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Neoral compared to Sandimmune is associated with a decrease in histologic severity of rejection in patients
I W Graziadei1, R H Wiesner, P J Marotta
1Division of Liver Transplantation, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
Transplantation
|October 6, 1997
Summary
Neoral demonstrated comparable efficacy to Sandimmune in preventing liver transplant rejection. However, Neoral significantly reduced moderate/severe rejection episodes and steroid-resistant rejection in OLT patients.
Area of Science:
- Immunology
- Transplantation Medicine
- Pharmacology
Background:
- Investigating the clinical efficacy of microemulsion formulation of cyclosporine (Neoral) versus Sandimmune (SIM).
- Focus on patients undergoing primary orthotopic liver transplantation (OLT).
Purpose of the Study:
- To compare the efficacy and safety of Neoral and SIM in OLT patients.
- To evaluate the incidence and severity of rejection episodes.
Main Methods:
- Randomized, double-blind controlled study with 33 primary OLT patients.
- Patients received either Neoral or SIM (10 mg/kg/day) post-transplant.
- Rejection episodes diagnosed histologically and graded mild, moderate, or severe.
Main Results:
- No significant difference in total rejection episodes between Neoral and SIM groups.
- Neoral group had significantly lower moderate/severe histologic rejection (3 vs. 9, P=0.027).
- Neoral patients were free of steroid-resistant rejection requiring OKT3 treatment.
Conclusions:
- Neoral is safe and effective for primary OLT patients.
- Neoral offers an advantage by reducing moderate/severe and steroid-resistant rejection.
- Neoral represents an improved therapeutic option for post-liver transplant immunosuppression.