Teriparatide has been commercially available in the United States (US) for over 3 years. This summary spans the early experience with this therapy. As of December 31, 2005, over 235 000 patients had filled a prescription for teriparatide world-wide. Data collected from July to December 2004, from 15,000 retail pharmacies in the US, indicated that the mean age of patients was 67.5 years, and more recent data collected from January through October 2005 indicated that 90% of patients were female. According to market research conducted with prescribing physicians from February through March of 2005, it is estimated that over 80% of patients receiving prescriptions for teriparatide had already experienced one or more prior fractures. Since teriparatide is administered subcutaneously, it is important that patients receive training on the use of the teriparatide injection device (i.e., the pen device). Educational programs are available for those who have been prescribed teriparatide therapy. Patients may also contact a customer care program regarding a variety of topics, including pen device use. Based on patient feedback, design changes have been implemented in the pen device to facilitate optimal use. Updates have also been made to the prescribing information to reflect the post-marketing surveillance experience. Adverse experiences reported to date have been consistent with the current product label and with cumulative teriparatide clinical trial experience. As of December 31, 2005 no reports of pathology-confirmed osteosarcoma have been received for individuals who have been treated with teriparatide, either with the commercially available drug or in clinical trials. We are unaware of any reports of osteosarcoma in association with other preparations of teriparatide, or other peptides of parathyroid hormone, either in the setting of clinical trials or from marketed drug experience.

译文

Teriparatide已在美国 (US) 商业化销售超过3年。此摘要涵盖了这种疗法的早期经验。截至2005年12月31日,全球已有235 000多名患者填写了teriparatide的处方。从7月到2004年12月,从美国15,000家零售药店收集的数据表明,患者的平均年龄为67.5岁,从1月到2005年10月收集的最新数据表明,90% 的患者是女性。根据从2月到3月2005年的处方医生进行的市场研究,据估计,接受teriparatide处方的患者中有80% 以上已经经历过一次或多次骨折。由于teriparatide是皮下给药的,因此患者接受有关使用teriparatide注射装置 (即pen装置) 的培训非常重要。接受过teriparatide治疗的人可以使用教育计划。患者还可以就各种主题 (包括笔式设备的使用) 联系客户服务计划。根据患者的反馈,已经在pen设备中实施了设计更改,以促进最佳使用。还对处方信息进行了更新,以反映上市后的监督经验。迄今为止报告的不良经验与当前产品标签和累积的teriparatide临床试验经验一致。截至2005年12月31日,尚未收到已使用市售药物或临床试验用teriparatide治疗的患者的病理证实骨肉瘤的报告。我们不知道骨肉瘤与其他teriparatide制剂或甲状旁腺激素的其他肽相关的任何报道,无论是在临床试验中还是从上市药物经验中。

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