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Original Article
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Volume 331:358-363 August 11, 1994 Number 6
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Long-Term Efficacy and Safety of Cyclosporine in Renal-Transplant Recipients
James F. Burke, John D. Pirsch, Eleanor L. Ramos, Daniel R. Salomon, Donald M. Stablein, David H. Van Buren, and John C. West

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ABSTRACT

Background and Methods The safety of long-term immunosuppression with cyclosporine in renal-transplant recipients is not well understood. This drug may cause a progressive toxic nephropathy, but it also preserves renal function because it prevents rejection. To determine the effect of cyclosporine on renal function and graft rejection, we conducted a retrospective analysis of data on 1663 renal-transplant recipients at six centers.

Results The rate of graft survival was 78 percent (median follow-up, 36 months). Grafts were lost in 279 patients (17 percent), mostly because of acute rejection (68 patients) or chronic graft dysfunction that was unresponsive to a reduction in the dose of cyclosporine (125 patients); 92 patients died with functioning grafts. The median change in the serum creatinine concentration in all patients after transplantation was less than 0.001 mg per deciliter per month (<0.09 µmol per liter per month). Patients who had episodes of rejection had decreased rates of long-term graft function and survival. Eight percent of patients with functioning grafts at one year had first episodes of rejection more than one year after transplantation. These late first rejections were associated with noncompliance with therapy (in 34 percent), blood cyclosporine concentrations that were marginally lower than those of patients who had no episodes of rejection, and a low rate of successful reversal of rejection (77 percent, vs. 97 percent in patients with rejection during the first year; P<0.001).

Conclusions The majority of renal-transplant patients tolerate long-term cyclosporine therapy without evidence of progressive toxic nephropathy. Graft failure is most often due to rejection. .


Source Information

From the Thomas Jefferson University Hospital Transplant Program, Philadelphia (J.F.B.); the University of Wisconsin Transplant Program, Madison (J.D.P.); the Brigham and Women's Hospital Renal Transplant Program, Boston (E.L.R.); the University of Florida Kidney Transplant Program, Gainesville (D.R.S.); the EMMES Corporation, Potomac, Md. (D.M.S.); the Vanderbilt University Transplant Center, Nashville (D.H.V.B.); and the Transplant Section, Department of Surgery, Geisinger Medical Center, Danville, Pa. (J.C.W.).

Address reprint requests to Dr. Salomon at the Department of Molecular and Experimental Medicine -- SBR5, Scripps Research Institute, 10666 N. Torrey Pines Rd., La Jolla, CA 92037.

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Related Letters:

Efficacy and Safety of Cyclosporine in Renal-Transplant Recipients
Singh A. K., Bennett W. M., Burke J. F., Pirsch J. D., Salomon D. R.
Extract | Full Text  
N Engl J Med 1994; 331:1777-1778, Dec 29, 1994. Correspondence

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