前蛋白转化酶枯草溶菌素/克新9型抑制剂起始治疗后他汀类药物停药与随后的动脉粥样硬化性心血管疾病事件之间的关联。
Association between statin discontinuation after proprotein convertase subtilisin/kexin type 9 inhibitor initiation and subsequent atherosclerotic cardiovascular disease events.
作者信息
Peasah Samuel K, Lee Tiffany, Do Duy, Huang Yan, Inneh Angela, Patel Urvashi, Aiyer Aryan N, Good Chester B
机构信息
UPMC Value-Based Pharmacy Initiatives, Center for High-Value Health Care, UPMC Health Plan, Pittsburgh, PA.
Evernorth Research Institute, Windermere, FL.
出版信息
J Manag Care Spec Pharm. 2025 Apr;31(4):377-385. doi: 10.18553/jmcp.2025.31.4.377.
BACKGROUND
Clinical guidelines recommend the use of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) in patients with atherosclerotic cardiovascular disease (ASCVD) and nonoptimal low-density lipoprotein.
OBJECTIVE
To evaluate the association between discontinuation of statin use after PCSK9i initiation and subsequent ASCVD events.
METHODS
This pre-post retrospective comparative study used national administrative data of adult statin medication users (age ≥18 years) with an index PCSK9i claim (January 1, 2019, to April 30, 2021), prior ASCVD diagnosis, and a 2-year follow-up period. Proportions and probability of ASCVD events post-index (PCSK9i) vs pre-index (PCSK9i) for patients who discontinued statins (discontinued cohort) and those who continued statins (continued cohort) were compared. Propensity score weighting was used to balance patient baseline characteristics. Multivariate Poisson regression and time-to-event Cox regression models were used to assess the association between statin discontinuation and ASCVD events.
RESULTS
There were 294 and 46 patients in the continued and discontinued cohorts, respectively. Unweighted results showed that patients in the continued cohort were more likely to receive high-intensity statins (32% vs 22%; = 0.4) and have a Charlson Comorbidity Index score of 3 or more (62% vs 54%; = 0.5) at baseline. Baseline statin adherence was lower in the discontinued cohort (6.7% vs 59%; < 0.001) but 30% each in the propensity 1:1 matched cohort. The 2 cohorts (after matching) had similar ASCVD event prevalence (discontinued cohort: 24% vs continued cohort: 26%) in the baseline and the same lower prevalence (6.5% each; > 0.9) in the 24-month follow-up period. The odds of any ASCVD event post-index was comparable between the 2 cohorts (reference: continued cohort; odds ratio = 1.88; 95% CI = 0.28-14.6; = 0.51). There were no statistically significant differences between the 2 groups in the Cox regression ( = 0.47).
CONCLUSIONS
Post-ASCVD event rates were significantly lower in both cohorts, but discontinuation of statins was not associated with unfavorable ASCVD outcomes.
背景
临床指南建议在患有动脉粥样硬化性心血管疾病（ASCVD）且低密度脂蛋白未达理想水平的患者中使用前蛋白转化酶枯草溶菌素/kexin 9型抑制剂（PCSK9i）。
目的
评估启动PCSK9i治疗后停用他汀类药物与随后发生的ASCVD事件之间的关联。
方法
这项前后回顾性比较研究使用了成年他汀类药物使用者（年龄≥18岁）的全国行政数据，这些使用者有首次PCSK9i索赔记录（2019年1月1日至2021年4月30日），既往有ASCVD诊断，且随访期为2年。比较了停用他汀类药物的患者（停药队列）和继续使用他汀类药物的患者（继续用药队列）在索引后（PCSK9i）与索引前（PCSK9i）发生ASCVD事件的比例和概率。使用倾向评分加权来平衡患者的基线特征。多变量泊松回归和事件发生时间Cox回归模型用于评估他汀类药物停用与ASCVD事件之间的关联。
结果
继续用药队列和停药队列分别有294例和46例患者。未加权结果显示，继续用药队列的患者在基线时更有可能接受高强度他汀类药物治疗（32%对22%；P = 0.4），且Charlson合并症指数评分≥3（62%对54%；P = 0.5）。停药队列的基线他汀类药物依从性较低（6.7%对59%；P < 0.001），但在倾向1:1匹配队列中均为30%。两个队列（匹配后）在基线时的ASCVD事件患病率相似（停药队列：24%对继续用药队列：26%），在24个月随访期的患病率同样较低（均为6.5%；P > 0.9）。索引后发生任何ASCVD事件的几率在两个队列之间相当（参考：继续用药队列；比值比 = 1.88；95%置信区间 = 0.28 - 14.6；P = 0.51）。Cox回归中两组之间无统计学显著差异（P = 0.47）。
结论
两个队列的ASCVD事件发生率均显著降低，但停用他汀类药物与不良ASCVD结局无关。
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