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老年女性中地诺单抗和唑来膦酸的持续使用情况:一项基于人群的队列研究。

Persistence with denosumab and zoledronic acid among older women: a population-based cohort study.

作者信息

Tremblay Éric, Perreault Sylvie, Dorais Marc

机构信息

Institut d'excellence en santé et en services sociaux (INESSS), 2535, boul. Laurier, 5e, Québec, Québec, G1V 4M3, Canada.

Faculté de pharmacie de l'Université de Montréal, Montréal, Québec, Canada.

出版信息

Arch Osteoporos. 2016 Dec;11(1):30. doi: 10.1007/s11657-016-0282-3. Epub 2016 Sep 27.

DOI:10.1007/s11657-016-0282-3
PMID:27679503
Abstract

UNLABELLED

Persistence to denosumab or zoledronic acid was increased compared to oral bisphosphonates.

INTRODUCTION

Denosumab and zoledronic acid are alternative therapies to oral bisphosphonates. Few studies have assessed persistence of those agents.

METHODS

Incident users of denosumab and zoledronic acid were identified using healthcare databases of public drug insurance plan of Quebec province, Canada. Patients initiating therapy between October 1, 2008, and June 30, 2013, and aged 50 years and over were eligible. A persistence rate was assessed over a 2-year period. We assess the proportion of patients receiving the second, third, and fourth injections within a specific delay of predicted time of renewal of both agents. The predictors of non-persistence were analyzed using a Cox regression model only among women.

RESULTS

Among 12,689 incident users, 97.2 % were women. Kaplan-Meier analysis showed a slow decline of persistence after initiating zoledronic acid compared to denosumab therapy, dropping to 81.6 and 63.3 % after 1 and 2 years of follow-up using the permissive gaps of 56 days, in contrast to zoledronic acid, where persistence rate still stays at 74.8 % after 2 years of follow-up using the permissive gap of 112 days. The likelihood of non-persistence was significantly higher among new users of denosumab and zoledronic acid among older patients and year of initiation; but depression and diabetes are only predictors of non-persistence among the zoledronic group. Concomitant use of calcium and vitamin D supplements was at low level which may compromise the clinical efficacy.

CONCLUSION

The persistence rate to denosumab and zoledronic acid was higher to the published data of oral bisphosphonates. The second intention of treatment seems to target more severe patients which may more likely to be compliant.

摘要

未标注

与口服双膦酸盐相比,地诺单抗或唑来膦酸的持续性有所提高。

引言

地诺单抗和唑来膦酸是口服双膦酸盐的替代疗法。很少有研究评估这些药物的持续性。

方法

利用加拿大魁北克省公共药物保险计划的医疗保健数据库识别地诺单抗和唑来膦酸的新使用者。2008年10月1日至2013年6月30日开始治疗且年龄在50岁及以上的患者符合条件。在2年期间评估持续性率。我们评估了在两种药物预测更新时间的特定延迟内接受第二、第三和第四针注射的患者比例。仅在女性中使用Cox回归模型分析非持续性的预测因素。

结果

在12689名新使用者中,97.2%为女性。Kaplan-Meier分析显示,与地诺单抗治疗相比,开始唑来膦酸治疗后持续性下降缓慢,在使用56天宽容间隔进行1年和2年随访后分别降至81.6%和63.3%,而对于唑来膦酸,在使用112天宽容间隔进行2年随访后持续性率仍保持在74.8%。在老年患者和开始治疗年份中,地诺单抗和唑来膦酸新使用者的非持续性可能性显著更高;但抑郁症和糖尿病仅是唑来膦酸组中非持续性的预测因素。钙和维生素D补充剂的联合使用水平较低,这可能会影响临床疗效。

结论

地诺单抗和唑来膦酸的持续性率高于已发表的口服双膦酸盐数据。二次治疗的意向似乎针对病情更严重的患者,这些患者可能更易依从。

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