Comparative efficacy and safety of the fixed versus unfixed combination of latanoprost and timolol in Chinese patients with open-angle glaucoma or ocular hypertension
| Autor: | Yao-Hua Sheng, Ke Yao, Zheng Zhong, Jian Ge, Xing-huai Sun, Jia-Liang Zhao, Yu-Min Li, Xiao-Xin Li, Nai-Xue Sun |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Intraocular pressure Time Factors genetic structures Glaucoma Ocular hypertension Timolol chemistry.chemical_compound lcsh:Ophthalmology Prevalence Latanoprost Morning Incidence General Medicine Middle Aged Treatment Outcome Prostaglandins F Synthetic Drug Therapy Combination Female Glaucoma Open-Angle Research Article medicine.drug Adult China medicine.medical_specialty Evening Adolescent Open angle glaucoma Adrenergic beta-Antagonists Young Adult Ophthalmology medicine Humans Antihypertensive Agents Intraocular Pressure Aged Retrospective Studies Dose-Response Relationship Drug business.industry medicine.disease eye diseases Surgery chemistry lcsh:RE1-994 Ocular Hypertension sense organs Ophthalmic Solutions business Follow-Up Studies |
| Zdroj: | BMC Ophthalmology BMC Ophthalmology, Vol 11, Iss 1, p 23 (2011) |
| ISSN: | 1471-2415 |
| DOI: | 10.1186/1471-2415-11-23 |
| Popis: | Background A 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. Methods This 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). Results Baseline 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. Conclusions A 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 registration Clinicaltrials.gov registration: NCT00219596 |
| Databáze: | OpenAIRE |
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