他汀类药物剂量说明、药物依从性和低密度脂蛋白胆固醇：一项他汀类药物新使用者队列研究。
Statin Dosing Instructions, Medication Adherence, and Low-Density Lipoprotein Cholesterol: a Cohort Study of Incident Statin Users.
机构信息
Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA, USA.
Sutter Health, Palo Alto Medical Foundation Research Institute, Palo Alto, CA, USA.
出版信息
J Gen Intern Med. 2019 Nov;34(11):2559-2566. doi: 10.1007/s11606-019-05180-7. Epub 2019 Jul 31.
BACKGROUND
Robust evidence is lacking on optimal timing of statin administration and its impact on patient outcomes.
OBJECTIVE
This study aims to evaluate among incident statin users the relationship between those prescribed evening vs. daily dosing instructions, medication adherence, and changes in low-density lipoprotein cholesterol (LDL-c).
DESIGN
This is an observational cohort study at Sutter Health, a community-based healthcare system, 2010-2016.
PARTICIPANTS
Patients were ≥ 35 years of age as of the first statin prescription (baseline), with 12 to 36 months of electronic health record activity before and after baseline. Incident use was defined as no statin prescription in 12 months prior to baseline.
MAIN MEASURES
Differences in medication adherence (proportion of days covered ≥ 0.80) over 12 months from baseline and mean change in LDL-c between 12 and 24 months from baseline were measured using regression modeling, adjusting for baseline demographics and clinical, prescriber, and statin characteristics.
KEY RESULTS
Among 31,252 patients with valid statin prescriptions between 2010 and 2016, 5099 eligible incident statin users (mean age, 63 years) were identified, of whom 53% were prescribed evening and 47% daily dosing instructions. No difference in likelihood of statin adherence over 12 months was observed for evening vs. daily dosing (adjusted odds ratio [OR] 0.90; 95% CI 0.75, 1.08). No differences were observed in mean change in LDL-c (adjusted mean difference 1.42 mg/dL; 95% CI - 1.02, 3.89) or likelihood of attaining LDL-c < 70 mg/dL (adjusted OR 0.83; 95% CI 0.67, 1.04) for evening vs. daily dosing over a mean of 19 months follow-up.
CONCLUSIONS
Among incident statin users from a real-world clinical setting, those with daily and evening dosing instructions had similar adherence rates and mean changes in LDL-c. Given potential clinical equipoise for evening and daily dosing, clinicians should consider patient-tailored statin dosing instructions to reduce potentially unnecessary regimen complexity.
背景
缺乏关于他汀类药物给药最佳时机及其对患者结局影响的有力证据。
目的
本研究旨在评估新开始使用他汀类药物的患者中，处方晚间给药与每日给药的患者之间药物依从性及低密度脂蛋白胆固醇（LDL-c）变化的关系。
设计
这是 2010 年至 2016 年在 Sutter Health（一个社区为基础的医疗保健系统）进行的观察性队列研究。
参与者
患者在首次他汀类药物处方（基线）时年龄≥35 岁，在基线前后有 12 至 36 个月的电子健康记录活动。新开始使用定义为在基线前 12 个月内没有他汀类药物处方。
主要措施
使用回归模型测量从基线开始的 12 个月内药物依从性（≥0.80 的覆盖天数比例）的差异和从基线开始的 12 至 24 个月内 LDL-c 的平均变化，同时调整基线人口统计学特征以及临床、处方医生和他汀类药物特征。
主要结果
在 2010 年至 2016 年期间有有效他汀类药物处方的 31252 名患者中，确定了 5099 名符合条件的新开始使用他汀类药物的患者（平均年龄 63 岁），其中 53%被开处晚间给药，47%被开处每日给药。在 12 个月的药物依从性方面，晚间与每日给药无显著差异（调整后的比值比[OR]0.90；95%置信区间[CI]0.75，1.08）。在 LDL-c 的平均变化方面也无差异（调整后的平均差值 1.42mg/dL；95%CI-1.02，3.89）或在 LDL-c＜70mg/dL 的达标率方面也无差异（调整后的 OR 0.83；95%CI0.67，1.04），这些差异的随访时间平均为 19 个月。
结论
在来自真实临床环境的新开始使用他汀类药物的患者中，每日和晚间给药的患者具有相似的依从率和 LDL-c 的平均变化。鉴于晚间和每日给药在临床方面可能具有同等效果，临床医生应考虑个体化的他汀类药物给药方案，以减少潜在的不必要的方案复杂性。
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