The safety and tolerability of cyclosporine emulsion versus cyclosporine in a randomized, double-blind comparison in primary renal allograft recipients

Transplantation

Volumn 61, Issue 6, 1996, Pages 968-970

  Barone, Gary ^a   Bunke, C Martin ^b   Choc Jr , M Gerry ^c   Hricik, Donald E ^d   Jin, Judy Hyun Ju ^c   Klein, Jon B ^e   Marsh, Christopher L ^f   Min, David I ^g   Pescovitz, Mark D ^h   Pollak, Raymond ⁱ   Pruett, Timothy L ^j   Stinson, James B ^k   Thompson, John S ^l   Vasquez, Eva ⁱ   Waid, Thomas ^l   Wombolt, Duane G ^m   Wong, Robert L ^c  

^a UNIVERSITY OF ARKANSAS AT LITTLE ROCK   (United States)

^b UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^c Sandoz Pharma Ltd   (Switzerland)

^d UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^e UNIVERSITY OF LOUISVILLE   (United States)

^f UNIVERSITY OF WASHINGTON   (United States)

^g UNIVERSITY OF IOWA HOSPITALS AND CLINICS   (United States)

^h INDIANA UNIVERSITY   (United States)

ⁱ UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^j UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

^k Latter Day Saints Hospital   (United States)

^l UNIVERSITY OF KENTUCKY MEDICAL CENTER   (United States)

^m EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

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Author keywords

[No Author keywords available]

Indexed keywords

CYCLOSPORIN;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; GRAFT REJECTION; GRAFT SURVIVAL; HUMAN; KIDNEY ALLOGRAFT; MAJOR CLINICAL STUDY; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECIPIENT;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; BIOLOGICAL AVAILABILITY; CAPSULES; CYCLOSPORINE; DOUBLE-BLIND METHOD; EMULSIONS; FEMALE; GRAFT SURVIVAL; HUMANS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED;

EID: 9244239156     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007890-199603270-00021     Document Type: Article

References (7)

1. Vonderscher J, Meinzer A. Rationale for the development of Sandimmune Neoral. Transplant Proc 1994; 26: 2925.
2. Mueller EA, Kovarik JM, van Bree JB, Lison AE, Kutz K. Pharmacokinetics and tolerability of a microemulsion formulation of cyclosporine in renal allograft recipients - a concentration-controlled comparison with the commercial formulation. Transplantation 1994; 57: 1178.
3. Kovarik JM, Mueller EA, van Bree JB, Arns W, Renner E, Kutz K. Within-day consistency in cyclosporine pharmacokinetics from a microemulsion formulation in renal transplant patients. Ther Drug Monit 1994; 16: 232.
4. Kahan BD, Dunn J, Fitts C, et al. Reduced inter- and intrasubject variability in cyclosporine pharmacokinetics in renal transplant recipients treated with a microemulsion formulation in conjunction with fasting, low-fat meals, or high-fat meals. Transplantation 1995; 59: 505.
5. Kahan BD, Dunn J, Fitts C, et al. The Neoral formulation: improved correlation between cyclosporine trough levels and exposure in stable renal transplant recipients. Transplant Proc 1994; 26: 2940.
6. Lindholm A, Kahan BD. Influence of cyclosporine pharmacokinetics, trough concentrations, and AUC monitoring on outcome after kidney transplantation. Clin Pharmacol Ther 1993; 54: 205.
7. Schroeder TJ, Hariharan S, First MR. Relationship between cyclosporine bioavailability and clinical outcome in renal transplant recipients. Transplant Proc 1994; 26: 2787.