diabetes

Abstract: OBJECTIVES: To project the long-term clinical and economic outcomes of treatment with biphasic insulin aspart 30 (BIAsp 70/30, 30\% soluble and 70\% protaminated insulin aspart) vs. insulin glargine in insulin-naive type 2 diabetes patients failing to achieve glycemic control with oral antidiabetic agents alone (OADs). METHODS: Baseline patient characteristics and treatment effect data from the recent INITIATE clinical trial served as input to a peer-reviewed, validated Markov/Monte-Carlo simulation model. INITIATE demonstrated improvements in HbA1c favouring BIAsp 70/30 vs. glargine (-0.43\%; p < 0.005) and greater efficacy in reaching glycaemic targets among patients poorly controlled on OAD therapy. Effects on life expectancy (LE), quality-adjusted life expectancy (QALE), cumulative incidence of diabetes-related complications and direct medical costs (2004 USD) were projected over 35 years. Clinical outcomes and costs were discounted at a rate of 3.0\% per annum. Sensitivity analyses were performed. RESULTS: Improvements in glycaemic control were projected to lead to gains in LE (0.19 +/- 0.24 years) and QALE (0.19 +/- 0.17 years) favouring BIAsp 70/30 vs. glargine. Treatment with BIAsp 70/30 was also associated with reductions in the cumulative incidences of diabetes-related complications, notably in renal and retinal conditions. The incremental cost-effectiveness ratio was \$46 533 per quality-adjusted life year gained with BIAsp 70/30 vs. glargine (for patients with baseline HbA1c >/= 8.5\%, it was \$34 916). Total lifetime costs were compared to efficacy rates in both arms as a ratio, which revealed that the lifetime cost per patient treated successfully to target HbA1c levels of <7.0\% and

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 diabetes;  guidelines;  

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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: As newer oral diabetes agents continue to emerge on the market, comparative evidence is urgently required to guide appropriate therapy. PURPOSE: To summarize the English-language literature on the benefits and harms of oral agents (second-generation sulfonylureas, biguanides, thiazolidinediones, meglitinides, and alpha-glucosidase inhibitors) in the treatment of adults with type 2 diabetes mellitus. DATA SOURCES: The MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched from inception through January 2006 for original articles and through November 2005 for systematic reviews. Unpublished U.S. Food and Drug Administration and industry data were also searched. STUDY SELECTION: 216 controlled trials and cohort studies and 2 systematic reviews that addressed benefits and harms of oral diabetes drug classes available in the United States. DATA EXTRACTION: Using standardized protocols, 2 reviewers serially abstracted data for each article. DATA SYNTHESIS: Evidence from clinical trials was inconclusive on major clinical end points, such as cardiovascular mortality. Therefore, the review was limited mainly to studies of intermediate end points. Most oral agents (thiazolidinediones, metformin, and repaglinide) improved glycemic control to the same degree as sulfonylureas (absolute decrease in hemoglobin A1c level of about 1 percentage point). Nateglinide and alpha-glucosidase inhibitors may have slightly weaker effects, on the basis of indirect comparisons of placebo-controlled trials. Thiazolidinediones were the only class that had a beneficial effect on high-density lipoprotein cholesterol levels (mean relative increase, 0.08 to 0.13 mmol/L [3 to 5 mg/dL]) but a harmful effect on low-density lipoprotein (LDL) cholesterol levels (mean relative increase, 0.26 mmol/L [10 mg/dL]) compared with other oral agents. Metformin decreased LDL cholesterol levels by about 0.26 mmol/L (10 mg/dL), whereas other oral agents had no obvious effects on LDL cholesterol levels. Most agents other than metformin increased body weight by 1 to 5 kg. Sulfonylureas and repaglinide were associated with greater risk for hypoglycemia, thiazolidinediones with greater risk for heart failure, and metformin with greater risk for gastrointestinal problems compared with other oral agents. Lactic acidosis was no more common in metformin recipients without comorbid conditions than in recipients of other oral diabetes agents. LIMITATIONS: Data on major clinical end points were limited. Studies inconsistently reported adverse events other than hypoglycemia, and definitions of adverse events varied across studies. Some harms not assessed in trials or observational studies may have been overlooked. CONCLUSIONS: Compared with newer, more expensive agents (thiazolidinediones, alpha-glucosidase inhibitors, and meglitinides), older agents (second-generation sulfonylureas and metformin) have similar or superior effects on glycemic control, lipids, and other intermediate end points. Large, long-term comparative studies are needed to determine the comparative effects of oral diabetes agents on hard clinical end points.

 diabetes;  glycemic control;  clinical 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: 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: 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: 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: 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: 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: OBJECTIVE: To examine the role of self-monitoring of blood glucose (SMBG) in the management of diabetes mellitus. METHODS: Current trends and published evidence are reviewed. RESULTS: Despite the widespread evidence that lowering glycemic levels reduces the risks of complications in patients with diabetes, little improvement in glycemic control has been noted among patients in the United States and Europe in recent years. Although SMBG has been widely used, considerable controversy surrounds its role in achieving glycemic control. The high cost of test strips has made considerations regarding appropriate recommendations for SMBG a priority, especially in light of the current climate of health-care cost-containment. Existing clinical recommendations lack specific guidance to patients and clinicians regarding SMBG practice intensity and frequency, particularly for those patients not treated with insulin. Previous studies of the association between SMBG and glycemic control often found weak and conflicting results. CONCLUSION: A reexamination of the role of SMBG is needed, with special attention to the unique needs of patients using different diabetes treatments, within special clinical subpopulations, and during initiation of SMBG versus its ongoing use. Further understanding of the intensity and frequency of SMBG needed to reflect the variability in glycemic patterns would facilitate more specific guideline development. Educational programs that focus on teaching patients the recommended SMBG practice, specific glycemic targets, and appropriate responses to various blood glucose readings would be beneficial. Continuing medical education programs for health-care providers should suggest ways to analyze patient SMBG records to tailor medication regimens. For transfer or communication of SMBG reports to the clinical staff, a standardized format that extracts key data elements and allows quick review by health-care providers would be useful. Because the practice of SMBG is expensive, the cost-effectiveness of SMBG needs to be carefully assessed.

 diabetes;  review;  SMBG;  

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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: 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: 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: BACKGROUND: The Diabetes Prevention Program (DPP) demonstrated that interventions can delay or prevent the development of type 2 diabetes. OBJECTIVE: To estimate the lifetime cost-utility of the DPP interventions. DESIGN: Markov simulation model to estimate progression of disease, costs, and quality of life. DATA SOURCES: The DPP and published reports. TARGET POPULATION: Members of the DPP cohort 25 years of age or older with impaired glucose tolerance. TIME HORIZON: Lifetime. PERSPECTIVES: Health system and societal. INTERVENTIONS: Intensive lifestyle, metformin, and placebo interventions as implemented in the DPP. OUTCOME MEASURES: Cumulative incidence of diabetes, microvascular and neuropathic complications, cardiovascular complications, survival, direct medical and direct nonmedical costs, quality-adjusted life-years (QALYs), and cost per QALY. RESULTS OF BASE-CASE ANALYSIS: Compared with the placebo intervention, the lifestyle and metformin interventions were estimated to delay the development of type 2 diabetes by 11 and 3 years, respectively, and to reduce the absolute incidence of diabetes by 20% and 8%, respectively. The cumulative incidence of microvascular, neuropathic, and cardiovascular complications were reduced and survival was improved by 0.5 and 0.2 years. Compared with the placebo intervention, the cost per QALY was approximately 1100 dollars for the lifestyle intervention and $31 300 for the metformin intervention. From a societal perspective, the interventions cost approximately 8800 dollars and 29,900 dollars per QALY, respectively. From both perspectives, the lifestyle intervention dominated the metformin intervention. RESULTS OF SENSITIVITY ANALYSIS: Cost-effectiveness improved when the interventions were implemented as they might be in routine clinical practice. The lifestyle intervention was cost-effective in all age groups. The metformin intervention did not represent good use of resources for persons older than 65 years of age. LIMITATIONS: Simulation results depend on the accuracy of the underlying assumptions, including participant adherence. CONCLUSIONS: Health policy should promote diabetes prevention in high-risk individuals.

 prevention;  diabetes;  glycemic control;  economic evaluation;  metformin;  lifestyle;  

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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 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: 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: 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: 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: 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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 prevention;  diabetes;  glycemic control;  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 AND RATIONALE: Recent data suggest that insulin glargine might be a cost-effective alternative to conventional insulin therapy in patients with type 2 diabetes mellitus (T2DM). The aim of this observational study was to evaluate the treatment costs of insulin glargine in combination with oral antidiabetic drugs (OADs) compared with conventional insulin therapy in T2DM in everyday clinical practice. PATIENTS AND METHODS: Data were obtained from a cohort of 678 patients with T2DM not adequately controlled by OADs alone (HbA1c mean 9.1 +/- 1.7\%). Patients received either insulin glargine in addition to oral therapy or were switched to conventional insulin therapy. Treatment and dosing decisions were made at the physicians discretion, reflecting everyday practice. Patients were followed for 2-4 months. Primary outcome parameters were total treatment costs and clinical efficacy. RESULTS: The two therapeutic regimens were equally effective in decreasing HbA1c to 7.8\% (p < 10(-9)). Patients in the insulin glargine plus OAD group controlled their blood glucose level at endpoint with a median of 60 test strips per month and those in the conventional insulin therapy group with a median of 80 strips per month (p = 0.000000739). Total daily costs of insulin, needles, glycemic control and OAD treatment per patient were similar in the two treatment groups (insulin glargine group 1.91 Euro vs conventional group 1.99 Euro). CONCLUSION: The two treatment regimens were equally effective in improving glycemic control. These results were achieved with significantly lower insulin doses and fewer blood glucose test strips in the insulin glargine group, which therefore led to cost equivalence when compared with conventional insulin therapy.

 prevention;  diabetes;  glycemic control;  Insulin;  economic evaluation;  

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Abstract: OBJECTIVE: Safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 70/30, prebreakfast and presupper) were compared with once-daily insulin glargine in type 2 diabetic subjects inadequately controlled on oral antidiabetic drugs (OADs). RESEARCH DESIGN AND METHODS: This 28-week parallel-group study randomized 233 insulin-naive patients with HbA(1c) values >/=8.0% on >1,000 mg/day metformin alone or in combination with other OADs. Metformin was adjusted up to 2,550 mg/day before insulin therapy was initiated with 5-6 units BIAsp 70/30 twice daily or 10-12 units glargine at bedtime and titrated to target blood glucose (80-110 mg/dl) by algorithm-directed titration. RESULTS: A total of 209 subjects completed the study. At study end, the mean HbA(1c) value was lower in the BIAsp 70/30 group than in the glargine group (6.91 +/- 1.17 vs. 7.41 +/- 1.24%, P 8.5% (-3.13 +/- 1.63 vs. -2.60 +/- 1.50%, respectively; P 8.5%.

 diabetes;  Insulin;  clinical trial;  INITIATE;  

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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: 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: 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: 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: Aims. To evaluate the structured PROSIT(R) disease management programme for high-risk diabetic patients in primary care with respect to the cardio-vascular risk profile and mortality. Subjects and Methods. Retrospectively 55 albuminuric Type 2 diabetic patients included into the PROSIT(R) programme from 1994 to 1999 (intervention group: age 66.6 +/- 10.5 years, known duration of diabetes 8.9 +/- 6.5 years) were compared with 58 albuminuric patients not participating in the PROSIT(R) programme (control group: age 68.5 +/- 10.4 years, known duration of diabetes 8.5 +/- 6.7 years). Within PROSIT(R) a structured multifactorial intervention programme was applied. The main characteristics of this intervention were strict follow-ups of the patients risk profile every three months and the use of quality management methods (definition of target values, structured documentation, central data feedback with diagnostic and therapeutic recommendations based on European guidelines). The cardio-vascular risk profile, therapeutic intervention, and secondary diabetic complications were compared between both groups in 1994 and 1999. Results. In the period from 1994 to 1999 the intervention group showed a significant improvement in the vascular risk profile, while the control group did not. In 1999 the mean arterial blood pressure was significantly lower compared to the control group (115 +/- 13 mm Hg vs. 125 +/- 16 mm Hg, p < 0.05). The HbA1c improved only in the intervention group and in 1999 it was significantly lower than in the control group (7.0 +/- 1.3 \% vs. 8.4 +/- 1.8 \%, p < 0.01). Moreover, the occurrence of clinical endpoints in the intervention group could be reduced: Both the mortalitly rate (14.5 \% vs. 34.5 \%, p < 0.05) and the rate of new myocardial infarctions (6 \% vs. 20 \%, p < 0.05) of the intervention group were significantly lower. Conclusions. Participation of albuminuric Type 2 diabetic patients and their physicians in a structured intervention programme showed positive effects on the cardio-vascular risk profile and endpoints compared with a group of non-participating patients and physicians.

 diabetes;  screening;  MICROALBUMINURIA;  clinical trial;  PROSIT;  

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Abstract: AIMS/HYPOTHESIS: The aim of this study was to develop a simulation model for type 2 diabetes that can be used to estimate the likely occurrence of major diabetes-related complications over a lifetime, in order to calculate health economic outcomes such as quality-adjusted life expectancy. METHODS: Equations for forecasting the occurrence of seven diabetes-related complications and death were estimated using data on 3642 patients from the United Kingdom Prospective Diabetes Study (UKPDS). After examining the internal validity, the UKPDS Outcomes Model was used to simulate the mean difference in expected quality-adjusted life years between the UKPDS regimens of intensive and conventional blood glucose control. RESULTS: The models forecasts fell within the 95% confidence interval for the occurrence of observed events during the UKPDS follow-up period. When the model was used to simulate event history over patients lifetimes, those treated with a regimen of conventional glucose control could expect 16.35 undiscounted quality-adjusted life years, and those receiving treatment with intensive glucose control could expect 16.62 quality-adjusted life years, a difference of 0.27 (95% CI: -0.48 to 1.03). CONCLUSIONS/INTERPRETATIONS: The UKPDS Outcomes Model is able to simulate event histories that closely match observed outcomes in the UKPDS and that can be extrapolated over patients lifetimes. Its validity in estimating outcomes in other groups of patients, however, remains to be evaluated. The model allows simulation of a range of long-term outcomes, which should assist in informing future economic evaluations of interventions in type 2 diabetes.

 diabetes;  economic evaluation;  UKPDS;  

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Abstract: OBJECTIVE: The objective of this study was to describe an approach to modeling the efficiency of an intervention by focusing on an established intermediate end point directly. A case study addresses the economic efficiency of obtaining dual glycemic control over time, according to initial choice of treatment. METHODS: From the perspective of a payer in the United States, instead of the usual approach of basing the model on projecting long-term diabetic complications from glycemic control, this model focuses directly on glycemic control. Treatment changes and associated health-care utilization needed to address postprandial glucose. After assigning each of 10000 drug-naive patients, HbA1c, age, race, and sex based on distributions from a randomized clinical trial, the model applies the efficacy of nateglinide compared to metformin. Sensitivity analyses were carried out for all parameters. Costs are reported in year 2000 US dollars and discounted at 3\%. RESULTS: In the base case, starting on nateglinide and increasing the time in dual glycemic control over 3 years by 2.4 months led to savings of US dollars 295 compared to starting on metformin. Savings increased with stricter treatment criteria but decreased if glycemic control was better initially. CONCLUSIONS: This study illustrates the use of an efficiency model that focuses directly on the relevant short-term end point: glycemic control. Starting patients with nateglinide is shown to be an efficient way of obtaining dual glycemic control during the first 3 years of treatment.

 prevention;  diabetes;  glycemic control;  economic evaluation;  metformin;  nateglinide;  

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