Rutgers New Jersey School of Medicine, Newark, New Jersey, USA.
Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Am J Ophthalmol. 2019 Aug;204:97-104. doi: 10.1016/j.ajo.2019.03.002. Epub 2019 Mar 9.
To compare the intraocular pressure (IOP)-lowering efficacy and safety of netarsudil once daily (QD) and timolol twice daily (BID).
Double-masked, randomized, phase 3, noninferiority study.
Patients with open-angle glaucoma or ocular hypertension (unmedicated baseline IOP >20 to <30 mm Hg at 8:00 AM) were randomized to netarsudil ophthalmic solution 0.02% QD (PM) or timolol ophthalmic solution 0.5% BID. The primary endpoint was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3 in patients with baseline IOP <25 mm Hg (per-protocol population). Safety was recorded over the 6-month treatment period.
A total of 186 patients from each treatment arm were included in the primary efficacy analysis. Netarsudil QD met the criteria for noninferiority to timolol BID. Mean treated IOP ranged from 16.3 to 17.9 mm Hg for netarsudil and 16.7 to 17.6 for timolol, with mean reductions from baseline of 3.9 to 4.7 mm Hg and 3.8 to 5.2 mm Hg, respectively. In prespecified secondary analyses, netarsudil demonstrated noninferiority to timolol in patients with baseline IOP <27 mm Hg and <30 mm Hg. The IOP-lowering effects of netarsudil were sustained over 6 months of treatment. No treatment-related serious adverse event (AE) was reported for either study drug. However, statistically significant reductions in mean heart rate were recorded at all study visits for the timolol group. The most frequent ocular AE among netarsudil-treated patients was conjunctival hyperemia (47.9%), which was predominately mild.
Netarsudil QD (PM), a first-in-class IOP-lowering medication, was noninferior to timolol BID and was associated with tolerable ocular AEs.
比较每日一次（QD）使用奈塔舒地尔和每日两次（BID）使用噻吗洛尔的降眼压疗效和安全性。
双盲、随机、3 期、非劣效性研究。
开角型青光眼或高眼压症患者（未经治疗的基础眼压在上午 8 点时为 20-30mmHg）被随机分配至奈塔舒地尔 0.02%QD（PM）或噻吗洛尔 0.5%BID 滴眼。主要终点为基础眼压<25mmHg 的患者在第 2、6 周和第 3 个月上午 8 点、上午 10 点和下午 4 点的平均眼压（意向性治疗人群）。在 6 个月的治疗期间记录安全性。
来自每个治疗组的 186 例患者被纳入主要疗效分析。奈塔舒地尔 QD 符合非劣效于噻吗洛尔 BID 的标准。奈塔舒地尔的平均治疗眼压为 16.3-17.9mmHg，噻吗洛尔为 16.7-17.6mmHg，平均基线降低 3.9-4.7mmHg 和 3.8-5.2mmHg。在预先指定的次要分析中，奈塔舒地尔在基础眼压<27mmHg 和<30mmHg 的患者中显示出非劣效性。奈塔舒地尔的降眼压作用在 6 个月的治疗中持续。两种研究药物均未报告与治疗相关的严重不良事件（AE）。然而，噻吗洛尔组在所有研究访视时均记录到平均心率显著降低。奈塔舒地尔治疗患者中最常见的眼部 AE 是结膜充血（47.9%），主要为轻度。
奈塔舒地尔 QD（PM），一种新型降眼压药物，非劣效于噻吗洛尔，且与可耐受的眼部 AE 相关。
