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C.C. Murphy, K.H. Greiner, J. Plskova, J.V. Forrester, A.D. Dick; Prospective Randomised Trial of Tacrolimus Versus Cyclosporin Therapy for Non-Infectious Posterior Segment Intraocular Inflammation . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2413.
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Purpose: To compare the efficacy and tolerability of tacrolimus and cyclosporin in the management of non-infectious posterior segment intraocular inflammation (PSII). Methods: 28 patients with non-infectious PSII requiring 2nd line immunosuppression were randomly assigned to tacrolimus or cyclosporin therapy. Treatment success was defined as an increase in logMAR acuity of at least 2 lines, a decrease in BIO score of 1 or more, resolution of signs of posterior segment inflammation, or the ability to reduce maintenance prednisolone to acceptable levels, all in the absence of significant adverse effects. Treatment failure was defined as either no improvement in clinical activity or intolerance necessitating cessation of therapy. Results: 14 patients were recruited into each treatment group. The mean age was 47 years (range 19-67) and 18 (64%) patients were female. The mean follow up was 8 months (range 2-18). 8 patients (57%) on cyclosporin and 12 patients (86%) on tacrolimus achieved a successful outcome. 6 patients (43%) and 2 patients (14%) failed on cyclosporin and tacrolimus, respectively. There was no significant difference in relapse rate (7/14 for cyclosporin versus 8/14 for tacrolimus) or effect on visual acuity or BIO score between the two groups. Systolic and diastolic blood pressure increased by 9.6% (95% CI 3.8-15.5) and 18.2% (95% CI 2.7-33.6) respectively in the cyclosporin group, compared with 3.7% (95% CI 1.1-6.4) and 3.7% (95% CI 1.1-6.2) in the tacrolimus group (p=0.08). Side effects of headache (40% versus 14.3%), fatigue (46.7% versus 7.1%), gingival hypertrophy (26.7% versus 7.1%), and hirsutism (26.7% versus 7.1%) were more common with cyclosporin than tacrolimus but neurological side effects were more common with tacrolimus (71.4% versus 53.3%). Serum creatinine increased by a mean value of 8.7% (95% CI 3.3-13.0) in the cyclosporin group compared with 1.8% (95% CI 0.5-3.3) in the tacrolimus group (p=0.02). Conclusions: Although tacrolimus and cyclosporin were equally efficacious, tacrolimus had advantages in respect of fewer side effects, a milder hypertensive effect, and significantly less renal dysfunction.
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