A comparison was made of the efficacy, tolerability, safety and steady state pharmacokinetics of
Sandimmun and
Neoral in 11 stable
atopic dermatitis patients already on
Sandimmun. The study was of an open, crossover design. At entry into the trial, patients were switched to
Neoral for 28 days. Treatment was switched back to
Sandimmun for Days 28 to 42. The morning dose was given fasting, the evening dose after a standard meal. All measures of
eczema severity improved during the
Neoral treatment period.
Neoral was markedly better tolerated with fewer side-effects. Switching from
Sandimmun to
Neoral at the same dose resulted in less variable pharmacokinetic profiles in both fasted and fed states. There was an increase in bioavailability with better, less variable and faster absorption, with a slightly reduced tmax, a higher mean Cmax (+43%) and a higher mean AUC (+30%) in fasted, but not fed patients. Higher trough levels (Cmin) occurred throughout for
Neoral. These differences between the two formulations were not associated with any changes in safety parameters. Overall,
Neoral was equivalent or superior to
Sandimmun in tolerability and efficacy when given on a 1:1 dose basis.