Over 40% of all new kidney transplant patients in the USA receive an organ from a living donor.2 The retrospective study assessed data from over 7,000 living donor kidney transplant recipients registered within the US organ transplant registry United Network for Organ Sharing (UNOS) and aimed to compare organ survival over three years in patients receiving one of the two most commonly used immunosuppressive regimens: Neoral or tacrolimus, both in combination with mycophenolate mofetil and steroids.
The study concluded that three-year graft (organ) survival rates for the transplanted kidney were significantly higher in patients who received Neoral compared to patients who received tacrolimus. Specifically, the results showed that:
- patients who received tacrolimus had a 28% higher risk of losing their transplanted organ or of dying (all cause graft failure) than patients who received Neoral (hazard ratio of 1.28). When patients who died with a functioning organ were excluded from the analysis of organ failures, patients treated with tacrolimus had a 25% higher risk of losing their organ (hazard ratio of 1.25).
- transplanted kidneys in patients who were taking Neoral were expected to survive for four years longer on average than in patients taking tacrolimus, according to the results of another prognostic tool, the 'estimated graft half-life' (20.8 years graft half-life survival time for the Neoral group vs 16.1 years for the tacrolimus group, all cause graft failure).
Lead investigator Dr. Steven Takemoto, of the UCLA School of Medicine, Los Angeles, commented: "Outcomes data are an accurate reflection of how different therapies perform in the real world. It is important to know the longer-term effect of different immunosuppressive treatments on survival of transplanted organs.
Analysis of data from transplant registries provides an opportunity to examine outcomes from many thousands of patients over an extended time period, provided the data are statistically adjusted to match the two groups as closely as possible in terms of other criteria, such as patient and donor age, race, sex and genetic compatibility. Using this approach, our study indicated a clear advantage for Neoral versus the main alternative, tacrolimus, in prolonging the survival of transplanted kidneys from living donors."
Anne Frankton, a transplant coordinator at Nottingham City Hospital, UK, commented: "Living donor transplantation is a huge emotional and physical investment for both the patient and donor. The loss of a transplanted kidney is a devastating event under any circumstances but is particularly traumatic in the case of living donors who have donated one of their kidneys to help a loved one and endured major surgery in the process. For the person losing the transplant it means a return to the ordeal of regular dialysis, involving hours hooked up to a blood-cleaning machine three times a week and the consequent impairment of their independence and quality of life. It is therefore vital that studies like this are undertaken to help doctors find ways to reduce the risk of transplant failure."
Approximately 30,000 people in Europe and the US receive kidney transplants each year, a significant number of these are from living donors.2 Immunosuppressive treatment is vital to prevent the body rejecting the new organ. Neoral is the main component of current immunosuppressive treatment strategies in transplant patients and remains the most commonly prescribed immunosuppressant worldwide.
This release contains certain "forward-looking statements," relating to the Company's business, which can be identified by the use of forward-looking terminology such as "long-term chances", "expected to", or similar expressions, or by express or implied discussions regarding potential future sales of Neoral. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions.
Many factors could cause the actual results to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There can be no guarantees that Neoral will reach any particular sales levels.
Any results expressed or implied by such forward-looking statements can be affected by, among other things, uncertainties relating to product development and clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20-F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 77 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
NOTES TO EDITORS:
· Graft half-life is an estimate of the length of time for half of the patients in a study to lose their transplanted organ. This measurement, based on rates of loss in years two to three, estimates long-term differences in organ survival times between the two treatment groups.
· For an electronic and downloadable version of this press release, please visit the transplantation media resource site http://www.transplantsquare.com.
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Novartis International AG
Novartis Communication
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References:
1. Bunnapradist S, Daswani A, Takemoto SK. Graft survival following living donor renal transplantation: a comparison of tacrolimus and cyclosporine microemulsion with mycophenolate mofetil and steroids. Presented at 2003 American Transplant Congress, Washington DC.
2. http://www.optn.org. Data Reports, National Data. Available at: http://www.optn.org/latestData/rptData.asp
Journal
American Journal of Transplantation