Three-month experience with XXXX once-daily regimen in stable renal allografts.

@entity1 @entity644 @entity490 @entity1140 @entity1011
INTRODUCTION: MR-4, the new oral formulation of @entity1140 that allows once-daily dosing, may improve @entity1 compliance. The purpose of this study was to evaluate the safety and efficacy parameters among a group of stable renal allografts after conversion to MR-4. METHODS: We enrolled 82 stable kidney recipients, who had received their grafts 43.9 +/- 38.3 months prior. They were of mean age 56 +/- 12 years and included 70.7% @entity1 . Sixty-six @entity1 were converted on a milligram-for-milligram basis from their total daily dose; the remaining @entity1 were converted at the physician's discretion. Three @entity1 were excluded: 1 because of the development of @entity490 , and 2 because of dosing errors. @entity1140 trough levels and renal function tests were evaluated at entry and on days 7, 30, and 90. RESULTS: Only 5 (7.6%) converted @entity1 required a later dose adjustment. In the group of 61 @entity1 who did not require this adjustment, the mean @entity1140 trough levels decreased during the first week (6.8 +/- 1.7 to 5.8 +/- 2.0; P < .000). Thirty-eight @entity1 completed 3 months of follow-up. Their @entity1140 trough levels, serum @entity1011 levels, and @entity644 remained stable. The number of capsules per @entity1 needed after the conversion to MR-4 was lower (3.9 +/- 1.6 versus 2.9 +/- 1.0; P < .000). There were no cases of acute rejection episodes. CONCLUSION: Based on a milligram-for-milligram conversion, only 7.6% of our @entity1 required a dose adjustment. With this conversion, an initial decrease in @entity1140 trough levels was documented at day 7, which remained stable to the end of the study. The @entity1 needed a lower number of capsules. These results supported the safety of MR-4.
