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

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

Author Silva, H. T. Google Scholar
Felipe, C. R. Google Scholar
Machado, PGP Google Scholar
Garcia, R. Google Scholar
Motegi, S. Google Scholar
Hosaka, B. H. Google Scholar
Hanzawa, N. M. Google Scholar
Park, S. I. Google Scholar
Casarini, D. Google Scholar
Lima, V. C. Google Scholar
Franco, M. Google Scholar
Medina-Pestana, J. O. Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Abstract 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.
Language English
Date 2003-05-01
Published in Transplantation Proceedings. New York: Elsevier B.V., v. 35, n. 3A, p. 177S-180S, 2003.
ISSN 0041-1345 (Sherpa/Romeo, impact factor)
Publisher Elsevier B.V.
Extent 177S-180S
Access rights Closed access
Type Article
Web of Science ID WOS:000182991100035

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