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Cyclosporine neoral: a local experience
M R Nampoory1, K V Johny, J N Costandi
1Department of Medicine, Mubarak Al-Kabeer Teaching Hospital and Faculty of Medicine, Kuwait University, Kuwait.
Summary
The new oral formulation Sandimune Neoral (SIM-NOF) offers superior bioavailability and predictable absorption compared to traditional Cyclosporine (SIM). This improved formulation ensures more consistent immunosuppression levels in renal transplant patients.
Area of Science:
- Pharmacology
- Nephrology
- Transplantation Medicine
Background:
- Cyclosporine (CsA) is a vital immunosuppressant.
- Traditional Cyclosporine (SIM) exhibits variable bioavailability and absorption.
- A new oral formulation, Sandimune Neoral (SIM-NOF), was developed to address these limitations.
Purpose of the Study:
- To evaluate the tolerability, efficacy, and safety of Sandimune Neoral (SIM-NOF).
- To compare SIM-NOF with traditional Cyclosporine (SIM) regarding bioavailability, absorption patterns, and consistency of 12-hour trough levels.
Main Methods:
- A prospective, open-label, crossover study involving 14 renal transplant recipients.
- Patients initially received SIM for 12 weeks, followed by a 2-week run-in, then switched to SIM-NOF for 12 weeks on a 1:1 dose conversion.
- Cyclosporine 12-hour trough levels and absorption profiles were monitored throughout the study.
Main Results:
- SIM-NOF demonstrated a predictable absorption profile, peaking at 2 hours, unlike the erratic levels seen with SIM.
- The time to maximum concentration (Tmax) was significantly shorter for SIM-NOF (2.0 hours) compared to SIM (3.7 hours) (p<0.0001).
- Maximum concentration (Cmax) was higher for SIM-NOF (2149) versus SIM (1942) (p=0.008).
Conclusions:
- Sandimune Neoral (SIM-NOF) is a superior oral formulation of Cyclosporine compared to traditional Sandimune (SIM).
- SIM-NOF provides more consistent and predictable immunosuppression, crucial for managing renal transplant recipients.
- No specific adverse effects were noted with the new formulation.
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