Abstract
Abstract: :
Purpose: To evaluate the safety and efficacy of bimatoprost for the treatment of glaucoma and ocular hypertension in the "real–life" clinical practices of physicians throughout the United States and in Puerto Rico, Canada, Germany, Australia, and Thailand. Methods: Open–label, noncomparative surveillance trial included patients who had a diagnosis of glaucoma or ocular hypertension and were in need of additional intraocular pressure (IOP)–lowering or were intolerant of other ocular hypotensive medications. Physicians prescribed bimatoprost 0.03% as monotherapy, adjunctive therapy, or replacement therapy. Results: Overall, 14,465 patients were enrolled. Fifty–nine percent of participants were female; 74.2% were white, and 14.2% were black. Diagnosis type was 89.0% open–angle glaucoma. The majority of patients were on IOP–lowering medications at the time of enrollment. Mean IOP at baseline was 21.9 mm Hg. After 30 days of bimatoprost therapy, the mean IOP was 17.3 mm Hg, which was a significant reduction (P<.001) from baseline of 4.6 mm Hg (19.3% from baseline). A larger percentage of patients achieved target levels of IOP from ≤12 mm Hg to ≤18 mm Hg with bimatoprost therapy (64.6%) than at baseline (21.8%). In addition, 29.9% of patients achieved a target of ≤15 mm Hg compared with 6.8% of patients at baseline. When asked whether they would continue to prescribe bimatoprost to their patients with elevated IOP, 89.8% of physician investigators said they would do so. Conclusions: This is the largest open–label study of bimatoprost to date. Results demonstrate that bimatoprost is highly effective as monotherapy, adjunctive therapy, and replacement therapy for glaucoma and ocular hypertension patients in "real–life" clinical practice around the world. Bimatoprost allows patients to reach low target IOP levels.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure • lipids