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OBJECTIVE -- To assess the cost-effectiveness of intensive versus conventional therapy for 8 years as applied in the Steno-2 study in patients with type 2 diabetes and microalbuminuria. RESEARCH DESIGN AND METHODS -- A Markov model was developed to incorporate event and risk data from Steno-2 and account Danish-specific costs to project life expectancy, quality-adjusted life expectancy (QALE), and lifetime direct medical costs expressed in year 2005 Euros. Clinical and cost outcomes were projected over patient lifetimes and discounted at 3% annually. Sensitivity analyses were performed. RESULTS -- Intensive treatment was associated with increased life expectancy, QALE, and lifetime costs compared with conventional treatment. Mean ± SD undiscounted life expectancy was 18.1 ± 7.9 years with intensive treatment and 16.2 ± 7.3 years with conventional treatment (difference 1.9 years). Discounted life expectancy was 13.4 ± 4.8 years with intensive treatment and 12.4 ± 4.5 years with conventional treatment. Lifetime costs (discounted) for intensive and conventional treatment were €45,521 ± 19,697 and €41,319 ± 27,500, respectively (difference €4,202). Increased costs with intensive treatment were due to increased pharmacy and consultation costs. Discounted QALE was 1.66 quality-adjusted life-years (QALYs) higher for intensive (10.2 ± 3.6 QALYs) versus conventional (8.6 ± 2.7 QALYs) treatment, resulting in an incremental cost-effectiveness ratio of €2,538 per QALY gained. This is considered a conservative estimate because accounting prescription of generic drugs and capturing indirect costs would further favor intensified therapy. CONCLUSIONS -- From a health care payer perspective in Denmark, intensive therapy was more cost-effective than conventional treatment. Assuming that patients in both arms were treated in a primary care setting, intensive therapy became dominant (cost- and lifesaving). [ABSTRACT FROM AUTHOR]

OBJECTIVE -- The purpose of this study was to assess agreement between glomerular filtration rate (GFR) and the decline in GFR estimated with the Modification of Diet in Renal Disease (MDRD) Study Group equation or the Cockcroft-Gault formula and measured by the plasma clearance of 51Cr-EDTA. RESEARCH DESIGN AND METHODS -- We followed a cohort of 156 microalbuminuric type 2 diabetic patients for 8 years with four measurements of GFR and another cohort of 227 type 2 diabetic patients with overt diabetic nephropathy for 6.5 (range 3-17) years with seven (3-22) measurements of GFR. RESULTS -- For patients with microalbuminuria, mean ± SD baseline GFR was 117 ± 24 measured, 92 ± 20 estimated (MDRD equation), or 103 ± 24 ml ⋅ min-1 per 1.73 m² estimated (Cockcroft-Gault formula) (both P < 0.001); 95% limits of agreement were -66.1 to 20.3 (MDRD equation) and -58.7 to 30.7 (Cockcroft-Gault formula). The rate of decline in GFR was 4.1 ± 4.2 measured, 2.9 ± 2.8 estimated (MDRD equation), or 3.4 ± 3.2 ml ⋅ min-1 per 1.73 m² estimated (Cockcroft-Gault formula) (both P < 0.001). For patients with overt nephropathy, baseline GFR was 84 ± 30 measured, 73 ± 24 estimated (MDRD equation), or 81 ± 28 ml ⋅ min-1 per 1.73 m² estimated (Cockcroft-Gault formula) (both P < 0.001) with 95% limits of agreement -47 to 25 (MDRD equation) and -39 to 33 (Cockcroft-Gault formula). The rate of decline in GFR was 5.2 ± 4.1 measured, 4.2 ± 3.8 estimated (MDRD equation), and 4.6 ± 4.1 ml ⋅ min-1 per 1.73 m² estimated (Cockcroft-Gault formula) (both P < 0.001). CONCLUSIONS -- Particularly in microalbuminuric (hyperfiltering) patients, GFR is significantly underestimated with wide limits of agreement by the MDRD equation as well as by the Cockcroft-Gault formula. The rate of decline in GFR is also significantly underestimated with both equations. This makes GFR estimations based upon these equations unacceptable for monitoring kidney function in type 2 diabetic patients with incipient and overt diabetic nephropathy. [ABSTRACT FROM AUTHOR]