ACEI

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: 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: 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: 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: OBJECTIVE: We examined factors associated with screening for albuminuria and initiation of ACE inhibitor or angiotensin receptor blocker (ARB) treatment in diabetic patients. RESEARCH DESIGN AND METHODS: We conducted surveys and medical record reviews for 5,378 patients participating in a study of diabetes care in managed care at baseline (2000-2001) and follow-up (2002-2003). Factors associated with testing for albuminuria were examined in cross-sectional analysis at baseline. Factors associated with initiating ACE inhibitor/ARB therapy were determined prospectively. RESULTS: At baseline, 52% of patients not receiving ACE inhibitor/ARB therapy and without known diabetic kidney disease (DKD) were screened for albuminuria. Patients > or =65 years of age, those with higher HbA(1c), those with cardiovascular disease (CVD), and those without hyperlipidemia were less likely to be screened. Of the patients with positive screening tests, 47% began ACE inhibitor/ARB therapy. Initiation of therapy was associated with positive screening test results, BMI > or =25 kg/m(2), treatment with insulin or oral antidiabetic agents, peripheral neuropathy, systolic blood pressure > or =140 mmHg, and CVD. Of the patients receiving ACE inhibitor/ARB therapy or with known DKD, 63% were tested for albuminuria. CONCLUSIONS: Screening for albuminuria was inadequate, especially in older patients or those with competing medical concerns. The value of screening could be increased if more patients with positive screening tests initiated ACE inhibitor/ARB therapy. The efficiency of screening could be improved by limiting screening to diabetic patients not receiving ACE inhibitor/ARB therapy and without known DKD.

 diabetes;  ACEI;  arb;  screening;  MICROALBUMINURIA;  health quality assessment;  

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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: 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: 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: 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: 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: 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: OBJECTIVE: To describe the direct medical costs associated with type 2 diabetes, as well as its treatments, complications, and comorbidities. RESEARCH DESIGN AND METHODS: We studied a random sample of 1,364 subjects with type 2 diabetes who were members of a Michigan health maintenance organization. Demographic characteristics, duration of diabetes, diabetes treatments, glycemic control, complications, and comorbidities were assessed by surveys and medical chart reviews. Annual resource utilization and costs were assessed using health insurance claims. The log-transformed annual direct medical costs were fitted by multiple linear regression to indicator variables for demographics, treatments, glycemic control, complications, and comorbidities. RESULTS: The median annual direct medical costs for subjects with diet-controlled type 2 diabetes, BMI 30 kg/m(2), and no microvascular, neuropathic, or cardiovascular complications were 1,700 dollars for white men and 2,100 dollars for white women. A 10-kg/m(2) increase in BMI, treatment with oral antidiabetic or antihypertensive agents, diabetic kidney disease, cerebrovascular disease, and peripheral vascular disease were each associated with 10-30\% increases in cost. Insulin treatment, angina, and MI were each associated with 60-90\% increases in cost. Dialysis was associated with an 11-fold increase in cost. CONCLUSIONS: Insulin treatment and diabetes complications have a substantial impact on the direct medical costs of type 2 diabetes. The estimates presented in this model may be used to analyze the cost-effectiveness of interventions for type 2 diabetes.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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Abstract: The number of therapeutic options for people with type 2 diabetes is increasing. Large-scale clinical trials have delineated the health benefits of tight glycemic control with these interventions, including the reduction of long-term diabetes-related complications. These long-term complications compromise quality of life and ultimately account for mortality in most patients with diabetes. Despite the high price tag of managing the long-term complications of hyperglycemia, few economic incentives have been presented for investing in intensive glycemic control. Recent cost-benefit analyses, however, provide insight into the major cost drivers that yield a short-term return on investment for preventive measures. This article highlights cost-effective measures that have been successfully utilized in the managed care setting to simultaneously improve health and economic outcomes of diabetes within the first few years of implementation.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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Abstract: AIMS: To compare the out-patient costs and process quality of preventing secondary complications in patients with Type 2 diabetes mellitus in France, Germany, Italy, The Netherlands, Sweden, Switzerland, and the UK. METHODS: A total of 188 European physician practices assessed annual services for one hypothetical average patient (cost evaluation) and 178 practices reported retrospective data on one or two real patients (quality evaluation) in 2000/2001. In countries with a detailed fee-for-service schedule (Germany, Italy, and Switzerland) reimbursement fees were used to approximate costs. These fee-for-service schedules were also used to develop index (average) fees for all countries, in order to measure resource utilization. The following process quality indicators were evaluated: control of HbA1c; control of lipids; urine test for (micro)albuminuria; control of blood pressure; foot examination; neurological examination; eye examination; and patient education. For each country an average quality rating was calculated by weighting the response to each quality indicator with the level of scientific evidence. RESULTS: Average quality ratings ranged from 0.40 in The Netherlands to 0.62 in the UK (0 = lowest rating; 1 = highest rating). Total annual costs for secondary prevention were higher in Switzerland than in Germany and Italy (EUR475, EUR381, and EUR283, respectively). Resource utilization was highest in Germany and lowest in the UK. CONCLUSIONS: The overall quality of preventive services documented was found to be poor in the seven European countries studied. The UK rated as both the most effective and the most efficient country in providing secondary prevention in Type 2 diabetes.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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

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 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

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Abstract: BACKGROUND: Angiotensin-converting-enzyme (ACE) inhibitor therapy can significantly delay the progression of diabetic nephropathy to end-stage renal failure (ESRF). The main obstacle to successful compliance with this therapy is the cost to the patients. The authors performed a cost-utility analysis from the government's perspective to see whether the province or territory should pay for ACE inhibitors for type I diabetic nephropathy on the assumption that cost is a major barrier to compliance with this important therapy. METHODS: A decision analysis tree was created to demonstrate the progression of type I diabetes with macroproteinuria from the point of prescription of ACE inhibitor therapy through to ESRF management, with a 21-year follow-up. Drug compliance, cost of ESRF treatment, utilities and survival data were taken from Canadian sources and used in the cost-utility analysis. One-way and two-way sensitivity analyses were performed to test the robustness of the findings. RESULTS: Compared with a no-payment strategy, provincial payment of ACE inhibitor therapy was found to be highly cost-effective: it resulted in an increase of 0.147 in the number of quality-adjusted life-years (QALYs) and an annual cost savings of $849 per patient. The sensitivity analyses indicated that the cost-effectiveness depends on compliance, effect of benefit and the cost of drug therapy. Changes in the compliance rate from 67% to 51% could result in a swing in cost-effectiveness from a savings of $899 to an expenditure of more than $1 million per additional QALY. A 50% reduction in the cost of ACE inhibitors would result in a cost savings of $299 per additional QALY with compliance rates as low as 58% in the provincial payment strategy. INTERPRETATION: Provincial coverage of ACE inhibitor therapy for type I diabetes with macroproteinuria improves patient outcomes, with a decrease in cost for ESRF services.

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

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Abstract: BACKGROUND AND OBJECTIVE: Even though there are simple and cost-effective means for the early diagnosis of diabetic nephropathy, only a small proportion of diabetics in Germany is regularly tests for microalbuminuria. On the basis of evidence-based knowledge and of international guidelines the PROSIT project (proteinuria screening and intervention) aims to make good this deficiency in the German Federal Republic by introducing nephropathy screening and a structured intervention to improve blood sugar and blood pressure regulation, optimizing lipid metabolism and nutritional intake. It was the aim of this study to assess with a computer-aided diabetes model the clinical value and cost-effectiveness of such an intervention. PATIENTS AND METHODS: From data collected for 589 diabetics who participated in the PROSIT project, the short-time effects after one year on HbA1c, systolic blood pressure and lipid levels were obtained and cost-effectiveness compared with that of standard care. Life expectancy, life-time costs to be met by health insurance and event frequency of the diabetic nephropathy stages were calculated with a Markov model for type 2 diabetics. RESULTS: PROSIT improved individual life expectancy by 0.23 years with reduction of life-time costs by DM 9,772 (ca. \$4,900). The cumulative incidence of microalbuminuria was lowered by 30.5\%, that of terminal renal failure by 55.9\%. Even after discounting the results (i.e. the inclusion of time preference for cost and benefit) and stepwise changes of all variables by +/- 10\%, PROSIT remained the more cost-effective variant. CONCLUSION: From a health economy viewpoint PROSIT is superior to standard management. Early recognition of albuminuria and the introduction of a multifactorial treatment strategy make it possible to delay progression to terminal renal failure. In addition to its clinical benefits, prevention of dialysis and transplantation would reduce the annual savings of the health care system by several billion DM.

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

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Abstract: BACKGROUND: Diabetes mellitus is a strong risk factor for cardiovascular and renal disease. We investigated whether the angiotensin-converting-enzyme (ACE) inhibitor ramipril can lower these risks in patients with diabetes. METHODS: 3577 people with diabetes included in the Heart Outcomes Prevention Evaluation study, aged 55 years or older, who had a previous cardiovascular event or at least one other cardiovascular risk factor, no clinical proteinuria, heart failure, or low ejection fraction, and who were not taking ACE inhibitors, were randomly assigned ramipril (10 mg/day) or placebo, and vitamin E or placebo, according to a two-by-two factorial design. The combined primary outcome was myocardial infarction, stroke, or cardiovascular death. Overt nephropathy was a main outcome in a substudy. FINDINGS: The study was stopped 6 months early (after 4.5 years) by the independent data safety and monitoring board because of a consistent benefit of ramipril compared with placebo. Ramipril lowered the risk of the combined primary outcome by 25\% (95\% CI 12-36, p=0.0004), myocardial infarction by 22\% (6-36), stroke by 33\% (10-50), cardiovascular death by 37\% (21-51), total mortality by 24\% (8-37), revascularisation by 17\% (2-30), and overt nephropathy by 24\% (3-40, p=0.027). After adjustment for the changes in systolic (2.4 mm Hg) and diastolic (1.0 mm Hg) blood pressures, ramipril still lowered the risk of the combined primary outcome by 25\% (12-36, p=0.0004). INTERPRETATION: Ramipril was beneficial for cardiovascular events and overt nephropathy in people with diabetes. The cardiovascular benefit was greater than that attributable to the decrease in blood pressure. This treatment represents a vasculoprotective and renoprotective effect for people with diabetes.

 diabetes;  ACEI;  nephropathy;  clinical trial;  HOPE;  ramipril;  

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Abstract: BACKGROUND: Angiotensin-converting-enzyme inhibitors improve the outcome among patients with left ventricular dysfunction, whether or not they have heart failure. We assessed the role of an angiotensin-converting-enzyme inhibitor, ramipril, in patients who were at high risk for cardiovascular events but who did not have left ventricular dysfunction or heart failure. METHODS: A total of 9297 high-risk patients (55 years of age or older) who had evidence of vascular disease or diabetes plus one other cardiovascular risk factor and who were not known to have a low ejection fraction or heart failure were randomly assigned to receive ramipril (10 mg once per day orally) or matching placebo for a mean of five years. The primary outcome was a composite of myocardial infarction, stroke, or death from cardiovascular causes. The trial was a two-by-two factorial study evaluating both ramipril and vitamin E. The effects of vitamin E are reported in a companion paper. RESULTS: A total of 651 patients who were assigned to receive ramipril (14.0 percent) reached the primary end point, as compared with 826 patients who were assigned to receive placebo (17.8 percent) (relative risk, 0.78; 95 percent confidence interval, 0.70 to 0.86; P<0.001). Treatment with ramipril reduced the rates of death from cardiovascular causes (6.1 percent, as compared with 8.1 percent in the placebo group; relative risk, 0.74; P<0.001), myocardial infarction (9.9 percent vs. 12.3 percent; relative risk, 0.80; P<0.001), stroke (3.4 percent vs. 4.9 percent; relative risk, 0.68; P<0.001), death from any cause (10.4 percent vs. 12.2 percent; relative risk, 0.84; P=0.005), revascularization procedures (16.3 percent vs. 18.8 percent; relative risk, 0.85; P<0.001), cardiac arrest (0.8 percent vs. 1.3 percent; relative risk, 0.62; P=0.02), [corrected] heart failure (9.1 percent vs. 11.6 percent; relative risk, 0.77; P<0.001), and complications related to diabetes (6.4 percent vs. 7.6 percent; relative risk, 0.84; P=0.03). CONCLUSIONS: Ramipril significantly reduces the rates of death, myocardial infarction, and stroke in a broad range of high-risk patients who are not known to have a low ejection fraction or heart failure.

 ACEI;  clinical trial;  HOPE;  ramipril;  

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Abstract: OBJECTIVE: To determine how effective angiotensin-converting enzyme (ACE) inhibitors must be in preventing diabetic nephropathy to warrant early and routine therapy in all Pima Indians with type 2 diabetes mellitus. DESIGN: A computerized medical decision analysis model was used to compare strategy 1, screening for microalbuminuria and treatment of incipient nephropathy as currently recommended with ACE inhibitor therapy, with strategy 2, a protocol wherein all patients were routinely administered an ACE inhibitor 1 year after diagnosis of type 2 diabetes mellitus. The model assumed that ACE inhibitors can block, at least in part, the pathogenic mechanisms responsible for early diabetic nephropathy (microalbuminuria). RESULTS: The model predicted that strategy 2 would produce more life-years at less cost than strategy 1, if routine drug therapy reduced the rate of development of microalbuminuria by 21% in all patients. Only a 9% reduction in the rate of development of microalbuminuria was cost-effective at $15,000 per additional life-year gained, and only a 2.4% reduction was cost-effective at $75,000 per additional life-year gained for strategy 2 over strategy 1. CONCLUSIONS: Routine ACE inhibitor therapy in Pima Indians with type 2 diabetes mellitus could prove more effective and even cost saving than the currently recommended approach of microalbuminuria screening. A prospective trial examining this goal should be considered.

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

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Abstract: BACKGROUND: Although guidelines recommend angiotensin-converting enzyme inhibitors for diabetic patients with microalbuminuria, this strategy requires that providers adhere to screening recommendations. In addition, the benefit of angiotensin-converting enzyme inhibitors in normoalbuminuric patients was recently demonstrated. OBJECTIVE: To evaluate the cost-effectiveness of treating all patients with type 2 diabetes. DESIGN: Markov model simulating the progression of diabetic nephropathy. DATA SOURCES: Randomized trials estimating the progression of diabetic nephropathy with and without angiotensin-converting enzyme inhibitors. TARGET POPULATION: Patients 50 years of age with newly diagnosed type 2 diabetes (fasting plasma glucose level > or = 7.8 mmol/L [140 mg/dL]). TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: Patients received angiotensin-converting enzyme inhibitors, screening for microalbuminuria, or screening for gross proteinuria. OUTCOME MEASURES: Lifetime cost, quality-adjusted life expectancy, and marginal cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: Screening for gross proteinuria had the highest cost and the lowest benefit. Compared with screening for microalbuminuria, treating all patients was more expensive (\$15240 and \$14940 per patient) but was associated with increased quality-adjusted life expectancy (11.82 and 11.78 quality-adjusted life-years). The marginal cost-effectiveness ratio was \$7500 per quality-adjusted life-year gained. RESULTS OF SENSITIVITY ANALYSIS: Results were sensitive to the cost, effectiveness, and quality of life associated with angiotensin-converting enzyme inhibitor therapy, as well as age at diagnosis. The model was relatively insensitive to adherence with screening and costs of treating end-stage renal disease. CONCLUSIONS: Treating all middle-aged diabetic patients with angiotensin-converting enzyme inhibitors is a simple strategy that provides additional benefit at modest additional cost. The strategy assumes that patients meet the older diagnostic criteria for diabetes and makes sense only for those who are not bothered by treatment.

 prevention;  diabetes;  ACEI;  nephropathy;  MICROALBUMINURIA;  economic evaluation;  DM2;  lisinopril;  

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Abstract: BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors attenuate the decline in renal function in diabetic patients with microalbuminuria. However, no data are available on the use of ACE inhibitors to prevent the decrease in renal function in normotensive, normoalbuminuric patients with type 2 diabetes. OBJECTIVE: To evaluate the effect of prolonged ACE inhibition on renal function and albuminuria in patients with type 2 diabetes. DESIGN: Randomized, double-blind, placebo-controlled trial with 6-year follow-up. SETTING: Eight outpatient clinics coordinated by a department of medicine in a university hospital. PATIENTS: 156 patients in whom type 2 diabetes was diagnosed after 40 years of age who had a baseline mean blood pressure less than 107 mm Hg and albuminuria (albumin excretion < or = 30 mg/24 h). INTERVENTION: Enalapril, 10 mg/d, or placebo. MEASUREMENTS: Degree of albuminuria at 24 hours, creatinine clearance, blood pressure, and hemoglobin A1c values. RESULTS: Enalapril therapy decreased albumin excretion from a mean +/- SD of 11.6 +/- 7 mg/24 h to 9.7 +/- 6 mg/24 h at 2 years. This was followed by a gradual increase to 15.8 +/- 8 mg/24 h at 6 years. In the placebo group, albumin excretion increased from 10.8 +/- 8 mg/24 h to 26.5 +/- 10 mg/24 h at 6 years (P = 0.001 for enalapril compared with placebo). Transition to microalbuminuria occurred in 15 of 79 (19%) placebo recipients and 5 of 77 (6.5%) enalapril recipients. Enalapril treatment resulted in an absolute risk reduction of 12.5% (95% CI, 2% to 23%; P = 0.042) for development of microalbuminuria. After 6 years, creatinine clearance decreased from 1.78 +/- 0.13 mL/s to 1.63 +/- 0.12 mL/s (mean decrease, 0.025 mL/s per year) in enalapril recipients and from 1.81 +/- 0.15 mL/s to 1.57 +/- 0.17 mL/s (mean decrease, 0.04 mL/s per year) in placebo recipients (P = 0.040). Hemoglobin A1c values decreased modestly in both groups. Mean blood pressure remained normal (< 107 mm Hg) in all patients. CONCLUSIONS: Enalapril attenuated the decline in renal function and reduced the extent of albuminuria in normotensive, normoalbuminuric patients with type 2 diabetes. Further research is needed to determine whether this treatment forestalls the development of overt nephropathy.

 diabetes;  ACEI;  nephropathy;  enalapril;  clinical trial;  DM2;  

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Abstract: PREVALENCE: The prevalence of abnormally elevated urinary albumin excretion rate (> 30 mg/24 h) is approximately 40\% in insulin-dependent and in non-insulin-dependent diabetic patients. Diabetes has become the leading cause of end-stage renal failure in Europe, USA and Japan. Approximately 90\% of the direct and indirect costs of caring for diabetic patients are spent on the complications of diabetes. RISK FACTORS: Identification of patients at high risk of developing diabetic nephropathy is possible by screening for microalbuminuria (30-300 mg/24 h). Additional risk factors/ markers for development of nephropathy are male sex, genetic predisposition, ethnic conditions, early onset of diabetes, poor metabolic control, hyperfiltration, elevated prorenin and smoking. Elevated urinary albumin excretion rate indicates a substantially increased cardiovascular morbidity and mortality risk in diabetic patients. PREVENTION OF NEPHROPATHY: Randomized controlled trials in normotensive insulin-dependent and in non-insulin-dependent diabetic patients with persistent microalbuminuria indicate that angiotensin converting enzyme (ACE) inhibitors diminish urinary albumin excretion rate, and postpone and may even prevent progression to clinical overt nephropathy. These findings indicate that screening and intervention programs could probably save lives and lead to considerable economic savings. TREATMENT OF NEPHROPATHY: Systemic blood pressure elevation to a hypertensive level is an early and frequent phenomenon in diabetic nephropathy. Furthermore, nocturnal blood pressure elevation (non-dippers) occurs more frequently in patients with nephropathy. Systemic blood pressure elevation, hyperglycaemia, albuminuria and the D polymorphism in the ACE gene accelerate the progression of diabetic nephropathy. Studies of the impact of other potential progression promoters (i.e. smoking, hyperlipidaemia and protein intake) have yielded conflicting results. Effective blood pressure reduction using ACE inhibitors or drugs of other classes, or both, frequently in combination with diuretics reduces albuminuria, delays the progression of nephropathy, postpones renal failure and improves survival in patients with diabetic nephropathy. Antihypertensive treatment for diabetic nephropathy extends life and saves money.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  DM1;  DM2;  

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Abstract: The objective of this study was to determine how effective angiotensin-converting enzymes (ACEs) must be in preventing diabetic nephropathy to warrant routine administration to insulin-dependent diabetic patients. A Markov model was used to compare three strategies designed to prevent the development of end-stage renal disease in insulin-dependent diabetic patients. Strategy I, screening for microalbuminuria and treatment of incipient nephropathy as currently recommended, was compared with strategy II, a protocol in which patients were routinely administered an ACE inhibitor 5 years after diagnosis of diabetes, and strategy III, in which patients at high risk for nephropathy were routinely treated and low-risk patients followed a protocol in which patients were treated with an ACE inhibitor if they developed hypertension and/or macroproteinuria. The model predicted that strategy II would produce as many quality-adjusted life-years as strategy I at nearly the same cost if routine drug therapy reduced the rate of development of microalbuminuria by 26\% in all patients. Strategy III produced as many quality-adjusted life-years at less cost than strategy I if a high-risk cohort could be identified with a rate of developing microalbuminuria at four times the rate of low-risk patients and if drug therapy reduced the rate of developing microalbuminuria in this high-risk group by 20\%. In conclusion, routine ACE inhibitor therapy could prove to be cost-effective, especially if high-risk individuals could be identified. A prospective trial examining this goal should be considered.

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

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Abstract: Diabetic nephropathy is one of the major complications of insulin-dependent diabetes mellitus (IDDM), with proteinuria being the main clinical manifestation of diabetic nephropathy. Most patients who develop overt proteinuria progress to end-stage renal disease (ESRD), usually within 5 to 7 years; ESRD necessitates dialysis or renal transplantation. Although a relationship between blood pressure reduction and delaying of ESRD has been assumed for a long time, only recently has a controlled randomised clinical trial shown that the treatment of diabetic nephropathy with an ACE inhibitor can significantly delay the loss of renal function and, therefore, ESRD. Consistent with the clinical trial on which this economic evaluation was based, the costs and consequences of 2 alternatives were considered: (i) patients subject to blood pressure control with only antihypertensive medication, but without an ACE inhibitor (placebo group) and (ii) patients given ACE inhibitor therapy (captopril group) with similar blood pressure control to the placebo group. This cost-effectiveness analysis was performed from the perspective of the Italian National Health Service [Servizio Sanitario Nazionale (SSN)]. Accordingly, only direct costs related to publicly funded healthcare services were included. The number of dialysis-years avoided (DYA) was the clinical end-point. A 10-year time horizon was considered for the economic evaluation. Captopril therapy was dominant, being at the same time more effective and less costly. The total cost for the captopril alternative during the 10-year period was 21,901,625 Italian lire (L; 1993 values) per patient, while total cost for the placebo alternative was L30,352,590 per patient. Compared with placebo, 20.01 DYA per 100 patients treated were estimated with captopril therapy during the trial period, equivalent to 2.4 months per patient. The robustness of this result was confirmed by sensitivity analysis: for both extremes, captopril remained dominant. This economic evaluation, requested by the Italian Ministry of Health, demonstrated savings in healthcare expenditure with the use of an ACE inhibitor in patients with proteinuria.

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

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Abstract: Antihypertensive drugs slow the progressive decline in renal function seen in patients with insulin-dependent diabetes and nephropathy. In a recent study, the ACE inhibitor captopril protected against this deterioration in renal function. We developed an economic model to analyse the cost impact of ACE inhibitor treatment on progression to endstage renal failure (ESRF) in diabetic patients over 4 years. Two scenarios were compared: one describing the progression of a cohort of 1000 patients receiving 25 mg captopril three times daily, and the other for an equivalent cohort without such prophylactic treatment. Previously published data were used to estimate the transition rates for each stage from the onset of renal failure until death. All direct costs were discounted by an annual rate of 6\%, and were subjected to sensitivity analysis. The discounted cost saving of ACE inhibitor treatment for a cohort of 1000 patients was estimated as 0.95 million pounds over 4 years. Under sensitivity analysis, these results were very robust to variations in the costs of ESRF treatment. Prophylactic treatment with ACE inhibitors was predicted to provide substantial increases in life expectancy and reduction in the incidence of ESRF, while also providing significant economic savings.

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

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Abstract: A controlled, double-blind trial, carried out by Lewis and al., has shown that in 409 patients presenting with insulin-dependent diabetes, proteinuria in excess of 500 mg/day and plasma creatinine of less than 221 mumol/l, captopril treatment was able to reduce the risk of combined events (mortality, renal dialysis and transplantation) by 50\% (p = 0.006) and that of doubling plasma creatinine by 48\% (p = 0.007). We evaluated the cost/benefit ratio of this treatment on the basis of the medical outcome of this study and economic data for the French health-care system. The cost of the treatment by captopril is totally offset by the reduction in costs obtained by postponing dialysis and kidney transplantation, concomitant antihypertensive treatment and hospitalisation. In this study, the health expenditure savings in the captopril group amounted to 6 million French Francs. Spending 100.-Francs on captopril to treat diabetic nephropathy yielded savings of 575.-Francs. This economic advantage, plus a reduction of 6 in the number of deaths, corresponding to 131 life-years saved, demonstrates the favorable cost-benefit ratio of this treatment strategy.

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

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Abstract: OBJECTIVE: The results of a recent clinical trial. The Effect of ACE inhibition on Diabetic Nephropathy, demonstrated that captopril reduced the rate of renal failure, end-stage renal disease (ESRD), and death in patients with IDDM and nephropathy. The purpose of this study was to determine the cost-benefit and cost-effectiveness of captopril as a therapy in patients with IDDM as well as the potential savings for all patients with diabetes and nephropathy. RESEARCH DESIGN AND METHODS: We used the results from a randomized, placebo-controlled trial comparing captopril (207 patients) with placebo (202 patients), whose purpose was to determine whether captopril has kidney-protecting properties independent of its effect on blood pressure in diabetic nephropathy to develop a model of medical treatment for patients before progression to ESRD. To model the course of illness after progression to ESRD and to extend the model to patients with NIDDM, we used data from the U.S. Renal Data System and published literature. Medical resource cost data were based predominantly upon Medicare reimbursement levels, published wholesale drug prices, and surveying health care providers. The economic model uses a payer perspective to estimate direct cost. The cost to society (indirect cost) associated with lost patient productivity due to ESRD was also estimated. Using this information, we predicted the costs incurred annually and over a lifetime if patients with IDDM and NIDDM and overt nephropathy were treated with either placebo or captopril. We also constructed a model of the overall prevalence of diabetic nephropathy to estimate the aggregate savings in total U.S. health care expenditures. RESULTS: Treatment with captopril resulted in an absolute direct cost savings or benefit of \$32,550 per patient with IDDM over the course of a lifetime compared to treatment with placebo. For patients with NIDDM, the direct cost savings totaled \$9,900 per patient. Absolute savings were found for indirect costs as well: \$84,390 per patient with IDDM and \$45,730 per patient with NIDDM. If captopril therapy were initiated in 1995 for patients with either IDDM or NIDDM and nephropathy, the aggregate health care cost savings (i.e. direct cost savings alone) would be \$189 million a year for the year 1999 and \$475 million a year in 2004, the present value of cumulative health care cost savings for these 10 years would be \$2.4 billion. CONCLUSIONS: The use of captopril in diabetic nephropathy will provide significant savings in health care costs; in addition, it will result in savings in indirect cost, which reflects the broader societal benefit.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  DM1;  DM2;  

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Abstract: Randomized controlled trials (RCTs), such as the Diabetes Control and Complications Trial (DCCT), usually evaluate the efficacy of a single treatment strategy. The DCCT, for example, evaluates intensive diabetes management aimed at achieving glucose levels as close to normal as possible to modify specific pathophysiological outcomes--specifically, the development or worsening of microvascular disease. In contrast, longitudinal observational studies, such as the type II diabetes Patient Outcome Research Team (PORT) study, address medical effectiveness; that is, how well prevailing treatments work in clinical practice settings. The PORT relies heavily on patient-reported measures of general and diabetes-specific health status, in addition to using complications as major study outcomes. In the type II diabetes PORT, 4,000 patients with type II diabetes and a wide range of socioeconomic, demographic, and disease characteristics, from three widely dispersed geographic settings and varying systems of care, are being followed for a 2.5-year period. Data are collected from periodic self-administered patient questionnaires and from administrative data bases. In the PORT study, nonmutable confounders, such as case-mix, and potentially mutable features, such as patients preferences for treatment, health habits, regimen adherence, family support, and physicians interpersonal style, are carefully measured. The PORT study will examine the effectiveness of preventive care and established disease treatment in relation to eye, cardiovascular, and extremity disease, measuring and relating use of health-care services to patient outcomes. The results have the potential for maximizing quality of care and minimizing use of services in type II diabetes by matching physician-level profiles of patient outcomes with medical-care-process data and making this information accessible to practicing physicians.

 prevention;  diabetes;  ACEI;  nephropathy;  economic evaluation;  

Abstract: BACKGROUND. Renal function declines progressively in patients who have diabetic nephropathy, and the decline may be slowed by antihypertensive drugs. The purpose of this study was to determine whether captopril has kidney-protecting properties independent of its effect on blood pressure in diabetic nephropathy. METHODS. We performed a randomized, controlled trial comparing captopril with placebo in patients with insulin-dependent diabetes mellitus in whom urinary protein excretion was > or = 500 mg per day and the serum creatinine concentration was or = 1.5 mg per deciliter, creatinine clearance declined at a rate of 23 +/- 25 percent per year in the captopril group and at a rate of 37 +/- 25 percent per year in the placebo group (P = 0.01). Captopril treatment was associated with a 50 percent reduction in the risk of the combined end points of death, dialysis, and transplantation that was independent of the small disparity in blood pressure between the groups. CONCLUSIONS. Captopril protects against deterioration in renal function in insulin-dependent diabetic nephropathy and is significantly more effective than blood-pressure control alone.

 prevention;  diabetes;  ACEI;  nephropathy;  Captopril;  clinical trial;  

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Abstract: OBJECTIVE: To evaluate the long-term effect of angiotensin-converting enzyme inhibition on proteinuria and on the rate of decline in kidney function in patients with type II diabetes mellitus and microalbuminuria. DESIGN: Randomized, double-blind, placebo-controlled trial. Each patient was followed for 5 years. SETTING: Six clinics for diabetes mellitus coordinated by a department of medicine in a university hospital in Israel. PATIENTS: Ninety-four normotensive, type II diabetic patients with microalbuminuria and normal renal function. INTERVENTION: The patients were randomly assigned to receive enalapril, 10 mg per day, or placebo. Any increase in blood pressure was treated with long-acting nifedipine. MEASUREMENTS: Albuminuria, blood pressure, serum creatinine, fasting blood glucose, and glycosylated hemoglobin levels, every 3 to 4 months. RESULTS: In the patients treated with enalapril, albuminuria decreased from 143 +/- 64 (mean +/- SD) mg/24 h to 122 +/- 67 mg/24 h during the first year. Thereafter, we observed a slow increase to 140 +/- 134 mg/24 h after 5 years. In the placebo group, albuminuria increased from 123 +/- 58 mg/24 h to 310 +/- 167 mg/24 h after 5 years. (Difference in rate of change in proteinuria [P < 0.05]). Kidney function (expressed as mean reciprocal creatinine) declined by 13% in the placebo group and remained stable (-1%) in the enalapril group (P < 0.05). Control of blood glucose levels remained stable, in both groups, throughout the study. The mean blood pressure was stable in the enalapril group (initial group mean, 99 +/- 2.1 mm Hg; fifth-year mean, 100 +/- 3.2 mm Hg) and increased in the placebo group from an initial mean value of 97 +/- 3.2 mm Hg to 102 +/- 3.4 mm Hg at the end of the study period (P = 0.082). CONCLUSIONS: In normotensive patients with diabetes mellitus type II, the institution of angiotensin-converting enzyme inhibition during early stages of diabetic nephropathy results in long-term stabilization of plasma creatinine levels and of the degree of urinary loss of albumin. These effects are probably independent of the antihypertensive action of these agents.