Houston Eye Associates, Houston, TX, USA.
Wheaton Eye Clinic, Wheaton, IL, USA.
Curr Med Res Opin. 2021 Jun;37(6):1011-1020. doi: 10.1080/03007995.2021.1901222. Epub 2021 Mar 27.
Assess the real-world efficacy of netarsudil, either as monotherapy or concomitant therapy, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) requiring modification of intraocular pressure (IOP)-lowering treatment.
Multicenter, prospective, interventional, open-label, Phase 4 study, clinical trial registration number: NCT03808688. Netarsudil ophthalmic solution 0.02% was prescribed at the recommended once-daily dosage, with treatment regimens determined by the investigators. Netarsudil could be used alone or in combination with other IOP-lowering medications, consistent with standard clinical practice. Primary efficacy endpoint: percentage reduction from baseline IOP at week 12.
Among 261 enrolled patients, 242 received ≥1 netarsudil dose and had ≥1 follow-up IOP measurement (efficacy population). Mean IOP in patients who were treatment-naïve at baseline and using netarsudil as monotherapy ( = 24) decreased by 16.9%. Netarsudil monotherapy was comparable in efficacy to prior therapy across subgroups, and those who replaced prostaglandin analog ( = 57) monotherapy demonstrated reduction of 2.5% from prostaglandin analog-treated baseline values. Among patients who used netarsudil as concomitant therapy ( = 151), reductions in mean IOP (± standard deviation) to week 12 were seen across subgroups who added netarsudil to a single agent (4.3 ± 2.88 mmHg; 20.5%) or ≥2 classes of concomitant therapy (4.5 ± 4.08 mmHg; 20.9%) and who used netarsudil to replace ≥1 other drug classes (0.4 ± 2.47 mmHg; 1.7%). Of 260 netarsudil-treated patients, 41 (15.8%) discontinued, including 29 (11.2%) due to adverse events.
In the real-world treatment of patients with OAG or OHT, netarsudil consistently maintained IOP control when it replaced previous IOP-lowering therapies and provided additional IOP-lowering efficacy when added to other treatments.
评估 netarsudil 在需要降低眼内压（IOP）治疗的开角型青光眼（OAG）或高眼压症（OHT）患者中的真实世界疗效，该药可作为单药或联合治疗。
多中心、前瞻性、干预性、开放标签、4 期研究，临床试验注册号：NCT03808688。推荐的每日一次剂量开处 netarsudil 滴眼液 0.02%，由研究者确定治疗方案。netarsudil 可单独使用或与其他降低 IOP 的药物联合使用，符合标准临床实践。主要疗效终点：治疗 12 周时与基线相比 IOP 的降低百分比。
在 261 名入组患者中，242 名患者接受了≥1 次 netarsudil 剂量且至少有 1 次随访 IOP 测量（疗效人群）。基线时未经治疗且使用 netarsudil 作为单药治疗的患者的平均 IOP 降低了 16.9%。netarsudil 单药治疗在疗效方面与既往治疗在各亚组中相当，且替代前列腺素类似物（PGA）单药治疗的患者（n=57）与 PGA 治疗基线值相比降低了 2.5%。在作为联合治疗使用 netarsudil 的患者中（n=151），无论添加至单药治疗（平均 IOP 降低 4.3±2.88mmHg；20.5%）还是≥2 类联合治疗（4.5±4.08mmHg；20.9%），或替代≥1 种其他药物类别（平均 IOP 降低 0.4±2.47mmHg；1.7%），netarsudil 均能降低平均 IOP，各亚组患者在 12 周时均观察到这一结果。在 260 名接受 netarsudil 治疗的患者中，41 名（15.8%）停药，其中 29 名（11.2%）因不良事件停药。
在真实世界中治疗 OAG 或 OHT 患者时，netarsudil 替代既往的 IOP 降低疗法时可维持 IOP 控制，与其他治疗联合应用时可提供额外的降 IOP 疗效。
