Document Detail

Azathioprine/methylprednisolone versus cyclophosphamide in proliferative lupus nephritis. A randomized controlled trial.
MedLine Citation:
PMID:  16820790     Owner:  NLM     Status:  MEDLINE    
Until recently, intravenous cyclophosphamide pulses with oral corticosteroids were regarded standard therapy for proliferative lupus nephritis (LN). Azathioprine, a less toxic alternative, was never proven to be inferior. In the first Dutch lupus nephritis study (enrollment between 1995 and 2001), we randomized 87 proliferative LN patients to either cyclophosphamide pulses (750 mg/m(2), 13 pulses in 2 years) combined with oral prednisone (CY) or to azathioprine (2 mg/kg/day in 2 years) combined with intravenous pulses of methylprednisolone (3 x 3 pulses of 1000 mg) and oral prednisone (AZA). After a median follow-up of 5.7 years (interquartile range 4.1-7.2 years), doubling of serum creatinine was more frequent in the AZA group, although not statistically significant (relative risk (RR): 4.1, with 95% confidence interval (95% CI): 0.8-20.4). Relapses occurred more often in the AZA group (RR: 8.8, 95% CI: 1.5-31.8). Creatinine and proteinuria at last visit did not differ between the two treatment arms. Moreover, 88.4% of the patients in the AZA arm were still free of cyclophosphamide treatment. During the first 2 years, the frequency of remission was not different, but infections, especially herpes zoster virus infections (HZV) were more frequent in the AZA group. Parameters for ovarian function did not differ between the two groups. In conclusion, in this open-label randomized controlled trial, cyclophosphamide was superior to azathioprine with regard to renal relapses and HZV. At last follow-up, there were no differences in serum creatinine or proteinuria between the two groups. However, since our study lacked sufficient power, longer follow-up is needed to reveal putative differences.
C Grootscholten; G Ligtenberg; E C Hagen; A W L van den Wall Bake; J W de Glas-Vos; M Bijl; K J Assmann; J A Bruijn; J J Weening; H C van Houwelingen; R H W M Derksen; J H M Berden;
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-07-05
Journal Detail:
Title:  Kidney international     Volume:  70     ISSN:  0085-2538     ISO Abbreviation:  Kidney Int.     Publication Date:  2006 Aug 
Date Detail:
Created Date:  2006-08-10     Completed Date:  2006-09-26     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  0323470     Medline TA:  Kidney Int     Country:  United States    
Other Details:
Languages:  eng     Pagination:  732-42     Citation Subset:  IM    
Division of Nephrology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
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MeSH Terms
Administration, Oral
Anti-Inflammatory Agents / administration & dosage,  therapeutic use*
Azathioprine / administration & dosage,  therapeutic use*
Creatinine / blood
Cyclophosphamide / administration & dosage,  therapeutic use*
Drug Therapy, Combination
Immunosuppressive Agents / administration & dosage,  therapeutic use*
Injections, Intravenous
Lupus Nephritis / blood,  drug therapy*,  pathology
Methylprednisolone / administration & dosage,  therapeutic use*
Middle Aged
Mycophenolic Acid / analogs & derivatives,  therapeutic use
Prednisolone / administration & dosage,  therapeutic use
Remission Induction
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Immunosuppressive Agents; 24280-93-1/Mycophenolic Acid; 446-86-6/Azathioprine; 50-18-0/Cyclophosphamide; 50-24-8/Prednisolone; 60-27-5/Creatinine; 83-43-2/Methylprednisolone; 9242ECW6R0/mycophenolate mofetil
Comment In:
Kidney Int. 2006 Aug;70(4):616-8   [PMID:  16900218 ]

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