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骨质疏松症患者对品牌与非专利双膦酸盐的依从性:法国国家医疗保险数据库中的一项新用户队列研究。

Adherence with brand versus generic bisphosphonates among osteoporosis patients: a new-user cohort study in the French National Healthcare Insurance database.

作者信息

Viprey Marie, Xue Yufeng, Rousseau Aurélie, Payet Cécile, Chapurlat Roland, Caillet Pascal, Dima Alexandra, Schott Anne-Marie

机构信息

Hospices Civils de Lyon, Pôle de Sante Publique, Lyon, France.

Univ. Lyon, Université Claude Bernard Lyon 1, HESPER EA 7425, Lyon, France.

出版信息

Sci Rep. 2020 May 4;10(1):7446. doi: 10.1038/s41598-020-64214-x.

Abstract

Several studies documented declines in treatment adherence with generic forms of oral bisphosphonates in osteoporosis compared to branded forms, while others did not support this relation. Our aim was to compare medication adherence with brand versus generic forms of oral bisphosphonates. A new-user cohort study was conducted using routinely collected administrative and healthcare data linked at the individual level extracted from a nationwide representative sample of the French National Healthcare Insurance database. We included all patients aged 50 and older, new users of oral bisphosphonates for primary osteoporosis between 01/01/2009 and 31/12/2015. Two components of adherence were measured: implementation (continuous multiple-interval measure of medication availability version 7; CMA7) and persistence (time to discontinuation). The sample was composed of 1,834 in the "brand bisphosphonate" group and 1,495 patients in the "generic bisphosphonate" group. Initiating oral bisphosphonate treatment with brand was associated with a higher risk of discontinuation within 12 months (Hazard Ratio = 1.08; 95%CI = [1.02;1.14]). The risk of good implementation (CMA7 ≥ 0.90) was significantly lower in "brand bisphosphonate" group (Risk Ratio = 0.90; 95%CI = [0.85; 0.95]). We did not find any evidence to support the hypothesis of a lower adherence to generic bisphosphonates. In fact, prescribing of generic bisphosphonates led to a higher persistence rate and to better implementation at 1 year.

摘要

多项研究记录了与品牌剂型相比,骨质疏松症患者使用口服双膦酸盐仿制药时治疗依从性下降的情况,而其他研究则不支持这种关系。我们的目的是比较口服双膦酸盐品牌剂型与仿制药型的药物依从性。我们利用从法国国家医疗保险数据库的全国代表性样本中提取的、在个体层面上常规收集的行政和医疗数据,开展了一项新用户队列研究。我们纳入了所有年龄在50岁及以上、在2009年1月1日至2015年12月31日期间首次使用口服双膦酸盐治疗原发性骨质疏松症的患者。我们测量了依从性的两个组成部分:实施情况(药物可及性版本7的连续多间隔测量;CMA7)和持续性(停药时间)。样本包括“品牌双膦酸盐”组的1834名患者和“双膦酸盐仿制药”组的1495名患者。开始使用品牌口服双膦酸盐治疗在12个月内停药的风险更高(风险比=1.08;95%置信区间=[1.02;1.14])。“品牌双膦酸盐”组良好实施(CMA7≥0.90)的风险显著更低(风险比=0.90;95%置信区间=[0.85;0.95])。我们没有发现任何证据支持对双膦酸盐仿制药依从性较低的假设。事实上,开具双膦酸盐仿制药的处方导致了更高的持续率和1年时更好的实施情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf10/7198539/8c16a8082f3f/41598_2020_64214_Fig1_HTML.jpg

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