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Antiproteinuric therapy and Fabry nephropathy: factors associated with preserved kidney function during agalsidase-beta therapy
Journal article   Open access   Peer reviewed

Antiproteinuric therapy and Fabry nephropathy: factors associated with preserved kidney function during agalsidase-beta therapy

David G Warnock, Christie P Thomas, Bojan Vujkovac, Ruth C Campbell, Joel Charrow, Dawn A Laney, Leslie L Jackson, William R Wilcox and Christoph Wanner
Journal of medical genetics, Vol.52(12), pp.860-866
12/2015
DOI: 10.1136/jmedgenet-2015-103471
PMCID: PMC4717450
PMID: 26490103
url
https://doi.org/10.1136/jmedgenet-2015-103471View
Published (Version of record) Open Access

Abstract

Nephropathy is an important feature of classical Fabry disease, which results in alpha-galactosidase A deficiency and cellular globotriaosylceramide accumulation. We report the safety and efficacy of antiproteinuric therapy with ACE inhibitors or angiotensin II receptor blockers (ARBs) in a study of classical Fabry patients receiving recombinant agalsidase-beta therapy. The goal was maintenance of urine protein to creatinine ratio (UPCR) <0.5 g/g or a 50% reduction in baseline UPCR for 24 patients at eight study sites. The change in estimated glomerular filtration rate (eGFR) was assessed over 21 months of treatment. 18 out of 24 patients achieved the UPCR goal with eGFR slopes that were significantly better than six patients who did not achieve the UPCR goal (-3.6 (-4.8 to -1.1) versus -7.0 (-9.0 to -5.6) mL/min/1.73 m(2)/year, respectively, p=0.018). Despite achieving the UPCR goal, 67% (12/18 patients) still progressed with an eGFR slope <-2 mL/min/1.73 m(2)/year. Regression analysis showed that increased age at initiation of agalsidase-beta therapy was significantly associated with worsened kidney outcome. Hypotension and hyperkalaemia occurred in seven and eight patients, respectively, which required modification of antiproteinuric therapy but was not associated with serious adverse events. This study documents the effectiveness of agalsidase-beta (1 mg/kg/2 weeks) and antiproteinuric therapy with ACE inhibitors and/or ARB in patients with severe Fabry nephropathy. Patients had preservation of kidney function if agalsidase-beta treatment was initiated at a younger age, and UPCR maintained at or below 0.5 g/g with antiproteinuric therapy. NCT00446862.
alpha-Galactosidase - therapeutic use Glomerular Filtration Rate Isoenzymes - therapeutic use Kidney - drug effects Prospective Studies Humans Middle Aged Fabry Disease - complications Kidney Diseases - drug therapy Male Treatment Outcome alpha-Galactosidase - adverse effects Angiotensin-Converting Enzyme Inhibitors - therapeutic use Angiotensin-Converting Enzyme Inhibitors - adverse effects Isoenzymes - adverse effects Adult Female Fabry Disease - drug therapy Kidney Diseases - etiology Drug Therapy, Combination Angiotensin Receptor Antagonists - therapeutic use Kidney - physiopathology Angiotensin Receptor Antagonists - adverse effects

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