Wednesday, August 13, 2008

At Least Half Of All Kidney Transplant Recipients Benefit From Drug Level Testing To Prevent Organ Rejection

From Medical News Today:

Data presented at the 22nd International Congress of The Transplantation Society provides further direction to transplant doctors to test the immunosuppression drug levels of patients who are most at risk of rejecting their transplanted organ. The data, a follow-up analysis of the FDCC* study of 901 kidney transplant recipients, shows that the active component in CellCept, mycophenolic acid (MPA), should be measured in 'at risk'patients.

"By measuring the dependable levels of MPA we identified that patients with less than 30mg*h/l were more likely to reject their organ in the first month after transplantation and this trend was even more pronounced in 'at risk' patients," commented Dr. Teun van Gelder, Internist-Nephrologist, Department of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, The Netherlands. "Therapeutic drug monitoring (TDM), as the measure is known, allows doctors to alter the dose of CellCept and deliver the optimal immunosuppression needed to prevent rejection. We're now seeing an increased interest and acceptance of TDM in clinical practice to ensure more transplants are successful," he added.

Immunosuppressive therapy is life-sustaining and lifelong for most transplant patients. Finding the best possible balance between providing sufficient immunosuppression to prevent rejection whilst minimising the side effects associated with the use of more toxic anti-rejection drugs, such as calcineurin inhibitors (CNIs) and steroids, is a key goal in transplant medicine.

The introduction of CellCept containing regimens has allowed doctors to reduce the dosage of these more toxic drugs, but some patients may need higher doses of CellCept to prevent organ rejection.

Annually, it is estimated that 70,000 transplants are carried out world-wide, but over 130,000 people are currently on the transplant waiting list. This underscores the importance of preventing any unnecessary loss of a transplanted organ.**

'At risk' patients are generally considered to have:

  • Delayed function of the transplanted organ

  • Second or third transplantation

  • Raised levels (>15%) of naturally circulating defence antibodies, which play a role in initiating rejection

  • Low donor/recipient compatibility

*The FDCC study findings are supported by the results of two similar trials investigating low-dose CNI or CNI-free CellCept based regimens. The OptiCept trial found that a reduced level of CNI with a therapeutic monitored dose of CellCept is not inferior to that of a fixed-dose of CellCept and the standard-dose of CNI. The Spare the Nephron study showed that a CellCept-based regimen in combination with sirolimus is associated with improved renal function when compared with the CellCept-based regimen in combination with CNIs; this improvement was seen without increasing the risk of acute rejection.

Read the complete article for information on the studies and the role of Roche in transplantation.

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1 comment:

michael thomas said...

Where in the article or the studies mentioned is the statement or any similar statemet"at least half of all kidney transplant recipients benefit from drug level testing to prevent organ rejection"when speaking of Cellcept and MPA?
I believe the stement made was that checking MPA levels may be beneficial to "at risk " patients - such patients to my knowledge being a very small minority of all kidney transplant patients and then only those being dosed with Cellcept.
Please just a bit of accuracy and lot less hyperbole
Michael Thomas