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Comparison of Adherence, Persistence, and Clinical Outcome of Generic and Brand-name Statin Users: A Retrospective Cohort Study Using the Japanese Claims Database

Gao, Jingwei 京都大学 DOI:10.14989/doctor.k24188

2022.09.26

概要

Statins are recommended for primary and secondary prevention of cardiovascular diseases. However, patients do not always adhere to their prescribed treatments in real-world situations. Non-adherence to statin treatment results in an increased risk of cardiovascular events and all-cause mortality. There is a lack of evidence regarding adherence, persistence, and their influence on clinical outcomes associated with generic drug use in the Japanese population. This study compared adherence, persistence, and clinical outcomes of patients who initiated brand-name and generic statins in the Japanese population.

This study identified a cohort of patients ≥18 years old who initiated brand-name or generic statins between 2014 and 2016 in a Japanese claims database. 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. For the adherence outcome, differences in continuous variables were tested with the Mann-Whitney U test, while differences in the distribution of categorical variables were tested with the chi-square test. Hazard ratios (HRs) and 95% confidential intervals (CIs) of non-persistence and MACCE in the two groups were compared with a conditional Cox proportional hazards model.

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). The primary results are supported by most subgroup analyses and sensitivity analyses, with only the subgroup analyses of simvastatin users, pitavastatin users, and secondary prevention patients demonstrating discrepancies, which are likely due to the smaller sample size, shorter follow-up and or the characteristics of the subgroup.

This study suggested higher adherence and persistence in patients who initiated generic statin treatment, but differences in clinical outcome were not significant. The non-significant result in clinical outcomes suggested the equivalent effectiveness between generic and brand-name statins. It is possible that the better adherence and persistence in generic drug recipients may be due to the lower copayment fees.

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