Open AccessTacrolimus is highly effective in both dual and triple therapy regimens following renal transplantation
Author(s) -
Segoloni G.,
Bonomini V.,
Maresca M.C.,
Arisi L.,
GonzalezMolina M.,
Tarantino A.,
Castillo D.,
Ortuño J.,
Carmellini M.,
Capdevila L.,
Arias M.,
Garcia J.,
Rigotti P.
Publication year - 2000
Publication title -
transplant international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.998
H-Index - 82
eISSN - 1432-2277
pISSN - 0934-0874
DOI - 10.1111/j.1432-2277.2000.tb02054.x
Subject(s) - medicine , tacrolimus , transplantation , azathioprine , gastroenterology , leukopenia , randomized controlled trial , incidence (geometry) , surgery , chemotherapy , disease , physics , optics
This open, multicenter, randomized, parallel‐group study evaluated the efficacy and safety of tacrolimus‐based dual and triple therapy regimens. For this 3‐month study (with 12‐month follow up), 491 adult renal transplant patients were randomized and received either dual therapy (tacrolimus/corticosteroids; 246 patients) or triple therapy (tacrolimus/corticosteroids/azathioprine; 245 patients). Patient survival rates at months 3 and 12 were 99.2 (dual) vs 99.6% (triple) and 97.8 vs 98.7%, respectively. Graft survival rates at months 3 and 12 were 94.1 (dual) vs 95.4 % (triple) and 92.8 vs 93.3%, respectively. After 3 months, the incidences of treated acute rejection were 28.8 (dual) and 29.7% (triple); and 7.6 (dual) and 5.4% (triple) for corti‐costeroid‐resistant acute rejections. Between months 4 and 12, three new first rejections were reported, (dual: 2, triple: 1). For leukopenia (1.3 vs 11.7%; P < 0.001) and anemia (14.8 vs 23.0 %, P = 0.026), significantly higher incidences were reported in the triple therapy group. The incidence of de novo insulin‐dependent diabetes was 5.6 (dual) and 4.0% (triple) at month 3. In terms of efficacy, no difference between the treatment groups was observed.