In the AWARD-7 study, conducted in T2D and moderate-to-severe CKD, DU treatment was associated with slower decline in estimated glomerular filtration rate (eGFR) compared to IG. One-year treatment with DU 1.5 mg weekly was associated with a lower rate of CKD outcomes, including eGFR decline ≥40% or end-stage renal disease (ESRD), compared to IG at similar levels of glycemic control and blood pressure. The aim of this post hoc analysis was to determine risk of these CKD outcomes between treatments in albuminuria subgroups. Participants with T2D and CKD stages 3-4 were randomized (1:1:1) to DU 0.75 mg or 1.5 mg weekly versus titrated IG daily, added-on to titrated insulin lispro, for one year. The occurrence of the composite outcome of eGFR decline ≥40% or ESRD was compared between treatments using a Cox proportional hazards model time-to-first event analysis. At baseline, treatment groups had similar eGFR by albuminuria subgroups (Table). The majority of events occurred in patients with macroalbuminuria (Table). Compared to IG, the incidence rate of the composite endpoint was significantly lower for DU 1.5 mg in the overall study population and in those with macroalbuminuria.
In conclusion, the risk of ≥40% eGFR decline or ESRD outcomes was reduced by more than half for DU 1.5 mg compared to IG, particularly in the macroalbuminuric subgroup.
K.R. Tuttle: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Goldfinch Bio. Research Support; Self; Eli Lilly and Company. B.L. Rayner: Advisory Panel; Self; AstraZeneca, Servier. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Cipla Medpro, Novartis AG. M. Lakshmanan: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. B. Woodward: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. A. Kwan: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. M. Konig: Employee; Self; Eli Lilly and Company, Eli Lilly and Company. F.T. Botros: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.
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