Microvascular and Cardiovascular Outcomes According to Renal Function in Patients Treated With Once-Weekly Exenatide: Insights From the EXSCEL Trial

Nov 24, 2019Diabetes care

Small Vessel and Heart Health in Patients with Different Kidney Function Taking Weekly Exenatide: Results from the EXSCEL Trial

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Abstract

Exenatide did not significantly change estimated glomerular filtration rate (eGFR) with a least squares mean difference of 0.21 mL/min/1.73 m².

Macroalbuminuria occurred in 2.2% of patients treated with exenatide compared to 2.5% in the placebo group.
No significant differences in retinopathy rates were observed between treatment groups.
Unadjusted analyses showed no reduction in renal composite outcomes with exenatide.
After adjustment, renal composite outcomes showed a significant reduction for the second composite measure (HR 0.85).
CV risk reductions were modestly present in patients with eGFR ≥60 mL/min/1.73 m², specifically for stroke (HR 0.74) and CV death (HR 1.08).

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OBJECTIVE: To evaluate the impact of once-weekly exenatide (EQW) on microvascular and cardiovascular (CV) outcomes by baseline renal function in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).

RESEARCH DESIGN AND METHODS: Least squares mean difference (LSMD) in estimated glomerular filtration rate (eGFR) from baseline between the EQW and placebo groups was calculated for 13,844 participants. Cox regression models were used to estimate effects by group on incident macroalbuminuria, retinopathy, and major adverse CV events (MACE). Interval-censored time-to-event models estimated effects on renal composite 1 (40% eGFR decline, renal replacement, or renal death) and renal composite 2 (composite 1 variables plus macroalbuminuria).

RESULTS: EQW did not change eGFR significantly (LSMD 0.21 mL/min/1.73 m[95% CI -0.27 to 0.70]). Macroalbuminuria occurred in 2.2% of patients in the EQW group and in 2.5% of those in the placebo group (hazard ratio [HR] 0.87 [95% CI 0.70-1.07]). Neither renal composite was reduced with EQW in unadjusted analyses, but renal composite 2 was reduced after adjustment (HR 0.85 [95% CI 0.74-0.98]). Retinopathy rates did not differ by treatment group or in the HbA-lowering or prior retinopathy subgroups. CV outcomes in those with eGFR <60 mL/min/1.73 mdid not differ by group. Those with eGFR ≥60 mL/min/1.73 mhad nominal risk reductions for MACE, all-cause mortality, and CV death, but interactions by renal function group were significant for only stroke (HR 0.74 [95% CI 0.58-0.93];for interaction = 0.035) and CV death (HR 1.08 [95% CI 0.85-1.38];for interaction = 0.031). 2 2 2 1c P P

CONCLUSIONS: EQW had no impact on unadjusted retinopathy or renal outcomes. CV risk was modestly reduced only in those with eGFR ≥60 mL/min/1.73 min analyses unadjusted for multiplicity. 2

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Microvascular and Cardiovascular Outcomes According to Renal Function in Patients Treated With Once-Weekly Exenatide: Insights From the EXSCEL Trial

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