Future immunosuppressive agents in solid-organ transplantation.
OBJECTIVE
To review the pharmacology, pharmacokinetics, efficacy, and safety of mycophenolate sodium, everolimus, and FTY720.


METHODS
Clinical trials and abstracts evaluating mycophenolate sodium, everolimus, and FTY720 in solid-organ transplantation were considered for evaluation. English-language studies and published abstracts were selected for inclusion.


RESULTS
Mycophenolate sodium has recently been approved by the Food and Drug Adminstration for marketing in the United States; everolimus and FTY720 are immunosuppressive agents that may soon be available in the United States. These agents have proven efficacy in reducing the incidence of acute rejection in solid-organ transplantation. Clinical trials have shown that these newer agents are relatively well tolerated. The most common adverse events associated with these agents were gastrointestinal and hematologic effects (mycophenolate sodium); hyperlipidemia, increased serum creatinine, and hematologic effects (everolimus): and gastrointestinal effects, headache, and bradycardia (FTY720).


CONCLUSIONS
Mycophenolate sodium has been approved in some European countries and the United States. Everolimus has been approved in some European countries and a new drug application has been submitted to the Food and Drug Administration. FTY720 is currently in phase III clinical trials and submission to the Food and Drug Administration for approval is a few years away. The approval of these agents will furnish the transplant practitioner with even more options for immunosuppression.
Gabardi
Steven
S
Brigham and Women's Hospital, Boston, MA, USA.
Cerio
Jeffrey
J
D017277:Drug Approval; D004347:Drug Interactions; D016903:Drug Monitoring; D000068338:Everolimus; D000068876:Fingolimod Hydrochloride; D005544:Forecasting; D006085:Graft Survival / Q000187:drug effects / Q000276:immunology; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods / Q000639:trends*; D007166:Immunosuppressive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D009173:Mycophenolic Acid / Q000494:pharmacology / Q000627:therapeutic use*; D016377:Organ Transplantation / Q000009:adverse effects; D011409:Propylene Glycols / Q000494:pharmacology / Q000627:therapeutic use*; D012449:Safety; D020123:Sirolimus / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use*; D013110:Sphingosine / Q000031:analogs & derivatives; D014181:Transplantation Immunology; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D000068338:Everolimus; D000068876:Fingolimod Hydrochloride; D009173:Mycophenolic Acid; D013110:Sphingosine; D020123:Sirolimus