Ifuku Emiko, Yoshimura Takeshi, Uzawa Toyonobu, Hokonohara Tadami
Post Marketing Surveillance Department, Regulatory Affairs and Reliability Assurance Center, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Medical Affairs Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Osteoporos Sarcopenia. 2019 Jun;5(2):44-50. doi: 10.1016/j.afos.2019.06.002. Epub 2019 Jun 26.
To reassess the safety and efficacy of once-weekly teriparatide 56.5 μg in osteoporosis patients with a high fracture risk.
This postmarketing observational study was conducted at 72 weeks according to the package insert. Of the 3573 Japanese osteoporosis patients in the safety analysis set, 91.80% were women, the mean age was 78.1 years, and 69.89% had a history of prevalent fragility fractures, indicating that a high proportion of patients at high risk of fracture were enrolled.
Persistence with weekly teriparatide treatment was 59.36%, and 38.95% at 24 and 72 weeks, respectively. Adverse drug reactions (ADRs) were reported in 898 patients (25.13%), and serious ADRs were reported in 26 patients (0.73%). The most frequent ADRs were nausea, vomiting, and headache. The cumulative incidence of new vertebral fractures 72 weeks after the start of treatment was 3.31%. Increases in the bone mineral density were observed in the lumbar spine, femoral neck, and proximal femur. The serum levels of the bone formation markers, procollagen type I N-terminal propeptide and bone-type alkaline phosphatase, increased slightly at 24 weeks and then decreased to baseline levels. At 24 and 72 weeks, the bone resorption markers, serum cross-linked N-terminal telopeptide of type I collagen and urinary cross-linked N-terminal telopeptide of type I collagen, were the same as or slightly lower than at baseline. Visual analogue scale scores for low back pain also decreased.
The present results showed that once-weekly teriparatide may also be useful for osteoporosis patients with a high risk of fracture.
重新评估每周一次注射56.5μg特立帕肽对骨折高风险骨质疏松症患者的安全性和有效性。
本上市后观察性研究按照药品说明书进行了72周。在安全性分析集中的3573名日本骨质疏松症患者中，91.80%为女性，平均年龄为78.1岁，69.89%有既往脆性骨折史，这表明纳入了高比例的骨折高风险患者。
每周一次特立帕肽治疗的持续率分别为59.36%、24周时为38.95%、72周时为38.95%。898名患者（25.13%）报告了药物不良反应（ADR），26名患者（0.73%）报告了严重ADR。最常见的ADR是恶心、呕吐和头痛。治疗开始72周后新椎体骨折的累积发生率为3.31%。腰椎、股骨颈和股骨近端的骨矿物质密度有所增加。骨形成标志物I型前胶原N端前肽和骨型碱性磷酸酶的血清水平在24周时略有升高，然后降至基线水平。在24周和72周时，骨吸收标志物I型胶原血清交联N端肽和I型胶原尿交联N端肽与基线水平相同或略低于基线水平。下背痛的视觉模拟评分也有所下降。
目前的结果表明，每周一次的特立帕肽可能对骨折高风险的骨质疏松症患者也有用。
