Effectiveness of monthly intravenous ibandronate injections in a real-world setting: Subgroup analysis of a postmarketing observational study
Effectiveness of monthly intravenous ibandronate injections in a real-world setting: Subgroup analysis of a postmarketing observational study
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每月静脉注射伊班膦酸钠在现实环境中的有效性：上市后观察性研究的亚组分析
DOI：
10.1016/j.afos.2019.02.002
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发表时间：
2019
影响因子：
2
通讯作者：
Chiemi Yamagiwa
中科院分区：
文献类型：
--
作者：
Y. Takeuchi;J. Hashimoto;Hiroyuki Kakihata;Yousuke Nishida;M. Kumagai;Chiemi Yamagiwa
目的 一项针对日本骨质疏松症患者的前瞻性上市后观察性研究证明，每月静脉注射 (IV) 伊班膦酸钠具有良好的安全性和一致的有效性。在这里，我们介绍了该研究的亚组分析。方法对以下亚组的腰椎 (L2-4) 骨矿物质密度 (BMD) 增益进行了评估：年龄 <75 岁或≥75 岁、是否存在椎骨骨折、既往接受过双膦酸盐 (BP) 治疗以及同时与未接受骨质疏松症药物治疗。还检查了骨折的累积发生率和骨转换标志物的相对变化。结果 在 1062 名入组患者中，1025 名患者每月静脉注射 1mg 伊班膦酸钠，并进行为期 12 个月的评估。无论年龄多大或骨折的发生率如何，伊班膦酸钠的 BMD 增益都是相当的。总体而言，515 名患者（50.2%）之前接受过骨质疏松症治疗；其中，166 人（16.1%）接受了其他 BP。既往接受过其他 BP 治疗的患者的平均 BMD 变化为 3.69%（95% 置信区间 [CI]，0.89%–6.50%），而未接受过骨质疏松症治疗的患者的平均 BMD 变化为 4.26%（95% CI，2.88%–5.64%）。在 510 名患者 (49.7%) 同时服用活性维生素 D 药物中，艾德骨化醇的平均 BMD 变化为 5.74% (95% CI, 2.53%–8.95%)，而单独使用伊班膦酸钠的平均 BMD 变化为 3.54% (95% CI, 1.98%–5.10%)。伊班膦酸钠和艾德骨化醇联合用药观察到骨折发生率最低，但亚组之间的差异不具有统计学显着性。结论 每月静脉注射伊班膦酸钠在分析的患者亚组中显示出可比的 BMD 增益。伊班膦酸钠与艾地骨化醇联合使用显示出比单独使用伊班膦酸钠更高的 BMD 增益和更低的骨折发生率。
ObjectivesThe favorable safety and consistent effectiveness of monthly intravenous (IV) ibandronate injections was demonstrated in a prospective, postmarketing, observational study in Japanese patients with osteoporosis. Here, we present subgroup analyses from the study.MethodsLumbar spine (L2–4) bone mineral density (BMD) gains were assessed in the following subgroups: aged <75 or ≥75 years, absence or presence of vertebral fractures, previous bisphosphonate (BP) treatment, and concomitant versus naïve osteoporosis drug treatment. The cumulative incidence of fractures and relative change in bone turnover markers were also examined.ResultsOf 1062 enrolled patients, 1025 received monthly IV ibandronate 1 mg and were assessed for 12 months. BMD gains with ibandronate were comparable, irrespective of older age or prevalent fractures. Overall, 515 patients (50.2%) had previously received osteoporosis treatment; of these, 166 (16.1%) received other BPs. Mean BMD changes were 3.69% (95% confidence interval [CI], 0.89%–6.50%) in patients previously treated with other BPs, and 4.26% (95% CI, 2.88%–5.64%) in patients who had not received prior osteoporosis treatment. Among the 510 patients (49.7%) concomitantly prescribed active vitamin D drugs, mean BMD changes were 5.74% (95% CI, 2.53%–8.95%) with eldecalcitol versus 3.54% (95% CI, 1.98%–5.10%) with ibandronate alone. The lowest fracture incidence was observed with the combination of ibandronate and eldecalcitol, but differences between the subgroups were not statistically significant.ConclusionsMonthly IV ibandronate demonstrated comparable BMD gains in the patient subgroups analyzed. Concomitant use of ibandronate with eldecalcitol showed a trend of higher BMD gains and lower fracture incidence than ibandronate alone.
影响因子：
3.3
作者：
Soen, Satoshi;Fukunaga, Masao;Tomomitsu, Tatsushi
通讯作者：
Tomomitsu, Tatsushi