Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial.
Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial.
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DOI：
10.1038/eye.2016.126
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发表时间：
2016-10
期刊：
影响因子：
3.9
通讯作者：
DuBiner, H. B.
中科院分区：
文献类型：
--
作者：
Fechtner, R. D.;Myers, J. S.;Hubatsch, D. A.;Budenz, D. L.;DuBiner, H. B.
2013年10月至2014年5月，在美国30个临床地点进行了为期6周的多中心、随机、双盲、平行组试验，以确定布林唑胺/溴莫尼定（BBFC）辅助前列腺素类似物（PGA）降低开角型青光眼或高眼压患者的眼压（IOP）是否优于载药+PGA。符合条件的患者是患有开角型青光眼或高眼压的成年人，平均IOP≥21和<32 mm Hg，而接受开放标签PGA（拉坦前列素、比马前列素或曲伏前列素）。在随机分配到掩盖BBFC或车辆辅助治疗之前，患者在磨合期每天输注一次PGA。蒙面治疗每天灌注3次，持续6周，患者继续每天使用一次PGA。主要疗效终点是第6周平均每日IOP（平均0800、1000、1500和1700小时时间点）的组间差异。在第6周，BBFC+PGA组的平均每日IOP低于载药组+PGA组（17.1±0.4 mm Hg vs 20.5±0.4 mm Hg；组间差异为- 3.4±0.5 mm Hg； P<0.0001； 95%置信区间为- 4.5至- 2.4 mm Hg）。与PGA单药治疗相比，BBFC+PGA可使平均每日IOP降低5.7 mm Hg（25%）。与单独使用PGA或与载体联合使用相比，BBFC治疗产生了累加性的降血压效果。BBFC可能为接受PGA单药治疗需要额外降低IOP的患者提供有效的治疗选择。
To determine whether intraocular pressure (IOP) lowering with fixed-combination brinzolamide/brimonidine (BBFC) adjunctive to a prostaglandin analog (PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapy This 6-week, multicenter, randomized, double-masked, parallel-group trial was conducted at 30 clinical sites in the United States between October 2013 and May 2014. Eligible patients were adults with open-angle glaucoma or ocular hypertension and with mean IOP ≥21 and <32 mm Hg, whereas receiving an open-label PGA (latanoprost, bimatoprost, or travoprost). Patients instilled a PGA once-daily in a run-in phase before randomization to masked BBFC or vehicle adjunctive treatment. Masked treatments were instilled 3 times daily for 6 weeks, and patients continued once-daily use of their PGA. The primary efficacy end point was the between-group difference in mean diurnal IOP (average of 0800, 1000, 1500, and 1700 hours time points) at week 6. At week 6, mean diurnal IOP with BBFC+PGA was lower than with vehicle+PGA (17.1±0.4 mm Hg vs 20.5±0.4 mm Hg; between-group difference, −3.4±0.5 mm Hg; P<0.0001; 95% confidence interval, −4.5 to −2.4 mm Hg). BBFC+PGA reduced mean diurnal IOP by 5.7 mm Hg (25%) from the baseline IOP achieved with PGA monotherapy. Therapy with BBFC produced an additive IOP-lowering effect compared with a PGA alone or in conjunction with vehicle. BBFC may provide an effective treatment option for patients receiving PGA monotherapy who require additional IOP reduction.
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