双膦酸盐和denosumab都是治疗骨质疏松症以预防骨折的主要方法。然而,目前还很少有试验直接比较两种药物治疗骨质疏松的预防骨折和安全性。我们的目的是使用全国范围的索赔数据库比较地诺单抗和双膦酸盐之间的疗效和安全性。数据库里有一千万,韩国健康保险审查和评估服务按年龄和性别分层抽样的整个韩国人口的20%。在2018年1月至2022年4月期间,228,367名年龄超过50岁并服用地诺单抗或双膦酸盐的受试者中,在1:1倾向评分匹配后对91,460名受试者进行了分析。主要结果是治疗有效性;完全骨折,骨质疏松性骨折,股骨骨折,骨盆骨折,椎骨骨折,药物不良反应;急性肾损伤,慢性肾病,和不典型的股骨骨折。完全骨折和骨质疏松性主要骨折,作为疗效的主要结果,在denosumab和双膦酸盐组中具有可比性(分别为HR1.06,95%CI0.98-1.15,p=0.14;HR1.13,95%CI0.97-1.32,p=0.12)。急性肾损伤的安全性,慢性肾病,和非典型股骨骨折也没有显示两组之间的任何差异。在根据年龄的亚组分析中,与70岁以下的双膦酸盐组相比,70岁以下的denosumab组发生急性肾损伤的风险显著较低(HR0.53,95%CI0.29~0.93,p=0.03).在反映临床实践的真实世界数据中,denosumab,和双膦酸盐对完全骨折和骨质疏松性主要骨折的有效性和急性肾损伤的安全性相当,慢性肾病,和不典型的股骨骨折。
本研究比较了地诺单抗和双膦酸盐的有效性和安全性,骨质疏松症的两种主要治疗方法,使用韩国全国范围内的大型索赔数据库。对来自91,460名50岁以上人群的数据进行的分析显示,两种药物在预防骨折或安全性结果(例如肾损伤和非典型股骨骨折)方面没有显着差异。然而,在70岁以下的患者中,denosumab与较低的急性肾损伤风险相关.总的来说,两种药物在骨质疏松症的实际治疗中表现出相似的有效性和安全性.
Both bisphosphonates and denosumab are the mainstays of treatment for osteoporosis to prevent fractures. However, there are still few trials directly comparing the prevention of fractures and the safety of 2 drugs in the treatment of osteoporosis. We aimed to compare the efficacy and safety between denosumab and bisphosphonates using a nationwide claims database. The database was covered with 10 million, 20% of the whole Korean population sampled by age and sex stratification of the Health Insurance Review and Assessment Service in South Korea. Among 228 367 subjects who were over 50 yr of age and taking denosumab or bisphosphonate from January 2018 to April 2022, the analysis was performed on 91 460 subjects after 1:1 propensity score matching. The primary outcome was treatment effectiveness; total fracture, major osteoporotic fracture, femur fracture, pelvic fracture, vertebral fracture, adverse drug reactions; acute kidney injury, chronic kidney disease, and atypical femoral fracture. Total fracture and osteoporotic major fracture, as the main outcomes of efficacy, were comparable in the denosumab and bisphosphonate group (HR 1.06, 95% CI, 0.98-1.15, P = .14; HR 1.13, 95% CI, 0.97-1.32, P = .12, respectively). Safety for acute kidney injury, chronic kidney disease, and atypical femoral fracture also did not show any differences between the 2 groups. In subgroup analysis according to ages, the denosumab group under 70 yr of age had a significantly lower risk for occurrences of acute kidney injury compared to the bisphosphonate group under 70 yr of age (HR 0.53, 95% CI, 0.29-0.93, P = .03). In real-world data reflecting clinical practice, denosumab and bisphosphonate showed comparable effectiveness for total fractures and major osteoporosis fractures, as well as safety regarding acute kidney injury, chronic kidney disease, and atypical femoral fracture.
This study compared the effectiveness and safety of denosumab and bisphosphonates, 2 primary treatments for osteoporosis, using a large South Korean nationwide claims database. Analysis of data from 91 460 individuals over 50 yr old showed no significant difference in preventing fractures or in safety outcomes such as kidney injury and atypical femoral fractures between the 2 drugs. However, among patients under 70, denosumab was associated with a lower risk of acute kidney injury. Overall, both medications demonstrated similar effectiveness and safety in the real-world treatment of osteoporosis.