Lanzl Ines, Hamacher Thomas, Rosbach Klaus, Ramez Mohammed Osman, Rothe Robert, Růžičková Eva, Karhanová Marta, Kimmich Friedemann
Private practice, Prien, Germany.
Clin Ophthalmol. 2013;7:901-10. doi: 10.2147/OPTH.S41640. Epub 2013 May 16.
The study reported here investigated the efficacy, tolerability, and safety of the preservative-free prostaglandin analog tafluprost 0.0015% in treatment-naive patients.
Data were collected in two non-interventional, prospective, multicenter, observational, open-label studies of identical design that were conducted in Germany and the Czech Republic. All subjects received preservative-free tafluprost 0.0015% once daily. Intraocular pressure (IOP) levels were recorded for each eye at untreated baseline and 3 months after initiation of medical treatment. The primary outcome was change in mean IOP from baseline to month 3. In the primary open-angle glaucoma (POAG) and ocular hypertension (OH) patient subgroups, analyses were stratified by the level of baseline IOP: ≥20 to 23 mmHg versus ≥24 mmHg. In addition, responder rates and the achievement of pre-specified IOP levels at month 3 were evaluated. Local tolerance of preservative-free tafluprost was evaluated by the patients at final visit. Overall satisfaction with the medical treatment was evaluated by both patients and physicians. All adverse events were recorded.
A total of 579 treatment-naive patients with POAG (n = 349), OH (n = 105), normal tension glaucoma (n = 71), exfoliative glaucoma (n = 27), or other glaucomas (n = 27) were included in this observational study. Mean IOP level at baseline for all patients was 23.6 ± 4.0 mmHg. Mean IOP at month 3 was 16.8 ± 2.9 mmHg (-28.8% vs baseline). At month 3, significant reductions in mean IOP (P < 0.001) were seen in all patients and all subgroups. Preservative-free tafluprost lowered mean IOP significantly in patients with POAG and OH with IOP levels ≥ 20 to 23 mmHg from 21.9 ± 1.1 mmHg at baseline to 16.5 ± 2.2 mmHg, and in the subgroup with IOP levels ≥ 24 mmHg from 26.2 ± 2.4 mmHg to 17.9 ± 2.4 mmHg. In the subgroups of patients with POAG and OH, an IOP response ≥20%, ≥30%, and ≥40% was achieved by 83.4%, 44.1%, and 12.8%, respectively. Overall, patients with higher baseline IOP values showed a better response than patients with lower baseline IOP levels. Preservative-free tafluprost was well tolerated and safe. After 3 months, 97.9% of all patients remained on therapy.
In this real-world observational study, treatment with once-daily preservative-free tafluprost proved efficacious, well tolerated, and safe in treatment-naive patients.
本研究调查了不含防腐剂的前列腺素类似物他氟前列素0.0015%在初治患者中的疗效、耐受性和安全性。
数据收集于两项设计相同的非干预性、前瞻性、多中心、观察性、开放标签研究，这两项研究分别在德国和捷克共和国进行。所有受试者每天接受一次不含防腐剂的他氟前列素0.0015%。在未经治疗的基线期和开始药物治疗3个月后，记录每只眼睛的眼压（IOP）水平。主要结局是从基线到第3个月平均IOP的变化。在原发性开角型青光眼（POAG）和高眼压症（OH）患者亚组中，分析按基线IOP水平分层：≥20至23 mmHg与≥24 mmHg。此外，评估了第3个月时的缓解率和达到预先设定的IOP水平的情况。在最后一次访视时，由患者评估不含防腐剂的他氟前列素的局部耐受性。患者和医生都评估了对药物治疗的总体满意度。记录所有不良事件。
本观察性研究共纳入579例初治患者，其中POAG患者349例、OH患者105例、正常眼压性青光眼患者71例、剥脱性青光眼患者27例或其他青光眼患者27例。所有患者基线时的平均IOP水平为23.6±4.0 mmHg。第3个月时的平均IOP为16.8±2.9 mmHg（与基线相比降低28.8%）。在第3个月时，所有患者和所有亚组的平均IOP均显著降低（P<0.001）。不含防腐剂的他氟前列素使IOP水平≥20至23 mmHg的POAG和OH患者的平均IOP从基线时的21.9±1.1 mmHg显著降低至16.5±2.2 mmHg，使IOP水平≥24 mmHg的亚组的平均IOP从26.2±2.4 mmHg降低至17.9±2.4 mmHg。在POAG和OH患者亚组中，IOP降低≥20%、≥30%和≥40%的患者分别占83.4%、44.1%和12.8%。总体而言，基线IOP值较高的患者比基线IOP水平较低的患者反应更好。不含防腐剂的他氟前列素耐受性良好且安全。3个月后，97.9%的患者仍在接受治疗。
在这项真实世界的观察性研究中，每天一次使用不含防腐剂的他氟前列素治疗在初治患者中被证明是有效、耐受性良好且安全的。
