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QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(十三)
al failure, and decreased urineoutput. None of the adverse reactions were reported as serious and all but one were mild to moderate inintensity. Three subjects discontinued due to decreased eGFR. Subjects with AEs of renal impairment hadlower mean eGFR values at baseline of 64.4 mL/min/1.73 m2 compared to 94.4 mL/min/1.73 m2 inoverall population treated with combination plus metformin therapy.
Dapagliflozin
Use of dapagliflozin was associated with increases in serum creatinine and decreases in eGFR (seeTable 2). In patients with normal or mildly impaired renal function at baseline, serum creatinine andeGFR returned to baseline values at Week 24. Renal-related adverse reactions, including renal failure andblood creatinine increase, were more frequent in patients treated with dapagliflozin (see Table 3). Elderlypatients and patients with impaired renal function were more susceptible to these adverse reactions (seeTable 3). Sustained decreases in eGFR were seen in patients with moderate renal impairment (eGFR 30 toless than 60 mL/min/1.73 m2). QTERNMET XR is contraindicated in patients with an eGFR less than45 mL/min/1.73 m2.
Table 2: Changes in Serum Creatinine and eGFR Associated with Dapagliflozin in the
Pool of 12 Placebo-Controlled Studies and Moderate Renal Impairment Studies
Pool of 12 Placebo-Controlled Studies
Placebo
N=1393
5 mg Dapagliflozin
N=1145
10 mg Dapagliflozin
N=1193
Baseline Mean Serum Creatinine
(mg/dL)
0.853 0.860 0.847
eGFR
(mL/min/1.73 m2
)
86.0 85.3 86.7
Week 1 Change Serum Creatinine
(mg/dL)
−0.003 0.029 0.041
eGFR
(mL/min/1.73 m2
)
0.4 −2.9 −4.1
Week 24 Change Serum Creatinine
(mg/dL)
−0.005 −0.001 0.001
Table 2: Changes in Serum Creatinine and eGFR Associated with Dapagliflozin in thePool of 12 Placebo-Controlled Studies and Moderate Renal Impairment Studies
eGFR
(mL/min/1.73 m2
)
0.8 0.8 0.3
Moderate Renal Impairment Study*
(eGFR 30 to less than 60 mL/min/1.73 m2
)
Placebo
N=84
5 mg Dapagliflozin
N=83
10 mg Dapagliflozin
N=85
Baseline Mean Serum Creatinine
(mg/dL)
1.46 1.53 1.52
eGFR
(mL/min/1.73 m2
)
45.6 44.2 43.9
Week 1 Change Serum Creatinine
(mg/dL)
0.01 0.13 0.18
eGFR
(mL/min/1.73 m2
)
0.5 −3.8 −5.5
Week 24 Change Serum Creatinine
(mg/dL)
0.02 0.08 0.16
eGFR
(mL/min/1.73 m2
)
0.03 −4.0 −7.4
Week 52 Change Serum Creatinine
(mg/dL)
0.10 0.06 0.15
eGFR
(mL/min/1.73 m2
)
−2.6 −4.2 −7.3
Moderate Renal Impairment Study
(eGFR 45 to less than 60 mL/min/1.73 m2
)
Placebo
N=161
10 mg Dapagliflozin
N=160
Baseline Mean Serum Creatinine
(mg/dL)
1.25 1.25
eGFR
(mL/min/1.73 m2
)
53.6 53.3
Week 4 Change Serum Creatinine
(mg/dL)
−0.02 0.09
eGFR
(mL/min/1.73 m2
)
1.3 −3.8
Week 12 Change Serum Creatinine
(mg/dL)
-0.02 0.08
eGFR
(mL/min/1.73 m2
)
1.5 −3.2
Week 24 Change Serum Creatinine
(mg/dL)
−0.003 0.06
Table 2: Changes in Serum Creatinine and eGFR Associated with Dapagliflozin in thePool of 12 Placebo-Controlled Studies and Moderate Renal Impairment Studies
eGFR(mL/min/1.73 m2)
0.8 −2.0
* QTERN is contraindicated in patients with an eGFR <45 mL/min/1.73 m2.
Table 3: Propor |
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