Intraocular pressure lowering efficacy and safety of travoprost 0.004 % as a replacement therapy in patients with open angle glaucoma or ocular hypertension  

作　　者：GE Jian SUN Xing-huai WANG Ning-li ZHAO Jia-liang WU Ling-ling CHEN Xiao-ming WANG Zhi-xin Benny Li 

机构地区：[1]Zhongshan Ophtllalmic Center, State Key Laboratory ofOphthalmology, Sun Yat-sen University, Guangzhou, Guangdong510060, China [2]Department of Ophtthalmology, Eye Ear Nose and Throat Hospital,School of Medicine, Fudan University, Shanghai 200031, China [3]Beijing Tongren Eye Center, Beijing Tongren Hospital, CapitalMedical University, Beijing Ophthalmology & Visual SciencesKey Laboratory, Beijing 100730, China [4]Department of Ophthalmology, Peking Union Medical CollegeHospital, Chinese Academy of Medical Sciences, Beijing 100730,China [5]Peking University Eye Center, Peking University Third Hospital,Beijing 100191, China [6]Depal~ment of Ophthalmology, West China Hospital, SichuanUniversity, Chengdu, Sichuan 610041, China [7]Alcon Research Ltd., 6201 South Freeway, Fort Worth, Texas76134, USA

出　　处：《Chinese Medical Journal》2010年第11期1417-1421,共5页中华医学杂志（英文版）

摘　　要：Background Travoprost has been widely used for the treatment of patients with open-angle glaucoma （OAG） or ocular hypertension （OH）. The aim of this study was to evaluate the intraocular pressure （lOP） lowering efficacy of travoprost 0.004% monotherapy in patients previously treated with other topical hypotensive medications, and in previously untreated patients. Methods This open-label, 12-week study in 1651 adult patients with ocular hypertension or open-angle glaucoma who were untreated or required a change in therapy （due to either inadequate efficacy or safety issues） as judged by the investigator was conducted at 6 sites in China. Previously treated patients were instructed to discontinue their prior medications at the first visit. All the patients were dosed with travoprost 0.004% once-daily at 8 p.m. in both eyes for 12 weeks. Efficacy and safety evaluations were conducted at week 4 and 12. lOP measurements were performed at the same time of day at the follow-up visits. Results For patients transitioned to travoprost, mean lOP reductions from baseline in untreated and treated patients with different prior medications at week 12 were： latanoprost, （4.3±4.6） mmHg; β-blocker, （6.3±4.0） mmHg; α-agonist, （7.5±4.3） mmHg; topical carbonic anhydrase inhibitors, （8.0±4.9） mmHg. All mean lOP changes from baseline were statistically significant （P 〈0.001）. No treatment-related serious adverse events were reported in this study. Conclusions In patients treated with other hypotensive medications or untreated, the lOP reduction with travoprost was significant. The results of this study demonstrated the potential benefit of using travoprost as a replacement therapy in order to ensure adequate lOP control. Travoprost administered once daily was safe and well tolerated in patients with glaucoma or ocular hypertension.Background Travoprost has been widely used for the treatment of patients with open-angle glaucoma （OAG） or ocular hypertension （OH）. The aim of this study was to evaluate the intraocular pressure （lOP） lowering efficacy of travoprost 0.004% monotherapy in patients previously treated with other topical hypotensive medications, and in previously untreated patients. Methods This open-label, 12-week study in 1651 adult patients with ocular hypertension or open-angle glaucoma who were untreated or required a change in therapy （due to either inadequate efficacy or safety issues） as judged by the investigator was conducted at 6 sites in China. Previously treated patients were instructed to discontinue their prior medications at the first visit. All the patients were dosed with travoprost 0.004% once-daily at 8 p.m. in both eyes for 12 weeks. Efficacy and safety evaluations were conducted at week 4 and 12. lOP measurements were performed at the same time of day at the follow-up visits. Results For patients transitioned to travoprost, mean lOP reductions from baseline in untreated and treated patients with different prior medications at week 12 were： latanoprost, （4.3±4.6） mmHg; β-blocker, （6.3±4.0） mmHg; α-agonist, （7.5±4.3） mmHg; topical carbonic anhydrase inhibitors, （8.0±4.9） mmHg. All mean lOP changes from baseline were statistically significant （P 〈0.001）. No treatment-related serious adverse events were reported in this study. Conclusions In patients treated with other hypotensive medications or untreated, the lOP reduction with travoprost was significant. The results of this study demonstrated the potential benefit of using travoprost as a replacement therapy in order to ensure adequate lOP control. Travoprost administered once daily was safe and well tolerated in patients with glaucoma or ocular hypertension.

关 键 词：TRAVOPROST prostaglandin analogue intraocular pressure GLAUCOMA 

分 类 号：TQ462.12[化学工程—制药化工] S823.3[农业科学—畜牧学]