Safety, tolerability and efficacy of cyclosporine microemulsion in heart transplant recipients: A randomized, multicenter, double-blind comparison with the oil based formulation of cyclosporine - Results at six months after transplantation

Eisen, Howard J., Hobbs, Robert E., Davis, Stacy F., Laufer, Guenther, Mancini, Donna M., Renlund, Dale G., Valantine, Hannah, Ventura, Hector and et al. (1999). Safety, tolerability and efficacy of cyclosporine microemulsion in heart transplant recipients: A randomized, multicenter, double-blind comparison with the oil based formulation of cyclosporine - Results at six months after transplantation. In: 17th Annual Meeting of the American-Society-of-Transplant-Physicians, Chicago, IL, United States, (663-671). 9-13 May 1998. doi:10.1097/00007890-199909150-00012


Author Eisen, Howard J.
Hobbs, Robert E.
Davis, Stacy F.
Laufer, Guenther
Mancini, Donna M.
Renlund, Dale G.
Valantine, Hannah
Ventura, Hector
et al.
Title of paper Safety, tolerability and efficacy of cyclosporine microemulsion in heart transplant recipients: A randomized, multicenter, double-blind comparison with the oil based formulation of cyclosporine - Results at six months after transplantation
Conference name 17th Annual Meeting of the American-Society-of-Transplant-Physicians
Conference location Chicago, IL, United States
Conference dates 9-13 May 1998
Journal name Transplantation   Check publisher's open access policy
Place of Publication Philadelphia, PA, United States
Publisher Lippincott Williams & Wilkins
Publication Year 1999
Sub-type Fully published paper
DOI 10.1097/00007890-199909150-00012
ISSN 0041-1337
1534-6080
Volume 68
Issue 5
Start page 663
End page 671
Total pages 8
Language eng
Formatted Abstract/Summary
Background: The introduction of cyclosporine has resulted in significant improvement in the survival of cardiac allograft recipients due to decreased mortality from infection and rejection. The original oil-based cyclosporine formulation exhibits variable and unpredictable bioavailability that correlates with an increased incidence of acute and chronic rejection in those patients in whom this is most pronounced. The primary objectives of this prospective, multicenter, randomized, double-blind study in cardiac transplant patients were: to compare the efficacy of cyclosporine microemulsion (CsA-NL) with oil-based cyclosporine (CsA-SM) as measured by cardiac allograft and recipient survival and the incidence and severity of acute rejection episodes; and to assess the safety and tolerability of CsA-NL compared with CsA-SM in this population. This report represents the analysis of results 6 months after transplantation.


Methods: A total of 380 patients undergoing their first cardiac transplant at 24 centers in the United States, Canada, and Europe were enrolled in this double-blind, randomized trial examining the safety and efficacy of CsA-NL versus CsA-SM. Rejection was diagnosed using endomyocardial biopsy and were graded according to standardized criteria of the International Society of Heart and Lung Transplantation (ISHLT). Clinical parameters were monitored during the study. Survival and freedom from were used for analysis as was Fisher's exact test for comparisons between groups.


Results: At 6 months after transplantation, allograft and patient survival were the same for both groups. The frequency of ISHLT grade 3A or greater episodes in the two groups was identical. Fewer CsA-NL patients (5.9%) required antilymphocyte antibody (ATG or OKT-3) therapy for rejection compared with the CsA-SM-treated patients (14.1%, P=0.01). Females with ISHLT rejection grade>=3A treated with CsA-NL had a 46% lower incidence of rejection compared with the CsA-SM-treated group (31.3% vs. 57.6%, P=0.032). Fewer infections were seen in the CsA-NL. With the exception of baseline and 1 week posttransplant creatinines which were higher in the CsA-NL group, the overall creatinine was not significantly different between the two groups.


Conclusions: This multicenter, randomized study of cardiac transplant recipients documented less severe rejection (in particular those requiring antibody therapy) and a lower incidence of infection in CsA-NL-treated patients. Results from the female subgroup analysis suggest that the improved bioavailability of CsA-NL might reduce the frequency of rejection episodes in female patients. The use of CsA-NL was not associated with an increased risk of adverse events.
Q-Index Code E1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Conference Paper
Collection: School of Medicine Publications
 
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Created: Mon, 14 Mar 2011, 10:08:32 EST