Fechtner Robert D, Harasymowycz Paul, Nixon Donald R, Vold Steven D, Zaman Fiaz, Williams Julia M, Hollander David A
Glaucoma Division, University of Medicine and Dentistry New Jersey, Newark, NJ, USA.
Clin Ophthalmol. 2011;5:945-53. doi: 10.2147/OPTH.S19999. Epub 2011 Jul 8.
To evaluate the additive intraocular pressure (IOP)-lowering efficacy and safety of fixed-combination brimonidine 0.2%/timolol 0.5% compared with timolol 0.5% at peak and trough effect when used as therapy adjunctive to latanoprost 0.005% in patients with glaucoma or ocular hypertension who require additional IOP lowering.
In this prospective, randomized, multicenter, investigator-masked, parallel-group study, patients were treated with latanoprost monotherapy for at least four weeks prior to baseline. At baseline on latanoprost, patients with IOP ≥21 mmHg in at least one eye were randomized to twice-daily fixed brimonidine-timolol (n = 102) or timolol (n = 102), each adjunctive to latanoprost for 12 weeks. IOP was measured at 8 am and 10 am at baseline, week 6, and week 12 and evaluated in the per protocol population. The primary efficacy endpoint was peak IOP lowering at 10 am, week 12. Safety measures included adverse events.
Baseline mean IOP was similar at 10 am in the treatment groups (brimonidine-timolol 23.4 mmHg; timolol 23.0 mmHg). The mean additional reduction from latanoprost-treated baseline IOP was 8.3 mmHg (35.5%) with fixed brimonidine-timolol and 6.2 mmHg (27.0%) with timolol at 10 am, week 12 (P < 0.001). Patients treated with fixed brimonidine-timolol adjunctive to latanoprost were significantly more likely than patients treated with adjunctive timolol to achieve an IOP <18 mmHg (P = 0.028) and a ≥20% reduction in IOP from baseline (P = 0.047) at both 8 am and 10 am in week 12. Adverse events occurred in 14.7% of fixed brimonidine-timolol patients and 12.7% of timolol patients. Biomicroscopy findings were similar between the treatment groups after 12 weeks of treatment.
Fixed-combination brimonidine-timolol reduced IOP significantly more effectively than timolol when used as adjunctive therapy to latanoprost in patients with glaucoma and ocular hypertension. Both fixed brimonidine-timolol and timolol were well tolerated as agents adjunctive to latanoprost.
在需要进一步降低眼压的青光眼或高眼压症患者中，评估0.2%溴莫尼定/0.5%噻吗洛尔固定复方制剂与0.5%噻吗洛尔在作为0.005%拉坦前列素辅助治疗时，在峰效应和谷效应时额外降低眼压的疗效及安全性。
在这项前瞻性、随机、多中心、研究者设盲、平行组研究中，患者在基线前接受拉坦前列素单药治疗至少四周。在拉坦前列素治疗的基线时，至少一只眼眼压≥21 mmHg的患者被随机分为每日两次的固定剂量溴莫尼定 - 噻吗洛尔组（n = 102）或噻吗洛尔组（n = 102），每组均作为拉坦前列素的辅助治疗用药12周。在基线、第6周和第12周的上午8点和10点测量眼压，并在符合方案人群中进行评估。主要疗效终点是第12周上午10点时眼压降低的峰值。安全指标包括不良事件。
治疗组上午10点时的基线平均眼压相似（溴莫尼定 - 噻吗洛尔组为23.4 mmHg；噻吗洛尔组为23.0 mmHg）。在第12周上午10点时，与拉坦前列素治疗的基线眼压相比，固定剂量溴莫尼定 - 噻吗洛尔组平均额外降低8.3 mmHg（35.5%），噻吗洛尔组平均额外降低6.2 mmHg（27.0%）（P < 0.001）。在第12周上午8点和10点时，接受拉坦前列素辅助治疗的固定剂量溴莫尼定 - 噻吗洛尔组患者比接受噻吗洛尔辅助治疗的患者更有可能使眼压<18 mmHg（P = 0.028），且眼压从基线降低≥20%（P = 0.047）。14.7%的固定剂量溴莫尼定 - 噻吗洛尔组患者和12.7%的噻吗洛尔组患者发生了不良事件。治疗12周后，两组的生物显微镜检查结果相似。
在青光眼和高眼压症患者中，当作为拉坦前列素的辅助治疗时，溴莫尼定 - 噻吗洛尔固定复方制剂降低眼压的效果明显优于噻吗洛尔。溴莫尼定 - 噻吗洛尔固定复方制剂和噻吗洛尔作为拉坦前列素的辅助用药耐受性均良好。
