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Pulse versus daily oral cyclophosphamide for induction of remission in antineutrophil cytoplasmic antibody-associated vasculitis
Annals of Internal Medicine, 05/20/09
Groot KD et al. – Study demonstrates that pulse cyclophosphamide regimen induced remission of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis as well as the daily oral regimen at a reduced cumulative cyclophosphamide dose and caused fewer cases of leukopenia.
Methods- Aim was to compare pulse cyclophosphamide with daily oral cyclophosphamide for induction of remission
- 42 centers in 12 European countries
- 149 pts with ANCA-associated vasculitis with renal involvement but not immediately life-threatening disease, randomized to:
- Pulse cyclophosphamide, 15 mg/kg every 2 to 3 wks (76 pts), or
- Oral cyclophosphamide, 2 mg/kg per day (73 pts), plus prednisolone
- Primary outcomes: time to remission
- Secondary outcomes: change in renal function, adverse events, and cumulative dose of cyclophosphamide
- Groups did not differ in time to remission or proportion of pts who achieved remission at 9 mo
- 13 pts in the pulse group and 6 in the daily oral group achieved remission by 9 mo and subsequently had relapse
- Absolute cumulative cyclophosphamide dose in the daily oral group was greater than that in the pulse group
- The pulse group had a lower rate of leukopenia
- The study was not powered to detect a difference in relapse rates between the 2 groups; duration of f/u was limited
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