通用型拉坦前列素与品牌前列素类似物治疗原发性开角型青光眼的比较疗效
Comparative Effectiveness of Generic Latanoprost Versus Branded Prostaglandin Analogs for Primary Open Angle Glaucoma.
作者信息
Kim Diana H, Addis Victoria M, Pan Wei, VanderBeek Brian L
机构信息
a Drexel University College of Medicine , Philadelphia , Pennsylvania , USA.
b Scheie Eye Institute, Department of Ophthalmology , University of Pennsylvania Perelman School of Medicine , Philadelphia , Pennsylvania , USA.
出版信息
Ophthalmic Epidemiol. 2019 Feb;26(1):63-71. doi: 10.1080/09286586.2018.1516786. Epub 2018 Sep 6.
PURPOSE
The purpose of the study is to determine the comparative effectiveness of generic latanoprost (GL) to its branded (BL) counterpart and other brand-name prostaglandin analogs (bPGAs) in preventing the need for additional therapy in the treatment of primary open angle glaucoma (POAG).
METHODS
Retrospective cohort study using US commercial medical claims data. All new POAG patients from 2000 to 2015 who initiated treatment with either GL or BL were included. Exclusion occurred for having less than 2 years of time in the plan prior to diagnosis, previous use of glaucoma medications, or any diagnosis of glaucoma other than POAG at any time. Analyses compared GL to BL and also to those who received any branded PGA after 2011 (when the generic became available). Cox proportional hazard regression was used to assess the hazards of filling a prescription for a second IOP-lowering medication or having surgical intervention, individually and either outcome combined.
RESULTS
A total of 6317 and 4150 POAG patients were treated with GL and BL, respectively. After 2010, 6317 GL and 3703 brand-name prostaglandin analog (bPGA) POAG patients met criteria for inclusion. After adjustment, compared to BL, the GL conferred a reduced hazard of having a glaucoma procedure performed (hazard ratio [HR] = 0.72, 95% CI: 0.62-0.84, p < 0.001) and the combined outcome (HR = 0.90, 95% CI: 0.83-0.97, p = 0.006) but was not associated with having a second IOP medication (HR = 0.95, 95% CI: 0.87-1.03, p = 0.18). Compared to the bPGAs, however, GL conferred a reduced hazard in each comparison (second IOP medication HR = 0.87, 95% CI: 0.81-0.94, p < 0.001; surgery HR = 0.70, 95% CI: 0.61-0.81, p < 0.001; combined HR = 0.85, 95% CI: 0.79-0.92, p < 0.001). Sensitivity analyses confirmed these findings.
CONCLUSIONS
GL was no less and possibly more effective in preventing the need for additional intervention than branded PGAs.
目的
本研究的目的是确定通用型拉坦前列素（GL）与其品牌对应物（BL）以及其他品牌的前列腺素类似物（bPGA）在预防原发性开角型青光眼（POAG）治疗中额外治疗需求方面的比较效果。
方法
使用美国商业医疗理赔数据进行回顾性队列研究。纳入2000年至2015年所有开始使用GL或BL进行治疗的新POAG患者。排除标准为诊断前在计划中的时间少于2年、既往使用过青光眼药物或在任何时间有除POAG以外的任何青光眼诊断。分析将GL与BL进行比较，也与2011年（通用型上市后）接受任何品牌PGA治疗的患者进行比较。使用Cox比例风险回归分别评估开具第二种降低眼压药物处方或进行手术干预的风险，以及将这两种结果合并后的风险。
结果
分别有6317例和4150例POAG患者接受了GL和BL治疗。2010年后，6317例使用GL和3703例使用品牌前列腺素类似物（bPGA）的POAG患者符合纳入标准。调整后，与BL相比，GL降低了进行青光眼手术的风险（风险比[HR]=0.72，95%置信区间：0.62-0.84，p<0.001）以及合并结果的风险（HR=0.90，95%置信区间：0.83-0.97，p=0.006），但与开具第二种降低眼压药物无关（HR=0.95，95%置信区间：0.87-1.03，p=0.18）。然而，与bPGA相比，GL在各项比较中均降低了风险（开具第二种降低眼压药物的HR=0.87，95%置信区间：0.81-0.94，p<0.001；手术的HR=0.70，95%置信区间：0.61-0.81，p<0.001；合并结果的HR=0.85，95%置信区间：0.79-0.92，p<0.001）。敏感性分析证实了这些结果。
结论
在预防额外干预需求方面，GL的效果不低于品牌PGA，甚至可能更有效。
Zotero 插件