Association of mycophenolic acid dose with efficacy and safety events in kidney transplant patients receiving tacrolimus: An analysis of the Mycophenolic acid Observational REnal transplant registry

Cataldo Doria, Stuart M. Greenstein, Mohanram Narayanan, Kimi Ueda, Anne Wiland, Kevin McCague, Bashir Sankari, Laurence Chan

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Dose-finding studies for mycophenolic acid (MPA) in tacrolimus-treated kidney transplant patients are lacking. Methods: Data from 901 de novo kidney transplant recipients enrolled in the prospective, non-interventional Mycophenolic acid Observational REnal (MORE) transplant registry were analyzed according to baseline daily MPA dose (<2000, 2000 or >2000 mg). Results: The proportion of patients receiving 2000 and <2000 mg was 77.6% and 19.9% at baseline, 74.5% and 23.3% at month 1, 62.4% and 35.5% at month 3, 48.5% and 50.2% at month 6, and 44.1% and 55.2% at month 12. More patients were maintained on 2000 mg with enteric-coated mycophenolate sodium (EC-MPS) vs. mycophenolate mofetil (month 6, 52.7% vs. 43.0% [p = 0.02]; month 12, 47.3% vs. 39.4% [p = 0.08]). Multivariate modeling showed no significant effect of baseline MPA dose on 12-month risk of biopsy-proven acute rejection, graft loss or estimated GFR, or on safety events including MPA discontinuation other than a higher rate of gastrointestinal adverse events in patients with an initial MPA dose >2000 mg (p = 0.029) vs. 2000 mg. Conclusions: These findings suggest that an initial MPA dose of <2000 mg does not compromise 12-month efficacy in tacrolimus-treated kidney transplants, but controlled trials are required and the lower threshold for MPA dose remains to be defined.

Original languageEnglish (US)
JournalClinical Transplantation
Volume26
Issue number6
DOIs
StatePublished - Nov 2012

Fingerprint

Mycophenolic Acid
Tacrolimus
Registries
Transplants
Kidney
Safety

Keywords

  • Immunosuppression
  • Kidney transplantation
  • Mycophenolic acid
  • Outcomes

ASJC Scopus subject areas

  • Transplantation

Cite this

Association of mycophenolic acid dose with efficacy and safety events in kidney transplant patients receiving tacrolimus : An analysis of the Mycophenolic acid Observational REnal transplant registry. / Doria, Cataldo; Greenstein, Stuart M.; Narayanan, Mohanram; Ueda, Kimi; Wiland, Anne; McCague, Kevin; Sankari, Bashir; Chan, Laurence.

In: Clinical Transplantation, Vol. 26, No. 6, 11.2012.

Research output: Contribution to journalArticle

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title = "Association of mycophenolic acid dose with efficacy and safety events in kidney transplant patients receiving tacrolimus: An analysis of the Mycophenolic acid Observational REnal transplant registry",
abstract = "Background: Dose-finding studies for mycophenolic acid (MPA) in tacrolimus-treated kidney transplant patients are lacking. Methods: Data from 901 de novo kidney transplant recipients enrolled in the prospective, non-interventional Mycophenolic acid Observational REnal (MORE) transplant registry were analyzed according to baseline daily MPA dose (<2000, 2000 or >2000 mg). Results: The proportion of patients receiving 2000 and <2000 mg was 77.6{\%} and 19.9{\%} at baseline, 74.5{\%} and 23.3{\%} at month 1, 62.4{\%} and 35.5{\%} at month 3, 48.5{\%} and 50.2{\%} at month 6, and 44.1{\%} and 55.2{\%} at month 12. More patients were maintained on 2000 mg with enteric-coated mycophenolate sodium (EC-MPS) vs. mycophenolate mofetil (month 6, 52.7{\%} vs. 43.0{\%} [p = 0.02]; month 12, 47.3{\%} vs. 39.4{\%} [p = 0.08]). Multivariate modeling showed no significant effect of baseline MPA dose on 12-month risk of biopsy-proven acute rejection, graft loss or estimated GFR, or on safety events including MPA discontinuation other than a higher rate of gastrointestinal adverse events in patients with an initial MPA dose >2000 mg (p = 0.029) vs. 2000 mg. Conclusions: These findings suggest that an initial MPA dose of <2000 mg does not compromise 12-month efficacy in tacrolimus-treated kidney transplants, but controlled trials are required and the lower threshold for MPA dose remains to be defined.",
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AU - Greenstein, Stuart M.

AU - Narayanan, Mohanram

AU - Ueda, Kimi

AU - Wiland, Anne

AU - McCague, Kevin

AU - Sankari, Bashir

AU - Chan, Laurence

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N2 - Background: Dose-finding studies for mycophenolic acid (MPA) in tacrolimus-treated kidney transplant patients are lacking. Methods: Data from 901 de novo kidney transplant recipients enrolled in the prospective, non-interventional Mycophenolic acid Observational REnal (MORE) transplant registry were analyzed according to baseline daily MPA dose (<2000, 2000 or >2000 mg). Results: The proportion of patients receiving 2000 and <2000 mg was 77.6% and 19.9% at baseline, 74.5% and 23.3% at month 1, 62.4% and 35.5% at month 3, 48.5% and 50.2% at month 6, and 44.1% and 55.2% at month 12. More patients were maintained on 2000 mg with enteric-coated mycophenolate sodium (EC-MPS) vs. mycophenolate mofetil (month 6, 52.7% vs. 43.0% [p = 0.02]; month 12, 47.3% vs. 39.4% [p = 0.08]). Multivariate modeling showed no significant effect of baseline MPA dose on 12-month risk of biopsy-proven acute rejection, graft loss or estimated GFR, or on safety events including MPA discontinuation other than a higher rate of gastrointestinal adverse events in patients with an initial MPA dose >2000 mg (p = 0.029) vs. 2000 mg. Conclusions: These findings suggest that an initial MPA dose of <2000 mg does not compromise 12-month efficacy in tacrolimus-treated kidney transplants, but controlled trials are required and the lower threshold for MPA dose remains to be defined.

AB - Background: Dose-finding studies for mycophenolic acid (MPA) in tacrolimus-treated kidney transplant patients are lacking. Methods: Data from 901 de novo kidney transplant recipients enrolled in the prospective, non-interventional Mycophenolic acid Observational REnal (MORE) transplant registry were analyzed according to baseline daily MPA dose (<2000, 2000 or >2000 mg). Results: The proportion of patients receiving 2000 and <2000 mg was 77.6% and 19.9% at baseline, 74.5% and 23.3% at month 1, 62.4% and 35.5% at month 3, 48.5% and 50.2% at month 6, and 44.1% and 55.2% at month 12. More patients were maintained on 2000 mg with enteric-coated mycophenolate sodium (EC-MPS) vs. mycophenolate mofetil (month 6, 52.7% vs. 43.0% [p = 0.02]; month 12, 47.3% vs. 39.4% [p = 0.08]). Multivariate modeling showed no significant effect of baseline MPA dose on 12-month risk of biopsy-proven acute rejection, graft loss or estimated GFR, or on safety events including MPA discontinuation other than a higher rate of gastrointestinal adverse events in patients with an initial MPA dose >2000 mg (p = 0.029) vs. 2000 mg. Conclusions: These findings suggest that an initial MPA dose of <2000 mg does not compromise 12-month efficacy in tacrolimus-treated kidney transplants, but controlled trials are required and the lower threshold for MPA dose remains to be defined.

KW - Immunosuppression

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KW - Outcomes

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