6% (6/70) and 6 5% (4/62) in the steroid avoidance and steroid wi

6% (6/70) and 6.5% (4/62) in the steroid avoidance and steroid withdrawal groups, respectively (P = 0.75). Seven steroid avoidance patients and nine steroid withdrawal patients discontinued study drug due to adverse events. The incidence of infections during months 6 to 36 was 64.3% (n = 45) in the steroid avoidance group and 77.4% (n Z-DEVD-FMK? = 48) in the steroid withdrawal group. The significant difference in cytomegalovirus (CMV) infection reported as an adverse event in the DOMINOS study population at month 6 (12.5% versus 22.7%, P = 0.045) became nonsignificant during months 6�C36 (10.0% versus 6.5%, P = 0.48). The proportion of patients receiving antihypertensive treatment, lipid-lowering treatment or hypoglycemic treatment at month 36 was 94.9%, 69.2%, and 15.4%, respectively, in the steroid avoidance group compared to 88.

5%, 73.6%, and 13.8% in the steroid withdrawal group. Body mass index (BMI) at time of transplant was 24.9 �� 3.7kg/m2 versus 25.3 �� 4.7kg/m2 in the steroid avoidance and steroid withdrawal arms, respectively (P = 0.85), and 25.6 �� 4.3kg/m2 versus 27.5 �� 6.1kg/m2 at month 36 (P = 0.13). The increase in BMI was not significantly different between randomized groups (mean difference 0.82kg/m2; 95% CI ?0.33, 1.98; 0.16). However, when the change in BMI was compared between those patients who remained steroid free throughout follow-up (n = 35) and those who received steroids at some point (n = 75) and for whom BMI data were available at baseline and month 36, the increase was significantly lower in the steroid-free cohort (0.52 �� 0.50 versus 1.97 �� 0.

34 in steroid-treated patients, P = 0.019). 4. Discussion Maintenance steroid therapy remains widespread following kidney transplantation, both in recent clinical trials [18, 19] and in daily practice, although the shift towards steroid avoidance or sparing continues to gather momentum. A meta-analysis by Pascual et al. has confirmed that steroid avoidance or withdrawal is possible in kidney transplantation [13] but the optimal timing for steroid-free immunosuppression has not been clearly defined. Results from this observational follow-up trial suggest that early intensified EC-MPS dosing with CNI therapy and IL-2RA induction may permit long-term steroid avoidance in a substantial proportion of low-risk kidney transplant recipients without compromising efficacy to three years after transplant.

There was no statistically significant difference for graft survival between patients who did or did not initially receive steroid therapy. In the DOMINOS study population, BPAR Cilengitide was not more frequent in the steroid avoidance group at month 3 or month 6 versus the steroid withdrawal group, and no episodes of BPAR in the steroid avoidance group were more severe than grade IIA [9]. In the INFINITY study, the incidence of BPAR at month 36 was numerically higher in the steroid avoidance group (20.0% versus 11.5% with steroid withdrawal), as reported elsewhere [2].

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