title: Steroid withdrawal at 3 months after kidney transplantation: a comparison of two tacrolimus-based regimens.
abstract: The 6 month prospective, randomized study compared the steroid-sparing potential of two tacrolimus-based regimens after renal transplantation. A total of 489 patients were randomized (1:1) to receive tacrolimus/mycophenolate mofetil (MMF)/steroids (n = 243; group Tac/MMF/S) or tacrolimus/azathioprine/steroids (n = 246; group Tac/Aza/S). At 3 months, steroids were tapered off in 267 (54.6%) patients free from steroid-resistant acute rejection and with serum creatinine concentrations <160 micromol/l. The incidence of biopsy-confirmed acute rejection at month 3 was lower in group Tac/MMF/S compared with group Tac/Aza/S (18.1% vs. 26.0%,P = 0.035). Moreover, more patients in the Tac/MMF/S group met the criteria for steroid withdrawal than in the Tac/Aza/S group (60.5% vs. 48.8%; P < 0.01). The incidence of acute rejection during months 4-6 was low in all groups, both for patients on steroid-free dual therapy (Tac/MMF: 2.7%, Tac/Aza: 0.8%) and for patients who continued steroid maintenance therapy (Tac/MMF/S: 3.5%, Tac/Aza/S: 7.1%). Moreover, kidney function was well preserved in steroid-free patients with month 6 median serum creatinine levels of 119.5 micromol/l (Tac/MMF), and 115.1 micromol/l (Tac/Aza). For patients who continued to receive steroids, month 6 median creatinine levels were 130.5 micromol/l (Tac/MMF/S) and 132.8 micromol/l (Tac/Aza/S). The criteria for the selection of patients to discontinue steroids were adequate. Both tacrolimus-based regimens allowed the safe discontinuation of steroids in low-risk patients at month 3. The Tac/MMF combination was superior in the prevention of acute rejections and more patients met the chosen criteria for steroid withdrawal.
authors.affiliation: Department of Transplantology, Szpital Wojewodzki, Poznan, Poland. zwlodar@yahoo.co.uk
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Wlodarczyk
authors.forename: Janusz
authors.initials: J
authors.lastname: Walaszewski
authors.forename: Ferenc
authors.initials: F
authors.lastname: Perner
authors.forename: Stefan
authors.initials: S
authors.lastname: Vitko
authors.forename: Marek
authors.initials: M
authors.lastname: Ostrowski
authors.forename: Petr
authors.initials: P
authors.lastname: Bachleda
authors.forename: Franciszek
authors.initials: F
authors.lastname: Kokot
authors.forename: Marian
authors.initials: M
authors.lastname: Klinger
authors.forename: Pal
authors.initials: P
authors.lastname: Szenohradszky
authors.forename: Pavel
authors.initials: P
authors.lastname: Studenik
authors.forename: Pavel
authors.initials: P
authors.lastname: Navratil
authors.forename: Laszlo
authors.initials: L
authors.lastname: Asztalos
authors.forename: Boleslaw
authors.initials: B
authors.lastname: Rutkowski
authors.forename: Karoly Nagy
authors.initials: KN
authors.lastname: Kalmar
authors.forename: David
authors.initials: D
authors.lastname: Hickey
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001379:Azathioprine / Q000008:administration & dosage; D003404:Creatinine / Q000097:blood; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016030:Kidney Transplantation / Q000009:adverse effects / Q000473:pathology / Q000502:physiology; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011239:Prednisolone / Q000008:administration & dosage; D011446:Prospective Studies; D013256:Steroids / Q000008:administration & dosage*; D016559:Tacrolimus / Q000008:administration & dosage*
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids; D011239:Prednisolone; D003404:Creatinine; D009173:Mycophenolic Acid; D001379:Azathioprine; D016559:Tacrolimus; D008775:Methylprednisolone