Lesk Mark R, Koulis Theodoro, Sampalis Fotini, Sampalis John S, Bastien Natacha R
Department of Ophthalmology, University of Montreal, Montreal, Quebec, Canada.
Ann Pharmacother. 2008 Apr;42(4):498-504. doi: 10.1345/aph.1K565. Epub 2008 Mar 25.
Treatment of glaucoma is aimed at reducing intraocular pressure (IOP) to prevent further damage to the optic nerve. For patients who do not respond to monotherapy, combination treatment may be effective in achieving therapeutic reduction or target IOP.
To evaluate the effectiveness and safety of dorzolamide 2% with timolol 0.5% alone or combined with latanoprost in reducing IOP in a real-world setting.
A prospective, open-label, multicenter, nonrandomized interventional study was designed. Three hundred fifty patients with primary open-angle glaucoma or ocular hypertension and uncontrolled IOP after latanoprost monotherapy for 4 or more weeks were treated with combination dorzolamide-timolol twice daily added to their existing latanoprost therapy (D/T-Add-On; n = 280) or dorzolamide-timolol twice daily monotherapy (D/T-Switch; n = 70). The primary effectiveness outcome measure was the change in IOP after 6 and 12 weeks of treatment.
Of the total population, 313 patients completed this trial (248 D/T-Add-On; 65 D/T-Switch). After 12 weeks, the mean +/- SD IOP decrease was -6.3 +/- 3.6 mm Hg (-28.1%) and -5.8 +/- 4.9 mm Hg (-23.5%) in the D/T-Add-On and D/T-Switch groups, respectively (both p < 0.001). Therapeutic response rates (defined as IOP reduction >20%) after 12 weeks of treatment for the D/T-Add-On and the D/T-Switch groups were 66.4% (186/280) and 52.9% (37/70), respectively. There were 116 predominantly mild, nonserious adverse events attributed to the study drugs, reported by 86 (24.6%) patients. The most frequent adverse events were eye irritation (n = 42; 12.0%) and taste perversion (n = 15; 4.3%). No serious adverse events related to the study medications were reported.
In patients with primary open-angle glaucoma or ocular hypertension and elevated IOP while on monotherapy with latanoprost, switching to dorzolamide-timolol or combining dorzolamide-timolol with latanoprost are effective and safe treatment options for reducing IOP and achieving therapeutic response.
青光眼的治疗旨在降低眼压(IOP),以防止对视神经造成进一步损害。对于单药治疗无反应的患者,联合治疗可能有效实现眼压的治疗性降低或达到目标眼压。
在实际临床环境中评估2%多佐胺与0.5%噻吗洛尔单独使用或与拉坦前列素联合使用降低眼压的有效性和安全性。
设计了一项前瞻性、开放标签、多中心、非随机干预性研究。350例原发性开角型青光眼或高眼压症患者,在接受拉坦前列素单药治疗4周或更长时间后眼压仍未得到控制,将每日两次的多佐胺-噻吗洛尔联合用药添加到其现有的拉坦前列素治疗方案中(D/T添加组;n = 280),或每日两次使用多佐胺-噻吗洛尔单药治疗(D/T转换组;n = 70)。主要有效性结局指标是治疗6周和12周后的眼压变化。
在全部患者中,313例患者完成了该试验(248例D/T添加组;65例D/T转换组)。12周后,D/T添加组和D/T转换组的平均±标准差眼压降低分别为-6.3±3.6 mmHg(-28.1%)和-5.8±4.9 mmHg(-23.5%)(均p < 0.001)。D/T添加组和D/T转换组治疗12周后的治疗反应率(定义为眼压降低>20%)分别为66.4%(186/280)和52.9%(37/70)。有116例主要为轻度、非严重的不良事件归因于研究药物,86例(24.6%)患者报告了这些事件。最常见的不良事件是眼部刺激(n = 42;12.0%)和味觉异常(n = 15;4.3%)。未报告与研究药物相关的严重不良事件。
对于原发性开角型青光眼或高眼压症且在接受拉坦前列素单药治疗时眼压升高的患者,转换为多佐胺-噻吗洛尔或多佐胺-噻吗洛尔与拉坦前列素联合使用是降低眼压并实现治疗反应的有效且安全的治疗选择。