P-151: Modeling the clinical outcomes of Tarka in diabetic nephropathy

The purpose of this study was to determine the long-term clinical and economic outcomes of combined ACE-inhibitor and calcium antagonist therapy (Tarka) versus standard care for preventing the development of end-stage renal disease in type 2 diabetic patients with hypertension and macroproteinuria in the United States. A Markov model was developed to estimate the lifetime clinical outcomes and costs of prevention diabetic nephropathy by using ACE-inhibitor or calcium antagonist mono-therapy versus combination treatment (Tarka). Probabilities, unit costs, resource utilization data and utilities were obtained from published literature, clinical trial reports, and a national database (USRDS). Progression of renal failure was measured using the rate of proteinuria as indicator. The analysis measured cost from a third-party payer perspective and clinical outcomes as gains in reduction of mortality, life years gained and Quality Adjusted Life Years (QALYs). In the 5-year analysis Tarka yielded a 5.5% reduction in mortality, when it was compared to Trandolapril (18.6% vs. 24.1%) and a 6.2% reduction compared to Verapamil (18.6% vs. 24.8%). In the 10-year analysis Tarka resulted in a 7.0% reduction in mortality, when it was compared to Trandolapril (54.8% vs. 61.8%) and a 7.8% reduction compared to Verapamil (54.8% vs. 62,6%). In the lifetime analysis Tarka resulted in a 0.9 year gain in life expectancy, when it was compared to Trandolapril (10.1 vs. 9.2) and 1 year gain in life expectancy compared to Verapamil (10.1 vs. 9.1). The lifetime model yielded a gain of 0.7 QALYs when it was compared to Trandolapril (7.6 vs. 6.9) and a gain of 0.8 QALYs compared to Verapamil (7.6 vs. 6.8). From the payer perspective Tarka was cost saving compared with standard therapy (ACE inhibitors and calcium antagonists) over all time horizons (5, 10 years and life-time horizon). The conclusion is that the use of Tarka yields superior clinical outcomes in terms of mortality, life years gained and QALYs, while the higher drug costs for Tarka were offset by reductions in other costs. Consequently Tarka is a cost-effective treatment in patients with overt proteinuria without extra health care costs.