Comparative efficacy and safety of the fixed versus unfixed combination of latanoprost and timolol in Chinese patients with open-angle glaucoma or ocular hypertension

BMC Ophthalmology

Research Article

Xiao-Xin Li¹  Jia-Liang Zhao²  Xing-Huai Sun³  Zheng Zhong⁴  Yao-Hua Sheng⁵  Nai-Xue Sun⁶  Yu-Min Li⁷  Ke Yao⁸  Jian Ge⁹ 

[1] Beijing University People's Hospital, Beijing, China;Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, China;Eye & ENT Hospital of Fudan University, Shanghai, China;Medical Affairs, Pfizer Investment Co. Ltd., China;Shanghai Jiaotong University, Xin Hua Hospital of Medical School, Shanghai, China;Xi'an Jiao Tong University, 2nd Hospital, Xi'an, China;Zhe Jiang University, 1st Hospital, Hangzhou, China;Zhe Jiang University, 2nd Hospital, Hangzhou, China;Zhong Shan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China;

关键词: Timolol;    Latanoprost;    Ocular Hypertension;    Bimatoprost;    Travoprost;   

DOI  :  10.1186/1471-2415-11-23

 received in 2011-03-02, accepted in 2011-08-19,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundA noninferiority trial was conducted to evaluate the efficacy of a single evening dose of fixed-combination latanoprost 50 μg/mL and timolol 0.5 mg/mL (Xalacom®; LTFC), in Chinese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who were insufficiently controlled on β-blocker monotherapy or β-blocker-based dual therapy.MethodsThis 8-week, randomized, open-label, parallel-group, noninferiority study compared once-daily evening dosing of LTFC with the unfixed combination of latanoprost, one drop in the evening, and timolol, one drop in the morning (LTuFC). The primary efficacy endpoint was the mean change from baseline to week 8 in diurnal intraocular pressure (IOP; mean of 8 AM, 10 AM, 2 PM, 4 PM IOPs). LTFC was considered noninferior to LTuFC if the upper limit of the 95% confidence interval (CI) of the difference was < 1.5 mmHg (analysis of covariance).ResultsBaseline characteristics were similar for LTFC (N = 125; POAG, 70%; mean IOP, 25.8 mmHg) and LTuFC (N = 125; POAG, 69%; mean IOP, 26.0 mmHg). Mean diurnal IOP changes from baseline to week 8 were -8.6 mmHg with LTFC and -8.9 mmHg with LTuFC (between-treatment difference: 0.3 mmHg; 95%-CI, -0.3 to 1.0). Both treatments were well tolerated.ConclusionsA single evening dose of LTFC was at least as effective as the unfixed combination of latanoprost in the PM and timolol in the AM in reducing IOP in Chinese subjects with POAG or OH whose IOP was insufficiently reduced with β-blocker monotherapy or β-blocker-based dual therapy. LTFC is an effective and well tolerated once-daily treatment for POAG and OH.Trial registrationClinicaltrials.gov registration: NCT00219596

【 授权许可】

CC BY   
© Zhao et al; licensee BioMed Central Ltd. 2011