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Clinical experience with everolimus (Certican): optimizing dose and tolerability.
Julio Pascual1, Roberto Marcén, Joaquín Ortuño
1Servicio de Nefrologia, Hospital Ramón y Cajal, Madrid, Spain. jpascual.hrc@salud.madrid.org
Transplantation
|May 10, 2005
Summary
Everolimus (Certican) effectively manages transplant patients by reducing nephrotoxicity. Adverse events like lymphocele and arthralgia can be managed with dose adjustments or other treatments, avoiding therapy discontinuation.
Area of Science:
- Transplantation immunology
- Pharmacology
- Clinical trial analysis
Background:
- Everolimus (Certican) is a novel proliferation signal inhibitor used in transplant patients.
- It enables calcineurin inhibitor dose reduction, minimizing nephrotoxicity without compromising immunosuppression.
- Potential adverse events include lymphocele, arthralgia, edema, and hyperlipidemia.
Observation:
- Case studies from an Everolimus Phase III trial (A2306) illustrate adverse event management.
- Management strategies included steroid boluses for acute rejection, povidone-iodine for lymphocele, and furosemide for edema.
- Hyperlipidemia was managed with statins, and arthralgia with Everolimus dose reduction.
Findings:
- Everolimus combined with reduced cyclosporine demonstrated efficacy.
- Adverse events were manageable without necessitating Everolimus discontinuation.
- Dose reduction of Everolimus was sometimes required, particularly for arthralgia, while maintaining therapeutic trough levels.
Implications:
- Everolimus-related adverse events can be effectively managed through targeted interventions or dose modifications.
- Therapeutic efficacy is generally maintained even with dose adjustments.
- Discontinuation of Everolimus therapy is typically avoidable, supporting its continued use in immunosuppression protocols.