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B. G. Busbee, J. S. Heier, D. Waterbury, C. Awh, G. Stoller, T. Cleary, P. Daniels; Comparison of Vitreous PGE2 Concentrations of Ketorolac 0.4%, Bromfenac 0.09%, and Nepafenac 0.1% in Patients Undergoing Vitrectomy. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5169.
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To compare the vitreous penetration and PGE2 inhibition of three NSAIDs: ketorolac tromethamine 0.4% (Acular LS), bromfenac 0.09% (Xibrom) and nepafenac sodium 0.1% (Nevanac)
Investigator-masked, randomized, multicenter evaluation of 32 eyes scheduled to undergo 3-port pars plana vitrectomy for multiple etiologies, including epiretinal membrane, macular hole, retinal detachment, and diabetic retinopathy. Patients were randomized to receive either ketorolac QID, bromfenac BID, or nepafenac TID (based on the FDA-approved dosing regimen) for three days prior to surgery. A control group of 5 eyes were not treated pre-operatively with a topical NSAID. Samples were snap frozen in two cryotubes and sent on dry ice for drug concentration analysis with HPLC and PGE2 inhibition via laboratory assays.
Ketorolac inhibited PGE2 (189.6 pg/mL) to a greater extent than did nepafenac (267.7 pg/mL), bromfenac (247.2 pg/mL), or control (270.6 pg/mL). These differences were statistically significant for ketorolac versus nepafenac (P=.028) and ketorolac versus control (P=.047). There were no significant differences in PGE2 inhibition between either nepafenac versus control (P=.944) or bromfenac versus control (P=.569). Ketorolac achieved greater concentrations in the vitreous (5.0 ng/mL) than did nepafenac (1.7 ng/mL), bromfenac (1.5 ng/mL), or amfenac (the active moiety of nepafenac) (1.6 ng/mL) but there were no significant between-group differences (P≥.071).
Statistically significantly lower PGE2 levels were achieved in the ketorolac-treated eyes relative to nepafenac-treated eyes and untreated control eyes. Neither nepafenac- nor bromfenac-treated eyes achieved statistically significantly lower vitreous levels of PGE2 relative to untreated control eyes. Ketorolac achieved greater vitreous concentrations than did nepafenac/amfenac or bromfenac, though these levels were not statistically significant.
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