新治疗患者中从品牌阿托伐他汀转换为通用阿托伐他汀的依从性：一项使用医疗保险理赔数据的回顾性队列研究
Adherence to changing from brand-name to generic atorvastatin in newly treated patients: a retrospective cohort study using health insurance claims.
作者信息
Mano Yasunari, Fukushima Shota, Kuroda Hisayuki, Ohshima Hiroyuki, Kato Yoshinori, Ohuchi Kaori, Maezawa Kayoko, Momose Yasuyuki, Ikeda Shunya, Asahi Mariko
机构信息
Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
出版信息
J Pharm Health Care Sci. 2015 Apr 1;1:12. doi: 10.1186/s40780-015-0013-8. eCollection 2015.
BACKGROUND
Effect of statin therapy has been reported to be associated with patient's adherence. Atorvastatin was available in Japan as a brand-name product beginning in 2000. The first atorvastatin generics were introduced in Japan in November 2011. The objective of this study was to analyze whether changing from a brand-name atorvastatin to a generic product would affect patient adherence.
METHODS
We conducted a retrospective cohort study that included adult patients who received newly prescribed brand-name atorvastatin between June 1, 2011 and May 31, 2012, using a health insurance claims database in Japan. Patients were classified by the presence or absence of changing to a generic during the 6 months from December 1, 2011 to May 31, 2012 (the index period). The first prescription date for the generic or brand product during the index period was defined as the index date. Adherence to therapy was assessed by the proportion of days covered (PDC) and persistence of treatment by time to discontinuation.
RESULTS
There were 135 patients changing to generic atorvastatin and 147 continuing with the brand-name product. There was no significant difference in decrease of PDC from pre- to post-index date between the changed cohort and continued cohort (-8.6% vs -10.3%, respectively; P = 0.443). After adjusting for baseline covariates, including adherence in pre-index date, no statistically significant differences were observed in the adjusted odds of adherence between the cohorts (adjusted odds ratio = 0.83, 95% confidence interval (CI) = 0.46-1.53). There was also no significant difference in persistence between two cohorts in the 180-day after post-index date. After analysis of a Cox proportional hazard regression model controlling for baseline covariates, including adherence in pre-index date, no statistically significant differences were observed for the hazard of non-persistence between the cohorts (adjusted hazard ratio = 0.96, 95% CI = 0.60-1.53).
CONCLUSIONS
Changing from a brand-name atorvastatin to generic product did not affect adherence for patients newly treated with atorvastatin.
背景
据报道，他汀类药物治疗效果与患者依从性相关。阿托伐他汀自2000年起在日本作为品牌药上市。2011年11月，首批阿托伐他汀仿制药在日本推出。本研究的目的是分析从品牌阿托伐他汀更换为仿制药是否会影响患者依从性。
方法
我们进行了一项回顾性队列研究，纳入了2011年6月1日至2012年5月31日期间新开具品牌阿托伐他汀处方的成年患者，使用了日本的医保理赔数据库。根据在2011年12月1日至2012年5月31日这6个月内（索引期）是否更换为仿制药对患者进行分类。索引期内仿制药或品牌药的首次处方日期定义为索引日期。通过覆盖天数比例（PDC）评估治疗依从性，并通过停药时间评估治疗持续性。
结果
有135例患者更换为阿托伐他汀仿制药，147例患者继续使用品牌药。更换队列和持续队列在索引日期前后PDC的下降无显著差异（分别为-8.6%和-10.3%；P = 0.443）。在调整包括索引日期前的依从性在内的基线协变量后，两组之间调整后的依从性优势比无统计学显著差异（调整后的优势比 = 0.83，95%置信区间（CI） = 0.46 - 1.53）。索引日期后180天内，两组之间的持续性也无显著差异。在分析控制了包括索引日期前的依从性在内的基线协变量的Cox比例风险回归模型后，两组之间非持续性风险无统计学显著差异（调整后的风险比 = 0.96，95%CI = 0.60 - 1.53）。
结论
从品牌阿托伐他汀更换为仿制药对新接受阿托伐他汀治疗的患者的依从性没有影响。
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