Intensified Dosing Regimen May Lower Rejection Rate

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This article is part of our ongoing coverage of Renal Week 2009. Click here for a complete list of our Renal Week Live articles.


Key Points

  • An intensified-dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) in combination with basiliximab and standard doses of cyclosporine (CsA) may result in a lower rate of rejection without compromising safety and tolerability.
  • The findings point to a potential novel therapeutic approach leading to significantly higher mycophenolic acid exposure during the early post-operative period.

An intensified-dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) in combination with basiliximab and standard doses of cyclosporine (CsA) may result in a lower rate of rejection without compromising safety and tolerability, according to new data presented at ASN's Renal Week 2009.

The findings point to a potential novel therapeutic approach leading to significantly higher mycophenolic acid exposure during the early post-operative period.

Researchers in Germany conducted an open-label, randomized, phase 2, six-month parallel group pilot study to examine the safety, efficacy, and tolerability of an initially intensified dosing regimen of EC-MPS during the first six months post-transplantation.

They randomized 128 new kidney transplant patients treated with basiliximab, steroids, and standard CsA to either a standard EC-MPS dose (1,440 mg/daily) or an intensified EC-MPS dosing regimen (2,880 mg/daily for two weeks, following by 2,160 mg/daily for four weeks and 1,440 mg daily).

The intensified-dosing regimen did not result in a higher rate of hematologic adverse effects or higher risk for infections. It was associated with more gastrointestinal events than the standard-dose group (81% vs. 75%), but rates of diarrhea were identical.

At six months, the incidence of biopsy-proven acute rejection was significantly lower in the intensified-dosing regimen group (3.2% vs.16.9% in the standard-dose group), but patient survival was similar (98.4% vs. 96.9%), as was graft survival (96.8% vs. 96.9%).

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