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Tacrolimus in heart transplantation.
1Heart Transplant Program, Hospital Juan Canalejo, A Coruña, Spain.
Transplantation Proceedings
|September 10, 2003
Summary
Tacrolimus (Tac) offers similar outcomes to cyclosporine (CsA) after heart transplant but with fewer side effects like hypertension. It is a viable alternative, potentially improving quality of life for certain patients.
Area of Science:
- Immunology
- Transplantation Medicine
- Pharmacology
Background:
- Tacrolimus (Tac) is a calcineurin inhibitor used for immunosuppression after heart transplant (HT).
- Cyclosporine (CsA) has been the standard immunosuppressant, but Tacrolimus has emerged as a significant alternative.
- Early trials compared Tacrolimus with oil-based CsA in HT patients, providing initial efficacy and safety data.
Purpose of the Study:
- To compare the efficacy and safety of Tacrolimus versus Cyclosporine in heart transplant recipients.
- To evaluate Tacrolimus as an alternative immunosuppressant, considering its side effect profile and impact on patient quality of life.
- To explore the effectiveness of Tacrolimus in combination with other immunosuppressants like mycophenolate mofetil (MMF).
Main Methods:
- Two multicenter randomized trials compared Tacrolimus with oil-based CsA, combined with azathioprine and steroids.
- A pilot study investigated Tacrolimus with MMF and steroids, focusing on maintaining specific serum mycophenolic acid levels.
- Ongoing European trials compare Tacrolimus with Neoral CsA, both with MMF, steroids, and induction antibodies.
Main Results:
- Tacrolimus and CsA showed similar patient survival rates and incidences of rejection, nephrotoxicity, diabetes, and infections.
- The Tacrolimus group experienced a lower incidence of arterial hypertension and, in one study, dyslipidemia.
- Tacrolimus demonstrated effectiveness in rescuing steroid-resistant acute rejection and showed potential benefits in quality of life by avoiding gingival hyperplasia and hirsutism.
Conclusions:
- Tacrolimus is a valid alternative to CsA in heart transplant immunosuppression, offering comparable efficacy with a potentially better side effect profile.
- Tacrolimus may be preferable for patients with arterial hypertension or dyslipidemia and could improve treatment compliance in female and pediatric populations.
- Further research is ongoing to clarify the efficacy and safety of Tacrolimus-based regimens, particularly in combination with MMF or rapamycin.