The Pharmaceutical Journal
Vol 277 No 7483 p706
22/29 December 2007

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Low-dose tacrolimus regimen shows benefits in kidney transplant patients

Kidney transplant patients receiving 12 months treatment with a regimen consisting of daclizumab, mycophenolate mofetil and corticosteroids, in combination with low-dose tacrolimus, may have a better outcome in terms of renal function, allograft survival and acute rejection rates, than those treated with regimens containing daclizumab induction plus low-dose ciclosporin or low-dose sirolimus, or standard dose ciclosporin without induction, say researchers.

They randomised 1,645 renal transplant patients to receive either ciclosporin, mycophenolate mofetil and corticosteroids, or daclizumab induction, mycophenolate mofetil and corticosteroids in combination with low-dose ciclosporin, low-dose tacrolimus or low-dose sirolimus. Patients receiving the low-dose tacrolimus were found to have a higher mean glomerular filtration rate (65.4ml per minute).

Acute rejection was lower in the low-dose tacrolimus group, and allograft survival was highest. A similar proportion of patients in each group experienced adverse events during treatment, but serious adverse events were more common in the low-dose sirolimus group (New England Journal of Medicine 2007;357:2562).

However, an accompanying editorial points out weaknesses in the study, including the racial mix of the study cohort, the short timescale of the study, patients’ exposure to ciclosporin, tacrolimus and sirolimus, and pharmacokinetic issues.

The author of the editorial (Ibid, p2625) concludes: “The question of whether such an approach would improve long-term function of renal allografts and the overall health and quality of life of kidney-transplant recipients remains unanswered.”

Andrea Devaney, lead renal pharmacist at the Oxford Radcliffe Hospitals NHS Trust, commented: “The holy grail in transplantation is how to avoid or minimise the incidence of chronic allograft nephropathy. This trial reports on a strategy to minimise calcineurin inhibitor exposure from the outset.”