A Cochrane review [Abstract] 1 included 48 studies with a total of 7 803 subjects. Steroid withdrawal or avoidance showed no effect on mortality or graft loss including death (table T1, T2). Steroid avoidance or withdrawal showed a higher risk of graft loss excluding death than conventional steroid use (table T1, T2).
| Outcome - Follow-up: 1 year | Relative effect(95% CI) | Assumed risk - Steroid maintenance | Corresponding risk - Steroid withdrawal (95% CI) | No of participants(studies) |
|---|---|---|---|---|
| Mortality | RR 0.68 (0.36 to 1.3) | 22 / 1000 | 15 / 1000(8 to 29) | 1913 (10) |
| Graft loss (excluding death) | RR 1.17 (0.72 to 1.92) | 32 / 1000 | 38 / 1000(23 to 62) | 1817 (8) |
| Acute rejection | RR 1.77 (1.2 to 2.61) | 152 / 1000 | 268 / 1000(182 to 396) | 1913 (10) |
| Outcome - Follow-up: 1 year | Relative effect(95% CI) | Assumed risk - Control- Steroid maintenance | Corresponding risk - Steroid avoidance (95% CI) | No of participants(studies) |
|---|---|---|---|---|
| Mortality | RR 0.96 (0.52 to 1.8) | 31 / 1000 | 30 / 1000(16 to 56) | 1462 (10) |
| Graft loss (excluding death) | RR 1.09 (0.64 to 1.86) | 42 / 1000 | 46 / 1000(27 to 79) | 1211 (7) |
| Acute rejection | RR 1.58 (1.08 to 2.3) | 204 / 1000 | 323 / 1000(221 to 470) | 835 (7) |
A meta-analysis 2 assessed the safety and efficacy of steroid withdrawal or avoidance in high-risk kidney transplant. 7 cohort studies and 1 RCT, involving a total of 22 075 patients, were included. In pooled analysis there was comparable graft loss (RR 0.91, 95% CI 0.76 to 1.09) between the steroid withdrawal or avoidance and corticosteroid maintenance groups, but with reduced mortality in the non-steroid group (RR 0.90, 95% CI 0.84 to 0.98). A subanalysis suggested that non-steroid use was not associated with increased graft loss in patients undergoing steroid withdrawal within 1 week of transplantation, in African American recipients, or in patients with follow-up >5 years. Steroid withdrawal or avoidance was not associated with an increased risk of acute rejection (RR 0.95, 95% CI 0.75 to 1.21) or cytomegalovirus infection (RR 1.86, 95% CI 1 to 3.47); however, it was associated with a reduced risk of posttransplant diabetes mellitus (RR 0.60, 95% CI 0.37 to 0.97).
A analysis 3 included 4184 adult simultaneous liver-kidney recipients on tacrolimus-based regimens at 1 year post-transplant. The use of steroid-sparing regimens increased post-transplant, from 16.1% at discharge to 88.0% at 5 years. In multivariate analysis, use of a steroid-sparing regimen at 1 year was associated with a 21% decreased risk of mortality compared to steroid-containing regimens and 20% decreased risk of liver graft failure, without differences in kidney graft loss risk.
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment in half of the studies).
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