Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost
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DOI：
10.2147/opth.s19999
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发表时间：
2011-01-01
影响因子：
2.2
通讯作者：
Hollander, David A.
中科院分区：
文献类型：
--
作者：
Fechtner, Robert D.;Harasymowycz, Paul;Hollander, David A.
目的：评价0.2%溴莫尼定/0.5%噻吗洛尔固定复方制剂与0.5%噻吗洛尔相比，在需要额外降低眼压的青光眼或高眼压患者中用作拉坦前列素0.005%的替代治疗时，在峰值和谷值效应时的额外降低眼压（IOP）疗效和安全性。在这项前瞻性、随机化、多中心、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4周。在拉坦前列素基线时，至少一只眼IOP >= 21 mmHg的患者被随机分配至每日两次固定溴莫尼定-噻吗洛尔（n = 102）或噻吗洛尔（n = 102），每种药物均连续使用拉坦前列素12周。在基线、第6周和第12周的上午8点和上午10点测量IOP，并在符合方案人群中进行评价。主要疗效终点为第12周上午10点的峰值IOP降低。结果：基线平均IOP在上午10点在治疗组（溴莫尼定，噻吗洛尔23.4毫米汞柱，噻吗洛尔23.0毫米汞柱）相似。第12周上午10点，固定溴莫尼定-噻吗洛尔组较拉坦前列素治疗基线IOP平均额外降低8.3 mmHg（35.5%），噻吗洛尔组为6.2 mmHg（27.0%）（P < 0.001）。在第12周上午8点和上午10点，接受固定溴莫尼定-噻吗洛尔治疗的患者比接受固定噻吗洛尔治疗的患者更有可能达到IOP <18 mmHg（P = 0.028）和IOP较基线降低>20%（P = 0.047）。14.7%的固定溴莫尼定-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。生物显微镜检查结果是相似的治疗组后，12周的treatment.Conclusion：固定组合溴莫尼定噻吗洛尔降低眼压显着更有效地比噻吗洛尔时，用于对拉坦前列素在青光眼和高眼压症患者的辅助治疗。固定溴莫尼定-噻吗洛尔和噻吗洛尔作为抗拉坦前列素药物均耐受良好。
Objective: 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.Methods: 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.Results: 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.Conclusion: 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.