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Abstract #24264 Published in IGR 11-3
Treatment of patients with primary open-angle glaucoma with a fixed combination of brimonidine 0.2%/timolol 0.5%: Multicenter, open-label, observational study in Germany
Thelen U; Buchholz P; Kimmich FCurrent Medical Research and Opinion 2009; 25: 1003-1009
OBJECTIVE: At the introduction of the fixed-combination of brimonidine/timolol in Germany in 2006, a non-interventional, multicenter, observational, open-label study was initiated to evaluate efficacy, tolerability, and safety of this preparation in a broad patient population. METHODS: The study population comprised patients with bilateral primary open-angle glaucoma or ocular hypertension with insufficient intraocular pressure (IOP) control who participating physicians determined required a change of medication, and who switched to exclusive use of the new fixed-combination brimonidine 0.2%/timolol 0.5%. Patient demographics and information on specific risk factors were collected. IOP readings were recorded for each eye at treated baseline (previous therapy), 4 to 6 weeks, and 12 weeks after changing to twice-daily brimonidine/ timolol. Tolerability was measured using a four-step scale ranging from excellent to poor. All adverse events were recorded. RESULTS: Mean treated baseline IOP ( ±SD) for all patients (N = 861) was 20.8 ± 3.5 mmHg. Five hundred sixty-five patients switched from monotherapy, 138 patients switched from other fixed combinations, and 158 patients had been using non-fixed combinations of up to four different active agents. The brimonidine/timolol fixed combination provided an additional IOP decrease in most pretreatment subgroups, with an overall reduction to 16.9 (plus or minus) 2.6 mmHg after 4 to 6 weeks and to 16.5 ± 2.7 mmHg after 12 weeks. Both of these values were significantly lower than baseline IOP (p<0.001). A target pressure of <18 mmHg was achieved in 79.5% of all eyes at week 12. Tolerability of fixed-combination brimonidine/timolol was rated excellent or good by the physicians for 97.1% of patients, and by 93.4% 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 brimonidine 0.2%/timolol 0.5% was effective, well tolerated, and safe in a broad POAG patient population.
Dr. U.Thelen, Klosterstrasse 53, D-48143, Munster, Germany. uthelen@lycos.de
Classification:
11.13.3 Betablocker and brimonidine (Part of: 11 Medical treatment > 11.13 Combination therapy)