Tacrolimus is highly effective in both dual and triple therapy regimens following renal transplantation

Abstract

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 corticosteroid-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.

A prospective randomized multicenter study of tacrolimus in combination with sirolimus in renal-transplant recipients

“…1) and were substantially lower than the SRL trough levels reported in combination therapies of cyclosporin and SRL (1,14). In this study, SRL was added to a standard Tac regimen; Tac doses and trough levels were very similar to previous studies (15)(16)(17)(18).…”

Long-term outcome of ATG vs. Basiliximab induction

“…immunosuppression based on Tacrolimus compared to triple immunosuppression including azathioprine did not prove any difference in the rate of acute rejection episodes at 3-year follow-up [26,27]. In additional studies, the incidence of acute rejection was higher in patients treated with a combination of ATG, cyclosporine and azathioprine (21AE2%) compared to ATG, Tacrolimus and azathioprine (15AE1%, P = 0AE177) [28].…”

New Onset Diabetes Mellitus in Patients Receiving Calcineurin Inhibitors: A Systematic Review and Meta-Analysis

“…Prospective, multicenter 1 6 mo TAC + Steroids = 28% (n = 64) Segoloni (2000;86) Prospective, randomized,…”