Ophthalmology Department, Hôpital Edouard Herriot, 5, Place d'Arsonval, 690437 Lyon Cedex 03, France.
BMC Ophthalmol. 2010 Feb 24;10:4. doi: 10.1186/1471-2415-10-4.
Prospective, multicenter, randomized, double-masked trials have shown latanoprost instilled once daily to be at least as effective as and generally superior to timolol administered twice daily and to be as effective as other frequently prescribed prostaglandin analogues. This study prospectively assessed the efficacy of latanoprost monotherapy in a large cohort of treatment-naive patients with a broad range of baseline intraocular pressure (IOP) levels treated in actual clinical practice settings.
This prospective, open-label, multicenter, uncontrolled, phase IV study included treatment-naive ocular hypertension or open-angle glaucoma subjects initiating latanoprost once daily (evening). IOP levels were measured at baseline and after 1 and 3 months. The primary efficacy outcome was mean change in IOP from baseline to month 3. Analyses were stratified by baseline IOP: > or = 20 and <24 mmHg vs > or = 24 mmHg.
Efficacy analyses (intent to treat) included 572 subjects: 20 to <24 mmHg group, N = 252; > or = 24 mmHg group, N = 320. Mean baseline IOP levels were 22.2 +/- 0.9 mmHg and 26.7 +/- 2.8 mmHg, respectively. At month 3, significant IOP reductions were seen in both groups (p < 0.0001, within-group differences); reductions were smaller in the 20 to <24 mmHg group (-6.3 +/- 2.4 vs -9.2 +/- 3.7 mmHg, respectively; -28.0 +/- 10.6% vs -34.1 +/- 11.9%, respectively). An IOP reduction of > or = 30% from baseline to month 3 was noted in 48.4% and 65.6% of subjects, respectively (p < 0.0001). At month 3, targets IOPs of < or = 18 mmHg were achieved by > or = 70% of subjects in both groups. Latanoprost was well tolerated with an adverse event profile similar to that reported in the literature.
This "real world" study found once-daily latanoprost to be effective and safe in treatment-naive ocular hypertension or open-angle glaucoma patients. Patients with baseline IOP levels of 20 to <24 mmHg as well as > or = 24 mmHg benefitted from initial latanoprost therapy.
NCT00647101.
前瞻性、多中心、随机、双盲试验表明，每日一次滴用拉坦前列素的疗效至少与每日两次滴用噻吗洛尔相当，且通常优于噻吗洛尔，与其他常用的前列腺素类似物的疗效相当。本研究前瞻性评估了拉坦前列素单药治疗在大范围基础眼压（IOP）水平的初治患者中的疗效，这些患者在实际临床环境中接受治疗。
这是一项前瞻性、开放标签、多中心、非对照、IV 期研究，包括初治的高眼压症或开角型青光眼患者，起始接受每晚一次滴用拉坦前列素。在基线时和 1 个月和 3 个月后测量 IOP 水平。主要疗效终点为从基线到第 3 个月的 IOP 平均变化。分析按基线 IOP 分层：≥20mmHg 且＜24mmHg 与≥24mmHg。
意向治疗的疗效分析包括 572 例患者：20mmHg 至＜24mmHg 组，N=252 例；≥24mmHg 组，N=320 例。两组的平均基线 IOP 水平分别为 22.2±0.9mmHg 和 26.7±2.8mmHg。在第 3 个月，两组均可见 IOP 显著降低（p＜0.0001，组内差异）；20mmHg 至＜24mmHg 组的降幅较小（分别为-6.3±2.4mmHg 和-9.2±3.7mmHg，分别为-28.0±10.6%和-34.1±11.9%）。分别有 48.4%和 65.6%的患者在第 3 个月时的 IOP 降幅≥30%（p＜0.0001）。在第 3 个月，两组均有≥70%的患者达到了＜或=18mmHg 的目标 IOP。拉坦前列素具有良好的耐受性，不良事件谱与文献报道相似。
本“真实世界”研究发现，初治的高眼压症或开角型青光眼患者每日一次滴用拉坦前列素具有疗效和安全性。基础 IOP 水平为 20mmHg 至＜24mmHg 和≥24mmHg 的患者均从初始拉坦前列素治疗中获益。
NCT00647101。
