Safety and efficacy of sirolimus in kidney transplant patients and in patients with coronary artery disease undergoing angioplasty

Date
2003-05-01Author
Silva, H. T.
Felipe, C. R.
Machado, PGP
Garcia, R.
Motegi, S.
Hosaka, B. H.
Hanzawa, N. M.
Park, S. I.
Casarini, D.
Lima, V. C.
Franco, M.
Medina-Pestana, J. O.
Type
ArtigoISSN
0041-1345Is part of
Transplantation ProceedingsDOI
10.1016/S0041-1345(03)00232-XMetadata
Show full item recordAbstract
We show the key results of our 4-year experience with sirolimus in kidney transplant patients and in nontransplanted patients undergoing coronary angioplasty.Methods: Recipients of one-haplotype living-related kidney allografts were randomized to receive sirolimus (2 mg/d, n = 35) or azathioprine (2 mg/kg per day, n = 35). Recipients of fully mismatched living kidney allografts (n = 55) received sirolimus (2 mg/day). High-risk recipients of black ethnicity (n = 68) were randomized to target whole-blood trough sirolimus concentrations between 8 and 12 ng/mL or 15 to 20 ng/mL. All kidney transplant patients received cyclosporine and prednisone. Sirolimus/cyclosporine pharmacokinetic studies were performed in 40 patients receiving 2 mg (n = 20) or 5 mg (n = 20) of sirolimus 7 days after transplantation. in the coronary intervention study, 12 patients at high risk for in-stent restenosis received sirolimus for 28 days after angioplasty.Results: the incidence of biopsy-confirmed acute rejection was 11.4% in recipients of one-haplotype. living-related kidney allografts, 16.4% in recipients of fully mismatched living kidney allografts, and 15% (8 to 12 ng/mL) and 4% (15 to 20 ng/mL) in high-risk recipients of black ethnicity. Cyclosporine exposure was higher after morning administration compared to evening administration. There were poor correlations between sirolimus and cyclosporine exposures. the 4-month follow-up angiography revealed no restenosis (stenosis diameter > 50%), a late loss of 0.56 +/- 0.40 mm, and a loss index of 0.33 +/- 0.30. the follow-up 3D-intravascular ultrasound restudy showed an in-stent relative volumetric obstruction of 9.9 +/- 5.5%. Sirolimus in highly effective in preventing kidney allograft acute rejection and in-stent coronary restenosis.
Citation
Transplantation Proceedings. New York: Elsevier B.V., v. 35, n. 3A, p. 177S-180S, 2003.Collections
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