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Type 2 diabetes is the leading cause of end-stage renal disease (ESRD) in most industrialized countries in Europe. The RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan) Study evaluated the renal protective effects of losartan versus placebo on a background of non-ACE-I/non-AIIA conventional antihypertensive therapy in 1513 patients with type 2 diabetes and nephropathy. Losartan reduced the incidence of doubling of serum creatinine, end-stage renal disease (ESRD), or death by 16% (P=0.022) and reduced the risk of progression to ESRD, defined as the initiation of dialysis or transplantation, by 29% (P=0.002). We set out to estimate the potential effect of losartan on the burden and costs associated with ESRD over 3.5 years in the European Union (EU). The risk reduction in new cases of ESRD was calculated by combining type 2 diabetes population estimates for the EU with the percent absolute risk reduction of ESRD in patients treated with losartan as observed in RENAAL. The number of days each patient experienced ESRD was defined as the length of time from onset of ESRD until the minimum of death or 3.5 years. ESRD-free person-years avoided with losartan treatment were calculated by combining the population estimate with the ESRD days avoided divided by number of days in a year. ESRD costs from Germany were used to approximate the potential cost savings from reduced time with ESRD and fewer ESRD cases on a EU wide basis. There are approximately 700,000 diagnosed type 2 diabetes patients with proteinuria (urine albumin/creatinine >or=300 mg/g) in the EU. The addition of losartan to the treatment regimen of these patients is expected to lead to a reduction of 44,100 cases of ESRD, 64,400 fewer person-years with ESRD, and reduce ESRD-related costs by euro 2.6 billion over 3.5 years based on RENAAL data. Treatment with losartan not only reduced the incidence of ESRD, but also can result in substantial cost savings in the European Union.

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

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