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*
Department of Medicine, Hennepin County Medical Center, Minneapolis,
Minnesota
Division of Biostatistics, University of Minnesota, Minneapolis,
Minnesota
Department of Biostatistics, University of Tennessee, Memphis,
Tennessee.
Correspondence to Dr. Bertram L. Kasiske, Department of Medicine, Hennepin County Medical Center, 701 Park Avenue South, Minneapolis, MN 55415. Phone: 612-347-6088; Fax: 612-347-2003; E-mail: kasis001{at}tc.umn.edu
Abstract. Since the publication of previous meta-analyses of
cyclosporine (CsA) and prednisone withdrawal in renal transplant recipients,
several additional randomized controlled trials with longer follow-up have
been reported. Currently, in nine prednisone withdrawal trials (n =
1461), the proportion of patients with acute rejection was increased by 0.14
(95% confidence interval = 0.10 to 0.17, P < 0.001). In nine
prednisone withdrawal trials (n = 1899), the relative risk (RR; RR =
1.0 indicates no risk) of graft failure after withdrawal was also increased
(RR = 1.40; range, 1.09 to 1.70, P = 0.012). There was no evidence of
between-study heterogeneity for either acute rejection or graft failure in the
prednisone withdrawal trials by a
2 test (P >
0.05). In 10 CsA withdrawal trials (n = 1049), the proportion of
patients with acute rejection was increased by 0.11 (0.07 to 0.15, P
< 0.001). In 12 trials (n = 1151), the RR of graft failure after
CsA withdrawal was 1.06 (95% confidence interval, 0.82 to 1.29, P =
0.646), but a
2 test indicated that there was study
heterogeneity. However, there was no evidence of heterogeneity in the six
studies (n = 632) with at least 4.0 yr (5.8 ± 1.7) of
follow-up (RR = 0.92; range, 0.64 to 1.20, P = 0.569) or in the seven
trials (n = 962) published in peer-reviewed journals (RR = 0.95;
range, 0.70 to 1.20 P = 0.682). Finally, in three trials (n
= 259) that compared CsA and prednisone withdrawal, there was a nonsignificant
trend for less graft failure with CsA withdrawal (RR = 0.63; range, 0.08 to
1.16, P = 0.190). Thus, unlike prednisone withdrawal, CsA withdrawal
in select patients seems to impart little risk of long-term graft failure.
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