD), reduce the cumulative incidence of ESRD, increase life expectancy, and reduce overall direct medical costs. Irbesartan treatment of patients with type 2 diabetes, hypertension, and microalbuminuria may lead to major improvements in long-term patient outcomes, with substantial cost savings as an added bonus to third party payers.

 diabetes;  arb;  nephropathy;  MICROALBUMINURIA;  irbesartan;  blood pressure control;  economic review;  

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Abstract: There are substantial healthcare costs associated with the provision of renal replacement therapy. Patients with diabetes mellitus are the largest and fastest growing group developing end-stage renal disease (ESRD) in the United Kingdom (UK). Treatment leading to a slowing of progression to ESRD in diabetic patients could lead to considerable cost savings. Using treatment-specific probabilities derived from the Irbesartan in Diabetic Nephropathy Trial (IDNT), the cost effectiveness of treating patients with hypertension, type II diabetes and nephropathy with irbesartan, amlodipine or control was calculated using a Markov model. UK-specific ESRD-related data were retrieved from published sources to reflect local management practices, ESRD outcomes and costs. Mean 10-year costs and changes in life expectancy due to ESRD delayed or avoided were calculated. Future costs and clinical benefits were discounted at 6.0 and 1.5% per annum and extensive sensitivity analyses were performed. Delay in the onset of ESRD with irbesartan led to cost savings of £5125 and £2919/patient and improvements in projected discounted life expectancy of 0.07 and 0.21 years over 10 years vs amlodipine and control, respectively. The costs of treatment of ESRD were the main contributor to the total costs. The cost of trial medications had only a minor impact. These results were robust in a wide range of plausible assumptions. Given that the IDNT efficacy results could be translated to a UK setting, treating patients with hypertension, type II diabetes and overt nephropathy with irbesartan was cost saving over a 10-year period compared to amlodipine and control.

 prevention;  diabetes;  arb;  nephropathy;  irbesartan;  economic evaluation;  IDNT;  

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Abstract: A significant subgroup of patients with diabetes mellitus are predisposed to developing diabetic nephropathy and it is in this subgroup that other diabetes- related complications, and in particular greatly increased cardiovascular disease risk, are concentrated. The high personal, social and financial costs of managing end-stage renal failure and the other complications associated with diabetic nephropathy make a powerful case for screening and effective intervention programmes to prevent the condition or retard its progression. As major breakthroughs in finding genetic susceptibility factors remain elusive, screening efforts continue to be based on microalbuminuria testing, despite increasing recognition of its limitations as a positive predictor of nephropathy. Interventions have been extensively studied, but results remain conflicting. Economic evaluations of such screening and intervention programmes are essential for health planners, yet models of the cost/benefit ratio of such interventions often rely on a rather slim evidence base. Where economic models are developed, they are frequently based on those papers that propound the greatest clinical benefits of a given intervention, leading to a possible over-estimation of the advantages of the chosen approach. Furthermore, the benefits of even such generally accepted interventions as ACE inhibitor treatment are less firmly established than generally appreciated. Lifestyle interventions are instinctively attractive, but are by no means a low-cost option (as is often assumed by both medical professionals and politicians). This review critically assesses the evidence for clinical efficacy and economic benefit of microalbuminuria screening and interventions such as intensive glycaemic control, antihypertensive treatment, ACE inhibition and angiotensin receptor blockade, dietary protein restriction and lipid-modifying therapy. The various costs associated with diabetic nephropathy are so great that even expensive interventions may have a favourable cost/benefit ratio, provided they are truly effective.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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Abstract: OBJECTIVE: Current guidelines recommend treating patients with type 1 diabetes mellitus with ACE inhibitors after the onset of microalbuminuria. Recent clinical trials have shown ACE inhibitors can affect the development of nephropathy when initiated prior to the onset of microalbuminuria. Our objective is to examine the cost effectiveness of treating adults aged over 20 years with an ACE inhibitor (captopril) immediately following diagnosis of type 1 diabetes versus treating them after the onset of microalbuminuria. DESIGN: Using a semi-Markov model, we calculated four main outcome measures: lifetime direct medical costs (discounted), QALYs, cumulative incidence of end-stage renal disease (ESRD), and number of days of ESRD over a lifetime. Medical costs are in 1999 US dollars. SETTING: All analyses were from the viewpoint of a single US payer responsible for all direct medical costs, including screening for microalbuminuria, ACE inhibitor treatment (captopril), management of major diabetic complications, and routine annual medical costs not specific to diabetes. METHODS: We applied the model to a hypothetical cohort of 10,000 persons newly diagnosed with type 1 diabetes. Distribution of sex and race/ethnicity within the cohort is representative of the general US population. RESULTS: We estimated that the incremental cost of early use of captopril for the average adult with type 1 diabetes is USD 27,143 per QALY. This level varies considerably with age and glycaemic level. When the age at onset of diabetes is 20 years and glycosylated haemoglobin (HbA(1c)) level is 9%, the cost-effectiveness ratio is USD 13,814 per QALY. When the age at onset is 25 years and HbA(1c) level is 7%, the cost-effectiveness ratio is USD 39,530 per QALY. CONCLUSION: This model, with its underlying assumptions and data, suggests that early treatment with captopril provides modest benefit at reasonable cost effectiveness, from the US single-payer perspective, in the prevention of ESRD compared with delaying treatment until diagnosis of microalbuminuria. Early treatment with other ACE inhibitors will provide similar cost effectiveness if they have equivalent efficacy, compliance and price per dose. Treatment may be considered among patients at age 20 years with new onset of type 1 diabetes. This conclusion is sensitive to the extent that ACE inhibitors delay onset of microalbuminuria. Other factors such as the patient's age and glycaemic level must be considered when deciding to initiate early treatment.

 prevention;  diabetes;  ACEI;  nephropathy;  MICROALBUMINURIA;  economic evaluation;  DM1;  

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Abstract: CONTEXT: Chronic kidney disease is a growing public health problem. Screening for early identification could improve health but could also lead to unnecessary harms and excess costs. OBJECTIVE: To assess the value of periodic, population-based dipstick screening for early detection of urine protein in adults with neither hypertension nor diabetes and in adults with hypertension. DESIGN, SETTING, AND POPULATION: Cost-effectiveness analysis using a Markov decision analytic model to compare a strategy of annual screening with no screening (usual care) for proteinuria at age 50 years followed by treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II-receptor blocker (ARB). MAIN OUTCOME MEASURE: Cost per quality-adjusted life-year (QALY). RESULTS: For persons with neither hypertension nor diabetes, the cost-effectiveness ratio for screening vs no screening (usual care) was unfavorable (282 818 dollars per QALY; incremental cost of 616 dollars and a gain of 0.0022 QALYs per person). However, screening such persons beginning at age 60 years yielded a more favorable ratio (53 372 dollars per QALY). For persons with hypertension, the ratio was highly favorable (18 621 dollars per QALY; incremental cost of 476 dollars and a gain of 0.03 QALYs per person). Cost-effectiveness was mediated by both chronic kidney disease progression and death prevention benefits of ACE inhibitor and ARB therapy. Influential parameters that might make screening for the general population more cost-effective include a greater incidence of proteinuria, age at screening (53 372 dollars per QALY for persons beginning screening at age 60 years), or lower frequency of screening (every 10 years: 80 700 dollars per QALY at age 50 years; 6195 dollars per QALY at age 60 years; and 5486 dollars per QALY at age 70 years). CONCLUSIONS: Early detection of urine protein to slow progression of chronic kidney disease and decrease mortality is not cost-effective unless selectively directed toward high-risk groups (older persons and persons with hypertension) or conducted at an infrequent interval of 10 years.

 prevention;  diabetes;  nephropathy;  screening;  MICROALBUMINURIA;  economic evaluation;  

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Abstract: BACKGROUND: The RENAAL study enrolled 1,513 patients with type 2 diabetes mellitus and nephropathy defined by the presence of proteinuria (urinary albumin: creatinine ratio 300 mg/g or proteinuria > 500 mg per day). Compared to placebo, losartan therapy reduced by 16\% (p=0.02) the risk of a composite endpoint (doubling of baseline serum creatinine level, end stage renal disease, or death) and by 28\% (p=0.002) the risk of progression to end stage renal disease (ESRD). METHODS: The objective of this study was to compare, using French economic data, the additional cost of losartan therapy with the savings in cost generated by a decrease in the number of end stage renal disease days. Prospectively collected health care resource utilization were used (N(losartan)=751, N(placebo)=762). The follow-up period was 4 years. RESULTS: The mean cumulative cost of losartan over 4 years was 1,603 euros per patient. The reduction in the number of ESRD days over 4 years in patients treated with losartan significantly decreased costs associated with ESRD by 7,438 euros per patient (CI 95\%: 3,029 euros - 11,847 euros, p=0.001). Compared to the placebo group, the average cost per patient over 4 years in the losartan group was lower by 5,834 euros (CI 95\%: 1,407 euros - 10,301 euros

 prevention;  diabetes;  arb;  nephropathy;  RENAAL;  losartan;  economic evaluation;  

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Abstract: OBJECTIVE: To evaluate the within-trial effect of losartan and conventional antihypertensive therapy (CT) compared with placebo and CT on the economic cost associated with end-stage renal disease (ESRD). RESEARCH DESIGN AND METHODS: The Reduction of End Points in Type 2 Diabetes With the Angiotensin II Antagonist Losartan (RENAAL) study was a multinational double-blind randomized placebo-controlled clinical trial designed to evaluate the renal protective effects of losartan on a background of CT (excluding ACE inhibitors and angiotensin II receptor agonists [AIIAs]) in patients with type 2 diabetes and nephropathy. The primary composite end point was doubling of serum creatinine, ESRD, or death. Data on the duration of ESRD were used to estimate the economic benefits of slowing the progression of nephropathy. The cost associated with ESRD was estimated by combining the days each patient experienced ESRD with the cost of ESRD over time. The cost of ESRD for individuals with diabetes was estimated using data from the U.S. Renal Data System. Total cost was estimated as the sum of the cost associated with ESRD and the cost of study therapy. RESULTS-We estimated that losartan and CT compared with placebo and CT reduced the number of days with ESRD by 33.6 per patient over 3.5 years (P = 0.004, 95% CI 10.9-56.3). This reduction in ESRD days resulted in a decrease in cost associated with ESRD of 5144 US dollars per patient (P = 0.003, 95% CI 1701 to 8587 US dollars). After accounting for the cost of losartan, the reduction in ESRD days resulted in a net savings of 3522 US dollars per patient over 3.5 years (P = 0.041, 143 to 6900 US dollars). CONCLUSIONS: Treatment with losartan in patients with type 2 diabetes and nephropathy not only reduced the incidence of ESRD, but also resulted in substantial cost savings.

 prevention;  diabetes;  arb;  nephropathy;  RENAAL;  losartan;  economic evaluation;  

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Abstract: BACKGROUND: In the Irbesartan in Diabetic Nephropathy Trial (IDNT), treatment with irbesartan demonstrated 23 and 20% reductions in the combined endpoint of doubling of serum creatinine (DSC), end-stage renal disease (ESRD) or death in patients with hypertension, type 2 diabetes and overt nephropathy compared with amlodipine and control, respectively. A simulation model was developed to project long-term cost consequences of the IDNT in Belgium and France. METHODS: A Markov model simulated progression from nephropathy to DSC, ESRD and death in patients with hypertension, type 2 diabetes and overt nephropathy. Treatment-specific probabilities were derived from IDNT. Country-specific ESRD-related data were retrieved from published sources. Delay in onset of ESRD, life expectancy and mean lifetime costs were calculated for patients with a baseline age of 59 years. Future costs were discounted at 3% per annum (p.a.), and clinical benefits were discounted at 0 and 3% p.a. Extensive sensitivity analyses were performed. RESULTS: Onset of ESRD was delayed with irbesartan by 1.41 and 1.35 years vs amlodipine and control, respectively. When a 10-year time horizon was considered, delay in ESRD onset led to anticipated improvements in life expectancy of 0.13 years vs amlodipine and 0.26 years vs control. Irbesartan was associated with cost savings of 14 949 and 9205/patient in Belgium, and 20 128 and 13 337 in France, vs amlodipine and control, respectively. The results were robust under a wide range of plausible assumptions. CONCLUSIONS: Treating patients with hypertension, type 2 diabetes and overt nephropathy using irbesartan was both cost- and life-saving compared with amlodipine and control.

 diabetes;  arb;  nephropathy;  irbesartan;  economic evaluation;  IDNT;  

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 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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Abstract: OBJECTIVES: To investigate the marginal cost-effectiveness of different targets for the reduction of blood pressure and the cost-effectiveness of adding acetylsalicylic acid (ASA) to the treatment of hypertension. DESIGN: Patients with hypertension were randomized to three target groups for blood pressure; < or =90, < or =85 and < or =80 mmHg. Patients were also randomly assigned ASA and placebo. The average follow-up time was 3.8 years. The direct costs for drugs, visits, hospitalizations, and side-effects were calculated and related to clinical outcome. SETTING: Resource utilization data from all the 26 countries in the study were pooled, and Swedish unit costs were applied to the aggregated resource utilization. SUBJECTS: A total of 18 790 patients, 50-80 years of age (mean 61.5 years), with a diastolic blood pressure between 100 and 115 mmHg (mean 105 mmHg). INTERVENTIONS: Antihypertensive treatment with the long-acting calcium antagonist felodipine was given to all patients. Additional therapy and dose increments in four further steps were prescribed to reach the randomized target blood pressure. Fifty per cent of the patients were ra