Integrating short-term risk marker changes into the PRE score accurately predicted the exenatide-induced renal risk reduction observed in EXSCEL (observed HR 0.87; 95% CI 0.77-0.99).
Observational
Can short-term changes in cardio-renal risk markers predict the long-term renal effects of exenatide in patients with type 2 diabetes?
Integrating short-term risk marker changes into a multivariable risk score accurately predicted the magnitude of long-term renal risk reduction with exenatide in patients with type 2 diabetes.
Hazard Ratio: 0.87 (95% CI 0.77–0.99)
AIM: To assess whether the previously developed multivariable risk prediction framework (PRE score) could predict the renal effects observed in the EXSCEL cardiovascular outcomes trial using short-term changes in cardio-renal risk markers. MATERIALS AND METHODS: Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated. The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD). Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes. RESULTS: Compared with placebo, mean HbA1c, BMI, SBP and total cholesterol were lower at 6 months with exenatide, as was the incidence of new microalbuminuria. The PRE score predicted a relative risk reduction for the 30% eGFR decline + ESRD endpoint of 11.3% (HR 0.89; 95% CI 0.83-0.94), compared with 12.7% (HR 0.87; 0.77-0.99) observed risk reduction. For the 40% eGFR decline + ESRD endpoint, the predicted and observed risk reductions were 11.0% (HR 0.89; 0.82-0.97) and 13.7% (HR 0.86, 0.72-1.04), respectively. CONCLUSIONS: Integrating short-term risk marker changes into a multivariable risk score predicted the magnitude of renal risk reduction observed in EXSCEL.
Idzerda et al. (Tue,) conducted a observational in Type 2 diabetes. Exenatide vs. Placebo was evaluated on Composite of a sustained 30% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD) (HR 0.87, 95% CI 0.77-0.99). Integrating short-term risk marker changes into the PRE score accurately predicted the exenatide-induced renal risk reduction observed in EXSCEL (observed HR 0.87; 95% CI 0.77-0.99).