A randomized, prospective multicenter pharmacoepidemiologic study of cyclosporine microemulsion in stable renal graft recipients

Transplantation

Volumn 62, Issue 12, 1996, Pages 1744-1752

  Keown, Paul ^a,o   Landsberg, David ^a   Halloran, Phillip ^b   Shoker, A ^c   Rush, David ^d   Jeffery, John ^d   Russell, David ^e   Stiller, Calvin ^f   Muirhead, Norman ^f   Cole, Edward ^g   Paul, Leen ^h   Zaltzman, J ^h   Loertscher, Rolf ⁱ   Daloze, Pierre ^j   Dandavino, Raymond ^k   Boucher, Anne ^k   Handa, P ^l   Lawen, Joseph ^m   Belitsky, Phillip ^m   Parfrey, Patrick ⁿ  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b UNIVERSITY OF ALBERTA HOSPITAL   (Canada)

^c ROYAL UNIVERSITY HOSPITAL   (Canada)

^d HEALTH SCIENCES CENTRE   (Canada)

^e ST JOSEPH S HOSPITAL   (Canada)

^f LONDON HEALTH SCIENCES CENTRE   (Canada)

^g UNIVERSITY HEALTH NETWORK   (Canada)

^h ST MICHAEL'S HOSPITAL   (Canada)

ⁱ ROYAL VICTORIA HOSPITAL   (Canada)

^j NOTRE DAME HOSPITAL   (Canada)

^k MAISONNEUVE ROSEMONT HOSPITAL   (Canada)

^l SAINT JOHN REGIONAL HOSPITAL   (Canada)

^m QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

ⁿ Health Sciences Centre St John's   (Canada)

^o VANCOUVER HOSPITAL AND HEALTH SCIENCES CENTRE   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOSPORIN;

CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERANCE; HUMAN; HUMAN TISSUE; KIDNEY GRAFT; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MICROEMULSION; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; AGED; CYCLOSPORINE; DRUG TOLERANCE; EMULSIONS; GRAFT REJECTION; HUMANS; INTESTINAL ABSORPTION; KIDNEY TRANSPLANTATION; MIDDLE AGED; PROSPECTIVE STUDIES;

EID: 1542422139     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007890-199612270-00009     Document Type: Article

References (24)

1. Lindholm A, Kahan BD. The use of cyclosporine in organ transplantation. In: Bach J-F, ed. T-cell-directed immunointervention. London: Blackwell Scientific Publications, 1993: 77.
2. Holt DW, Johnston A. Pharmacokinetics and monitoring of cyclosporine A. In: Thomson AW, Starzl TE, eds. Immunosuppressive drugs, developments in anti-rejection therapy. London: Edward Arnold, 1994: 37.
3. Mueller EA, Kovarik JM, van Bree JB, et al. Influence of a fat-rich meal on the pharmacokinetics of a new oral formulation of cyclosporine in a crossover comparison with the market formulation. Pharm Res 1994; 11: 151.
4. Trull AK, Tan KKC, Tan L, et al. Absorption of cyclosporin from conventional and new microemulsion oral formulations in liver transplant recipients with external biliary diversion. Br J Clin Pharmacol 1995; 39: 627.
5. Winkler M, Ringe B, Oldhafer K, et al. Influence of bile on cyclosporine adsorption from microemulsion formulation in primary liver transplants. Transpl Int 1995; 8: 324.
6. Savoldi S, Kahan BD. Relationship of cyclosporine pharmacokinetic parameters to clinical events in human renal transplantation. Transplant Proc 1986; 18: 120.
7. Kasiske BL, Heim-Duthoy K, Venkateswara Roa K, Awni WM. The relationship between cyclosporine pharmacokinetic parameters and subsequent acute rejection in renal transplant recipients. Transplantation 1988; 46: 716.
8. Kahan BD, Grevel J. Optimization of cyclosporine therapy in renal transplantation by a pharmacokinetic strategy. Transplantation 1988; 46: 631.
9. Keown PA, Stiller CR, Ulan RA, et al. Immunological and pharmacological monitoring in the clinical use of cyclosporine A. Lancet 1981; 1: 686.
10. Myers BD, Ross J, Newton L, et al. Cyclosporine-associated chronic nephropathy. N Engl J Med 1984; 311: 699.
11. Moyer TP, Post GR, Sterioff S, Anderson CF. Cyclosporine nephrotoxicity is minimized by adjusting dosage on the basis of drug concentration in blood. Mayo Clin Proc 1988; 63: 241.
12. Salomon D, Brunson M, Vansickler J, et al. A retrospective analysis of late renal graft function: correlation with mean cyclosporine levels and lack of evidence for chronic cyclosporine toxicity. Transplant Proc 1991; 23: 1018.
13. Levy G, Grant D. Potential for CsA-Neoral in organ transplantation. In: Kahan BD, ed. Cyclosporine, the ten-year experience. Norwalk, CT: Appleton & Lange, 1994: 2932.
14. Holt DW, Mueller EA, Kovarik JM, et al. The pharmacokinetics of Sandimmun Neoral: a new oral formulation of cyclosporine. In: Kahan BD, ed. Cyclosporine, the ten-year experience. Norwalk, CT: Appleton & Lange, 1994: 2935.
15. Kahan BD, Dunn J, Fitts C, et al. The Neoral formulation: improved correlation between cyclosporine trough levels and exposure in stable renal transplant patients. In: Kahan BD, ed. Cyclosporine, the ten-year experience. Norwalk, CT: Appleton & Lange, 1994: 2940.
16. Kovarik JM, Mueller EA, Van Bree JB, et al. Cyclosporine pharmacokinetics and variability from a microemulsion formulation - a multicenter investigation in kidney transplant patients. Transplantation 1994a; 58: 658.
17. Kovarik JM, Mueller EA, Van Bree JB, et al. Reduced inter- and intra-individual variability in cyclosporine pharmacokinetics from a microemulsion formulation. J Pharm Sci 1994b; 83: 444.
18. Kovarik JM, Mueller EA, Van Bree JB, et al. Within-day consistency in cyclosporine pharmacokinetics from a microemulsion formulation in renal transplant patients. Ther Drug Monit 1994c; 16: 232.
19. Mueller EA, Kallay Z, Kovarik JM, et al. Assessment of glomerular filtration rate after multiple administration of a new oral formulation of cyclosporine in clinically stable renal transplant patients. Transplant Proc 1995; 27: 834.
20. Mikhail G, Eadon H, Leaver N, Yacoub M. Use of Neoral in heart transplant recipients. In: Kahan BD, ed. Cyclosporine, the ten-year experience. Norwalk, CT: Appleton & Lange, 1994: 2985.
21. International Neoral Study Group. Safety and efficacy of Sandimmune Neoral compared with Sandimmune in new renal transplant recipients: results of a randomized, multicenter trial. Transplantation. Submitted.
22. Barone G, Martin Bunke C, Choc MG, et al. The safety and tolerability of cyclosporine emulsion versus cyclosporine in a randomized, double-blind comparison in primary renal allograft recipients. Transplantation 1996; 61: 968.
23. Canadian Institute for Health Information. Annual report 1996, Volume 1: dialysis and renal transplantation. Ottawa: Canadian Organ Replacement Register, 1996.
24. Johnston A, Sketris J, Marsden JT, et al. A limited sampling strategy for the measurement of cyclosporine AUC. Transplant Proc 1990; 22: 1345.