Open AccessLCPT once‐daily extended‐release tacrolimus tablets versus twice‐daily capsules: a pooled analysis of two phase 3 trials in important de novo and stable kidney transplant recipient subgroups
Author(s) -
Bunnapradist Suphamai,
Rostaing Lionel,
Alloway Rita R.,
WestThielke Patricia,
Denny Jason,
Mulgaonkar Shamkant,
Budde Klemens
Publication year - 2016
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/tri.12770
Subject(s) - medicine , tacrolimus , kidney transplant , immunosuppression , adverse effect , clinical trial , urology , kidney transplantation , kidney , transplantation
Summary African‐American and elderly kidney transplant recipients ( KTR ) have increased risk for poor clinical outcomes post‐transplant. Management of immunosuppression may be challenging in these patients and contribute to worse outcomes. A novel once‐daily formulation of tacrolimus ( LCPT ) has demonstrated noninferiority, similar safety, improved bioavailability, a consistent concentration time profile, and less peak and peak‐trough fluctuations vs. tacrolimus twice‐daily (Tac BID ). This pooled analysis of two phase 3 randomized, controlled trials, including 861 ( LCPT N = 428; Tac BID N = 433; 38% of patients were stable KTR , and 62% were de novo KTR ) patients, examined the efficacy of LCPT in KTR subgroups (blacks, females, and age ≥65). Overall, treatment failure [death, graft failure, centrally read biopsy‐proven acute rejection ( BPAR ), or lost to follow‐up] at 12 months was as follows: LCPT : 11.9%, BID Tac: 13.4% [−1.48% (−5.95%, 2.99%)]. BPAR rates were as follows: LCPT : 8.2%, Tac BID : 9.5% [−1.29% (−5.14%, 2.55%)]. Numerically, fewer treatment failure events with LCPT were found in the majority of subgroups, with significantly less treatment failure associated with LCPT among black KTR [−13.82% (−27.22%, −0.31%)] and KTR ≥65 [−13.46% (−25.27%, −0.78%)]. This pooled analysis suggests numerically lower efficacy failure rates associated with LCPT among high‐risk subgroups, in particular black KTR and KTR ≥65 years old.