Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study

• Published in: Current medical research and opinion Vol. 25; no. 4; p. 1037
• Main Authors: Feuerhake, Cord, Buchholz, Patricia, Kimmich, Friedemann
• Format: Journal Article
• Language: English
• Published: England 01.04.2009
• Subjects: Amides - adverse effects; Amides - therapeutic use; Antihypertensive Agents - adverse effects; Antihypertensive Agents - therapeutic use; Bimatoprost; Cloprostenol - adverse effects; Cloprostenol - analogs & derivatives; Cloprostenol - therapeutic use; Drug Administration Schedule; Drug Therapy, Combination; Female; Glaucoma, Open-Angle - drug therapy; Humans; Intraocular Pressure - drug effects; Male; Ocular Hypertension - drug therapy; Optic Disk - drug effects; Optic Disk - physiopathology; Timolol - adverse effects; Timolol - therapeutic use; Visual Fields - drug effects
• ISSN: 1473-4877
• DOI: 10.1185/03007990902816947

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. 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. 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 beta-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 beta-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. 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.