losartan

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

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

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

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

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

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

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Abstract: BACKGROUND: Diabetic nephropathy is the leading cause of end-stage renal disease. Interruption of the renin-angiotensin system slows the progression of renal disease in patients with type 1 diabetes, but similar data are not available for patients with type 2, the most common form of diabetes. We assessed the role of the angiotensin-II-receptor antagonist losartan in patients with type 2 diabetes and nephropathy. METHODS: A total of 1513 patients were enrolled in this randomized, double-blind study comparing losartan (50 to 100 mg once daily) with placebo, both taken in addition to conventional antihypertensive treatment (calcium-channel antagonists, diuretics, alpha-blockers, beta-blockers, and centrally acting agents), for a mean of 3.4 years. The primary outcome was the composite of a doubling of the base-line serum creatinine concentration, end-stage renal disease, or death. Secondary end points included a composite of morbidity and mortality from cardiovascular causes, proteinuria, and the rate of progression of renal disease. RESULTS: A total of 327 patients in the losartan group reached the primary end point, as compared with 359 in the placebo group (risk reduction, 16 percent; P=0.02). Losartan reduced the incidence of a doubling of the serum creatinine concentration (risk reduction, 25 percent; P=0.006) and end-stage renal disease (risk reduction, 28 percent; P=0.002) but had no effect on the rate of death. The benefit exceeded that attributable to changes in blood pressure. The composite of morbidity and mortality from cardiovascular causes was similar in the two groups, although the rate of first hospitalization for heart failure was significantly lower with losartan (risk reduction, 32 percent; P=0.005). The level of proteinuria declined by 35 percent with losartan (P<0.001 for the comparison with placebo). CONCLUSIONS: Losartan conferred significant renal benefits in patients with type 2 diabetes and nephropathy, and it was generally well tolerated.

 prevention;  diabetes;  arb;  nephropathy;  RENAAL;  losartan;  clinical trial;  

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