Document Detail


Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis.
MedLine Citation:
PMID:  17582159     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens (ANCA) is the most frequent cause of rapidly progressive glomerulonephritis. Renal failure at presentation carries an increased risk for ESRD and death despite immunosuppressive therapy. This study investigated whether the addition of plasma exchange was more effective than intravenous methylprednisolone in the achievement of renal recovery in those who presented with a serum creatinine >500 micromol/L (5.8 mg/dl). A total of 137 patients with a new diagnosis of ANCA-associated systemic vasculitis confirmed by renal biopsy and serum creatinine >500 micromol/L (5.8 mg/dl) were randomly assigned to receive seven plasma exchanges (n = 70) or 3000 mg of intravenous methylprednisolone (n = 67). Both groups received oral cyclophosphamide and oral prednisolone. The primary end point was dialysis independence at 3 mo. Secondary end points included renal and patient survival at 1 yr and severe adverse event rates. At 3 mo, 33 (49%) of 67 after intravenous methylprednisolone compared with 48 (69%) or 70 after plasma exchange were alive and independent of dialysis (95% confidence interval for the difference 18 to 35%; P = 0.02). As compared with intravenous methylprednisolone, plasma exchange was associated with a reduction in risk for progression to ESRD of 24% (95% confidence interval 6.1 to 41%), from 43 to 19%, at 12 mo. Patient survival and severe adverse event rates at 1 yr were 51 (76%) of 67 and 32 of 67 (48%) in the intravenous methylprednisolone group and 51 (73%) of 70 and 35 of (50%) 70 in the plasma exchange group, respectively. Plasma exchange increased the rate of renal recovery in ANCA-associated systemic vasculitis that presented with renal failure when compared with intravenous methylprednisolone. Patient survival and severe adverse event rates were similar in both groups.
Authors:
David R W Jayne; Gill Gaskin; Niels Rasmussen; Daniel Abramowicz; Franco Ferrario; Loic Guillevin; Eduardo Mirapeix; Caroline O S Savage; Renato A Sinico; Coen A Stegeman; Kerstin W Westman; Fokko J van der Woude; Robert A F de Lind van Wijngaarden; Charles D Pusey;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-06-20
Journal Detail:
Title:  Journal of the American Society of Nephrology : JASN     Volume:  18     ISSN:  1046-6673     ISO Abbreviation:  J. Am. Soc. Nephrol.     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-06-28     Completed Date:  2007-10-30     Revised Date:  2008-09-15    
Medline Journal Info:
Nlm Unique ID:  9013836     Medline TA:  J Am Soc Nephrol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2180-8     Citation Subset:  IM    
Affiliation:
Department of Medicine, Addenbrooke's Hospital, Cambridge, UK. dj106@cam.ac.uk
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MeSH Terms
Descriptor/Qualifier:
Adrenal Cortex Hormones / administration & dosage*
Adult
Aged
Aged, 80 and over
Combined Modality Therapy
Female
Humans
Injections, Intravenous
Kidney / blood supply*
Male
Methylprednisolone / administration & dosage*
Middle Aged
Plasma Exchange*
Severity of Illness Index
Vasculitis / therapy*
Chemical
Reg. No./Substance:
0/Adrenal Cortex Hormones; 83-43-2/Methylprednisolone
Comments/Corrections
Comment In:
J Am Soc Nephrol. 2007 Jul;18(7):1987-9   [PMID:  17596633 ]
Nefrologia. 2008;28 Suppl 2:6-7   [PMID:  18457546 ]
ACP J Club. 2008 Jan-Feb;148(1):11   [PMID:  18170998 ]
Nat Clin Pract Nephrol. 2008 Jan;4(1):14-5   [PMID:  17955040 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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