PDB12 Comparative Effectiveness Study of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers in Patients With Type 2 Diabetes

Abstract

and Ն9%, respectively. Compared with placebo, more patients achieved HbA1c Ͻ7% (39.4% vs 24.4%) and Ͻ8% (79.5% vs 60.6%) and fewer patients remained at or worsened to HbA1c Ͼ9% (4.2% vs 13.9%) with dapagliflozin. CONCLUSIONS: Dapagliflozin 10 mg/day reduced HbA1c across all baseline HbA1c categories; greater reductions were seen in patients with higher baseline HbA1c. Substantially more patients attained HEDIS HbA1c categories of Ͻ7% and Ͻ8% and substantially fewer patients remained at or worsened to HbA1c Ͼ9% with dapagliflozin, compared with placebo. Collectively, dapagliflozin provided better glycemic control than placebo over a range of HbA1c levels. OBJECTIVES:To evaluate the long-term clinical and economic consequences of saxagliptin in comparison with sulphonylurea available in the Russian market. METHODS:The analysis is based on the Cardiff Long Term Model (Clarke et al. 2004). Three scenarios were developed and tested. Scenario 1 "trial based scenario" (S1) the active treatment is saxagliptin (Onglyza®) added to metformin (MET), which is compared to MET plus sulphonylurea (SU); input data are derived from study D1680C00001 (Goke et al. 2010. Scenario 2 "real world scenario" (S2). Efficacy and safety data taken from study D1680C00001, the cohort was taken from the Russian Federal Diabetes Patient Register, time horizon was set to 40 years, HbA1c threshold of 9.0% was assumed. Scenario 3 "MET monotherapy scenario" (S3). Efficacy and safety data taken from a study of DeFronzo et al. 2009. Patient demographic characteristics were the same as in Scenario 2; time horizon -nine years as in the base case scenario 1. The cost-effectiveness analysis was performed from the government health care system's perspective. The costs applied were based on prices listed in the essential drug list (MoH 2010) and official standards of treatment developed by expert groups at the Ministry of Health level (Russian Federation). RESULTS: In S1 -MET plus saxagliptin was associated with an incremental costeffectiveness ratio (ICER) of Russian Roubles (RUB) 38,840 per QALY gained, and RUB 7,142,690 per life year gained (LYG) versus SU. In S2 -ICER of RUB 104,153 per QALY gained and RUB 9,884,121 per life year. In S3 -ICER resulted in RUB 20,353,081 per QALY and RUB 29,044,346 per life year gained. CONCLUSIONS: In both scenarios (1 and 2), assuming a willingness to pay threshold of RUB 800'000, saxagliptin would be considered cost-effective in the Russian setting.