loteprednol-etabonate and Acute-Disease

Topics: Acute Disease; Androstadienes; Anti-Inflammatory Agents; Humans; Loteprednol Etabonate; Prednisolone; Randomized Controlled Trials as Topic; Uveitis, Anterior

To compare the safety and efficacy of loteprednol etabonate 0.5% ophthalmic suspension with prednisolone acetate 1.0% ophthalmic suspension in reducing the ocular signs and symptoms associated with acute anterior uveitis.. Two prospective studies were conducted in sequence. Both were parallel, randomized, double-masked, active-controlled comparisons conducted at academic or private practice clinics in the United States. Efficacy was evaluated by the proportion of patients with a score of 0 for key signs and symptoms of uveitis. Intraocular pressure was increased regularly. The first study involved up to 42 days of treatment, starting with a dose of eight times per day. The second study involved up to 28 days of treatment, starting with a dose of 16 times per day.. In the first study (N = 70), the proportion of patients achieving resolution by the final visit was anterior chamber cell (74% loteprednol etabonate, 88% prednisolone acetate, P = .194) and flare (71% loteprednol etabonate, 81% prednisolone acetate, P = .330). In the second study (N = 175), the proportion of patients achieving resolution by the final visit was anterior chamber cell (72% loteprednol etabonate, 87% prednisolone acetate, P = .015) and flare (66% loteprednol etabonate, 82% prednisolone acetate, P = .017). In both studies, intraocular pressure increase of more than 10 mm Hg was observed more frequently in patients receiving prednisolone acetate (seven patients) than those receiving loteprednol etabonate (one patient).. Although a clinically meaningful reduction of signs and symptoms was noted in both treatment groups, loteprednol etabonate was less effective than prednisolone acetate in both of these controlled studies. However, the more favorable profile of loteprednol etabonate with respect to intraocular pressure increase may make it useful in many patients.

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Double-Blind Method; Drug Evaluation; Female; Humans; Intraocular Pressure; Loteprednol Etabonate; Male; Middle Aged; Ophthalmic Solutions; Prednisolone; Prospective Studies; Safety; Treatment Outcome; Uveitis, Anterior

This study objectively compares efficacy of dexamethasone Na phosphate 0.1%, fluorometholone 0.1% (FML), loteprednol etabonate 0.5% (Lotemax [LE]; Bausch & Lomb Pharmaceuticals, Inc., Tampa, FL), prednisolone acetate 1% (Pred Forte [PRED F]; Allergan Pharmaceuticals, Irvine, CA), and generic prednisolone acetate 1% (PRED A). These steroids were administered for 24 hours or 72 hours to New Zealand white rabbits with endotoxin-induced uveitis. Intraocular pressure (IOP), slit-lamp examination, and confocal microscopy were performed daily. Internalization of the glucocorticoid receptor (GC) was assayed in iris tissue by Western blot, and protein in aqueous humor by Bradford assay. Only LE and PRED F treatments significantly internalized GC receptor after 72 hours of treatment. Only LE and PRED A reduced protein concentration between 24 hours and 72 hours of treatment. All drugs improved clinical signs after 24 hours of treatment. None of the steroids promoted return of the inflammation-induced corneal thickness to baseline. While none returned IOP to baseline, LE was most effective. Confocal microscopy indicated that only treatment with LE reverted the abnormal endothelial-cell shape to normal. In conclusion, all steroid treatments reduced uveitis to some degree but LE was consistently effective. A longer observation period may be required to document the return of IOP and corneal thickness to baseline values.

Topics: Acute Disease; Administration, Topical; Androstadienes; Animals; Aqueous Humor; Blotting, Western; Conjunctiva; Corneal Stroma; Dexamethasone; Endothelium, Corneal; Eye Proteins; Fibrin; Fluorometholone; Glucocorticoids; Intraocular Pressure; Lipopolysaccharides; Loteprednol Etabonate; Male; Particle Size; Prednisolone; Rabbits; Receptors, Glucocorticoid; Suspensions; Time Factors; Uveitis, Anterior; Vitreous Body

Loteprednol etabonate, a new soft steroid designed for use as a local therapeutic, was compared to dexamethasone in rabbit experimental model for arthritis.. Joint inflammation was induced by local injection of antigen into the patellofemoral articulation in sensitized rabbits. Co-administration of either dexamethasone or loteprednol etabonate directly into the joint effectively blocked the inflammatory response. Both the synovial fluid cellular content and synovium histology were examined. The steroid treatments prevented the adverse inflammatory effects of antigen action. These results, together with previous studies showing decreased systemic activity of the soft steroid, indicate that the loteprednol etabonate could provide a therapeutic advantage over currently used intra-articular steroids for alleviating rheumatoid arthritis.

Topics: Acute Disease; Androstadienes; Animals; Anti-Inflammatory Agents; Arthritis, Experimental; Injections, Intra-Articular; Loteprednol Etabonate; Rabbits; Serum Albumin, Bovine; Synovial Fluid