Park Ki Ho, Simonyi Susan, Kim Chan Yun, Sohn Yong Ho, Kook Michael Scott
Department of Ophthalmology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 110-744, Korea.
BMC Ophthalmol. 2014 Dec 17;14:160. doi: 10.1186/1471-2415-14-160.
This study evaluates the efficacy and tolerability (ie, occurrence and severity of hyperemia) of bimatoprost 0.01% in treatment-naïve patients with open-angle glaucoma (OAG) or ocular hypertension in the Korean clinical setting.
In this multicenter, open-label, observational study, treatment-naïve patients with OAG, including patients with normal-tension glaucoma (NTG, defined as IOP ≤21 mm Hg), or ocular hypertension received bimatoprost 0.01% once daily. Hyperemia was assessed at baseline and weeks 6 and 12, graded by a masked evaluator using a photonumeric scale (0, +0.5, +1, +2, +3), and grouped as (0 to +1) and (+2 to +3). Shifts between groupings were reported as no change, improved ([+2 to +3] to [0 to +1]), or worsened ([0 to +1] to [+2 to +3]). Other adverse events were monitored. Mean IOP changes from baseline at weeks 6 and 12 were reported. Supplemental analyses were conducted for IOPs >21 versus ≤21 mm Hg.
Of 295 treatment-naïve patients included in the intent-to-treat/safety population, 73 (24.7%) had baseline IOP >21 mm Hg (mean, 25.7 ± 5.0 mm Hg) and 222 (75.3%) had baseline IOP ≤21 mm Hg (mean, 16.3 ± 3.0 mm Hg); 96.3% had hyperemia graded none (36.3%) to mild (17.3%). At week 12, hyperemia was graded none to mild in 83.7% (n = 220). Worsening occurred in 12.3% of patients by week 6 and 12.7% by week 12. Small improvements occurred in 0.8% and 0.5% of patients at weeks 6 and 12, respectively. Hyperemia scores were generally low and the majority of patients had no change in severity during the study. Mean IOP at weeks 6 and 12 was reduced to 16.4 ± 4.0 mm Hg (-34.5%; P < 0.0001) and 16.7 ± 3.9 mm Hg (-32.0%; P < 0.001) in the baseline-IOP >21 mm Hg group versus 13.3 ± 2.6 mm Hg (-17.8%; P < 0.001) and 13.7 ± 2.8 mm Hg (-15.9%; P < 0.001) in the baseline-IOP ≤21 mm Hg group, respectively.
In treatment-naïve patients, bimatoprost 0.01% induced low shifts in worsening of hyperemia and significant reductions in IOP, regardless of baseline IOP.
NCT01594970.
本研究评估了在韩国临床环境中，0.01%比马前列素对初治开角型青光眼（OAG）或高眼压症患者的疗效和耐受性（即充血的发生情况和严重程度）。
在这项多中心、开放标签、观察性研究中，初治的OAG患者，包括正常眼压性青光眼（NTG，定义为眼压≤21 mmHg）患者或高眼压症患者，每天接受一次0.01%比马前列素治疗。在基线、第6周和第12周评估充血情况，由一名盲态评估者使用数字量表（0、+0.5、+1、+2、+3）进行分级，并分为（0至+1）和（+2至+3）两组。报告分组之间的变化为无变化、改善（[+2至+3]变为[0至+1]）或恶化（[0至+1]变为[+2至+3]）。监测其他不良事件。报告第6周和第12周相对于基线的平均眼压变化。对眼压>21 mmHg与≤21 mmHg的情况进行了补充分析。
在意向性治疗/安全性人群纳入的295例初治患者中，73例（24.7%）基线眼压>21 mmHg（平均，25.7±5.0 mmHg），222例（75.3%）基线眼压≤21 mmHg（平均，16.3±3.0 mmHg）；96.3%的患者充血分级为无（36.3%）至轻度（17.3%）。在第12周时，83.7%（n = 220）的患者充血分级为无至轻度。到第6周时，12.3%的患者出现充血恶化，到第12周时为12.7%。在第6周和第12周时，分别有0.8%和0.5%的患者有轻微改善。充血评分总体较低，大多数患者在研究期间严重程度无变化。在基线眼压>21 mmHg组中，第6周和第12周的平均眼压分别降至16.4±4.0 mmHg（-34.5%；P < 0.0001）和16.7±3.9 mmHg（-32.0%；P < 0.001），而在基线眼压≤21 mmHg组中，分别降至13.3±2.6 mmHg（-17.8%；P < 0.001）和13.7±2.8 mmHg（-15.9%；P < 0.001）。
在初治患者中，无论基线眼压如何，0.01%比马前列素引起的充血恶化变化较小，眼压显著降低。
NCT01594970。
