Department of Orthopaedics, The Chinese PLA General Hospital, Beijing 100853, China.
Department of Orthopaedics, Xiangya Hospital, Central South University, Changsha 410008, China.
BMJ. 2023 Apr 18;381:e073435. doi: 10.1136/bmj-2022-073435.
To estimate the effect of denosumab compared with oral bisphosphonates on reducing the risk of type 2 diabetes in adults with osteoporosis.
Population based study involving emulation of a randomized target trial using electronic health records.
IQVIA Medical Research Data primary care database in the United Kingdom, 1995-2021.
Adults aged 45 years or older who used denosumab or an oral bisphosphonate for osteoporosis.
The primary outcome was incident type 2 diabetes, as defined by diagnostic codes. Cox proportional hazards models were used to estimate adjusted hazard ratios and 95% confidence intervals, comparing denosumab with oral bisphosphonates using an as treated approach.
4301 new users of denosumab were matched on propensity score to 21 038 users of an oral bisphosphonate and followed for a mean of 2.2 years. The incidence rate of type 2 diabetes in denosumab users was 5.7 (95% confidence interval 4.3 to 7.3) per 1000 person years and in oral bisphosphonate users was 8.3 (7.4 to 9.2) per 1000 person years. Initiation of denosumab was associated with a reduced risk of type 2 diabetes (hazard ratio 0.68, 95% confidence interval 0.52 to 0.89). Participants with prediabetes appeared to benefit more from denosumab compared with an oral bisphosphonate (hazard ratio 0.54, 0.35 to 0.82), as did those with a body mass index ≥30 (0.65, 0.40 to 1.06).
In this population based study, denosumab use was associated with a lower risk of incident type 2 diabetes compared with oral bisphosphonate use in adults with osteoporosis. This study provides evidence at a population level that denosumab may have added benefits for glucose metabolism compared with oral bisphosphonates.
评估地舒单抗与口服双膦酸盐相比，在降低骨质疏松症成人 2 型糖尿病风险方面的效果。
基于人群的研究，涉及使用电子健康记录模拟随机目标试验。
英国 IQVIA 医疗研究数据初级保健数据库，1995-2021 年。
年龄在 45 岁或以上、使用地舒单抗或口服双膦酸盐治疗骨质疏松症的成年人。
主要结局是通过诊断代码定义的 2 型糖尿病新发病例。使用 Cox 比例风险模型估计调整后的危险比和 95%置信区间，使用治疗意向方法比较地舒单抗与口服双膦酸盐。
4301 例新使用地舒单抗的患者根据倾向评分与 21038 例口服双膦酸盐使用者相匹配，并平均随访 2.2 年。地舒单抗使用者的 2 型糖尿病发生率为 5.7（95%置信区间 4.3 至 7.3）/1000 人年，口服双膦酸盐使用者为 8.3（7.4 至 9.2）/1000 人年。地舒单抗的起始治疗与 2 型糖尿病风险降低相关（危险比 0.68，95%置信区间 0.52 至 0.89）。与口服双膦酸盐相比，患有糖尿病前期的患者似乎从地舒单抗治疗中获益更多（危险比 0.54，0.35 至 0.82），而 BMI≥30 的患者也是如此（0.65，0.40 至 1.06）。
在这项基于人群的研究中，与口服双膦酸盐相比，地舒单抗治疗与骨质疏松症成人 2 型糖尿病发病风险降低相关。本研究在人群水平上提供了证据，表明与口服双膦酸盐相比，地舒单抗可能对葡萄糖代谢有额外益处。
Zotero 插件