Abstract
Background: AVOID was a randomized, double-blind, 6-mo. trial of adding aliskiren to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and nephropathy with residual proteinuria (urinary albumin creatinine ratio [UACR]>100mg/g) after ≥3 mo. of 100mg/d losartan. Aliskiren reduced mean UACR by 20% vs. placebo (P=.009). A previous study examined cost-effectiveness of aliskiren, but did not examine the potential effects of aliskiren on risks, costs, and quality of life effects of cardiovascular disease (CVD). Methods: A Markov model was used to project lifetime incidence of cardiovascular disease (CVD) and end-stage renal disease (ESRD), life years (LYs), quality-adjusted life years (QALYs), and expected lifetime costs (US healthcare system perspective) with losartan plus optimal antihypertensive therapy +/− aliskiren. Albuminuria progression by treatment was projected by generalized linear model regression equations fit to UACR from AVOID. Probabilities of CVD/ESRD by UACR and death without CVD/ESRD by age were obtained by calibrating the model to results for losartan and placebo in the RENAAL study. Other parameters were from published sources. Results: With losartan, mean UACR is projected to increase from approximately 790 mg/g at baseline to approximately 1700 mg/g at 3.5 years and to remain at this level for the duration of the model. Assuming the beneficial effects of aliskiren on the rate of progression of UACR persist for as long as patients remain on therapy, mean UACR with aliskiren plus losartan is projected to decline from 790 mg/g at baseline to 730 mg/g after 1 year, then increase to 740 mg/g after 4 years and remain at that level for the remainder of the model. Under these assumptions, adding aliskiren to losartan and optimal antihypertensive therapy is projected to reduce lifetime incidence of ESRD by 5% and CVD by 4%, increase LY by 0.19 and QALYs by 0.13. Expected lifetime costs are reduced by $7700, as savings from averted CVD ($1500) and ESRD ($12 800) more than offset additional costs associated with aliskiren treatment ($5400). Conclusion: Adding aliskiren to losartan in this setting leads to reduced cost and increased QALYs.
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