Diestelhorst Michael, Larsson Lill-Inger
Department of Ophthalmology, Univerisitäts-Augenklinik, University of Cologne, Cologne, Germany.
Ophthalmology. 2006 Jan;113(1):70-6. doi: 10.1016/j.ophtha.2005.06.027. Epub 2005 Nov 2.
To compare the efficacy and tolerability of fixed-combination latanoprost and timolol applied in the evening with the concomitant use of the individual components.
Twelve-week, randomized, double-masked, multicenter study.
Five hundred seventeen randomized patients with ocular hypertension; open-angle, pigmentary, or exfoliation glaucoma; and baseline (after washout) intraocular pressure (IOP) levels between 23 and 33 mmHg.
Patients received either the fixed combination of latanoprost and timolol once daily in the evening and a placebo in the morning and evening or the unfixed combination of latanoprost once daily in the evening and timolol in the morning and evening. Study visits were at weeks 2, 6, and 12.
The primary efficacy end point was mean change from baseline to week 12 in diurnal IOP (mean IOPs of 8 am, 12 pm, and 4 pm). The fixed combination was considered noninferior to the unfixed combination if the upper limit of the 95% confidence interval (CI) of the difference was <1.5 mmHg (analysis of covariance). Adverse events were recorded at each visit.
In all, 502 patients were included in intent-to-treat analyses (fixed combination, n = 255; unfixed combination, n = 247). For the fixed- and unfixed-combination groups, mean baseline diurnal IOP levels were 25.4 mmHg and 25.2 mmHg, respectively, and mean diurnal IOP reductions were 8.7 mmHg and 9.0 mmHg (between-treatment difference, 0.3 mmHg; 95% CI, -0.1 to 0.7 mmHg; P = 0.15). Both treatments were well tolerated.
The fixed combination of latanoprost and timolol administered once daily in the evening is not inferior to the unfixed combination of latanoprost once daily in the evening and timolol twice daily. The fixed combination provides an effective and well-tolerated alternative to multiple instillations.
比较晚间应用拉坦前列素与噻吗洛尔固定复方制剂和单独使用这两种药物的疗效及耐受性。
为期12周的随机、双盲、多中心研究。
517例随机分组的高眼压症患者；开角型、色素性或剥脱性青光眼患者；基线期（洗脱期后）眼压（IOP）水平在23至33 mmHg之间。
患者接受晚间每日一次的拉坦前列素与噻吗洛尔固定复方制剂，早晚给予安慰剂，或晚间每日一次的拉坦前列素与早晚各一次的噻吗洛尔非固定复方制剂。研究访视时间为第2周、第6周和第12周。
主要疗效终点为从基线到第12周日间眼压的平均变化（上午8点、中午12点和下午4点的平均眼压）。如果差异的95%置信区间（CI）上限<1.5 mmHg（协方差分析），则固定复方制剂被认为不劣于非固定复方制剂。每次访视时记录不良事件。
共有502例患者纳入意向性分析（固定复方制剂组，n = 255；非固定复方制剂组，n = 247）。固定复方制剂组和非固定复方制剂组的平均基线日间眼压水平分别为25.4 mmHg和25.2 mmHg，平均日间眼压降低分别为8.7 mmHg和9.0 mmHg（组间差异0.3 mmHg；95% CI，-0.1至0.7 mmHg；P = 0.15）。两种治疗耐受性均良好。
晚间每日一次给予的拉坦前列素与噻吗洛尔固定复方制剂不劣于晚间每日一次的拉坦前列素与每日两次的噻吗洛尔非固定复方制剂。固定复方制剂为多次滴眼提供了一种有效且耐受性良好的替代方案。
