Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3-030, Boston, MA, 02120, USA.
Beetham Eye Institute, Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA.
Drugs Aging. 2020 Apr;37(4):311-320. doi: 10.1007/s40266-020-00745-2.
There is a relative lack of head-to-head comparisons of denosumab against other osteoporosis drugs on safety. We aimed to explore ocular outcomes in patients with osteoporosis initiating denosumab vs zoledronic acid.
We conducted a cohort study using claims data (2010-15) from two large US commercial insurance databases including patients with osteoporosis who were aged 50 years or older and initiators of denosumab or zoledronic acid. The primary outcomes were (1) receipt of cataract surgery and development of (2) wet age-related macular degeneration and (3) dry age-related macular degeneration within 365 days after initiation of denosumab vs zoledronic acid. Propensity score fine stratification and weighting were used to control for potential confounding, and we calculated the incidence rate and hazard ratio for each outcome in the cohorts. The estimates from the two databases were combined with a fixed-effects model meta-analysis.
The study cohort included 50,821 denosumab and 67,471 zoledronic acid initiators. In the propensity score-weighted analysis, compared to zoledronic acid use, denosumab was associated with a modestly decreased risk of undergoing cataract surgery (hazard ratio 0.91; 95% confidence interval 0.85-0.98) but not with the risk of wet age-related macular degeneration (hazard ratio 1.29; 95% confidence interval 0.99-1.70) or dry age-related macular degeneration (hazard ratio 1.03; 95% confidence interval 0.98-1.09).
In this large population-based cohort study of 118,292 patients with osteoporosis, initiation of denosumab was associated with a modestly decreased risk of cataract surgery vs zoledronic acid. The risk of age-related macular degeneration was similar between the two drugs.
在安全性方面，有关地舒单抗与其他骨质疏松药物的直接比较相对较少。我们旨在探讨开始接受地舒单抗或唑来膦酸治疗的骨质疏松患者的眼部结局。
我们使用来自两个大型美国商业保险数据库的索赔数据（2010-15 年）进行了一项队列研究，该研究纳入了年龄在 50 岁及以上且开始接受地舒单抗或唑来膦酸治疗的骨质疏松患者。主要结局为：（1）在开始接受地舒单抗或唑来膦酸治疗后的 365 天内接受白内障手术的情况；（2）湿性年龄相关性黄斑变性的发生；（3）干性年龄相关性黄斑变性的发生。采用倾向评分精细分层和加权法来控制潜在混杂因素，并在队列中计算每个结局的发生率和风险比。来自两个数据库的估计值通过固定效应模型荟萃分析进行了合并。
研究队列纳入了 50821 例地舒单抗和 67471 例唑来膦酸使用者。在倾向评分加权分析中，与使用唑来膦酸相比，地舒单抗与白内障手术风险略有降低相关（风险比 0.91；95%置信区间 0.85-0.98），但与湿性年龄相关性黄斑变性风险（风险比 1.29；95%置信区间 0.99-1.70）或干性年龄相关性黄斑变性风险（风险比 1.03；95%置信区间 0.98-1.09）无关。
在这项针对 118292 例骨质疏松患者的大型基于人群的队列研究中，与唑来膦酸相比，开始接受地舒单抗治疗与白内障手术风险略有降低相关。两种药物的年龄相关性黄斑变性风险相似。
