Papaioannou Alexandra, Khan Aliya, Belanger Andre, Bensen William, Kendler David, Theoret Francois, Amin Mo, Brekke Lee, Erdmann Michelle, Walker Valery, Adachi Jonathan D
Medicine, McMaster University , Hamilton, ON , Canada.
Curr Med Res Opin. 2015;31(7):1391-401. doi: 10.1185/03007995.2015.1053049. Epub 2015 Jun 9.
The objective of this study was to evaluate persistence with denosumab among postmenopausal women with osteoporosis participating in the Canadian patient-support program (ProVital * ). Denosumab is an injectable therapeutic option for osteoporosis that is administered subcutaneously every 6 months.
ProVital, a support program in which patients voluntarily enroll, provides next injection reminder calls and educational material. A retrospective database analysis of patient self-reported data was conducted among osteoporotic women aged ≥50 who enrolled in the ProVital program and received their first denosumab injection between August 2010 and June 2011. To achieve 12 month persistence patients had to receive at least two denosumab injections, and to achieve 24 month persistence patients had to receive at least four denosumab injections, with consecutive injections no more than 6 months + 8 weeks apart. Logistic regression analysis was used to identify predictors of persistence.
A total of 1676 patients (mean age 74 years) were included. The 12 month persistence with denosumab was 81.6% (1367/1676 patients), and the 24 month persistence was 59.1% (991/1676 patients). Characteristics associated with both 12 and 24 month persistence were possession of private medication insurance and residence in Quebec. Additionally, age greater than 75, previous postmenopausal osteoporosis medication use, and fracture were associated with 24 month persistence.
Patient enrollment in the program was voluntary, so there may be selection bias for the patient population included in this study. Also, this study did not have a control group of patients who were not enrolled in a patient support program.
The persistence with denosumab among patients enrolled in the program was higher than historical persistence with oral bisphosphonates, and similar to persistence of patients in an education program taking teriparatide, patients taking bisphosphonates in a pharmaceutical care program, and two observational studies of denosumab.
本研究旨在评估参与加拿大患者支持项目（ProVital * ）的绝经后骨质疏松症女性使用地诺单抗的持续性。地诺单抗是一种用于治疗骨质疏松症的注射剂，每6个月皮下注射一次。
ProVital是一个患者自愿参加的支持项目，提供下次注射提醒电话和教育资料。对2010年8月至2011年6月期间参加ProVital项目并接受首次地诺单抗注射的≥50岁骨质疏松症女性患者的自我报告数据进行回顾性数据库分析。要实现12个月的持续性，患者必须接受至少两次地诺单抗注射；要实现24个月的持续性，患者必须接受至少四次地诺单抗注射，且连续注射间隔不超过6个月+8周。采用逻辑回归分析来确定持续性的预测因素。
共纳入1676例患者（平均年龄74岁）。地诺单抗的12个月持续性为81.6%（1367/1676例患者），24个月持续性为59.1%（991/1676例患者）。与12个月和24个月持续性相关的特征包括拥有私人药物保险和居住在魁北克。此外，年龄大于75岁、既往使用过绝经后骨质疏松症药物以及骨折与24个月持续性相关。
患者参加该项目是自愿的，因此本研究纳入的患者人群可能存在选择偏倚。此外，本研究没有未参加患者支持项目的对照组患者。
参加该项目的患者使用地诺单抗的持续性高于口服双膦酸盐类药物的既往持续性，与参加服用特立帕肽教育项目的患者、参加药物治疗项目服用双膦酸盐类药物的患者以及两项地诺单抗观察性研究中的患者持续性相似。
