Tamçelik Nevbahar, Izgi Belgin, Temel Ahmet, Yildirim Nilgun, Okka Mehmet, Özcan Altan, Yüksel Nurşen, Elgin Ufuk, Altan Çiğdem, Ozer Baris
Cerrahpaşa School of Medicine, Istanbul University.
Çapa School of Medicine, Istanbul University.
Clin Ophthalmol. 2017 Apr 19;11:723-731. doi: 10.2147/OPTH.S119963. eCollection 2017.
The objective of this study was to assess the intraocular pressure (IOP)-lowering efficacy, tolerability, safety, and usage patterns of prostaglandin analog/prostamide (PGA/P)-containing topical ocular hypotensives in ocular hypertension (OHT) and primary open-angle glaucoma in the Turkish clinical setting.
This non-interventional, multicenter study enrolled previously treated patients who failed to achieve target IOP (or experienced unacceptable adverse events [AEs]) and were prescribed a PGA/P-containing IOP-lowering agent. Treatment was initiated at baseline (V1), and patients returned at weeks 4-6 (V2) and 8-12 (V3). The primary efficacy measure was the change in IOP from baseline at V3 in each eye. The secondary measures were physician's assessment of IOP-lowering efficacy, patients (%) reaching target IOP determined at V1, hyperemia score, physician and patient assessment of study treatment tolerability at V3, and AE frequency/severity. A subgroup analysis of patients receiving the most common study treatment was conducted. All analyses were performed using the safety population (patients who received one or more doses and had any data available).
Of 358 enrolled patients, 60.6% had primary open-angle glaucoma, 29.9% had secondary open-angle glaucoma (protocol amendment), and 13.1% had OHT; 13 patients had multiple diagnoses. At V3, the mean IOP change from baseline was ≥-4.2 mmHg (≥21.1%). IOP met or was lower than the target in 81.7% of patients, 95% exhibited none to mild conjunctival hyperemia (most common AE), and tolerability was rated good/very good by >91.1% of patients and physicians. The results were similar in patients who received the most common study treatment, bimatoprost 0.03%/timolol 0.5% (bim/tim; n=310).
PGA/P-containing medications, including bim/tim, significantly reduced IOP in previously treated patients with open-angle glaucoma or OHT; most reached their target IOP or an IOP even lower than their target and reported good/very good tolerability. PGA/P-containing medications such as bim/tim should be considered as a safe, effective therapeutic option for Turkish patients who exhibit poor response, tolerance, or adherence to their previous therapy.
本研究的目的是评估在土耳其临床环境中，含前列腺素类似物/前列腺酰胺（PGA/P）的局部降眼压药物在高眼压症（OHT）和原发性开角型青光眼患者中的降眼压疗效、耐受性、安全性及使用模式。
这项非干预性多中心研究纳入了之前治疗后未能达到目标眼压（或经历不可接受的不良事件[AE]）且被处方含PGA/P降眼压药物的患者。在基线（V1）开始治疗，患者在第4 - 6周（V2）和第8 - 12周（V3）复诊。主要疗效指标是每只眼睛在V3时眼压相对于基线的变化。次要指标包括医生对降眼压疗效的评估、达到V1时确定的目标眼压的患者百分比、充血评分、医生和患者在V3时对研究治疗耐受性的评估以及AE的频率/严重程度。对接受最常见研究治疗的患者进行了亚组分析。所有分析均使用安全人群（接受一剂或多剂治疗且有任何可用数据的患者）。
在358名入组患者中，60.6%患有原发性开角型青光眼，29.9%患有继发性开角型青光眼（方案修订），13.1%患有高眼压症；13名患者有多种诊断。在V3时，眼压相对于基线的平均变化≥ - 4.2 mmHg（≥21.1%）。81.7%的患者眼压达到或低于目标值，95%的患者表现为无至轻度结膜充血（最常见的AE），超过91.1%的患者和医生将耐受性评为良好/非常好。接受最常见研究治疗的患者，即0.03%比马前列素/0.5%噻吗洛尔（bim/tim；n = 310），结果相似。
含PGA/P的药物，包括bim/tim，可使之前接受治疗的开角型青光眼或高眼压症患者的眼压显著降低；大多数患者达到了目标眼压或眼压甚至低于目标眼压，并报告耐受性良好/非常好。对于对先前治疗反应不佳、耐受性差或依从性差的土耳其患者，含PGA/P的药物如bim/tim应被视为一种安全有效的治疗选择。
