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A prospective trial of tacrolimus (FK 506) in clinical heart transplantation: Intermediate-term results

Pham, SM and Kormos, RL and Hattler, BG and Kawai, A and Tsamandas, AC and Demetris, AJ and Murali, S and Fricker, FJ and Chang, HC and Jain, AB and Starzl, TE and Hardesty, RL and Griffith, BP and Rose, EA and Castaneda, AR (1996) A prospective trial of tacrolimus (FK 506) in clinical heart transplantation: Intermediate-term results. Journal of Thoracic and Cardiovascular Surgery, 111 (4). 764 - 772. ISSN 0022-5223

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Abstract

Between January 1, 1989, and December 31, 1994, we have treated 122 primary heart recipients with FK 506 (group I) and 121 with cyclosporine (group II). Fifty patients in the cyclosporine (CyA) group received no lympholytic induction (CyA alone) and 71 others received lympholytic induction with either rabbit antithymocyte globulin or OKT3 (CyA+LI). The mean follow-up was longer in the FK 506 group than in the CyA groups (3.2 ± 1.3 vs 2.3 ± 1.8 years; p < 0.01). Patient survival did not differ on the basis of the type of immunosuppression used. At 3 months after transplantation, the freedom from rejection in the FK 506 group was higher than that of the CyA-alone group (47% vs 22%, p < 0.01) but similar to that of the CyA+LI group (47% vs 53%). The linearized rejection rate (episodes/100 patient-days) of the FK 506 group (0.09 episodes) was lower (p < 0.05) than that of the CyA-alone group (0.26) and the CyA+LI group (0.13). The requirement for pulsed steroids to treat rejection was less in common in the FK 506 group than in either CyA group. Eighteen patients in the CyA group had refractory rejections; all resolved with FK 506 rescue. Two patients in the FK 506 group had refractory rejection that resolved with total lymphoid irradiation (n = 1) and methotrexate therapy (n = 1). Patients receiving FK 506 had a lower risk of hypertension and required a lower dose of steroids. Although the mean serum creatinine concentration at 1 year was higher in the FK 506 group, this difference disappeared after 2 years. No patients required discontinuation of FK 506 because of its side effects. Our intermediate-term results indicate that FK 506 compares favorably with CyA as a primary immunosuppressant in heart transplantation.

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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Pham, SM
Kormos, RLkormos@pitt.eduKORMOS
Hattler, BG
Kawai, A
Tsamandas, AC
Demetris, AJ
Murali, S
Fricker, FJ
Chang, HC
Jain, AB
Starzl, TEtes11@pitt.eduTES11
Hardesty, RL
Griffith, BP
Rose, EA
Castaneda, AR
Centers: Other Centers, Institutes, Offices, or Units > Thomas E. Starzl Transplantation Institute
Date: 1 January 1996
Date Type: Publication
Journal or Publication Title: Journal of Thoracic and Cardiovascular Surgery
Volume: 111
Number: 4
Page Range: 764 - 772
DOI or Unique Handle: 10.1016/s0022-5223(96)70336-7
Institution: University of Pittsburgh
Refereed: Yes
ISSN: 0022-5223
Other ID: uls-drl:31735062133230, Starzl CV No. 1859
Date Deposited: 08 Apr 2010 17:31
Last Modified: 03 Feb 2019 04:55
URI: http://d-scholarship.pitt.edu/id/eprint/5245

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