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Lubitz SA, Baran DA, Alwarshetty MM, Pinney S, Kaplan S, Chan M, Courtney MC, Lansman SL, Spielvogel D, Gass AL.

Long-term Results of FK506 Monotherapy in Cardiac Transplant Recipients

J Heart Lung Transplant. 2006 Jun;25(6):699-706

Mount Sinai Medical Center, New York, New York, USA.

Conventional immunosuppression for heart transplantation is associated with various adverse effects. Tacrolimus monotherapy (TM) is an alternative strategy that minimizes exposure to additional immunosuppressants. METHODS: We retrospectively reviewed clinical data for all adult transplant recipients between January 1, 1996 and May 1, 2004. Clinical outcomes were analyzed according to immunosuppressive regimen. RESULTS: A total of 167 heart transplants were performed at our center. Eight patients died before receiving calcineurin inhibitors and were excluded from analysis. The mean follow-up for the 159 surviving patients was 1,520 +/- 78 days. Ninety of 124 patients initially treated with tacrolimus and corticosteroids were weaned to TM without the use of an anti-proliferative agent (Group A), resulting in an overall success rate of 75% at an average of 271 +/- 18 days after transplant. The remaining 69 recipients were treated with other tacrolimus- or cyclosporine-based regimens (Group B). Survival was significantly greater in Group A. The prevalence of high-grade rejection within the first year and incidence of cardiac allograft vasculopathy were similar between groups. Ten patients (11%) in Group A required recommencement of combination immunosuppression at an average of 768 +/- 772 days.

CONCLUSIONS: TM is achievable in the majority of cardiac transplant recipients. Patients who tolerated reduced immunosuppression enjoyed greater survival than those treated with other regimens, without additional high-grade rejection or vasculopathy. These promising results remain to be confirmed in a prospective trial.

PMID: 16730576

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