The data show no significant decline in renal function as measured by estimated glomerular filtration rate (eGFR) in treatment-naive patients (n=29); the mean change from baseline, 83.85 +/- 7.12 mL/min/1.73m(2), to 12 months was -1.29 +/- 4.34 mL/min/1.73 m(2), p=0.175. Results were similar in switch patients (n=62), the mean change from baseline, 81.96 +/- 4.57 mL/min/1.73m(2), to 12 months was -3.17 +/- 1.69 mL/min/1.73m(2), p=0.009.Biologic activity by reduction of pathological substrate globotriaosylceramide (Gb(3)) was also demonstrated by decline in both plasma Gb(3) (-2.60 +/- 0.52 nmol/mL; p<0.001 and -6.70 +/- 1.18 nmol/mL; p<0.001 for switch [n=56] and treatment naive patients [n=25] respectively) and creatinine normalized urine Gb(3) (-0.87 +/- 0.37 nmol/mg; p=0.009 and -2.11 nmol/mg; p=0.021) for switch and treatment naive patients respectively.
One Year Data Provide Evidence Of Effectiveness And Tolerability Of REPLAGAL® (agalsidase Alfa) In Fabry Patients
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