Palmer, A. J.

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

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.

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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.

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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.

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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 ı 12,658825 per patient while late irbesartan treatment was associated with a cost savings of ı 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.

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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 pound sterling 5125 and pound sterling 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.

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

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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.

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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.

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Abstract: OBJECTIVE: The aim of this study was to determine the most cost-effective time point for initiation of irbesartan treatment in hypertensive patients with type 2 diabetes and renal disease. RESEARCH DESIGN AND METHODS: This study was a Markov model-simulated progression from microalbuminuria to overt nephropathy, doubling of serum creatinine, end-stage renal disease, and death in hypertensive patients with type 2 diabetes. Two irbesartan strategies were created: early irbesartan 300 mg daily (initiated with microalbuminuria) and late irbesartan (initiated with overt nephropathy). These strategies were compared with control, which consisted of antihypertensive therapy with standard medications (excluding ACE inhibitors, other angiotensin-2 receptor antagonists, and dihydropyridine calcium channel blockers) with comparable blood pressure control, initiated at microalbuminuria. Transition probabilities were taken from the Irbesartan in Reduction of Microalbuminuria-2 study, Irbesartan in Diabetic Nephropathy Trial, and other published sources. Costs and life expectancy, discounted at 3% yearly, were projected over 25 years for 1,000 simulated patients using a third-party payer perspective in a U.S. setting. RESULTS: Compared with control, early and late irbesartan treatment in 1,000 patients were projected to save (mean +/- SD) 11.9 +/- 3.3 million dollars and 3.3 +/- 2.7 million dollars, respectively. Early use of irbesartan added 1,550 +/- 270 undiscounted life-years (discounted 960 +/- 180), whereas late irbesartan added 71 +/- 40 life-years (discounted 48 +/- 27) in 1,000 patients. Early irbesartan treatment was superior under a wide-range of plausible assumptions. CONCLUSIONS: Early irbesartan treatment was projected to improve life expectancy and reduce costs in hypertensive patients with type 2 diabetes and microalbuminuria. Later use of irbesartan in overt nephropathy is also superior to standard care, but irbesartan should be started earlier and continued long term.

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Abstract: BACKGROUND: End-stage renal disease (ESRD)-related health care costs are substantial. Improving clinical outcomes in patients at risk of progression to ESRD could lead to considerable health care savings. OBJECTIVE: We estimated the cost-effectiveness of irbesartan compared with placebo or amlodipine in the treatment of patients with type 2 diabetes mellitus, hypertension, and overt nephropathy. METHODS: Three treatments for hypertension patients with type 2 diabetes mellitus and nephropathy were assessed: (1) irbesartan, (2) amlodipine, and (3) placebo. A Markov model was developed based on primary data from the Irbesartan in Diabetic Nephropathy Trial and the United States Renal Data System. Projected survival and costs were compared for each treatment at 3-, 10-, and 25-year time horizons. Different assumptions of treatment benefits and costs were tested with use of sensitivity analyses. RESULTS: At 10 and 25 years, the model projected irbesartan to be both the least costly and most effective (ie, demonstrating a survival advantage) strategy. At 25

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

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