| Abstrakt: |
ABSTRACTObjective:To evaluate intraocular pressure (IOP)-lowering efficacy, tolerability, and safety of the fixed combination of bimatoprost 0.03 and timolol 0.5 (Ganfort†) among German patients. †Ganfort is a registered tradename of Allergan, Inc., Irvine, CA, USAMethods:Multicenter, observational, open-label study of patients with primary open angle glaucoma or ocular hypertension (n 606). As determined by participating physicians, patients had insufficient IOP control and required a medication change. They were switched to once-daily fixed-combination bimatoprost/timolol with no wash-out period. IOP was recorded at treated baseline, 4–6 weeks and 12 weeks after switching. Tolerability was measured using a 4-step scale (excellent, good, moderate, poor) and all adverse events were recorded.Results:A total of 405 patients switched from monotherapy, 97 switched from other fixed combinations, and 104 switched from non-fixed combinations. Among all patients, 32.5 had used prostaglandin analog (PGA) monotherapy, 8.7 had been using a fixed combination that included a PGA, and 6.9 had been using an adjunctive combination of a PGA and a β-blocker. Mean treated baseline IOP (±SD) for all patients was 20.7 ± 3.5 mmHg. Overall, changing medication to fixed-combination bimatoprost/timolol lowered IOP to 16.6 ± 2.7 mmHg (p < 0.001 vs. baseline) after 4–6 weeks and to 16.1 ± 2.6 mmHg (p < 0.001) after 12 weeks; reductions of 19.8 and 22.2, respectively. Combined bimatoprost/timolol provided an additional IOP reduction versus baseline in most subgroups based on prior treatment. At week 12, patients who had previously used a β-blocker achieved an additional 25.8 decrease from baseline and IOP was reduced by 22.6 in former PGA monotherapy patients. At week 12, 84.6 of all eyes reached a target pressure less than or equal to 18 mmHg. Tolerability of bimatoprost/timolol was rated excellent or good by the physicians for 98.7 of patients and by 96.7 of the patients themselves. Few adverse events occurred during the treatment period.Conclusions:Although this study was limited by its observational design, our results show that the fixed combination of bimatoprost 0.03/timolol 0.5 was effective, well tolerated, and safe in a broad patient population. [ABSTRACT FROM AUTHOR] |
