Yoshiki Fumito, Nishikawa Atsushi, Taketsuna Masanori, Kajimoto Kenta, Enomoto Hiroyuki
Medical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-Ku, Kobe, Japan.
Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., 7-1-5 Isogamidori, Chuo-Ku, Kobe, Japan.
J Orthop Sci. 2017 Mar;22(2):330-338. doi: 10.1016/j.jos.2016.11.022. Epub 2016 Dec 27.
Teriparatide is the first anabolic agent shown to reduce the risk of fractures in patients with osteoporosis. In Japan, teriparatide is prescribed to treat patients at high risk of fracture. Given that bisphosphonates are commonly used prior to teriparatide as treatment for osteoporosis, information on the effectiveness and safety of teriparatide with or without previous bisphosphonate treatment is helpful for physicians in clinical practice. This study aims to report the effectiveness and safety of teriparatide in treatment-naive and bisphosphonate-pretreated patients in Japan as real-world evidence.
A post hoc analysis of a postmarketing surveillance study was conducted in Japanese patients with osteoporosis at high risk of fracture who received 24-month treatment of daily teriparatide. Changes in bone turnover biomarkers and bone mineral density and incidence of new fractures were analyzed in treatment-naive as well as bisphosphonate-pretreated patients.
The analysis included 1433 patients (treatment-naive, n = 659; bisphosphonate-pretreated, n = 774). Bone mineral density increased significantly from baseline at 24 months in both treatment-naive (lumbar spine, 13.45%; femoral neck, 5.16%; total hip, 4.46%) and bisphosphonate-pretreated (lumbar spine, 11.20%; femoral neck, 2.22%; total hip, 0.67%) patients. The incidence rates of new vertebral and nonvertebral fractures at 24 months were 1.69% and 3.37%, respectively, in treatment-naive patients and 3.60% and 5.56%, respectively, in bisphosphonate-pretreated patients. The incidence of adverse drug reactions was 6% in treatment-naive patients and 10% in bisphosphonate-pretreated patients. The most common adverse drug reaction in treatment-naive and bisphosphonate-pretreated patients was nausea (0.91%) and hyperuricaemia (1.81%), respectively.
In this post hoc analysis, no new safety concerns and similar effectiveness of teriparatide were observed in Japanese patients with osteoporosis at high risk of fracture, regardless of their previous treatment status with bisphosphonates.
特立帕肽是首个被证实可降低骨质疏松症患者骨折风险的促合成代谢药物。在日本，特立帕肽被用于治疗骨折高风险患者。鉴于双膦酸盐类药物在特立帕肽之前常用于治疗骨质疏松症，了解特立帕肽在有无双膦酸盐类药物预处理情况下的有效性和安全性，对临床医生的实际工作很有帮助。本研究旨在报告特立帕肽在日本未接受过治疗及接受过双膦酸盐类药物预处理的骨质疏松症患者中的有效性和安全性，作为真实世界证据。
对一项上市后监测研究进行事后分析，研究对象为日本骨折高风险的骨质疏松症患者，他们接受了为期24个月的每日特立帕肽治疗。分析了未接受过治疗及接受过双膦酸盐类药物预处理患者的骨转换生物标志物、骨密度变化以及新发骨折的发生率。
分析纳入了1433例患者（未接受过治疗的患者659例；接受过双膦酸盐类药物预处理的患者774例）。在未接受过治疗的患者（腰椎，13.45%；股骨颈，5.16%；全髋，4.46%）和接受过双膦酸盐类药物预处理的患者（腰椎，11.20%；股骨颈，2.22%；全髋，0.67%）中，骨密度在24个月时均较基线显著增加。在未接受过治疗的患者中，24个月时新发椎体骨折和非椎体骨折的发生率分别为1.69%和3.37%，在接受过双膦酸盐类药物预处理的患者中分别为3.60%和5.56%。未接受过治疗的患者药物不良反应发生率为6%，接受过双膦酸盐类药物预处理的患者为10%。未接受过治疗的患者和接受过双膦酸盐类药物预处理的患者中最常见的药物不良反应分别为恶心（0.91%）和高尿酸血症（1.81%）。
在本次事后分析中，对于日本骨折高风险的骨质疏松症患者，无论其既往双膦酸盐类药物治疗情况如何，均未观察到特立帕肽有新的安全问题，且有效性相似。
