Holló Gábor, Vargha Péter, Kóthy Péter
Department of Ophthalmology, Semmelweis University, Budapest, Hungary.
Curr Med Res Opin. 2005 Dec;21(12):1943-8. doi: 10.1185/030079905X74916.
To investigate the influence of switching to travoprost on intraocular pressure (IOP) of chronic open-angle glaucoma (COAG) patients.
Multicentre, open-label, non-comparative, 12-week, phase IV study conducted at 10 academic and hospital centres in Hungary. Patients' compliance to use of the pre-study medication was confirmed at a visit 10 days before the baseline measurements, and compliance was monitored throughout the study period.
Of the 203 COAG patients three (1.48%) ceased travoprost medication due to ocular hyperaemia, and one subject was lost from follow-up. Self-reported compliance was optimal except for two patients. For the per-protocol analysis 197 patients were evaluable. IOP of the 37 per-protocol patients receiving additional travoprost medication decreased from 23.1 +/- 3.2 mmHg (mean +/- SD) to 17.3 +/- 2.6 mmHg at week 12 (p < 0.001). Switching the 121 per-protocol patients from latanoprost to travoprost IOP decrease from 20.8 +/- 3.5 mmHg to 17.7 +/- 2.4 mmHg (p < 0.001). IOP of the 11 patients switched from topical nonselective beta-blockers to travoprost decreased from 20.1 +/- 2.1 mmHg to 15.7 +/- 1.5 mmHg (p < 0.001). For the whole per-protocol population (n = 197) IOP decreased from 21.0 +/- 3.4 mmHg to 17.4 +/- 2.4 mmHg (p < 0.001). Defining responders as having an IOP decrease > 2.0 mmHg or >or= 5 mmHg at week 12, the responder rate was respectively 62.9% or 31% for the total study population; 86.5% or 54.1% when travoprost was added to the established therapy; 54.5% or 24.0% if latanoprost was switched to travoprost; and 90.9% or 36.4% for those who switched from beta-blockers.
Travoprost provided a clinically and statistically significant IOP decrease in uncontrolled COAG patients whose self-reported compliance to their previous topical medication was optimal. Our results suggest that the IOP reduction found after switching to travoprost is not explainable by improved compliance due to the clinical study situation.
研究转换为曲伏前列素对慢性开角型青光眼(COAG)患者眼压(IOP)的影响。
在匈牙利的10个学术和医院中心进行的多中心、开放标签、非对照、为期12周的IV期研究。在基线测量前10天的一次就诊时确认患者对研究前用药的依从性,并在整个研究期间监测依从性。
203例COAG患者中,3例(1.48%)因眼部充血停止使用曲伏前列素药物,1例失访。除2例患者外,自我报告的依从性最佳。符合方案分析时,197例患者可进行评估。37例接受额外曲伏前列素药物治疗的符合方案患者的眼压在第12周时从23.1±3.2 mmHg(平均值±标准差)降至17.3±2.6 mmHg(p<0.001)。121例从拉坦前列素转换为曲伏前列素的符合方案患者的眼压从20.8±3.5 mmHg降至17.7±2.4 mmHg(p<0.001)。11例从局部非选择性β受体阻滞剂转换为曲伏前列素的患者的眼压从20.1±2.1 mmHg降至15.7±1.5 mmHg(p<0.001)。对于整个符合方案人群(n=197),眼压从21.0±3.4 mmHg降至17.4±2.4 mmHg(p<0.001)。将第12周时眼压降低>2.0 mmHg或>或=5 mmHg定义为有反应者,整个研究人群的反应率分别为62.9%或31%;在已确立的治疗方案中加用曲伏前列素时为86.5%或54.1%;如果从拉坦前列素转换为曲伏前列素为54.5%或24.0%;从β受体阻滞剂转换者为90.9%或36.4%。
对于自我报告对先前局部用药依从性最佳的未控制COAG患者,曲伏前列素可使眼压在临床和统计学上显著降低。我们的结果表明,转换为曲伏前列素后发现的眼压降低不能用临床研究情况下依从性的改善来解释。