Long term IOP lowering efficacy of bimatoprost/timolol fixed combination: a 12 month prospective study.

I Lequeu, K Theuwis, L Abegāo Pinto, E Vandewalle, I Stalmans
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Abstract

Purpose: To evaluate the long-term IOP-lowering effect of an initially successful switch from prostaglandine-analog (PGA) monotherapy to bimatoprosttimolol fixed combination (BTFC) METHODS: Prospective, monocentric, open-labeled clinical trial. 30 patients with insufficient intraocular pressure (lOP) control under PGA monotherapy were screened. Following a one month run-in period of BTFC, patients who presented an effective IOP-lowering response were prospectively studied for an additional 11-month period. IOP, tolerability and safety (adverse reactions, slit lamp biomicroscopy) were further assessed at month 6 and month 12 after initiating BTFC.

Results: BTFC therapy significantly decreased IOP when compared to PGA monotherapy (PGA monotherapy: 17.3+/-3.8 mmHg; BTFC 1 month 13.2+/-3.3mmHg; p<0.05). This decrease from PGA-monotherapy IOP was sustained throughout the time-frame (6-month: 13.5+/-3.6mmHg; 12-month: 13.9+/-2.4mmHg; p<0.05 in pairwise comparison). There was no statistical difference in IOP between BTFC study visits (p>0.05). Of the 27 patients who had a satisfactory lOP-lowering response to BTFC after one month, 18 (66.7%) still had sufficient IOP control at the 12 month study visit. Therapy was discontinued at 1 month in 3 patients (2 due to intolerance to medication and 1 failing to achieve IOP control). No intolerability was reported beyond the 1 month of BTFC therapy.

Conclusion: In the majority of patients, the initial lOP lowering effect of replacing PGA monotherapy by BTFC seems to predict a long term response to the new treatment strategy.

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比马前列素/替洛尔固定联合治疗长期IOP降低疗效:一项为期12个月的前瞻性研究。
目的:评估从前列腺素类似物(PGA)单药治疗到比马替洛尔固定联合治疗(BTFC)的初步成功转换的长期降血压效果。方法:前瞻性、单中心、开放标记临床试验。筛选PGA单药治疗眼压(lOP)控制不足的患者30例。在一个月的BTFC磨合期后,对表现出有效降血压反应的患者进行了另外11个月的前瞻性研究。在开始BTFC后的第6个月和第12个月进一步评估IOP、耐受性和安全性(不良反应、裂隙灯生物显微镜)。结果:与PGA单药治疗相比,BTFC治疗显著降低IOP (PGA单药治疗:17.3+/-3.8 mmHg;BTFC 1个月13.2+/-3.3mmHg;p0.05)。27例患者在1个月后对BTFC有满意的降眼压反应,其中18例(66.7%)在12个月的研究访视时仍有足够的IOP控制。3例患者在治疗1个月后停止治疗(2例由于药物不耐受,1例未能达到IOP控制)。BTFC治疗1个月后无不耐受报告。结论:在大多数患者中,BTFC替代PGA单药治疗的初始lOP降低效果似乎预示着对新治疗策略的长期反应。
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