Chinese medical journal · 2010
Intraocular pressure lowering efficacy and safety of travoprost 0.004% as a replacement therapy in patients with open angle glaucoma or ocular hypertension.
Клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Ge Jian, Sun Xing-huai, Wang Ning-li, Zhao Jia-liang, Wu Ling-ling, Chen Xiao-ming, Wang Zhi-xin, Li Benny
Аннотация
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 (IOP) 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. IOP measurements were performed at the same time of day at the follow-up visits.
RESULTS: For patients transitioned to travoprost, mean IOP reductions from baseline in untreated and treated patients with different prior medications at week 12 were: latanoprost, (4.3 +/- 4.6) mmHg; beta-blocker, (6.3 +/- 4.0) mmHg; alpha-agonist, (7.5 +/- 4.3) mmHg; topical carbonic anhydrase inhibitors, (8.0 +/- 4.9) mmHg. All mean IOP 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 IOP 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 IOP control. Travoprost administered once daily was safe and well tolerated in patients with glaucoma or ocular hypertension.
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. IOP measurements were performed at the same time of day at the follow-up visits.
RESULTS: For patients transitioned to travoprost, mean IOP reductions from baseline in untreated and treated patients with different prior medications at week 12 were: latanoprost, (4.3 +/- 4.6) mmHg; beta-blocker, (6.3 +/- 4.0) mmHg; alpha-agonist, (7.5 +/- 4.3) mmHg; topical carbonic anhydrase inhibitors, (8.0 +/- 4.9) mmHg. All mean IOP 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 IOP 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 IOP control. Travoprost administered once daily was safe and well tolerated in patients with glaucoma or ocular hypertension.