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2016 ; 7
(1
): 139-51
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Cystatin C- and Creatinine-Based Estimates of Glomerular Filtration Rate in
Dapagliflozin Phase 3 Clinical Trials
#MMPMID26899432
Mende C
; Katz A
Diabetes Ther
2016[Mar]; 7
(1
): 139-51
PMID26899432
show ga
INTRODUCTION: To compare estimated glomerular filtration rate measured by serum
creatinine (eGFRcr) and serum cystatin C (eGFRcys) in patients with type 2
diabetes mellitus from dapagliflozin clinical trials. METHODS: Post hoc analysis
of data pooled from 9 phase 3, randomized, placebo-controlled, 24-week trials of
dapagliflozin. The correlation between eGFRcr and eGFRcys was modeled by a simple
linear regression. The proportions of patients with eGFR 30 to <60
and ?60 mL/min/1.73 m(2) based on creatinine versus cystatin C were compared.
RESULTS: Of 4745 total patients, 4294 (90.5%) had serum cystatin C data available
for calculation of eGFRcys. The correlation between eGFRcr and eGFRcys was poor
(R (2) = 30%). Of patients with eGFRcr 30 to <60 mL/min/1.73 m(2), 66% had
eGFR ?60 when recalculated based on cystatin C. Among patients with
eGFRcr ?60 mL/min/1.73 m(2), 95.8% had eGFR ?60 when estimated using cystatin C.
Decreases in HbA1c, body weight, and systolic blood pressure with dapagliflozin
were similar among patient subgroups defined by either eGFR estimate and were
statistically significant and clinically meaningful with dapagliflozin 10 mg/day
in most subgroups. CONCLUSION: The correlation between eGFRcr and eGFRcys was
poor. Renal function assessed by eGFRcr may be underestimated, and some patients
may be misdiagnosed with chronic kidney disease and/or unjustifiably deemed
ineligible for certain antidiabetes medications. This is in consonance with
guidelines suggesting using eGFRcys as a confirmatory measure when eGFRcr is
between 45 and <60 mL/min/1.73 m(2) with no evidence of kidney damage and/or in
other situations where eGFRcr may be unreliable. FUNDING: AstraZeneca.
free
free
free
