Department of Ophthalmology, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Yotsuya Shirato Eye Clinic, Yotsuya, Tokyo, Japan.
Jpn J Ophthalmol. 2023 Nov;67(6):668-677. doi: 10.1007/s10384-023-01022-6. Epub 2023 Aug 19.
A brimonidine tartrate 0.1%/brinzolamide 1% fixed-dose combination (BBFC) was recently approved for glaucoma and ocular hypertension treatment in Japan. We investigated the efficacy and safety of BBFC used concomitantly with prostaglandin analogs (PG) or a PG/beta-blocker fixed-dose combination (PG/beta FC).
This was a prospective, open-label, multicenter study.
We enrolled Japanese patients with open-angle glaucoma. BBFC (Ailamide) was concomitantly administered to either the PG or the PG/beta FC group, and intraocular pressure (IOP) and safety were evaluated at 4 and 12 weeks. The groups were stratified into low and high IOP baseline groups based on the median baseline IOP.
We enrolled 100 patients, 91 of whom completed the 12-week follow-up. The mean ages were 67.1 and 65.7 years in the PG group (n = 45, baseline IOP of 15.7 ± 2.3 mmHg) and the PG/beta FC group (n = 46, baseline IOP of 16.3 ± 2.3 mmHg), respectively. After BBFC administration, IOPs at 4 and 12 weeks were 13.0 ± 2.0 and 13.0 ± 2.6 mmHg (P < 0.0001) in the PG group, respectively, and 13.7 ± 2.4 and 13.7 ± 2.2 mmHg (P < 0.0001) in the PG/beta FC group, respectively. IOP decreased by - 2.0 ± 1.8 mmHg (P < 0.0001) and -1.9 ± 1.4 mmHg (P < 0.0001) in the low baseline PG group (14.1 mmHg) and low baseline PG/beta FC group (14.8 mmHg) at 12 weeks, respectively. Sixteen adverse events were identified, all of which were common and did not affect visual acuity.
BBFC can be used concomitantly with PG or PG/beta FC to reduce IOP without serious complications.
溴莫尼定酒石酸盐 0.1%/布林佐胺 1%固定剂量组合（BBFC）最近在日本被批准用于治疗青光眼和眼内高压。我们研究了 BBFC 与前列腺素类似物（PG）或 PG/β-受体阻滞剂固定剂量组合（PG/β FC）联合使用的疗效和安全性。
这是一项前瞻性、开放标签、多中心研究。
我们纳入了患有开角型青光眼的日本患者。BBFC（Ailamide）与 PG 或 PG/β FC 组联合使用，并在 4 周和 12 周时评估眼压（IOP）和安全性。根据基线 IOP 的中位数，将两组分为低基线 IOP 组和高基线 IOP 组。
我们共纳入 100 例患者，其中 91 例完成了 12 周的随访。PG 组（n=45，基线 IOP 为 15.7±2.3mmHg）和 PG/β FC 组（n=46，基线 IOP 为 16.3±2.3mmHg）患者的平均年龄分别为 67.1 岁和 65.7 岁。使用 BBFC 后，PG 组和 PG/β FC 组患者的 IOP 在第 4 周和第 12 周分别为 13.0±2.0mmHg 和 13.0±2.6mmHg（P<0.0001）和 13.7±2.4mmHg 和 13.7±2.2mmHg（P<0.0001）。低基线 PG 组（14.1mmHg）和低基线 PG/β FC 组（14.8mmHg）患者的 IOP 在第 12 周分别下降了-2.0±1.8mmHg（P<0.0001）和-1.9±1.4mmHg（P<0.0001）。
共发现 16 例不良事件，均为常见不良事件，不影响视力。
BBFC 可与 PG 或 PG/β FC 联合使用以降低 IOP，且无严重并发症。
