Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
J Cardiol. 2021 May;77(5):545-551. doi: 10.1016/j.jjcc.2020.12.003. Epub 2020 Dec 26.
Non-adherence to statin treatment results in an increased risk of cardiovascular events and all-cause mortality. This study compared adherence, persistence, and clinical outcomes of patients who initiated brand-name and generic statins in the Japanese population.
The retrospective cohort study included adult patients who initiated statins between 2014 and 2016. Primary adherence was measured as the proportion of days covered (PDC) within 1 year. Persistence was assessed using the proportion of non-persistent users. Any major adverse cardiac and cerebrovascular event (MACCE) was assessed as a clinical outcome. Propensity score matching was performed to adjust for confounding factors.
Among 47,770 patients who met inclusion criteria in the study, 32,130 (67.3%) initiated generic statins. The median age of the patients was 53 (interquartile range: 46-59) years and 60.2% were male. A higher proportion of patients with PDC ≥80% [60.2% vs. 57.1%; odds ratio, 1.14; 95% confidence interval (CI), 1.09-1.19; p<0.001] and a higher PDC value (median, 90.2% vs. 87.9%; difference, 2.3%; p<0.001) were observed in the generic group. Similarly, fewer patients discontinued statins in the generic group [24.2% vs. 27.7%; hazard ratio (HR), 0.91; 95% CI, 0.87-0.95; p<0.001]. Differences in MACCE occurrence were not significant between the groups (4.3% vs. 4.2%; HR, 1.04; 95% CI, 0.93-1.17; p=0.99).
Adherence and persistence were higher among generic statin recipients; nevertheless, no significant differences in clinical outcomes were noted between the two groups, suggesting that generic medication did not impair treatment benefits and may improve patient adherence.
他汀类药物治疗不依从会增加心血管事件和全因死亡率的风险。本研究比较了日本人群中使用品牌名和仿制药他汀类药物的患者的依从性、持久性和临床结局。
这项回顾性队列研究纳入了 2014 年至 2016 年期间开始使用他汀类药物的成年患者。主要依从性通过在 1 年内的用药天数比例（PDC）来衡量。持久性通过非持续使用者的比例来评估。任何主要不良心脏和脑血管事件（MACCE）都被评估为临床结局。采用倾向评分匹配来调整混杂因素。
在符合研究纳入标准的 47770 名患者中，32130 名（67.3%）患者开始使用仿制药他汀类药物。患者的中位年龄为 53 岁（四分位距：46-59 岁），60.2%为男性。PDC≥80%的患者比例更高[60.2% vs. 57.1%；比值比，1.14；95%置信区间（CI），1.09-1.19；p<0.001]，PDC 值更高（中位数，90.2% vs. 87.9%；差值，2.3%；p<0.001）。同样，仿制药组中停药的患者更少[24.2% vs. 27.7%；风险比（HR），0.91；95%CI，0.87-0.95；p<0.001]。两组间 MACCE 发生率无显著差异（4.3% vs. 4.2%；HR，1.04；95%CI，0.93-1.17；p=0.99）。
仿制药他汀类药物使用者的依从性和持久性更高；然而，两组间的临床结局无显著差异，表明仿制药并未损害治疗效果，反而可能提高了患者的依从性。
